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Boston Scientific Corp
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Health Care · Surgical & Medical Instruments & Apparatus · CIK 885725 · FY ends Dec 31
$50.47
-0.96 (-1.87%)
USD · as of 2026-08-18 · marketstack

Clinical trials

catalyst calendar across sponsors →
533 registered studies · 69 active

Studies where BSX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.

Of the 500 shown: 344 interventional · 156 observational · 281 with posted results

Held by 27 tracked-famous managers (PRIMECAP MANAGEMENT CO/CA/, D. E. Shaw & Co., Inc., TWO SIGMA INVESTMENTS, LP, JANE STREET GROUP, LLC, AQR CAPITAL MANAGEMENT LLC, +22 more) · FINRA short interest 1.0 days to cover (settled 2026-07-31) · government filings 180d: 4 congress / 11 executive

StudyPhaseStatusInterventionsConditionsEnrollmentPrimary completionReadout inUpdated
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryNCT02071134observationalImprovement in patient's quality of life (QoL) during the study as compared with baseline—RecruitingDevice: Deep Brain Stimulation (DBS)Parkinson's Disease1,500Dec 2038≤ 4,517 d2026-08-11
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)NCT04192591Rate of success at the 24-month follow-up visitOpen-label · TreatmentNot applicableActive, not recruitingDevice: Superion™ IDS deviceLumbar Spinal Stenosis166Feb 2038≤ 4,211 d2026-08-06
Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNSNCT06553625observationalChange in patient's quality of life (QoL) during the study as compared with baseline—RecruitingDevice: Radiofrequency AblationParkinson Disease, Dystonia, Essential Tremor, Movement Disorders200Dec 2035≤ 3,421 d2026-08-04
RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainNCT01719055observational—RecruitingDevice: neurostimulation systemPain4,800May 2035≤ 3,207 d2026-08-11
Intracept Minimally-invasive PROcedure for VErtebrogenic Back PainNCT06827262observationalChange in Disability (Oswestry Disability Index (ODI) from Baseline—RecruitingDevice: Intracept™ Intraosseous Nerve AblationChronic Low-back Pain, Vertebrogenic Pain Syndrome1,500Jul 2034≤ 2,903 d2026-08-11
IT Matters: The Erectile Restoration RegistryNCT04200937observationalChange from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra—Enrolling by invitationDevice: Tactra Malleable, Spectra™ Concealable Penile Prothesis, AMS Ambicor™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump, AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ PumpErectile Dysfunction450Jan 2031≤ 1,626 d2026-08-12
Patient Retrospective Outcomes (PRO)NCT01550575observationalResponder rate—RecruitingDevice: Non Boston Scientific Systems, Boston Scientific SystemsChronic Pain15,000Dec 2030≤ 1,595 d2026-08-11
Vercise™ DBS Dystonia Prospective StudyNCT02686125observationalProportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score—RecruitingDevice: Deep Brain Stimulation (DBS)Dystonia300Dec 2030≤ 1,595 d2026-08-06
BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)NCT04823663observationalSystem-related complication free rate—RecruitingDevice: Implant · Procedure: Electrophysiologic procedureCardiac Disease12,5002030-12-31in 1,595 d2026-07-24
Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)NCT04032470observationalChange in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST)—RecruitingDevice: Deep Brain Stimulation Systems (DBS)Essential Tremor500Dec 2029≤ 1,230 d2026-08-04
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart FailureNCT07069738Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.Randomized · Single-masked · TreatmentNot applicableRecruitingDevice: CRT-D with a Quadripolar LV lead, CRT-D with INGEVITY+ pace/sense leadHeart Failure - NYHA II - IV850Nov 2029≤ 1,199 d2026-08-04
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-upNCT07209852observationalLBBA Implant Success Rate—RecruitingDevice: Pacemaker leadBradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block1402029-08-31in 1,108 d2026-08-12
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)NCT07639684Serious Adverse EventsOpen-label · TreatmentNot applicableNot yet recruitingDevice: ESG with OverStitchType 2 Diabetes Mellitus (T2D), Obesity (BMI>30)50May 2029≤ 1,016 d2026-07-24
Stone and Laser Therapies Post-Market Study (SALT)NCT06982235observationalOccurrence of Serious Adverse Events related to BSC study devices—Active, not recruitingDevice: Ureteroscope system, Laser systemBenign Prostate Hypertrophy(BPH), Renal Calculi, Ureteral Stones, Kidney Stones, Calculi, Urinary, Urinary Tract Procedure238Feb 2029≤ 924 d2026-08-12
Deep Brain Stimulation (DBS) Retrospective Outcomes StudyNCT03664609observationalMean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline—RecruitingDevice: Deep Brain StimulationParkinson Disease, Essential Tremor, Dystonia5,000Dec 2028≤ 865 d2026-08-04
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic AreaNCT07035431Serious Adverse EventsOpen-label · TreatmentNot applicableRecruitingDevice: Endo-SPONGEAnastomotic Leaks, Hartmanns Stump Leakage66Dec 2028≤ 865 d2026-07-24
OPTION-EMEA Clinical TrialNCT07349121Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse EventsOpen-label · OtherNot applicableRecruitingDevice: Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case · Procedure: Concomitant Pulsed Field Ablation and Left Atrial Appendage ClosureAtrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation, Atrial Fibrillation Ablation Procedure, Concomitant Procedures500Dec 2028≤ 865 d2026-08-05
ADVENT Post Approval StudyNCT06431815observationalComposite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.—Active, not recruitingDevice: FARAPULSE™ Pulsed Field Ablation SystemParoxysmal Atrial Fibrillation228Oct 2028≤ 804 d2026-07-27
OverStitch NXT Endoscopic Suture SystemNCT07276815%TBWL (Defined as the percentage of total body weight loss)Randomized · Single-masked · TreatmentNot applicableNot yet recruitingDevice: OverStitch NXT Endoscopic Suture SystemWeight Loss1362028-10-31in 804 d2026-07-29
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)NCT07502599observationalPhysiologic Signal Detection via wearable holter monitor—RecruitingDevice: Wearable holter monitor, Wearable holter monitorOrthostatic Hypotension, Reflex Syncope40Sep 2028≤ 773 d2026-08-12
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial FibrillationNCT07187115Primary Safety EndpointRandomized · Open-label · TreatmentNot applicableActive, not recruitingDevice: FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative), FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping SystemAtrial Fibrillation (AF), Persistant Atrial Fibrillation699Jul 2028≤ 712 d2026-07-29
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial FibrillationNCT07575269Proportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.Open-label · TreatmentNot applicableRecruitingDevice: FARAFLEX Mapping and Pulsed Field Ablation (PFA) SystemParoxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation5712028-07-20in 701 d2026-08-06
Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')NCT07195708%TBWL (Defined as the percentage of total body weight loss)Randomized · Single-masked · TreatmentNot applicableRecruitingDevice: Treatment groupWeight Loss1442028-06-30in 681 d2026-07-29
Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection SystemNCT07455747observationalMajor Adverse Events—Not yet recruitingDevice: Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery diseaseExtracranial Carotid Artery Disease, TCAR, Transcarotid Artery Revascularization5,000May 2028≤ 651 d2026-07-16
Combined CM and STN Stimulation for Motor EpilepsyNCT07458217Mean change in seizure frequencyRandomized · Double-masked · TreatmentNot applicableNot yet recruitingDevice: Deep brain stimulationMotor Epilepsy102028-05-31in 651 d2026-08-03
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.NCT07669727observationalPrimary Safety Endpoint—Not yet recruitingDevice: TheraSphereHepatocellular Carcinoma (HCC)140May 2028≤ 651 d2026-07-31
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary EmbolismNCT06819865observationalRV vs LV end-diastolic diameter ratio—RecruitingDevice: EkoSonicTM Endovascular SystemAcute Pulmonary Embolism302028-05-30in 650 d2026-08-17
Safety and Effectiveness of Orbera365™ Intragastric Balloon SystemNCT07062094observationalRate of Subjects with Serious Adverse Events—RecruitingDevice: Intragastric BalloonObesity2002028-04-07in 597 d2026-08-13
AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary LesionsNCT06959524Target Lesion Failure (TLF) rateRandomized · Open-label · TreatmentNot applicableRecruitingDevice: Drug Eluting Balloon, Drug eluting stent · Procedure: Plain old balloon angioplastyCoronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries1,616Mar 2028≤ 590 d2026-07-30
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA SystemNCT07444320Device or procedure-related Composite Adverse Events (CAEs)Open-label · TreatmentNot applicableRecruitingDevice: FARAPULSE™ Pulsed Field Ablation (PFA) SystemParoxysmal Atrial Fibrillation, Persistent Atrial Fibrillation200Feb 2028≤ 559 d2026-07-27
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral VasculatureNCT04674969observationalMajor Adverse Events—RecruitingDevice: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.Peripheral Vascular Diseases5,000Jan 2028≤ 530 d2026-08-19
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) DeviceNCT06192758Maximum tolerated radiation dose of TheraSphere PCaOpen-label · OtherNot applicableActive, not recruitingDevice: TheraSphere PCaProstate, Cancer36Jan 2028≤ 530 d2026-07-31
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)NCT03053141observationalPhysician Feedback on Software Performance—RecruitingDevice: Rhythmia Mapping SystemCardiac Arrythmias100Dec 2027≤ 499 d2026-07-31
CHAMPION-AF Clinical TrialNCT04394546WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolismRandomized · Single-masked · PreventionNot applicableActive, not recruitingDevice: WATCHMAN FLX LAAC Device · Drug: Non-Vitamin K Oral AnticoagulantAtrial Fibrillation, Stroke, Bleeding3,000Dec 2027≤ 499 d2026-08-12
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate CancerNCT04905069Late Gastrointestinal (GI) ToxicityRandomized · Open-label · PreventionNot applicableActive, not recruitingDevice: SpaceOAR Vue SystemProstate Cancer500Dec 2027≤ 499 d2026-08-12
FARAPULSE™ Pulsed Field Ablation SystemNCT06762717observationalFailure-free rate—RecruitingDevice: FARAPULSE™ Pulsed Field Ablation systemParoxysmal AF5002027-12-31in 499 d2026-07-29
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)NCT07106970Primary Effectiveness Endpoint with Treatment Success.Randomized · Double-masked · TreatmentNot applicableRecruitingProcedure: Linear ablation, PVI alonePersistent Atrial Fibrillation6402027-12-30in 498 d2026-08-17
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current ControlNCT07190807Targeted Pain Responder RateOpen-label · TreatmentNot applicableRecruitingDevice: Boston Scientific WaveWriter Alpha™ SCS SystemsChronic Pain, Intractable Pain, Low Back Pain, Chronic Low-back Pain, Chronic Leg Pain, Leg Pain70Nov 2027≤ 468 d2026-08-11
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese PopulationNCT07458243observational• Procedural success—Not yet recruitingDevice: transcarotid artery revascularizationCarotid Artery Stenosis602027-09-30in 407 d2026-08-03
WATCHMAN FLX Pro European RegistryNCT07262255observationalNumber of participants with a safety event treated with the WATCHMAN FLX Pro—RecruitingDevice: Left atrial appendage closureNon-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure1,000Aug 2027≤ 377 d2026-08-13
TheraSphere With Durvalumab and Tremelimumab for HCCNCT05063565Objective Response Rate (ORR)Open-label · TreatmentPhase 2Active, not recruitingDevice: TheraSphere Y-90 glass microsphere therapy · Drug: Durvalumab (Imfinzi) immunotherapy, Tremelimumab immunotherapyHepatocellular Carcinoma100Jun 2027≤ 315 d2026-07-31
A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation ProcedureNCT07353710The incidence of procedure related serious adverse events and all adverse eventsOpen-label · DiagnosticNot applicableRecruitingDevice: ICE Image AcquisitionAtrial Arrhythmia, Intracardiac Echocardiography2002027-06-30in 315 d2026-08-19
TheraSphere Japan Pre-Market StudyNCT07377487Rate of hepatic disease control (DCR = complete response [CR], partial response [PR] or stable disease [SD]) at 3 months using the localized RECIST 1.1 criteria.Open-label · TreatmentNot applicableRecruitingDevice: TheraSphere Y-90 glass microsphereLiver Neoplasms512027-06-30in 315 d2026-07-23
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation SystemNCT06735534Primary safety endpoint rateOpen-label · TreatmentNot applicableRecruitingDevice: FARAPULSE™ Pulsed Field Ablation SystemPersistent Atrial Fibrillation376Apr 2027≤ 254 d2026-07-27
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial FibrillationNCT06808217observationalPrimary Safety Endpoint—Active, not recruitingDevice: FARAPULSE Pulsed Field Ablation SystemAtrial Fibrillation, Pulsed Field Ablation, FARAPULSE5502027-04-01in 225 d2026-07-28
Feasibility Study of the FARAFLEX Mapping and PFA SystemNCT06510556Device or procedure-related Composite Serious Adverse Events (CSAEs)Non-randomized · Open-label · TreatmentNot applicableRecruitingDevice: FARAFLEX Ablation Treatment, ELEVATE-COR Sub-studyAtrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF2502027-02-15in 180 d2026-07-27
FARAPULSE Workflow Assessment RegistryNCT06656884observationalAssociation of patient demographics with Index procedure Workflow-related variables—Active, not recruiting—Atrial Fibrillation (AF)5242027-02-15in 180 d2026-07-28
Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric BypassNCT07015424Total Body Weight LossRandomized · Open-label · TreatmentNot applicableRecruitingDevice: TORe with OverStitch · Behavioral: Intensive lifestyle modificationWeight Regain, Weight Loss108Nov 2026≤ 103 d2026-08-19
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBMNCT05303467The number of grade 3-5 non-hematological toxicitiesNon-randomized · Open-label · TreatmentPhase 1RecruitingDevice: TheraSphere GBMGlioblastoma Multiforme, Recurrent Glioblastoma362026-10-31in 73 d2026-07-31
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-AsiaNCT06686485observationalPeriprocedural or procedure-related Composite Serious Adverse Events will be assessed—RecruitingDevice: FARAPULSE™ PFA system and WATCHMAN LAAC Delivery SystemsConcomitant Procedures, Atrial Fibrillation, PFA, LAAC4332026-10-31in 73 d2026-07-23
Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI)NCT07537478observationalRespiratory rate detection - end tidal CO2—RecruitingDevice: Wearable Respiration mask - exercise, Wearable respiration MaskRespiration Rate Detection50Aug 2026≤ 12 d2026-08-12
SpaceIT Hydrogel System for Perirectal SpacingNCT06451614Primary Safety Endpoint - Acute Grade 3 or greater adverse events.Randomized · Open-label · TreatmentNot applicableActive, not recruitingDevice: SpaceIT Hydrogel System, Commercially available Boston Scientific SpacerProstate Cancer2302026-08-30in 11 d2026-08-12
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.NCT04790344Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.Open-label · DiagnosticNot applicableActive, not recruitingDevice: Investigational LUX-Dx ICM ImplantHeart Failure5252026-07-31actual—2026-08-04
SIMPLAAFY Clinical TrialNCT06521463Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT armRandomized · Single-masked · PreventionNot applicableActive, not recruitingDevice: WATCHMAN FLX Pro LAAC DeviceAtrial Fibrillation, Stroke, Bleeding1,8572026-07-07actual—2026-08-10
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)NCT06639451Target lesion primary patency rateOpen-label · TreatmentNot applicableActive, not recruitingDevice: RANGER™ Paclitaxel Coated Balloon CatheterArteriovenous Fistula Stenosis, Arteriovenous Fistula, Vascular Access1862026-04-01actual—2026-05-08
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial FibrillationNCT06096337Rate of randomized PFA or PFA Assigned subjects with PFA System inserted into the body, during the index or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious.Randomized · Open-label · TreatmentNot applicableActive, not recruitingDevice: FARAPULSE™ Pulsed Field Ablation (PFA) System · Drug: Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and DronedaronePersistent Atrial Fibrillation4842026-02-04actual—2026-07-27
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion CohortNCT06492174Number of Participants With Target Lesion FailureOpen-label · TreatmentPhase 3Active, not recruitingDevice: AGENT DCB 40 mmIn-Stent Restenosis202025-12-19actual—2026-07-16
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active MenNCT04838769International Prostate Symptom Score (IPSS) changeRandomized · Open-label · TreatmentNot applicableActive, not recruitingDevice: REZŪM · Drug: alpha blocker and 5-alpha reductase inhibitorBenign Prostatic Hyperplasia (BPH)1552025-12-11actual—2026-08-12
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation SystemNCT05501873observationalPrimary Effectiveness Endpoint—Active, not recruitingDevice: FARAPULSE Pulsed Field Ablation systemAtrial Fibrillation1,1732025-10-21actual—2026-08-19
Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary EmbolismNCT04790370PE-related mortalityRandomized · Single-masked · TreatmentPhase 4Active, not recruitingDrug: Anticoagulation with heparin · Device: EkoSonicTM Endovascular SystemPulmonary Embolism5442025-07-31actual—2026-07-01
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in ChinaNCT03736226observationalMACE rate—Active, not recruitingDevice: SYNERGYTM Stent SystemCardiovascular Diseases2,0002024-08-01actual—2026-07-29
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve ReplacementNCT03735667results2025-04-27Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort.Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableActive, not recruitingDevice: ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System, ACURATE Prime™ Transfemoral TAVR System XLAortic Stenosis1,9482024-06-14actual—2026-05-04
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia PacingNCT04798768results2025-06-26Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 MonthsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableActive, not recruitingDevice: mCRM Therapy SystemTachycardia, Ventricular, Arrhythmia, Ventricular2972024-05-06actual—2026-07-23
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)NCT04647253results2024-05-31Number of Participants With Target Lesion FailureRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Phase 3Active, not recruitingDevice: AGENT DCB, PTCA balloon catheterIn-Stent Restenosis6002023-10-02actual—2026-07-17
Paresthesia-Free Fast-Acting Subperception (FAST) StudyNCT04618471results2023-12-29Targeted Pain Responder RateOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableActive, not recruitingDevice: Boston Scientific WaveWriter SCS SystemChronic Pain1772022-12-14actual—2026-08-12
Intra-operative Pancreatoscopy in Patients With IPMNNCT03729453observationalRate of detection of discontinuous (skip) lesions along the main pancreatic duct—Active, not recruitingDevice: SpyGlassIntraductal Papillary Mucinous Neoplasm1002022-08-11actual—2026-07-24
ACURATE neo2™ Post Market Clinical Follow up StudyNCT04655248observationalPrimary Safety Endpoint:—Active, not recruitingDevice: Transcatheter Aortic Valve Implantation/ReplacementAortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases2502022-03-09actual—2025-06-25
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral RegurgitationNCT04147884Primary Technical Success EndpointOpen-label · Device feasibilityNot applicableActive, not recruitingDevice: Millipede Transcatheter Annuloplasty Ring System (Millipede System)Mitral Regurgitation Functional, Mitral Valve Disease, Cardiovascular Diseases42021-12-17actual—2026-07-22
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)NCT01385176results2020-01-06Change in Left Ventricular End-systolic Dimension (LVESD)Randomized · Double-masked · TreatmentNot applicableActive, not recruitingDevice: Implant of investigational device system · Procedure: Titration during the randomization phase, Titration after the randomization phase · Diagnostic test: Blood DrawHeart Failure, Congestive Heart Failure118May 2014actual—2026-08-14
AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDENCT06174805Serious Adverse EventsOpen-label · TreatmentNot applicableSuspendedsponsor's stated reason: Sponsor DecisionDevice: AXIOS(TM) Stent and Electrocautery Enhanced Delivery SystemGastric Outlet Obstruction67Aug 2027≤ 377 d2026-08-10
Hot AXIOS™ for Bile Duct Drainage in Malignant StenosisNCT06750146Quality of Life Measurement - Jaundice DimensionOpen-label · TreatmentNot applicableSuspendedsponsor's stated reason: Sponsor decisionDevice: Hot AXIOS™ Stent and Electrocautery Enhanced Delivery SystemMalignant Biliary Stenosis162May 2027≤ 285 d2026-08-11
Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT LossNCT06894498observationalProportion of subjects that maintain clinically significant weightloss at five-year visit—Terminatedsponsor's stated reason: Business decision.Other: No Intervention: Observational CohortObesity and Obesity-related Medical Conditions, Weight Loss22026-07-30actual—2026-08-04
RIVOS Feasibility (MBO)NCT06666699Technical SuccessOpen-label · Device feasibilityNot applicableWithdrawnsponsor's stated reason: Study has been withdrawn per decision of Sponsor.Device: EUS access deviceMalignant Biliary Obstruction02026-05-30—2025-09-22
RESCUE: Discontinuation of GLP-1NCT07190794observationalPercent total body weight loss (TBWL) at 1 year from baseline—Terminatedsponsor's stated reason: Business decisionDevice: OverStitch™ or OverStitch NXT™ · Behavioral: Lifestyle ModificationObesity182026-05-26actual—2026-07-24
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)NCT05302063Pain Relief in Limb PainOpen-label · TreatmentNot applicableCompletedDevice: Spinal Cord Stimulation (SCS)Chronic Pain282026-05-22actual—2026-05-28
A DirEct to PatieNt Study in Chronic PainNCT05515341observationalTargeted Pain Responder Rate—CompletedDevice: Commercially Approved Interventional Medical Device/Therapy for Chronic PainChronic Pain732026-05-20actual—2026-07-23
POLARx Post Approval Study (POLARx PAS)NCT06170606Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter ModelsOpen-label · TreatmentNot applicableCompletedDevice: Boston Scientific Cardiac Cryoablation SystemParoxysmal Atrial Fibrillation2002026-05-20actual—2026-07-27
iNod™ Ultrasound-Guided Needle Biopsy System StudyNCT05804435Proportion of patients where the needle is visualized by the iNOD system inside the lesionOpen-label · DiagnosticNot applicableWithdrawnsponsor's stated reason: Sponsor decisionDevice: iNod™ SystemSolitary Pulmonary Nodule, Multiple Pulmonary Nodules, Biopsy, Fine-Needle0Feb 2026—2024-03-08
MANDARIN (S6371)NCT05016245Time to progression (TTP)Randomized · Open-label · TreatmentPhase 3CompletedCombination product: TheraSphere™ Yttrium-90 Glass Microspheres · Procedure: conventional Transarterial Chemoembolization(cTACE)Inoperable Hepatocellular Carcinoma922026-02-13actual—2026-08-12
ACURATE Enhance Post Market StudyNCT06959862observationalPrimary Endpoint:—Withdrawnsponsor's stated reason: Boston Scientific made the decision to discontinue worldwide commercialization of the ACURATE valve platform.Device: Transcatheter Aortic Valve Implantation/ReplacementAortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases0Dec 2025—2025-06-24
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression StudyNCT06526546observationalChronic success in ADVENT Trial treated subjects compared between treatment groups.—Completed—Paroxysmal Atrial Fibrillation3642025-12-08actual—2026-03-02
Coordinated Reset Deep Brain StimulationNCT03732898Improvement in Quality of Life using new programming paradigm: PDQ-39Non-randomized · Single-masked · TreatmentNot applicableCompletedDevice: Novel Programming (nDBS), Conventional Programming (cDBS)Parkinson's Disease (PD)152025-11-12actual—2025-12-11
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral AnticoagulationNCT02928497Primary 7-Day Device/Procedural Safety EndpointRandomized · Open-label · PreventionNot applicableCompletedDevice: WATCHMAN LAAC Device Implant · Drug: Single Antiplatelet Therapy or No Therapy (Control)Stroke4812025-09-23actual—2026-04-13
Obsidio™ Conformable Embolic RegistryNCT06170619observationalPrimary effectiveness endpoint—CompletedDevice: Obsidio™ Conformable EmbolicHypervascular Tumors, Bleeding, Hemorrhage1252025-09-09actual—2026-06-01
Feasibility Study on the FARAVIEW TechnologyNCT06175234Number of subjects with PVI successOpen-label · TreatmentNot applicableCompletedDevice: Ablation TreatmentAtrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation502025-05-15actual—2025-09-17
Closed Loop Programming Evaluation Using External Responses for Deep Brain StimulationNCT03037398Difference in time to program between the two arms at Programming VisitRandomized · Double-masked · TreatmentNot applicableCompletedDevice: Vercise Deep Brain Stimulation SystemParkinson Disease722025-04-02actual—2025-04-03
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial FibrillationNCT05443594results2025-10-24Primary Safety Endpoint (PSE): Event Rate of Safety Events Post ProcedureNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation SystemPersistent Atrial Fibrillation6692025-02-11actual—2025-12-16
Radiofrequency (RF) Ablation Prospective Outcomes StudyNCT04673032results2026-04-15observationalPatient Global Impression of Change (PGIC)Study Protocol and Statistical Analysis Plan ↗—CompletedDevice: Radiofrequency AblationPain, Chronic2982025-02-07actual—2026-04-15
Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)NCT04069468observationalOverall Survival (OS)—CompletedDevice: TheraSphereHepatocellular Carcinoma1,2472024-12-31actual—2025-07-23
Clinical Trial of EPASS With Hot AXIOS SystemNCT05644951GOOSS 3 rate without MAEOpen-label · Supportive careNot applicableCompletedDevice: Hot AXIOS system used for EPASSGastric Outlet Obstruction512024-12-05actual—2025-12-03
SpyGlass Surgical StudyNCT05822635observationalTechnical success—CompletedDevice: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization SystemPancreatic Diseases, Bile Duct Diseases, Hepatic Disease342024-12-04actual—2025-01-08
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)NCT05282823results2025-12-02observationalSafety Event Free RateStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Boston Scientific Cardiac Cryoablation SystemParoxysmal Atrial Fibrillation2952024-10-29actual—2025-12-02
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)NCT06132568Clinical SuccessOpen-label · Device feasibilityNot applicableCompletedDevice: VITALYST SystemHigh-risk Percutaneous Coronary Intervention, Heart Disease, Coronary152024-10-24actual—2025-06-22
Watchman FLX Pro CT Pilot StudyNCT05567172results2025-12-09Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the DeviceOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Left atrial appendage closure device WM FLX ProNon-valvular Atrial Fibrillation (AF)432024-10-14actual—2025-12-09
MANTIS Endoscopic Clipping StudyNCT05653843results2025-08-12observationalNumber of Participants With Hemostasis of Active BleedingStudy Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: Endoscopic clip placement in the gastrointestinal tract.Hemostasis, Perforation Colon, Feeding Tube Complication, Endoscopy2402024-08-07actual—2025-08-12
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF AblationNCT03795298results2025-09-18Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic EmbolismRandomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: WATCHMAN FLX Implant · Drug: Market-approved OACAtrial Fibrillation1,6002024-07-24actual—2025-09-18
HEAL-LAA Clinical TrialNCT05809596results2025-10-15Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis SubjectsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: WATCHMAN FLX Pro LAAC DeviceAtrial Fibrillation, Bleeding, Stroke9492024-07-15actual—2025-11-04
WATCHMAN FLX™ CT StudyNCT05324371results2025-07-01Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the DeviceOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Watchman FLX DeviceThe Focus of the Study is to Reduce the Risk of Stroke and Life-threatening Bleeding Events in Patients With Non-valvular Atrial Fibrillation252024-05-30actual—2025-07-01
Artificial Urinary Sphincter Clinical OutcomesNCT04088331results2025-08-03observationalNumber of Subjects With Reduction in 24 Hour Pad Weight Test at 12 MonthsStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: AMS 800 Artificial Urinary SphincterStress Urinary Incontinence1452024-05-13actual—2026-01-14
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial FibrillationNCT03729830results2026-01-21observationalNumber of Participants Safety Event-free at 12 Months Post ProcedureStudy Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: Boston Scientific Open Irrigated Ablation CathetersParoxysmal Atrial Fibrillation4152024-05-03actual—2026-01-21
An Observational Study of Radiotherapy After Injection of SpaceOAR HydrogelNCT05735652results2025-03-26observationalChange of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection.Study Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: SpaceOAR HydrogelProstate Cancer142024-04-30actual—2025-05-30
Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)NCT05312970results2026-03-20Change in Varicose Veins Symptoms Questionnaire (VVSymQ)Randomized · Open-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗Phase 4Terminatedsponsor's stated reason: Enrollment challenges and a difficult insurance coverage landscapeDrug: Varithena® · Device: FDA-approved Endothermal Ablation (ETA) systemsVaricose Veins432024-04-04actual—2026-03-20
NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation SystemsNCT03240588results2025-05-08Pain Responder RateNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Neurostimulation SystemPain, Chronic5442024-03-08actual—2025-05-08
The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial FibrillationNCT05272852results2025-01-08Primary Safety Endpoint: Composite Safety Endpoint (CSE) Defined as the Incidence of the Following Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related, as Adjudicated by the CEDMCOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: FARAPULSE™ Pulsed Field Ablation System PlusPersistent Atrial Fibrillation802024-02-09actual—2025-01-08
CLBP Single-Arm Long-Term Follow-up StudyNCT05207813results2025-05-08observationalMean Change in ODI From Baseline to 5 Years Post Intracept ProcedureStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Intracept ProcedureChronic Low Back Pain422024-02-01actual—2025-05-08
Flexiva Pulse RegistryNCT05027971results2024-10-26observationalOccurrence of Serious Adverse Device Effects - Primary Safety EndpointStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Flexiva Pulse High Power Single-Use Laser FibersUrinary Calculi, Benign Prostatic Hyperplasia2012023-10-31actual—2025-05-29
The FARAPULSE FARA-Freedom TrialNCT05072964results2024-10-17Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial FlutterOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: FARAPULSE Pulsed Field Ablation SystemParoxysmal Atrial Fibrillation1802023-10-12actual—2024-10-17
Step and Walking Pattern From Cardiac Monitor StudyNCT04971993observationalStep Detection—Terminatedsponsor's stated reason: Resourcing challengesDevice: Wearable Cardiac MonitorHeart Failure NYHA Class II, Heart Failure NYHA Class III, Insertable Cardiac Monitor402023-10-11actual—2023-12-13
Non-Complex Biliary Stones DSC vs ERCNCT03421340results2024-11-08Number of Participants With Complete Stone ClearanceRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: DSC, ERCBiliary Stones2502023-09-18actual—2025-01-17
A RWS of the FARAPULSE in A Chinese Population With PAFNCT05493852results2024-12-16observationalNumber of Participants With Acute Procedural SuccessStudy Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: FARAPULSE Pulsed Field Ablation SystemParoxysmal Atrial Fibrillation302023-08-21actual—2025-01-31
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATPNCT02923726results2024-10-22All-Cause ShockRandomized · Single-masked · Basic scienceStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Arm 1 (ATP+Shock), Arm 2 (shock only)Sudden Cardiac Death2,6922023-07-06actual—2024-10-22
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter DefibrillatorNCT02787785results2024-08-22All-Cause MortalityRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Subcutaneous Implantable Cardioverter DefibrillatorTachycardia, Diabetes Mellitus, Cardiovascular Disease402023-06-30actual—2024-08-22
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial FibrillationNCT04580914results2025-01-16Rate of Primary Safety Events at 1-Month Post-ProcedureOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ · Informed Consent Form ↗Not applicableCompletedDevice: Treatment with IntellaNav StablePoint Ablation CatheterParoxysmal Atrial Fibrillation3212023-06-21actual—2025-01-16
TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.NCT05233098results2025-03-06observationalDelivered Activity of Tc-99m MAA (MBq) for Whole BodyStudy Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: Technetium-99m macroaggregated albumin (Tc-99m MAA)Hepatocellular Carcinoma62023-06-14actual—2025-03-06
SpaceOAR System RWS in ChinaNCT05407714results2024-02-22Primary Effectiveness EndpointOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: SpaceOAR TreatmentLocalized T1-T2 Prostate Cancer152023-06-12actual—2025-10-27
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance StudyNCT04732728results2024-11-25observationalICM System-related Complication-free Rate at 30 Days Post-implantStudy Protocol and Statistical Analysis Plan ↗—Completed—Atrial Fibrillation, Syncope, Cryptogenic Stroke7272023-05-18actual—2024-11-25
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial FibrillationNCT04612244results2024-11-20Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEsRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon AblationParoxysmal Atrial Fibrillation7062023-05-15actual—2024-11-20
Data Collection - Of Syncope Tilt Table Testing StudyNCT03721393observationalPhysiologic Signal Detection—CompletedDevice: Wearable heart monitorOrthostatic Hypotension, Reflex Syncope502023-05-08actual—2023-08-02
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation RhythmNCT03835338Freedom from AFRandomized · Open-label · TreatmentNot applicableWithdrawnsponsor's stated reason: Sponsor discretionDevice: Pulmonary Vein Isolation, LAA Isolation, LAA OcclusionPersistent Atrial Fibrillation02023-04-30—2022-03-31
LithoVue Elite RegistryNCT05201456observationalOccurrence of Serious Adverse Device Effects - Primary Safety Endpoint—Withdrawnsponsor's stated reason: Business decisionDevice: LithoVue Elite SystemKidney Stone, Urolithiasis02023-04-01—2023-12-18
Postmarket Outcomes Study for Evaluation of the Superion™ SpacerNCT04563793results2025-01-13observationalLow Back Pain Responder RateStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Superion™ IDSLumbar Spinal Stenosis1292023-03-20actual—2025-01-13
Cartesia eXTend 3D StudyNCT04577651results2024-03-29Change in Motor FunctionOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: 16-contact Directional Deep Brain StimulationParkinson Disease582023-02-27actual—2025-02-21
Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPANCT03455855results2024-09-19The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter StenosisOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Jetstream SystemAtherosclerosis722023-02-22actual—2024-10-29
Double-J PLUS Postmarket Registry StudyNCT04197583results2024-10-16observationalPercentage of Implanted Stents Meeting the Technical Success CriteriaStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Boston Scientific Ureteral Stents, Urinary Diversion StentUreter Obstruction3792023-01-16actual—2026-03-03
Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)NCT03613831observationaltarget patient's type—Withdrawnsponsor's stated reason: The sponsor has decided to stop the studyDevice: patient who used Rhythmia system and Orion catheterAtrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery0Dec 2022—2020-09-01
Clinical Outcomes of IVUS-guided Stenting Using the Boston Scientific Vici® Venous Stent System in Treating Patients With Chronic Non-malignant Iliofemoral Vein ObstructionNCT04856592The primary patency rate at 12 months post index procedureOpen-label · TreatmentNot applicableWithdrawnsponsor's stated reason: The study device VICI stent withdrawn from marketDevice: Boston Scientific Vici® Venous Stent System, Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)Chronic Venous Disorder, Venous Outflow Obstruction, Systemic Vein Outflow of Iliofemoral Vein02022-12-31—2021-11-01
SpyGlass™ Discover PercutaneousNCT04580940observationalAchieving clinical intent of procedure as indicated—CompletedDevice: SpyGlass™ Discover Digital SystemPancreatic Diseases, Bile Duct Obstruction, Bile Duct Diseases502022-12-14actual—2023-11-29
Cholangioscopy in Primary Sclerosing Cholangitis (PSC)NCT03766035observationalDiagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma—CompletedDevice: SpyGlass DS I - IIPrimary Sclerosing Cholangitis (PSC)432022-12-12actual—2023-01-25
Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)NCT05152966results2024-01-31Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: AblationPersistent Atrial Fibrillation202022-12-01actual—2024-02-28
Global Prospective Case Series Using a Single-Use DuodenoscopeNCT04103749results2023-12-12Number of Participants With Successful ERCP ProcedureOpen-label · OtherStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Exalt Model D Single-Use DuodenoscopeEndoscopic Retrograde Cholangiopancreatography5512022-11-23actual—2023-12-12
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary TrialNCT04909593results2024-12-06Perception ThresholdOpen-label · TreatmentStudy Protocol ↗Not applicableCompletedDevice: Spinal Cord StimulationChronic Pain, Intractable Pain, Low Back Pain, Pain, Neuropathic, Pain, Back212022-11-22actual—2024-12-06
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial FibrillationNCT04133168results2023-12-07Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter ModelsOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Boston Scientific Cardiac Cryoablation SystemParoxysmal Atrial Fibrillation4582022-11-10actual—2025-04-03
Exalt D Single-use Duodenoscope in ERCP Procedures in ChinaNCT04687774Number of patients complete the ERCP procedureOpen-label · DiagnosticNot applicableWithdrawnsponsor's stated reason: Strategy AdjustmentDevice: ExaltTM Model D Single-Use DuodenoscopeCholangiopancreatography0Sep 2022—2025-11-17
POLARx Cardiac Cryoablation System StudyNCT04250714results2024-02-12observationalSafety Event Free RateStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Boston Scientific Cardiac Cryoablation SystemAtrial Fibrillation4002022-09-26actual—2025-04-04
An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese PatientsNCT04085445observationalNumber of Participants with 12 months post index procedure—CompletedDevice: AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon CatheterChinese Patients Treated With Agent DCB5002022-08-31actual—2025-12-17
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of SurgeryNCT04676022results2024-05-08Responder RateRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: WaveWriter · Other: Conventional Medical ManagamentChronic Pain2412022-08-25actual—2025-03-06
A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent SystemNCT04807439observationalTarget Lesion Failure (TLF) rate—CompletedDevice: SYNERGY XLV (Megatron) Coronary Stent SystemAtherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease, Cardiovascular Diseases1002022-08-19actual—2023-10-23
Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation (LOCALIZE CF)NCT04740801Association between Local Impedance drop values and PV reconnectionsOpen-label · TreatmentNot applicableCompletedDevice: Ablation procedureParoxysmal Atrial Fibrillation602022-07-21actual—2023-05-11
ACURATE Prime XL Human Feasibility StudyNCT05224245Number of participants with Device SuccessOpen-label · Device feasibilityNot applicableCompletedDevice: ACURATE Prime XL Transfemoral Aortic Valve SystemAortic Stenosis132022-06-16actual—2023-06-15
Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure StudyNCT04112576observationalPhysiologic Signal Detection—CompletedDevice: Wearable cardiac monitorHeart Failure, Systolic, Heart Failure, Diastolic1002022-05-11actual—2023-04-07
Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver CancerNCT01556490results2023-11-08Overall Survival (OS) Results Are Based on the Modified Intent-to-treat (mITT)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: TheraSphereUnresectable Hepatocellular Carcinoma5262022-04-30actual—2023-11-08
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb IschemiaNCT03551496results2023-08-14Number of Participants With Primary PatencyRandomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗Phase 3CompletedCombination product: Drug Eluting Stent - Below the Knee · Device: Standard PTA Control ArmCritical Limb Ischemia2012022-04-21actual—2024-07-01
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility StudyNCT04674111results2024-04-24Number of Participants With Technical SuccessOpen-label · Device feasibilityStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)Coronary Artery Disease52022-04-08actual—2024-04-24
Acute Feasibility Investigation of a New S-ICD ElectrodeNCT03802110results2024-05-09Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in JoulesOpen-label · Device feasibilityStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.Ventricular Fibrillation422022-04-01actual—2024-05-09
A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal ArteriesNCT03037411results2026-03-31observationalParticipant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire.Study Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: Peripheral stentingArterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis2912022-03-24actual—2026-03-31
POCS in Liver Transplantation PatientsNCT03205072observationalImpact of Per-Oral Cholangioscopy on Patient Management—CompletedDevice: Spy Glass DSLiver Transplant; Complications422022-03-24actual—2022-07-28
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve ReplacementNCT04149535results2023-02-02The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Sentinel® Cerebral Protection SystemStroke3,0002022-02-01actual—2023-02-02
Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong KongNCT04096963results2024-08-12observationalPrimary Effectiveness EndpointStudy Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: The WATCHMAN FLX Delivery SystemNon-valvular Atrial Fibrillation502022-01-24actual—2024-08-12
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)NCT03875651observationalTarget Lesion Failure (TLF) rate—CompletedDevice: SYNERGY 4.50 mm and 5.0 mm Coronary Stent SystemAtherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease, Cardiovascular Diseases1002022-01-07actual—2023-12-14
Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial FibrillationNCT03852420Safety event free rate at 12 months post procedure.Open-label · TreatmentNot applicableWithdrawnsponsor's stated reason: Sponsor discretionDevice: LUMINIZE RF Balloon CatheterParoxysmal Atrial Fibrillation02021-12-31—2021-01-15
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)NCT04058990results2022-12-23Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)Randomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Device: Paclitaxel-Coated PTCA Balloon Catheter, SeQuent Please Drug Eluting Balloon Catheter with PaclitaxelCoronary Artery Disease1802021-12-22actual—2026-07-23
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial FibrillationNCT04474054results2023-04-21Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse EventsOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Catheter ablation to treat paroxysmal atrial fibrillationParoxysmal Atrial Fibrillation152021-12-21actual—2023-04-21
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary CancerNCT01774019results2023-04-10Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes LastRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemPancreatic Carcinoma2842021-12-13actual—2023-04-10
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDENCT03767881results2023-02-17Number of Days to Resolution of Acute CholecystitisOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: AXIOS(TM) Stent and Electrocautery Enhanced Delivery SystemCholecystitis, Acute302021-12-02actual—2023-02-17
WallFlex Pancreatic Metal Stent for Pancreatic Duct StricturesNCT02802020results2022-11-21Pain ReductionOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Pancreatic fully-covered self-expanding metal stent (FCSEMS)Chronic Pancreatitis672021-11-24actual—2022-11-21
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy RegistryNCT03075215results2023-10-02observationalCRT Response RateStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)Heart Failure2,0442021-11-15actual—2023-10-25
Precision Event Monitoring for Patients With Heart Failure Using HeartLogicNCT03579641observationalAssociation of HeartLogic sensors with 30-day HF re-admissionStudy Protocol ↗—CompletedDevice: HeartLogic SensorsHeart Failure, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy, Cardiovascular Disease, Heart Disease2,1842021-10-29actual—2022-10-25
S-ICD® System Post Approval StudyNCT01736618results2024-03-18observationalNumber of Participants Free From Type I ComplicationStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: S-ICD SystemPrimary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest1,7662021-10-15actual—2024-03-18
Focal Pain Outcomes Using Configurations Applied for Lateral StimulationNCT04073446results2023-03-29Change in Pain IntensityRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Spinal Cord StimulationChronic Pain32021-10-01actual—2023-03-29
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)NCT02654470observationalprocedural success—CompletedDevice: Watchman FLXNon-valvular Atrial Fibrillation3002021-09-28actual—2021-11-19
I Can sEe Left Atrial Appendage (ICELAA) Clinical StudyNCT04196335Rate of Device LeakOpen-label · TreatmentNot applicableCompletedDevice: intra-procedural intracardiac echocardiographyEfficacy, Self, Safety Issues1002021-09-24actual—2025-06-18
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D DevicesNCT02091011observationalDetermine the rate and cause of all-cause device replacements of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation.—Completed—Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator1,600Aug 2021actual—2022-08-02
To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in ChinaNCT04823221results2022-02-17observationalInternational Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.Study Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: Rezūm SystemBenign Prostatic Hyperplasia (BPH)222021-08-01actual—2022-03-02
Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial FibrillationNCT04170621results2024-01-30Safety at 30 DaysOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: AblationPersistent Atrial Fibrillation282021-07-14actual—2024-01-30
Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal ArteryNCT02921230results2024-10-28Number of Subjects With Primary Patency at 12 Months Post-procedureRandomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan: Protocol ↗ · Statistical Analysis Plan: Statistical Analysis Plan ↗Not applicableCompletedDevice: Peripheral stentingArterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis7752021-07-02actual—2025-02-24
Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic CancerNCT03998566results2023-02-27Safety EndpointOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: TraceIT Tissue Spacer implantationPancreatic Cancer62021-05-01actual—2023-02-27
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk SubjectsNCT03618095results2022-12-27Composite of All-cause Mortality and All Stroke.Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableTerminatedsponsor's stated reason: Investigational Medical Device is no longer availableDevice: LOTUS Edge Valve SystemAortic Valve Stenosis3822021-03-30actual—2022-12-27
China Greenlight Registry Study (Post-market)NCT03736512observationalThe GreenLight XPS system provides durable relief of BPH symptoms in subjects.—CompletedDevice: GreenLight XPS™ 532 nm Laser System with MoXy™ laser fiberBenign Prostatic Hyperplasia (BPH)302021-03-30actual—2023-11-15
Postmarket Registry for Evaluation of the Superion® SpacerNCT04087811results2023-04-04observationalVertiflex® Patient Satisfaction SurveyStudy Protocol ↗—CompletedDevice: Superion® Indirect Decompression System (IDS)Lumbar Spinal Stenosis1,6742021-03-01actual—2023-07-06
INGEVITY+ Active Fixation Pace/Sense Lead Clinical StudyNCT04346537results2022-05-12observationalPrimary Safety: Lead-related Complication-Free RateStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: INGEVITY+™ Pace/Sense LeadBradycardia1092021-03-01actual—2022-07-14
Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User ExperienceNCT04223830results2022-03-31Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) ProcedureOpen-label · OtherStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Exalt Model D Single-Use DuodenoscopeEndoscopic Retrograde Cholangiopancreatography2002021-02-22actual—2022-03-31
PROMUS PREMIER™ China Post-Approval StudyNCT03273023results2026-07-22observational12-month Major Adverse Cardiac Event (MACE) RateStudy Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent SystemCoronary Artery Disease2,0592020-12-28actual—2026-07-22
AXIOS CHINA (E7148)NCT03808272Technical success rateOpen-label · TreatmentNot applicableCompletedDevice: HOT AXIOS Stent and Electrocautery- Enhanced Delivery SystemPancreatic Pseudocyst and Walled-off Necrosis312020-12-24actual—2023-11-15
Ranger™ and Ranger™ SL (OTW) DCB) in ChinaNCT02944071results2022-03-10Major Adverse Events Through 30 Days Post-procedureOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon CatheterFemoropopliteal Artery Lesions1232020-12-22actual—2025-10-27
Cryoablation System FIM/CE Mark StudyNCT03723070results2021-07-19Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device EffectsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: The Cryterion Cardiac Cryoablation SystemAtrial Fibrillation882020-12-22actual—2025-04-04
A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial FibrillationNCT03714178results2022-05-04The Primary Safety Endpoint for This Study is the Composite Safety Endpoint (CSE) Defined as the Proportion of Patients With Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related.Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: FARAPULSE Endocardial Ablation SystemParoxysmal Atrial Fibrillation712020-12-21actual—2022-05-04
RESPOND EDGE Post Market StudyNCT04009720observationalAll-cause mortality (Primary Safety Endpoint)—Terminatedsponsor's stated reason: study device Lotus Edge was removed from the marketDevice: Lotus Edge DeviceAortic Valve Stenosis2002020-12-09actual—2021-07-15
PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial FibrillationNCT04170608results2022-05-04Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure.Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: FARAPULSE Endocardial Multi Ablation SystemParoxysmal Atrial Fibrillation102020-12-07actual—2022-05-04
Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary TrialNCT02988713results2022-04-04Patient ComfortOpen-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: ProgrammingChronic Pain352020-12-02actual—2022-04-18
Heart Failure and Sudden Cardiac Death Japan RegistryNCT03185832results2022-02-14observationalNumber of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D CohortsStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: CRT-D, ICD, PM / CRT-P · Other: Non-deviceHeart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death3542020-12-01actual—2022-02-14
A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCCNCT03295006observationalAlternative two-compartment TheraSphere dosimetry methodology—CompletedDevice: TheraSphereHepatocellular Carcinoma2092020-12-01actual—2021-04-21
REPRISE China - Clinical Evaluation in ChinaNCT03084510All-cause mortalityOpen-label · TreatmentNot applicableWithdrawnsponsor's stated reason: study device was recalled.Device: Lotus Edge™ Valve SystemStenoses, Aortic Valve02020-11-30actual—2023-11-15
Tracking Renal Tumors After Cryoablation EvaluationNCT01117779results2024-01-19observationalChanges in Lesion SizeStudy Protocol ↗ · Statistical Analysis Plan ↗—Terminatedsponsor's stated reason: Boston Scientific acquisition of BTG/Galil Medical - business decision made to stop follow-up earlyDevice: CryoablationKidney Neoplasms2462020-11-24actual—2024-01-19
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)NCT03257436results2022-01-03LV MSP Feature Related Complication-Free RateOpen-label · OtherStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: CRT-DLeft Ventricular Dysfunction5862020-11-19actual—2022-01-03
Study in the Treatment of HCC With a Radiopaque (RO) Bead (LC Bead LUMI™) Loaded With DoxorubicinNCT03452553Efficacy: Time to progression (TTP)Open-label · TreatmentNot applicableWithdrawnsponsor's stated reason: CMS disapproval, no alternative for sites/patient, risk of financial burden.Device: LC Bead LUMI™ (Radiopaque (RO) Bead) loaded with doxorubicinHepatocellular Carcinoma (HCC)02020-10-30—2021-04-21
Fast-Acting Subperception Study (FAST)NCT04231409results2022-01-24Overall Pain Responder RateRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableTerminatedsponsor's stated reason: Study follow-up activities affected by COVID-19Device: Boston Scientific Spectra WaveWriter SCS SystemChronic Pain412020-10-01actual—2022-01-24
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis StudyNCT01543256results2023-01-09Number of Participants With Stricture ResolutionRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: WallFlex™ Biliary RX Fully Covered Stent System RMV, Commercially available Plastic Stent Per Investigator preferenceBiliary Stricture1722020-09-21actual—2023-01-09
Strategic Management to Optimize Response To Cardiac Resynchronization TherapyNCT03089281results2022-04-05CRT ResponseRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: CRT-DHeart Failure6992020-09-15actual—2022-04-05
Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal CancerNCT01483027results2022-03-29Progression Free SurvivalRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: TheraSphereColorectal Cancer Metastatic4282020-08-31actual—2022-03-29
Multiple Cardiac Sensors for the Management of Heart FailureNCT03237858results2024-03-27Manage-HF Phase IRandomized · Open-label · DiagnosticStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: HeartLogic ON, HeartLogic OFFHeart Failure, Congestive2002020-07-21actual—2024-03-27
An International Pulmonary Embolism Registry Using EKOSNCT03426124results2023-02-22observationalChange in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)Study Protocol ↗ · Statistical Analysis Plan ↗—CompletedDevice: EkoSonic Endovascular System with thrombolyticPulmonary Embolism and Thrombosis1,4802020-06-30actual—2023-02-22
Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)NCT03605745results2021-08-10Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableTerminatedsponsor's stated reason: Sponsor decided to terminate the study due to business reasonsDevice: Prostatic Vapor AblationBPH With Urinary Obstruction, BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms472020-06-25actual—2021-08-10
Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial FibrillationNCT03232645results2021-08-09Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 AssessmentOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Ablation procedureParoxysmal Atrial Fibrillation622020-06-23actual—2021-09-05
Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)NCT03257254results2021-12-14observationalChange From Baseline in Wound PerimeterStudy Protocol ↗ · Statistical Analysis Plan ↗—CompletedDrug: VarithenaVenous Leg Ulcer762020-05-18actual—2021-12-14
AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE StudyNCT03525808results2021-12-20Number of Participants With Resolution of WON With Endoscopic DrainageOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: AXIOSWalled Off Pancreatic Necrosis402020-03-31actual—2021-12-20
Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFRNCT04098172results2021-06-07Fractional Flow Reserve (FFR)Open-label · DiagnosticStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Pressure GuidewireCardiovascular Diseases392020-03-11actual—2021-11-01
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) RegistryNCT01085435results2023-11-07observationalPerioperative S-ICD Complication Free RateStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: S-ICD SystemTachycardia, Ventricular9942020-02-29actual—2025-05-20
Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe EmphysemaNCT03360396results2021-11-03Percent Change in FEV1 at 6 MonthsRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Endobronchial CoilsEmphysema1202020-02-26actual—2023-08-28
Longitudinal Surveillance Study of the 4-SITE Lead/Header SystemNCT01596595results2021-02-21observationalPercentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-yearsStudy Protocol and Statistical Analysis Plan ↗—Completed—Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest1,8202020-02-18actual—2021-03-19
Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of MalignancyNCT03593681results2021-01-20observationalSensitivity and Specificity of Cytological Samples for Fallopian Tube InvolvementStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Hysteroscopic cell sampling of the fallopian tubeFallopian Tube Cancer, Ovarian Cancer, Ovarian Neoplasms, Ovary Cancer, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma, High Grade Serous Carcinoma, Peritoneal Carcinoma, Peritoneal Neoplasms, Adnexal Mass, Ovarian Diseases1502020-02-14actual—2021-01-20
Uphold LITE Post-Market Surveillance StudyNCT01917968results2021-03-15Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 MonthsNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Uphold Lightweight Vaginal Support System · Procedure: Traditional native tissue repairPelvic Organ Prolapse2892020-02-12actual—2021-05-20
Xenform Postmarket Surveillance StudyNCT01945580results2021-04-14Number of Participants With Success at 36 MonthsNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedProcedure: Prolapse RepairPelvic Organ Prolapse3742020-02-12actual—2021-04-14
Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure TechnologyNCT02702271results2022-06-14Number of Participants With a Safety EventNon-randomized · Open-label · PreventionStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: WATCHMAN FLXAtrial Fibrillation4582020-01-28actual—2022-06-14
A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)NCT03350542results2021-02-05Target Lesion Failure Rate at 12-monthsOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Phase 3CompletedDevice: SYNERGY 48 mmCoronary Artery Disease1002020-01-16actual—2021-05-14
Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total OcclusionsNCT03901079results2023-12-08observationalTechnical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the CollateralsStudy Protocol ↗ · Statistical Analysis Plan ↗—Terminatedsponsor's stated reason: HGRAC approval letter had expired. The enrollment speed of FAST CTO is much slower than planning and the scientific value becomes limited due to the delayed data readout anticipation.Other: single-arm studyCAD202020-01-10actual—2023-12-08
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection FractionNCT02433379results2021-01-08Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICDOpen-label · Supportive careStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: EMBLEM S-ICD SystemVentricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output1,1732019-12-06actual—2025-03-24
Registry Study to Evaluate the Performance and Safety of Roxwood Medical Catheters in Arteries of Participants With a Stenotic Lesion or Chronic Total Occlusion (CTO)NCT04059536observationalNumber of Participants with a Successful Index Procedure by Roxwood Medical Device(s)—Withdrawnsponsor's stated reason: Sponsor decisionDevice: Roxwood Anchoring Catheters · Drug: Acetylsalicylic Acid, HeparinChronic Total Occlusion, Atherosclerosis, Coronary Artery Disease, Peripheral Artery Disease02019-12-01—2021-07-21
RANGER™ Paclitaxel Coated Balloon vs Standard Balloon AngioplastyNCT03064126results2020-07-15Number of Participants With Primary Lesion PatencyRandomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗Phase 3CompletedDevice: RANGER™ Paclitaxel Coated Balloon · Drug: Paclitaxel · Procedure: Standard Balloon AngioplastyPeripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral, Plaque, Atherosclerotic, Occlusive Arterial Disease4402019-11-18actual—2024-10-29
Bronchial Thermoplasty in Severe Persistent AsthmaNCT01350336results2021-03-05Subjects Experiencing Severe Exacerbations (Rates)Open-label · TreatmentStatistical Analysis Plan ↗ · Study Protocol and Informed Consent Form ↗Not applicableCompletedDevice: Alair SystemSevere Asthma2842019-11-12actual—2021-03-05
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)NCT03847233results2020-12-28Number of Patients With Lesion SuccessOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Jetstream Atherectomy SystemPeripheral Arterial Disease312019-11-08actual—2021-08-16
Combining Mechanisms for Better Outcomes (COMBO)NCT03689920results2020-11-27Overall Pain Responder RateRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) SystemChronic Pain, Back Pain1742019-11-05actual—2022-01-11
Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver MalignanciesNCT03291379results2021-02-03To Assess the Safety and Tolerability of Treatment With BTG-002814Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Early Phase 1CompletedDrug: BTG-002814Carcinoma, Hepatocellular, Metastatic Colorectal Cancer82019-08-03actual—2021-07-19
Post Market Observational, Prospective, Multi-center StudyNCT01806636observationalChanges in Quality of Life (QOL) measures—TerminatedDevice: PneumRx Coil SystemEmphysema1,275Jul 2019actual—2021-07-16
EVOLVE Short DAPT StudyNCT02605447results2020-09-25Number of Participants Who Experienced Death or Myocardial Infarction (MI)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Phase 4CompletedDrug: 3 months of dual antiplatelet therapy (DAPT) · Device: SYNERGY Stent SystemCoronary Artery Disease2,0092019-07-17actual—2020-09-25
Bronchial Thermoplasty Global RegistryNCT02104856observationalProportion of patients who experience severe asthma exacerbations—CompletedDevice: Alair System (Bronchial Thermoplasty)Asthma1582019-06-26actual—2019-09-13
Cardiac Monitor Employee StudyNCT03826225observationalEvaluate WCM System End-To-End Performance—Completed—Arrhythmias, Cardiac202019-05-23actual—2019-07-08
To Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary DiseaseNCT03676972results2021-02-18Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From ProcedureOpen-label · DiagnosticStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: LithoVue Ureteroscope SystemUrinary Tract Disease602019-05-09actual—2021-11-01
Initial Case Series With Exalt Single-Use DuodenoscopeNCT03701958Successful ERCP procedureOpen-label · Device feasibilityNot applicableCompletedDevice: Exalt Model D Single-Use DuodenoscopeEndoscopic Retrograde Cholangiopancreatography602019-05-06actual—2022-02-08
Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure TechnologyNCT01760291results2021-11-24Number of Participants With Ischemic StrokeOpen-label · PreventionStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: WATCHMAN LAA Closure TechnologyAtrial Fibrillation576Apr 2019actual—2022-03-29
Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary EmbolismNCT02396758results2021-03-02Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio to 48 ± 6 Hours After the Start of the APT ProcedureRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Phase 4CompletedDevice: Ekosonic® Endovascular Device ultrasonic infusion catheter · Biological: Recombinant tissue plasminogen activatorPulmonary Embolism and Thrombosis1312019-04-30actual—2021-07-19
IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation SystemNCT03700372results2021-10-14Primary Safety: A Composite Safety Endpoint Consisting of the Subjects That Experience One or More Serious Adverse Events (SAEs) Related to the Investigational Procedure and/or Device Within 30 Days of the Ablation Procedure or Hospital Discharge.Open-label · TreatmentStudy Protocol and Statistical Analysis Plan: CS0172-001 ↗ · Study Protocol and Statistical Analysis Plan: CS0172-002 ↗—CompletedDevice: IOWA Approach Cardiac Ablation SystemParoxysmal Atrial Fibrillation72019-04-09actual—2021-10-14
Observation of ImageReady™ MR Conditional Defibrillation System in ChinaNCT03451721results2020-04-24The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -FreeOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: ImageReady™ MR Conditional Defibrillation SystemArrhythmia202019-03-12actual—2021-11-01
Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS SystemNCT02607527Acute Safety defined as incidence of adverse eventsOpen-label · Device feasibilityNot applicableCompletedDevice: Mitral Valve IRIS RingMitral Valve Insufficiency212019-01-17actual—2024-10-24
Bronchial Thermoplasty 10+ Year StudyNCT03243292observationalPrimary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.Study Protocol ↗—CompletedOther: Bronchial ThermoplastyAsthma1922019-01-10actual—2020-07-13
Data Collection Atrial Fibrillation Exploratory StudyNCT03647085observationalPhysiologic Signal Detection—Terminatedsponsor's stated reason: Due to COVID-19 and resourcing challengesDevice: Wearable cardiac monitorAtrial Fibrillation, Atrial Flutter272019-01-10actual—2022-06-09
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator SystemNCT03251937results2020-03-16Percentage of Subjects With 50% or Greater Reduction in Overall Pain From BaselineOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Spectra WaveWriter SCS SystemChronic Pain, Back Pain972019-01-09actual—2021-04-01
Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord StimulationNCT02093793results2020-07-08Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response RatesRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: PRECISION SCS Adapted for High-Rate SCSChronic Pain, Back Pain383Dec 2018actual—2020-11-13
IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial FibrillationNCT03700385results2020-09-23The Primary Safety Endpoint for This Study is the Incidence of Early-onset (Within 7 Days of the PEF Ablation Procedure) Primary Adverse Events (AEs).Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: IOWA Approach Endocardial Ablation SystemParoxysmal Atrial Fibrillation402018-12-21actual—2020-09-23
Study to Characterize Acute and Chronic Directional Aspects of Deep Brain StimulationNCT02835274results2020-02-07Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized PhaseRandomized · Double-masked · OtherStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: BSC Deep Brain Stimulation System with Directional LeadParkinson Disease122018-12-19actual—2020-11-19
RadioEmbolization for the ADvancement of Y90 Glass Microspheres RegistryNCT03516695observationalEffectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting—Terminatedsponsor's stated reason: due to Sponsor's ongoing and upcoming projects and overall research prioritiesDevice: TheraSphere®Liver Cancer952018-12-12actual—2021-04-21
REPRISE EDGE 29 mm EU StudyNCT02964962Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory.Open-label · TreatmentNot applicableWithdrawnsponsor's stated reason: Currently not moving forward with the studyDevice: 29 mm LOTUS Edge™ Valve SystemAortic Valve Stenosis02018-10-30—2019-07-05
Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014NCT03267992observationalRate of COPD Exacerbation—Terminatedsponsor's stated reason: Study enrollment was prematurely stopped for business reasons.Behavioral: COPD Co-Pilot AIR AppCOPD Symptoms After Coil Procedure92018-10-20actual—2021-07-16
VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord StimulationNCT02741297results2020-01-10Percentage of Low Back Pain RespondersOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Spinal Cord Stimulation (SCS) SystemChronic Pain732018-09-21actual—2021-01-05
Safety and Efficacy of Cryoablation for Metastatic Lung TumorsNCT01307501results2019-10-01Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: CryoablationMetastatic Lung Cancer402018-08-30actual—2021-07-19
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)NCT02916498results2019-10-02Patient Preferred Field ShapeRandomized · Double-masked · OtherStudy Protocol ↗Not applicableTerminatedsponsor's stated reason: Stopped due to a business decisionDevice: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation SystemChronic Neuropathic Pain in the Low Back and Legs162018-07-23actual—2021-01-29
Vela China Study: in Cutting And Hemostasis For Gastrointestinal Epithelial Neoplasia In Chinese PopulationNCT02636738Technique successOpen-label · TreatmentNot applicableTerminatedsponsor's stated reason: strategy changeDevice: Vela XL thulium laser, laser fiber and accessories.Indication for Modification of Patient Physical Status22018-04-01actual—2019-09-20
Multicenter Study of Cryoablation for Palliation of Painful Bone MetastasesNCT02511678results2019-09-04Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: CryoablationPain, Neoplasm Metastasis, Bone Metastasis of Diverse Origins732018-03-12actual—2021-07-19
Longitudinal Surveillance Registry (LSR) of ACUITY SpiralNCT00955708results2019-05-02observationalChronic Left Ventricular Lead-related Complication Free RateStudy Protocol ↗ · Statistical Analysis Plan ↗—Terminatedsponsor's stated reason: Early termination was granted by FDA based on study results meeting the post approval requirements.Device: ACUITY Spiral Left Ventricular LeadHeart Failure1,3082018-02-28actual—2019-05-02
Pre-operative Biliary SEMS RCT During Neoadjuvant TherapyNCT02238847results2020-02-17Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive SymptomsRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemPancreatic Cancer1192018-02-21actual—2020-02-17
Registry on WATCHMAN Outcomes in Real-Life Utilization WASP RegistryNCT01972295observationalProcedural complications, Stroke and Death—Completed—Atrial Fibrillation2012018-01-23actual—2019-08-21
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary IncontinenceNCT01784588results2019-06-06Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective MeasuresNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Solyx Single Incision Sling System, Obtryx II Sling SystemStress Urinary Incontinence2812018-01-17actual—2021-02-10
ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® StentNCT02574481results2019-01-07Percentage of Participants With Major Adverse Events (MAEs)Randomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: ELUVIA (Stent Implantation), Zilver PTX (Stent Implantation)Atherosclerosis of Native Arteries of the Extremities5242017-12-28actual—2023-05-08
Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil TreatmentNCT02499380results2019-06-25observationalChanges in 6 Minute Walk Distance (6MWD)Study Protocol ↗ · Statistical Analysis Plan ↗—Terminatedsponsor's stated reason: Study enrollment was prematurely stopped.Device: PneumRx Coil SystemEmphysema202017-12-08actual—2021-07-19
VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow ObstructionNCT02112877results2019-07-30Number of Participants With Major Adverse Events (MAE)Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Veniti Vici™ Venous Stent SystemChronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein2002017-12-05actual—2021-04-15
PROPPER Prospective Registry of Outcomes With Penile ProsthesisNCT01383018results2020-02-18observationalNumber of Participants With Penile Prosthesis Overall Subject SatisfactionStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: AMS Penile Prosthesis DevicesErectile Dysfunction, Impotence1,4572017-11-30actual—2021-02-12
Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular SystemNCT02159521results2020-02-18Change From Baseline in Villalta Score at Day 30 Post-EkoSonic® Study Treatment ProcedureOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Phase 4CompletedDevice: EkoSonic® Endovascular System · Biological: AlteplaseDeep Vein Thrombosis, Post-thrombotic Syndrome812017-11-30actual—2021-07-19
Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPHNCT02683980results2025-11-25Ablation TimeOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Lumenis Pulse P120H and Xpeeda side firing fiberTreatment of Benign Prostatic Hyperplasia202017-11-01actual—2025-11-25
ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot TrialNCT02764203Change in resting systolic blood pressure after daily dark chocolateOpen-label · Basic scienceNot applicableCompletedOther: Dark Chocolate · Device: Wearable devicesHealth Behavior, Blood Pressure672017-09-12actual—2017-10-04
Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)NCT02392351results2019-10-04OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 WeeksRandomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Renal Denervation (Vessix), Renal AngiographyHypertension512017-09-07actual—2021-02-11
LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)NCT02059057results2018-09-25Mean Change in Six Minute Walk Test (6MWT)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableTerminatedsponsor's stated reason: FDA approval of supplementation to IDE/protocol amendment to terminate subject long term follow upDevice: LVRC SystemEmphysema102Jun 2017actual—2021-07-19
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)NCT02733653results2018-09-10Primary Patency RateOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: Jetstream Atherectomy SystemPeripheral Arterial Disease602017-06-29actual—2019-01-08
iNod System Human Feasibility AssessmentNCT02832284results2018-11-23Acquisition of Adequate Specimens of Targeted Lung LesionsOpen-label · DiagnosticStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: iNod SystemSolitary Pulmonary Nodule, Biopsy, Fine-Needle232017-06-08actual—2021-02-11
Evaluation of PCLs Using Three EUS-FNA NeedlesNCT01711294results2020-11-12Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal VolumeRandomized · Open-label · DiagnosticStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: 19 G Flex Needle, 22 G Needle, 19 G NeedlePancreatic Cystic Lesions2502017-06-06actual—2021-01-15
A Study of ONCO-DOX in Locally Advanced Hepatocellular CarcinomaNCT02460991results2017-11-08Overall SurvivalRandomized · Open-label · TreatmentStudy Protocol, Statistical Analysis Plan, and Informed Consent Form ↗Phase 3Terminatedsponsor's stated reason: Slow enrollmentDevice: DEB-TACE · Drug: SorafenibHepatocellular Carcinoma, Hepatoma, Liver Cell Carcinoma22017-06-05actual—2021-02-12
The Captivator EMR RegistryNCT02482701observationalSuccessful endoscopic resection defined as complete resection of the delineated area, including all delineation markings, in a single procedure.—CompletedDevice: Captivator™ EMRBarrett's Esophagus291May 2017actual—2018-03-07
Prospective Registry on User Experience With The Mapping System For Ablation ProceduresNCT02698670observationalAcute Procedural Success—CompletedDevice: Rhythmia mapping system, IntellaMap Orion mapping catheterCardiac Arrhythmias577May 2017actual—2018-01-25
Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal VeinNCT01887717results2019-10-29Overall Survival (OS) From Time of RandomizationRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Phase 3Terminatedsponsor's stated reason: Poor Accrual.Device: TheraSphere® · Drug: SorafenibHepatocellular Carcinoma362017-05-23actual—2021-04-21
Rezum FIM Optimization StudyNCT02940392results2021-03-05Change in International Prostate Symptom ScoreOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Rezum SystemBenign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma, Prostatic Hyperplasia, Benign, Prostatic Hypertrophy, Prostatic Hypertrophy, Benign, Rezum152017-05-19actual—2021-03-05
ENABLE MRI (Magnetic Resonance Imaging)NCT02652481results2019-07-16Percentage of Participants Free From MR (Magnetic Resonance) Scan-related ComplicationsOpen-label · DiagnosticStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: ImageReady MR Conditional Defibrillation SystemMagnetic Resonance Imaging5002017-04-30actual—2021-01-25
Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation LeadsNCT02071173results2020-10-30Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 MonthsOpen-label · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗Not applicableCompletedDevice: ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation leadCardiac Resynchronization Therapy2,2442017-04-19actual—2021-01-07
RESPOND Post Market StudyNCT02031302results2019-11-12observationalAll-cause MortalityStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: Lotus Valve SystemAortic Valve Stenosis1,0642017-04-04actual—2021-11-19
Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)NCT02488239results2019-09-20observationalPercentage of Participants Without CRT-P Device Related ComplicationsStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: CRT-P indicated patientsPost Market Surveillance Study Following Clinical Routine64Mar 2017actual—2019-09-20
Study of Cryoablation for Metastatic Lung TumorsNCT01957787results2019-08-28Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗Not applicableCompletedDevice: CryoablationNeoplasm Metastasis1312017-03-09actual—2021-07-19
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve ReplacementNCT02202434results2019-07-30Percentage of Participants With Events Included in the Primary Safety EndpointRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableTerminatedsponsor's stated reason: RCT/Roll-in completed. CAS/21mm/Nested Registry terminated (investigational device is no longer available)Device: Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve SystemAortic Stenosis1,4252017-03-08actual—2021-12-17
Investigating Superion™ In Spinal StenosisNCT00692276results2020-08-25Percentage of Subjects With Clinically Significant Improvement in OutcomesRandomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Superion™ Interspinous Spacer, X-STOP® IPD® DeviceLumbar Spinal Stenosis, Intermittent Claudication391Feb 2017actual—2020-11-16
CoverEdge Algorithm Programming StudyNCT02492880results2018-08-07Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing QuestionnaireOpen-label · Basic scienceStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Precision Spectra™ SCS system programming featuresChronic Pain152017-02-21actual—2022-11-04
FAST Feasibility StudyNCT02470884Clinical Procedural SuccessOpen-label · TreatmentNot applicableCompletedDevice: Boston Scientific Fully Absorbable ScaffoldCoronary Artery Disease332017-01-31actual—2022-06-22
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting SettingsNCT02683993results2025-11-10Stone ClearanceRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiberStone Clearance202017-01-31actual—2026-01-14
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)NCT02491255Primary Safety Endpoint: Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complicationsOpen-label · TreatmentNot applicableCompletedDevice: Lotus Valve SystemAortic Stenosis702017-01-30actual—2021-09-28
Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception AmplitudeNCT02314000results2019-04-12Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From BaselineRandomized · Open-label · TreatmentNot applicableCompletedDevice: Precision or Precision Spectra Spinal Cord Stimulator SystemChronic Pain229Dec 2016actual—2021-02-11
Microparticle Enhanced Cytotoxic Transarterial Embolization TherapyNCT02694562results2019-02-15Freedom From Serious Adverse Events RateOpen-label · TreatmentNot applicableCompletedDevice: 40um Embozene TANDEM MicrospheresColorectal Carcinoma18Dec 2016actual—2019-02-15
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's DiseaseNCT01839396results2018-08-15Change in ON Time as Measured by Parkinson's Disease DiaryRandomized · Triple-masked · TreatmentNot applicableCompletedDevice: Deep Brain StimulationParkinson's Disease3132016-12-27actual—2023-07-13
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2NCT01715558observationalCombined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature—Completed—Bradyarrhythmia514Nov 2016actual—2017-05-09
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial FibrillationNCT01687166results2018-06-18Procedure-related Complication Free RateRandomized · Single-masked · TreatmentNot applicableCompletedDevice: Blazer Open-Irrigated Ablation Catheter (Boston Scientific), FDA Approved Open-Irrigated Ablation CatheterParoxysmal Atrial Fibrillation (PAF)398Oct 2016actual—2018-11-21
A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient OutcomesNCT02384096results2018-07-19Number of Participants With Paresthesia Coverage ≥50%Randomized · Single-masked · OtherNot applicableTerminatedDevice: Conventional single source programming, Precision Spectra SCS System advanced programmingChronic Pain17Oct 2016actual—2020-11-20
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve SystemNCT02854319Mean aortic valve pressure gradientOpen-label · TreatmentNot applicableTerminatedsponsor's stated reason: Investigational Medical Device is not available and the 15 patients enrolled completed their 1-yr follow-up per protocolDevice: LOTUS Edge Valve SystemAortic Valve Stenosis152016-10-25actual—2018-05-31
REPRISE Next Generation Delivery SystemNCT02329496Technical SuccessOpen-label · TreatmentNot applicableCompletedDevice: Lotus Valve and LOTUS Edge Valve SystemAortic Stenosis382016-10-06actual—2018-05-24
Self-Centering Guide Catheter Feasibility StudyNCT02639494results2018-08-29Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left VentricleOpen-label · Device feasibilityNot applicableCompletedDevice: Self-Centering Guide CatheterAortic Stenosis202016-10-06actual—2018-08-29
Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 StudyNCT02066467results2019-09-20observationalPhrenic Nerve Complication Free Rate—CompletedDevice: Left Ventricular lead implant: ACUITY X4® Lead FamilyHeartfailure863Sep 2016actual—2019-09-20
PLATINUM DiversityNCT02240810results2019-05-10observationalComposite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)—CompletedDevice: Percutaneous coronary intervention (Promus PREMIER)Atherosclerosis, Coronary Artery Disease1,501Sep 2016actual—2019-05-15
Short Term Pancreatic Stenting RegistryNCT02262845observationalClinical Success: Group A (PEP Risk)—CompletedDevice: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and PushersPost-ERCP Acute Pancreatitis, Pancreatic Duct Stricture, Pancreatic Duct Stones, Pancreatic Duct Leakage246Sep 2016actual—2017-03-21
SpyGlass AMEA RegistryNCT02281019observationalProcedural success for indeterminate strictures or undefined filling defects—CompletedProcedure: ERCP (Endoscopic Retrograde Cholangiopancreatography) · Device: SpyGlass DVS and SpyGlass Digital Simple (DS)Biliary Stricture, Biliary Obstruction Due to Common Bile Duct Stone, Periampullary Tumor, Hemobilia526Sep 2016actual—2019-07-10
WallFlex Esophageal Fully Covered (FC) Benign Anastomotic StrictureNCT01699542results2021-06-28Number of Dilation ProceduresRandomized · Open-label · TreatmentNot applicableCompletedDevice: WallFlex Esophageal RX Fully Covered Stent, Esophageal Bougie Dilator Per Investigator preferenceRefractory Anastomotic Esophageal Strictures182016-09-25actual—2021-06-28
The SENTRY Clinical StudyNCT01975090results2017-10-12Number of Subjects That Reported Clinical SuccessOpen-label · PreventionNot applicableCompletedDevice: SENTRY IVC FilterPulmonary Embolism, Deep Vein Thrombosis129Aug 2016actual—2021-10-27
INGEVITY™ Observational TrialNCT02166606results2019-08-20observationalPercentage of Leads Free From Complication—CompletedDevice: ImageReady MR Conditional Pacing System ImplantBradycardia1,184Jun 2016actual—2021-03-30
Quadripolar CRT-D On Currently Approved Lead SystemSNCT02232984results2019-02-18observationalNumber of Vectors With Phrenic Nerve Stimulation (PNS)—Completed—Heart Failure749Apr 2016actual—2019-04-09
SpyGlass Direct Visualization System Clinical Registry in ChinaNCT02287194observationalProcedural success rate—CompletedDevice: SpyGlassBiliary Tract Diseases1972016-04-30actual—2018-07-31
Prospective, Multi-Center All-Comer Biliary Canadian WallFlex RegistryNCT02261623observationalStent Functionality—CompletedDevice: WallFlex™ Biliary RX Fully Covered Stent System RMV, WallFlex™ Biliary RX Partially Covered Stent System, WallFlex™ Biliary RX Uncovered Stent SystemBiliary Strictures4152016-03-31actual—2020-01-06
Low Energy Therapy to Convert Ventricular TachycardiasNCT02891863results2017-07-17System and Procedure Related Adverse EventsOpen-label · TreatmentEarly Phase 1Terminatedsponsor's stated reason: FutilityDevice: LEVER Acute Study SystemVentricular Tachycardia9Mar 2016actual—2017-07-17
Observation of ImageReady™ MR Conditional Pacing System in ChinaNCT02636712results2020-01-27observationalPercentage of Participants Without Complications at MRI Visit + 1 Month.—CompletedDevice: ImageReady™ MR Conditional Pacing SystemArhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block, Carotid Sinus Hypersensitivity Reaction Syndrome, Vasovagal Syncope102016-03-16actual—2020-04-08
The Jetstream (JET) Post-market RegistryNCT01436435results2016-08-26Binary RestenosisOpen-label · TreatmentPhase 4CompletedDevice: Jetstream Atherectomy SystemPeripheral Arterial Diseases241Feb 2016actual—2016-10-19
Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra SystemNCT01638468results2016-11-01Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by EchocardiographyOpen-label · TreatmentPhase 4Terminatedsponsor's stated reason: Slow EnrollmentDevice: AngioJet Ultra PE Thrombectomy SystemPulmonary Embolism7Jan 2016actual—2018-12-05
Evaluation of Automatic Threshold AlgorithmsNCT02097290results2017-09-01Primary Safety Endpoint is to Evaluate the System-related Complication-free RateOpen-label · TreatmentNot applicableCompletedDevice: CRT-DHeart Failure216Jan 2016actual—2018-04-19
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) StudyNCT01608490results2017-06-27Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow upRandomized · Open-label · TreatmentNot applicableTerminatedsponsor's stated reason: FDA approval of supplementation to IDE to terminate subject long term follow upDevice: RePneu Lung Volume Reduction Coil SystemEmphysema315Dec 2015actual—2021-07-19
Post-Approval Study of PROMUS Element™ in ChinaNCT01677585observationalTarget Lesion Failure (TLF) rate—Completed—Coronary Artery Disease2,016Dec 2015actual—2022-02-24
COMFORT: A Multicenter, Open-label, Randomized, Crossover StudyNCT02462720results2018-01-23PainRandomized · Open-label · TreatmentPhase 4CompletedDrug: Varithena® · Device: Radiofrequency ablationVaricose Veins35Dec 2015actual—2021-04-21
Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade GliomaNCT02481960Safety measured by incidence of adverse events as assessed by CTCAE v4Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: The decision to terminate the trial was based on the slow rate of recruitment across the programme of studies\]Procedure: CM-BC2 Irinotecan drug-eluting beadGlioma52015-12-18actual—2021-04-21
Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISENCT01775735results2018-11-02Change in the Number of Moderate-to-severe Headache Days Per MonthRandomized · Double-masked · TreatmentNot applicableTerminatedDevice: Occipital nerve stimulatorMigraine Disorders282015-12-01actual—2020-11-13
Esophageal Fully Covered Metal Stents in Caustic Strictures StudyNCT01899300results2021-02-12Clinical SuccessOpen-label · TreatmentNot applicableCompletedDevice: Metal Stent (WallFlex™ Esophageal RX)Refractory Benign Esophageal Strictures Caused by Caustic Ingestion1Nov 2015actual—2021-02-12
Registry on WATCHMAN Outcomes in Real-Life UtilizationNCT01972282results2019-05-07observationalProcedural ComplicationsStudy Protocol and Statistical Analysis Plan ↗—CompletedDevice: WATCHMAN Left Atrial Appendage ClosurePatients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke1,025Nov 2015actual—2019-05-07
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation LeadNCT01856491results2017-11-20Complication Free RateOpen-label · TreatmentNot applicableCompletedDevice: RELIANCE 4-FRONT™ Passive Fixation lead implantationTachycardia, Ventricular Fibrillation, Ventricular Flutter1672015-11-02actual—2019-04-30
SYNERGY China: Assess SYNERGY Stent in ChinaNCT02499692results2016-01-18Technical Success RateOpen-label · TreatmentNot applicableCompletedDevice: SYNERGYTM Coronary Stent SystemCardiovascular Diseases103Oct 2015actual—2020-09-16
Study of Intraparenchymal Therapy as Adjunct Therapy in Patients With Recurrent, Resectable Glioblastoma Multiforme.NCT02433392Safety measured by incidence of adverse events as assessed by CTCAE v4.0Open-label · TreatmentPhase 1Terminatedsponsor's stated reason: The decision to terminate the trial was based on the slow rate of recruitment across the programme of studiesProcedure: CM-BC2Glioma9Jul 2015actual—2021-04-21
Pancreatic Metal Stents in Chronic PancreatitisNCT02135809Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitisOpen-label · TreatmentNot applicableCompletedDevice: WallFlex Pancreatic StentRefractory Pancreatic Duct Strictures, Painful Chronic Pancreatitis10Jun 2015actual—2019-07-09
Safety and Efficacy of Cryoablation for the Palliation of Painful Bone MetastasesNCT01461265Difference in worst pain scoresOpen-label · Supportive carePhase 1CompletedProcedure: CryoablationPain, Neoplasm Metastasis29Apr 2015actual—2021-07-16
Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)NCT01912339results2017-05-15Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-UpRandomized · Single-masked · TreatmentNot applicableCompletedDevice: Rezum System · Procedure: Rigid CystoscopyBenign Prostatic Hyperplasia, Lower Urinary Tract Symptom197Mar 2015actual—2020-04-13
Treatment of Resistant Hypertension by Renal Denervation in ChinaNCT02027012The mean reduction of systolic blood pressure measured by office-based blood pressure assessmentOpen-label · TreatmentNot applicableTerminatedsponsor's stated reason: company strategic changeDevice: Percutaneous renal denervation with the Vessix™ Renal Denervation SystemMedication-resistant Hypertension1Mar 2015actual—2020-09-14
The ACE Follow-up StudyNCT01429194SafetyOpen-label · TreatmentNot applicableCompletedProcedure: ACE StaplerObesity69Feb 2015actual—2015-06-16
Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) ConnectorNCT01643213results2016-06-13Subject's Treatment PreferenceRandomized · Double-masked · TreatmentNot applicableCompletedDevice: Non Boston Scientific SCS Trial Therapy, BSC approved SCS Trial Therapy w/ OMGChronic Pain27Feb 2015actual—2020-11-13
Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic CancerNCT01335945Abdominal pain reduction following cryoablation of the celiac plexusOpen-label · Supportive carePhase 1Terminatedsponsor's stated reason: Low enrollment \& subjects didn't survive to study end due to cancer progression.Procedure: CryoablationPain, Pancreatic Cancer14Jan 2015actual—2021-07-16
Safety and Performance Study of the INGEVITY LeadNCT01688843results2017-11-17Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)Open-label · TreatmentNot applicableCompletedDevice: INGEVITY leadBradycardia, Sinus Node Dysfunction1,060Jan 2015actual—2020-03-10
Evaluation of Multisensor Data in Heart Failure Patients With Implanted DevicesNCT01128166observationalHeart Failure (HF) events—CompletedDevice: COGNIS CRT-DHeart Failure975Dec 2014actual—2015-10-21
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery ProjectNCT01820637results2019-03-22Primary PatencyOpen-label · TreatmentNot applicableCompletedDevice: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)Atherosclerosis of Native Arteries of the Extremities57Dec 2014actual—2019-03-22
CUSTOM-DBS: Current Steering to Optimize Deep Brain StimulationNCT01896115results2017-02-16Therapeutic WindowRandomized · Double-masked · Basic scienceNot applicableCompletedDevice: Vercise DBS settingsParkinson's Disease40Dec 2014actual—2020-11-19
Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular CarcinomaNCT01798134results2016-06-27Freedom From Serious Adverse Event (SAE) at 30daysOpen-label · TreatmentNot applicableCompletedDevice: TANDEM™Hepatocellular Carcinoma25Nov 2014actual—2016-10-03
GreenLight XPS Laser System Retrospective Chart ReviewNCT02139969results2020-11-09observationalInternational Prostate Symptom Score (IPSS)—CompletedDevice: GreenLight XPS Laser SystemBenign Prostatic Hyperplasia956Nov 2014actual—2020-11-09
Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPHNCT01218672results2020-09-03International Prostate Symptom Score (IPSS)Randomized · Open-label · TreatmentNot applicableCompletedDevice: Photoselective Vaporization of the Prostate, Transurethral Resection of the ProstateBenign Prostatic Hyperplasia291Oct 2014actual—2020-09-03
ImageReady(TM) MR Conditional Pacing System Clinical StudyNCT01781078results2017-04-11Proportion of Participants Without MR Scan-related ComplicationsRandomized · Open-label · TreatmentNot applicableCompletedRadiation: MRI · Device: ImageReady System implantBradycardia, Sinus Node Dysfunction363Oct 2014actual—2019-12-03
The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)NCT01665053results2016-01-07Percentage of Participants With Target Lesion Failure (TLF) at 12 MonthsRandomized · Single-masked · TreatmentPhase 3CompletedDevice: PROMUS Element Plus, SYNERGYCoronary Artery Disease1,684Sep 2014actual—2019-01-30
PROMUS Element Plus US Post-Approval StudyNCT01589978results2016-05-03Cardiac Death or Myocardial Infarction Rate in PLATINUM-like PatientsOpen-label · TreatmentPhase 4CompletedDevice: PROMUS Element Plus Coronary Stent System · Drug: Aspirin, P2Y12 antagonistCoronary Artery Disease2,681Aug 2014actual—2018-07-26
EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)NCT01787799results2016-03-16In-stent Late LossOpen-label · TreatmentPhase 3CompletedDevice: SYNERGYAtherosclerotic Lesion(s)100Aug 2014actual—2016-03-16
SuperNOVA Clinical Stenting TrialNCT01292928results2016-01-20Primary Safety Endpoint and ComponentsOpen-label · TreatmentNot applicableCompletedDevice: Stent implantationAtherosclerosis of Native Arteries of the Extremities, Unspecified299Jul 2014actual—2017-03-08
SpaceOAR System Pivotal StudyNCT01538628results2021-03-19Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel InjectionRandomized · Single-masked · TreatmentPhase 3CompletedDevice: SpaceOAR SystemProstate Cancer222Jul 2014actual—2021-03-19
The EVOLVE China Clinical TrialNCT01966159results2016-02-18The In-stent Late Loss Measured by Quantitative Coronary AngiographyRandomized · Single-masked · TreatmentNot applicableCompletedDevice: SYNERGY Investigational Device, PE Plus Investigational DeviceCoronary Artery Disease412Jul 2014actual—2023-11-15
Safety and Performance Study of the Reliance 4-Front LeadNCT01772576results2017-06-02Complication Free RateOpen-label · TreatmentNot applicableCompletedDevice: Reliance 4-Front lead implantationTachycardia167Jun 2014actual—2017-07-02
PE PREMIER CHINA CLINICAL TRIALNCT02230254results2022-05-12Technical Success RateOpen-label · TreatmentNot applicableCompletedDevice: Percutaneous coronary intervention PROMUS PREMIERAtherosclerosis1012014-06-22actual—2022-05-12
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable PainNCT01665040results2019-01-03Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG ImplantationOpen-label · TreatmentNot applicableCompletedDevice: Neurostimulation device implantationChronic Pain40May 2014actual—2020-11-19
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystemNCT01627691results2019-09-10Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant ProcedureOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗Not applicableCompletedDevice: Lotus Valve SystemTranscatheter Aortic Valve Replacement2502014-05-30actual—2020-05-12
MADIT ASIA Cardiac Resynchronization TrialNCT01872234Primary EndpointRandomized · Open-label · TreatmentPhase 3Terminatedsponsor's stated reason: The study encountered significant difficulties in patient enrollment.Device: Two-lead CRT-PCongestive Heart Failure, Left Bundle Branch Block, Heart Failure, Systolic1Apr 2014actual—2014-04-30
Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone MetastasesNCT01461252Difference in worst pain scoresOpen-label · Supportive carePhase 1Withdrawnsponsor's stated reason: No patients were treated due to enrollment challenges.Procedure: Cryoablation, RadiationPain, Neoplasm Metastasis0Mar 2014actual—2021-07-16
Multiple Areas of Pain (MAP)NCT01583894results2014-12-30observationalMulti-site Pain Index—Completed—Chronic Pain828Mar 2014actual—2020-11-25
IntellaTip MiFi XP Ablation Catheter TrialNCT01730807Acute Procedural SuccessOpen-label · TreatmentNot applicableCompletedDevice: IntellaTip MiFi XP CatheterAtrial Flutter10Feb 2014actual—2017-05-04
Signal Transfer of Atrial Fibrillation Data to Guide Human TreatmentNCT01765075observationalRecord 20 sets of electrophysiological data with a multi-electrode mapping catheter.—Completed—Permanent Atrial Fibrillation25Feb 2014actual—2014-03-05
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRINCT01890512results2014-06-05observationalNumber of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit—Completed—Bradycardia20Jan 2014actual—2016-02-05
Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and CatheterNCT01642537Major device related adverse cardiac and cerebrovascular eventsOpen-label · DiagnosticNot applicableCompletedDevice: Rhythmia Mapping System and the Rhythmia Mapping CatheterCardiac Arrhythmias7Dec 2013actual—2021-06-04
Embozene Microspheres for Uterine Fibroid Embolization (UFE)NCT01675011results2015-02-12Primary EndpointRandomized · Double-masked · TreatmentNot applicableTerminatedsponsor's stated reason: Inadequate enrollmentDevice: Embozene® Microspheres, Embosphere®Uterine Fibroids4Dec 2013actual—2016-03-11
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery SystemNCT03043404Technical successOpen-label · TreatmentNot applicableCompletedDevice: Transcatheter aortic valve replacementAortic Stenosis42013-12-10actual—2019-07-05
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty CatheterNCT01541865results2015-10-16Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure AssessmentOpen-label · TreatmentNot applicableCompletedDevice: Renal DenervationHypertension146Nov 2013actual—2015-11-25
Shockless Implant EvaluationNCT00800384results2015-12-22First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic DeathRandomized · Single-masked · Supportive careNot applicableCompletedDevice: Implantable defibrillatorVentricular Fibrillation, Ventricular Tachycardia2,500Oct 2013actual—2018-03-30
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval RegistryNCT01294449results2014-12-04observationalAll-Cause Mortality—CompletedDevice: MADIT-CRT ICD, MADIT-CRT CRT-DHeart Failure394Oct 2013actual—2014-12-04
The OMEGA Clinical TrialNCT01419171results2014-08-159-month Target Lesion Failure (TLF) RateOpen-label · TreatmentNot applicableCompletedDevice: OMEGA™ Monorail Coronary Stent SystemAtherosclerosis, Coronary Artery Disease328Oct 2013actual—2014-09-25
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDicationsNCT00976482results2016-12-02observationalTwo-year All-cause Mortality—Completed—Bradyarrhythmia1,745Sep 2013actual—2017-02-01
Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial FlutterNCT01253200results2018-02-15Procedure-related Complication-free RateRandomized · Single-masked · TreatmentNot applicableCompletedDevice: Blazer® Open-Irrigated Ablation Catheter, Control CatheterAtrial Flutter302Sep 2013actual—2018-03-19
High Rate Spinal Cord Stimulation (SCS) for Chronic PainNCT01624740results2015-03-20Change in Back Pain IntensityRandomized · Double-masked · TreatmentNot applicableCompletedDevice: Low Rate Stimulation, High Rate StimulationChronic Pain20Sep 2013actual—2015-03-20
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial FibrillationNCT00129545results2015-05-15Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained DeathRandomized · Open-label · PreventionPhase 2/3CompletedDevice: WATCHMAN Left Atrial Appendage Closure Technology · Drug: WarfarinAtrial Fibrillation, Stroke800Aug 2013actual—2015-05-15
Registry of AngioJet Use in the Peripheral Vascular SystemNCT01086215results2014-11-03observationalChange in Degree of Occlusion From Baseline to Final Angiogram/Venogram.—Completed—Peripheral Vascular Disease, Embolism and Thrombosis, Venous Thrombosis500Jul 2013actual—2014-11-10
Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)NCT01334307St. George's Respiratory Questionnaire (SGRQ)Randomized · Open-label · TreatmentPhase 1CompletedDevice: Lung Volume Reduction Coil (LVRC) (PneumRx), ControlEmphysema47Jun 2013actual—2021-07-21
ION US Post-Approval StudyNCT01422889results2015-03-20observationalCardiac Death or Myocardial Infarction (CD/MI)—CompletedDevice: ION™ Coronary Stent SystemAtherosclerosis, Coronary Artery Disease1,120Jun 2013actual—2016-02-04
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery SyndromeNCT01036529results2013-10-28Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other TreatmentRandomized · Open-label · TreatmentPhase 4Terminatedsponsor's stated reason: Closed due to continued slow enrollment.Device: Precision Spinal Cord Stimulator · Procedure: Back SurgeryFailed Back Surgery Syndrome, Pain, Back Pain28May 2013actual—2020-11-16
Vercise Implantable Stimulator for Treating Parkinson's DiseaseNCT01221948results2015-11-13Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).Open-label · TreatmentPhase 2CompletedDevice: Deep Brain StimulationIdiopathic Parkinson's Disease53May 2013actual—2025-02-05
ULTrasound Accelerated ThrombolysIs of PulMonAry EmbolismNCT01166997results2016-10-18Reduction of RV/LV RatioRandomized · Single-masked · TreatmentPhase 3CompletedDevice: EkoSonic Endovascular System · Drug: Unfractionated heparinSubmassive Pulmonary Embolism59Apr 2013actual—2021-07-19
Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal ArteriesNCT01500031results2014-04-15Composite Rate of Major Adverse EventsOpen-label · TreatmentPhase 4CompletedDevice: OffRoad Re-entry Catheter SystemChronic Total Occlusion92Apr 2013actual—2014-04-15
Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord StimulationNCT01550562results2021-04-29Pain ReliefRandomized · Double-masked · TreatmentNot applicableTerminatedsponsor's stated reason: In \>9 months only 1 patient enrolled. Study stopped because design was too cumbersome and subjects not willing to participateDevice: Boston Scientific Precision Plus spinal cord stimulation therapyLow Back Pain1Apr 2013actual—2021-04-29
TAXUS Libertē Post Approval StudyNCT00997503results2015-04-13observationalCardiac Death or Myocardial Infarction—CompletedDevice: TAXUS Liberté Paclitaxel-Eluting Coronary Stent · Drug: prasugrel, placebo, aspirinCoronary Artery Disease4,199Mar 2013actual—2015-08-07
TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)NCT01242696observationalTarget Vessel failure—CompletedProcedure: Coronary artery stentingCoronary Heart Disease1,014Mar 2013actual—2017-02-03
Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ StentNCT01285999results2024-11-209 Month In-stent Late LossRandomized · Single-masked · TreatmentNot applicableCompletedDevice: PROMUS Element Coronary Stent System, TAXUS Liberté Coronary Stent SystemAtherosclerosis, Coronary Artery Disease500Mar 2013actual—2025-03-11
Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous EmphysemaNCT014210826 minute walk test (6MWT)Open-label · TreatmentPhase 2/3CompletedDevice: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)Emphysema10Mar 2013actual—2021-07-16
NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary LesionsNCT01703000results2014-03-21Technical Success RateOpen-label · TreatmentNot applicableCompletedDevice: Percutaneous coronary intervention (NG PROMUS)Atherosclerosis, Coronary Artery Disease100Mar 2013actual—2014-04-15
Rezum I Pilot Study for Benign Prostatic HyperplasiaNCT02943070results2021-02-24International Prostate Symptom Score (IPSS) Change From BaselineOpen-label · TreatmentNot applicableCompletedDevice: Rezum SystemProstatic Hyperplasia, Benign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma, Prostatic Hyperplasia, Benign, Prostatic Hypertrophy, Prostatic Hypertrophy, Benign, Rezum50Feb 2013actual—2021-03-16
Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis TherapyNCT01513759results2019-07-05Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of TherapyOpen-label · TreatmentPhase 3CompletedDrug: recombinant tissue plasminogen activator · Device: EKOS EkoSonic Endovascular SystemPulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism1502013-02-17actual—2021-07-19
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin TherapyNCT01182441results2018-07-26Primary Safety Endpoint (Device Group Only)Randomized · Open-label · TreatmentPhase 3CompletedDevice: WATCHMAN Device · Drug: WarfarinAtrial Fibrillation, Stroke407Jan 2013actual—2018-07-26
Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)NCT01328899St. George's Respiratory QuestionnaireOpen-label · TreatmentPhase 1/2CompletedDevice: Lung Volume Reduction Coil (LVRC) (PneumRx's)Emphysema60Jan 2013actual—2021-07-21
A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary IncontinenceNCT00998790results2018-10-22Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-upOpen-label · TreatmentNot applicableCompletedDevice: American Medical Systems (AMS) AdVance™ Male Sling SystemStress Urinary Incontinence114Dec 2012actual—2018-10-22
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation CatheterNCT01635881results2013-11-06Device Procedural SuccessOpen-label · TreatmentPhase 3CompletedDevice: Emerge™ 1.20 mm PTCA Dilatation CatheterCoronary Artery Disease60Dec 2012actual—2013-11-06
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure PatientsNCT00345592results2014-06-11Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial FibrillationRandomized · Open-label · TreatmentPhase 4CompletedDevice: Dual (atrial and ventricular) implantable defibrillator, Dual (atrial and ventricular) implantable defibrillator, Dual (atrial and ventricular) implantable defibrillatorHeart Failure, Congestive420Nov 2012actual—2017-03-28
WallFlex Biliary Fully Covered (FC) Benign Stricture StudyNCT01014390results2020-02-19Stent RemovabilityNon-randomized · Open-label · TreatmentPhase 3CompletedDevice: WallFlex Biliary RX Fully Covered Stent SystemBiliary Stricture187Nov 2012actual—2020-02-19
WallFlex Biliary Post Liver Transplant IDE PilotNCT01151280results2013-07-19Stricture Resolution at the Time of Stent Removal.Open-label · TreatmentNot applicableCompletedDevice: WallFlex Biliary Fully Covered StentAnastomotic Biliary Stricture Post Orthotopic Liver Transplant10Oct 2012actual—2013-12-25
Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation LeadNCT00180297results2021-07-01Implant Success Rate at Septal SiteRandomized · Single-masked · OtherNot applicableCompletedDevice: Endotak Reliance GVentricular Tachycardia, Ventricular Fibrillation215Sep 2012actual—2021-10-14
Japanese Assessment of Indication Based ProgrammingNCT01143220observationalProportion of patients that are programmed by the physician to anything other than the specific IBP parameter settings—CompletedOther: No specific interventionsHeart Failure, Arrhythmias, Cardiac235Sep 2012actual—2017-02-23
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)NCT01196897Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.Open-label · TreatmentNot applicableCompletedDevice: WATCHMAN LAA Closure Technology (Gen 4.0)Atrial Fibrillation69Sep 2012actual—2015-12-08
AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of EffectivenessNCT01350414results2016-09-26observationalSevere Exacerbations—CompletedDevice: Bronchial Thermoplasty with the Alair SystemAsthma181Sep 2012actual—2016-09-26
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate TherapyNCT00947310results2013-04-18Inappropriate ICD TherapyRandomized · Single-masked · TreatmentNot applicableCompletedDevice: Standard ICD programming, High rate cutoff, Long delayPrimary Prevention of Sudden Cardiac Arrest1,500Aug 2012actual—2018-08-08
Physiological Response to Exercise: Sensor Evaluation at Specified ExertionsNCT01229137observational—CompletedDevice: SRD-1 conversionHeart Failure71Aug 2012actual—2012-09-12
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance StudyNCT01148329observationalTarget Vessel Failure (TVF)—CompletedDevice: Coronary stentingCoronary Heart Disease1,010Jun 2012actual—2017-02-02
Ingenio Device Algorithm StudyNCT01441583results2024-03-21Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)Randomized · Single-masked · TreatmentNot applicableCompletedDevice: RAAT, RYTHMIQSinus Node Disease, AV Block, Heart Failure139Jun 2012actual—2024-03-21
ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0NCT01539629observationalCollect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.—CompletedDevice: Cardiac pacingHeart Failure50Jun 2012actual—2012-12-05
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEmNCT01383720results2016-05-09Clinical Procedural SuccessOpen-label · TreatmentNot applicableCompletedDevice: Lotus Valve SystemAortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease11May 2012actual—2017-06-20
High Septal Pacing for Cardiac Resynchronization TherapyNCT01325480observational—TerminatedDevice: Cardiac PacingHeart Failure, Left Bundle Branch Block, Heart Disease15Apr 2012actual—2012-06-21
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible VaricositiesNCT01197833results2014-09-15Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)Randomized · Double-masked · TreatmentPhase 3CompletedDrug: endovenous ablation+polidocanol injectable microfoam 0.125%, Endovenous ablation+polidocanol injectable microfoam 1.0%, Endovenous ablation+polidocanol injectable foam 2.0%Great Saphenous Vein Incompetence, Visible Varicosities117Mar 2012actual—2021-04-21
Detection of Phrenic Nerve Stimulation Using Sensors' SignalsNCT01233323observationalData collection—Completed—Heart Failure60Mar 2012actual—2017-02-03
The Jetstream G3™ Calcium StudyNCT01273623results2015-05-04Luminal Area ChangeOpen-label · TreatmentPhase 4CompletedDevice: Jetstream Atherectomy SystemPeripheral Arterial Disease55Mar 2012actual—2015-11-18
ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure TechnologyNCT00851578Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatmentOpen-labelNot applicableCompletedDevice: WATCHMANAtrial Fibrillation150Feb 2012actual—2015-01-27
Restoration of Atrioventricular Synchrony TrialNCT01275833results2017-06-26Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.Randomized · Open-label · OtherNot applicableTerminatedsponsor's stated reason: Difficult subject recruitmentDevice: Cardiac resynchronization therapy-defibrillatorFirst Degree AV Block2Jan 2012actual—2017-06-26
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)NCT01428076results2014-03-31Weight-adjusted Polidocanol Cmax (Serum)Randomized · Open-label · TreatmentPhase 1CompletedDrug: Polidocanol Endovenous Microfoam (PEM)Varicose Veins21Jan 2012actual—2021-04-21
A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)NCT01037907The cumulative number of new gadolinium-enhanced (GdE) T1 weighted lesions developing while on treatment (specifically the sum of new GdE T1 lesions seen on MRI at weeks 12, 16, 20 and 24).Randomized · Quadruple-masked · TreatmentPhase 2Terminatedsponsor's stated reason: Lack of efficacyDrug: Pleneva TM BGC20-0134, PlaceboRelapsing Remitting Multiple Sclerosis173Dec 2011actual—2022-06-03
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) IncompetenceNCT01072877results2014-05-16Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Polidocanol injectable foam (PEM), Placebo VehicleVaricose Veins279Dec 2011actual—2021-04-21
S-ICD® System IDE Clinical StudyNCT01064076results2017-03-27Percentage of Participants Free of Type I Complications at 180 Days.Open-label · TreatmentNot applicableCompletedDevice: S-ICD SystemTachycardia, Ventricular330Oct 2011actual—2017-03-27
Study of Chemoembolisation Using Irinotecan Bead Prior to Surgery in Metastatic Colorectal CancerNCT00844233Tumour resectability at surgeryOpen-label · TreatmentPhase 1/2CompletedDevice: Irinotecan BeadMetastatic Colorectal Cancer40Sep 2011actual—2021-07-21
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)NCT00893828observationalContinue detailed data collection of pressure readings from patients implanted with a RemonCHF device.—Completed—Heart Failure18Sep 2011actual—2017-02-17
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac ArteriesNCT00896337results2012-07-03Device- and/or Procedure-related Major Adverse Events (MAE)Open-label · TreatmentPhase 3CompletedDevice: Epic™ Nitinol Stent System · Drug: Anti-platelet therapy, Anti-coagulation therapyIliac Artery Stenosis125Sep 2011actual—2015-05-07
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) IncompetenceNCT01231373results2014-04-02Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)Randomized · Double-masked · TreatmentPhase 3CompletedDrug: polidocanol injectable foam, 0.125%, polidocanol injectable foam, 0.5%, polidocanol injectable foam, 1.0%, VehicleVaricose Veins235Sep 2011actual—2021-04-21
Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary StentNCT01135225Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedureRandomized · Single-masked · TreatmentNot applicableCompletedDevice: PROMUS(TM) Element (TM) Stent System, Evolution Stent SystemCoronary Artery Disease291Aug 2011actual—2017-02-03
Validity of Electronic Diary for Monitoring Varicose Veins SymptomsNCT01200199observationalTo assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins—Completed—Varicose Veins45Aug 2011actual—2021-04-21
Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection FractionNCT00670111results2017-05-19Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.Randomized · Quadruple-masked · TreatmentNot applicableTerminatedsponsor's stated reason: Difficulty in enrollmentDevice: Insignia Plus / Ultra (Guidant/Boston Scientific)Heart Failure32Jul 2011actual—2017-05-19
REASSURE AV RegistryNCT01074034results2017-06-14Inappropriate Shock Free RateOpen-label · TreatmentNot applicableCompletedDevice: AV Therapy Assessment-B301 investigational deviceSudden Cardiac Death, Bradycardia211Jun 2011actual—2017-08-01
Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up StudyNCT0113332730-day rate of major adverse eventsOpen-label · TreatmentNot applicableCompletedDevice: Carotid Artery StentingCarotid Artery Disease, Carotid Stenosis, Stroke100Jun 2011actual—2012-08-06
SAFEty of Two Strategies of ICD Management at ImplantationNCT00661037results2017-06-20observationalNumber of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up—CompletedDevice: Implantable defibrillator, Implantable defibrillatorVentricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death2,120May 2011actual—2017-07-21
Bion Occipital Nerve Stimulation (ONS) Compassionate Use StudyNCT01050959observationalProvision of one year of clinical and technical support—CompletedDevice: bionChronic, Medically Refractory Headache11Apr 2011actual—2020-11-13
TheraSphere for the Treatment of Liver MetastasesNCT00511862results2014-05-23Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)Non-randomized · Open-label · TreatmentPhase 2CompletedDevice: Yttrium 90 glass microspheresColorectal Cancer, Carcinoma, Neuroendocrine, Neoplasm Metastasis151Mar 2011actual—2021-05-13
PROMUS Element Japan Small Vessel TrialNCT01080261results2012-04-12Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)Open-label · TreatmentPhase 3CompletedDevice: PROMUS ElementAtherosclerosis, Coronary Artery Disease60Mar 2011actual—2016-03-29
Evaluation of the PneumRx Lung Volume Reduction Coil to Treat EmphysemaNCT01220908Quality of Life Assessment.Open-label · TreatmentNot applicableCompletedDevice: Lung Volume Reduction Coil (LVRC), CoilsEmphysema36Mar 2011actual—2023-05-11
Evaluation of Left Ventricular Autothreshold, Phase TwoNCT01242722observationalCollect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing—CompletedDevice: CRT-DHeart Failure100Mar 2011actual—2012-10-03
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL)NCT01500434results2012-02-14Target Lesion Failure (TLF)Open-label · TreatmentPhase 3CompletedDevice: PROMUS Element Coronary Stent System · Drug: Aspirin, ThienopyridineCoronary Artery Disease102Mar 2011actual—2019-03-26
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular BlockNCT01463358results2021-04-19Combined Endpoint Defined as First Occurrence Among the Following Events 1)Syncope Episode of Any Origin; 2)Presyncopal Episode With Documented Cardioinhibitory Origin 3) Atrioventricular Block of Any Degree Associated With Patient SymptomsRandomized · Open-label · TreatmentNot applicableCompletedDevice: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific), DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)Bifascicular Block, Syncope101Feb 2011actual—2021-04-19
APPROPRIATE - Rate Adaptive Pacing SensorNCT00757666results2017-06-14Mean Change in Functional Capacity (Peak VO2).Randomized · Double-masked · TreatmentNot applicableTerminatedsponsor's stated reason: Difficulty enrollment; higher than planned patient attrition and data attritionDevice: Rate adaptive pacemaker, Rate adaptive pacemakerHeart Diseases566Jan 2011actual—2017-06-14
RISA Extension Study - Long Term SafetyNCT00401986results2021-02-01observationalPercentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments—CompletedDevice: Bronchial thermoplasty with the Alair SystemAsthma14Dec 2010actual—2021-02-01
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small VesselsNCT01498692results2012-02-13Target Lesion Failure (TLF)Open-label · TreatmentNot applicableCompletedDevice: PROMUS Element Coronary Stent SystemCoronary Artery Disease94Dec 2010actual—2019-03-26
Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal CancerNCT00573131results2014-05-16Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CTRandomized · Single-masked · TreatmentPhase 2Terminatedsponsor's stated reason: OncoGel did not show any impact on overall tumor responseDrug: OncoGel (Paclitaxel gel), cisplatin, 5-FU · Radiation: radiation therapy · Procedure: esophageal resectionEsophageal Cancer, Adenocarcinoma of the Esophagus, Squamous Cell Carcinoma137Nov 2010actual—2022-06-22
A Carotid Stenting Boston Scientific Surveillance ProgramNCT00741091results2011-08-19Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)Open-label · TreatmentPhase 4CompletedDevice: Carotid WALLSTENT Monorail Endoprosthesis, FilterWire EZ™ System™Carotid Artery Disease1,097Oct 2010actual—2011-08-24
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery LesionsNCT00823212results2012-01-27Target Lesion Failure (TLF)Randomized · Single-masked · TreatmentPhase 3CompletedDevice: PROMUS Coronary Stent System, PROMUS Element Coronary Stent System · Drug: Aspirin, ThienopyridineCoronary Artery Disease1,530Sep 2010actual—2019-03-27
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)NCT00677014results2012-08-30Left Ventricular End-systolic Volume (LVESV)Randomized · Double-masked · TreatmentPhase 4CompletedDevice: AV Delay programming through cardiac resynchronization therapy, AV Delay programming through cardiac resynchronization therapy, AV Delay programming through cardiac resynchronization therapyHeart Failure1,060Jul 2010actual—2013-04-24
Common Sensing and Right Ventricular Automatic Capture (COGNATE)NCT01030705observational—Completed—Bradycardia, Chronotropic Incompetence80Jun 2010actual—2011-09-29
A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length CathetersNCT00778336results2011-04-26observationalChange From Baseline to Final Angiographic Results—Completed—Peripheral Vascular Diseases, Thrombosis, Venous Thrombosis452Mar 2010actual—2014-10-17
Comparative Registry of the PROmus™, ENdeavor™ and CYpher™ Drug Eluting StentsNCT00930878observationalRate of composite patient-oriented hierarchical Major Cardiac Events and its individual components (cardiac death, any Myocardial Infarction (MI) and Target Vessel Revascularisation (TVR) as classified by an External Medical Monitoring Committee.—CompletedDevice: Cardiac StentingPercutaneous Coronary Intervention1,934Mar 2010actual—2017-02-03
Feature Assessment Study for Indications Based ProgrammingNCT00711893observationalProportion of patients that are programmed by the physician to anything other than the recommended IBP setting—CompletedDevice: Cognis 100-D, Teligen DR and VR 100 HEVentricular Tachycardia, Ventricular Flutter, Ventricular Fibrillation, Heart Failure301Feb 2010actual—2017-02-23
PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)NCT01510327results2012-04-05Maximum Observed Everolimus Blood Concentration (Cmax)Open-label · TreatmentPhase 3CompletedDevice: PROMUS Element Everolimus-Eluting Coronary Stent System · Drug: Aspirin, ThienopyridineCoronary Artery Disease22Feb 2010actual—2019-03-26
AIR Extension Study - Long-Term Safety of Alair Treated SubjectsNCT00448812results2021-02-17Percentage of Subjects With Any Respiratory Adverse EventRandomized · Open-label · TreatmentNot applicableCompletedDevice: Bronchial Thermoplasty with the Alair SystemAsthma69Dec 2009actual—2021-02-17
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)NCT00628901results2011-08-22Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)Randomized · Single-masked · TreatmentPhase 4CompletedProcedure: Uterine Fibroid Embolization (UFE) · Device: Contour SE™ Microspheres, Embosphere® MicrospheresLeiomyoma, Uterine Fibroids, Uterine Neoplasms, Menorrhagia, Leiomyomatosis60Dec 2009actual—2012-07-11
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose VeinsNCT00928421results2014-04-02Responders to Treatment, Assessed by Duplex UltrasoundOpen-label · TreatmentPhase 2CompletedDrug: Polidocanol Endovenous Microfoam 0.125%Varicose Veins16Dec 2009actual—2021-05-13
AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial InfarctionNCT00275990ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECGRandomized · Open-label · TreatmentPhase 4CompletedDevice: rheolytic thrombectomy with direct stenting, direct stentingMyocardial Infarction501Oct 2009actual—2014-10-09
A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent GliomaNCT00479765results2014-05-15Occurence of Dose-limiting Toxicities (DLTs)Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: Sponsor business decision, not based on safety or efficacy dataDrug: OncoGel (ReGel/Paclitaxel)Glioblastoma Multiforme, Brain Neoplasms4Oct 2009actual—2022-06-22
Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure PatientsNCT00758121observational—Terminatedsponsor's stated reason: Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed OnDevice: Cardiac Resynchronization Therapy DefibrillatorHeart Failure56Oct 2009actual—2009-11-06
Beluga - Clinical Observations of Automatic Algorithms for Cardiac PacingNCT00286858observationalImpact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing—CompletedDevice: Insignia Ultra and Insignia AVTBradycardia, Sick Sinus Syndrome, Heart Block903Sep 2009actual—2021-01-28
TAXUS PERSEUS WorkhorseNCT00484315results2011-06-28Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.Randomized · Single-masked · TreatmentPhase 3CompletedDevice: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation, Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placementCoronary Artery Disease1,264Sep 2009actual—2014-05-08
A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™)NCT00824434results2012-03-07Cardiac Events (Composite)Open-label · TreatmentPhase 3CompletedDevice: PROMUS Element™Atherosclerosis, Coronary Artery Disease100Sep 2009actual—2012-08-30
Optimized Programming in Spinal Cord Stimulation (SCS) SystemNCT00871819results2012-04-04Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)Double-masked · Supportive carePhase 4CompletedDevice: Precision Spinal Cord Stimulation (SCS)Neuropathic Pain, Pain20Aug 2009actual—2013-11-27
Leader - Evaluation of Endotak RelianceNCT00180349observationalDefibrillation testing (DT) procedures and consequences on clinical outcomes—CompletedDevice: Endotak RelianceVentricular Tachycardia, Ventricular Fibrillation904Jul 2009actual—2017-04-14
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMANCT00478673results2012-08-07Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)Open-label · TreatmentPhase 4Terminatedsponsor's stated reason: Enrollment was terminated in June 2008 due to market withdrawal of the NexStent Carotid Stent System.Device: NexStent Carotid Stent System (Monorail Delivery System), FilterWire EZ™ Embolic Protection SystemCarotid Stenosis298Jul 2009actual—2012-08-07
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ IncompetenceNCT00758420results2014-03-24The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 WeeksRandomized · Single-masked · TreatmentPhase 2/3CompletedDrug: Varisolve (Polidocanol Endovenous Microfoam), Agitated SalineVaricose Veins77Jul 2009actual—2021-04-21
The Optical Coherence Tomography Drug Eluting Stent InvestigationNCT00776204Proportion of stent struts uncovered and/or malapposed at OCTRandomized · Open-label · TreatmentNot applicableCompletedDevice: JACTAX Drug eluting stent, JACTAX LD drug eluting stent, Taxus LibertèCoronary Artery Disease60Jul 2009actual—2017-03-01
MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization TherapyNCT00180271results2011-06-02Mortality From Any Cause or First Heart Failure (HF) EventRandomized · Open-label · TreatmentNot applicableCompletedDevice: Cardiac resynchronization therapy with defibrillation, Implantable Cardioverter Defibrillator (ICD)Tachycardia, Congestive Heart Failure1,820Jun 2009actual—2018-12-19
TAXUS PERSEUS Small VesselNCT00489541results2011-06-28In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)Non-randomized · Open-label · TreatmentPhase 3CompletedDevice: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantationCoronary Artery Disease224Jun 2009actual—2014-05-08
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) StudyNCT00801710CTO Crossing RateOpen-label · TreatmentNot applicableCompletedDevice: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)Coronary Artery Disease, Coronary Artery Chronic Total Occlusion42Jun 2009actual—2021-01-26
JACTAX LD Drug Eluting Stent TrialNCT00754975MACE rate at 9 monthsRandomized · Open-label · TreatmentNot applicableCompletedDevice: JACTAX LD DES, TAXUS™ Libertè™ DESCoronary Artery Disease130May 2009actual—2017-03-01
Evaluation of Left Ventricular AutoThresholdNCT00812201observationalThe objective of this study is to collect data to characterize the performance of the LVAT feature.—CompletedDevice: No intervention is used. Collection of signals only.Heart Failure80May 2009actual—2022-06-28
Treatment for Migraines With an Implantable DeviceNCT00286078results2016-08-09Migraine Frequency at 12 WeeksRandomized · Double-masked · TreatmentNot applicableCompletedDevice: PrecisionMigraine179Apr 2009actual—2019-07-30
Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg PainNCT00418301results2021-06-18Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS OffOpen-label · TreatmentNot applicableCompletedOther: Precision Spinal Cord Stimulation and PET ScanPain, Low Back Pain, Leg Pain15Apr 2009actual—2022-03-31
RIGHT: Rhythm ID Going Head-to-Head TrialNCT00148954results2011-12-26Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge VisitRandomized · Open-label · PreventionPhase 4CompletedDevice: VITALITY 2 Implantable Cardioverter Defibrillator, Medtronic Implantable Cardioverter DefibrillatorTachycardia1,962Mar 2009actual—2012-01-12
Safety and Efficacy of CryoCor™ Cryoablation for PAFNCT00231296Safety profile of interventionRandomized · Open-label · TreatmentNot applicableCompletedDevice: Cardiac CryoCor Cryoablation System · Drug: Medical managementAtrial Fibrillation174Mar 2009actual—2017-05-04
The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction StudyNCT00605631LVEDVRandomized · Single-masked · TreatmentNot applicableCompletedDevice: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead SystemPost Myocardial Infarction105Mar 2009actual—2017-04-05
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical InvestigationNCT01117792results2021-07-02Conversion of Induced Ventricular FibrillationOpen-label · TreatmentNot applicableCompletedDevice: subcutaneous implantable defibrillator (S-ICD) systemACC/AHA/NASPE Class 1, IIa or IIb Indications55Mar 2009actual—2021-07-02
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic SignalNCT00604903Serious adverse events related to implantation or the deviceOpen-label · Device feasibilityNot applicableCompletedDevice: Implant of Pressure sensor.Heart Failure42Feb 2009actual—2017-02-17
Hysteroscopic Cryomyolysis for the Treatment of Submucosal LeiomyomataNCT00731341results2011-07-01Number of Adverse EventsOpen-label · TreatmentNot applicableCompletedProcedure: Cryoablation for the treatment of uterine fibroidsUterine Fibroids, Leiomyoma, Menorrhagia3Feb 2009actual—2021-07-19
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization TherapyNCT00146848results2010-09-23Clinical Composite ScoreRandomized · Single-masked · TreatmentPhase 4CompletedDevice: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devicesHeart Failure1,742Jan 2009actual—2011-12-28
ACC - Atrial Contribution to CRTNCT00180323results2012-11-12Aortic Velocity Time Integral (VTI)Open-label · TreatmentNot applicableCompletedDevice: RenewalDilated Cardiomyopathy43Dec 2008actual—2021-02-11
The Prefyx PPS™ System eRegistryNCT00688181results2021-03-01observationalNumber of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up—CompletedDevice: The Prefyx PPS™ Pre-pubic Sling SystemStress Urinary Incontinence44Nov 2008actual—2021-03-01
Study of Occipital Nerve Stimulation for Drug Refractory MigraineNCT00747812results2012-08-03Number of Hours of HeadacheRandomized · Double-masked · TreatmentPhase 2Terminatedsponsor's stated reason: Sponsor closed enrollment early based on interim data from the PRISM US Pivotal Study.Device: PrecisionMigraine11Nov 2008actual—2020-11-27
"JACTAX" Trial Drug Eluting Stent TrialNCT00754728MACE at 9 monthsOpen-label · TreatmentNot applicableCompletedDevice: JACTAX DESCoronary Artery Disease103Nov 2008actual—2017-03-01
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator DataNCT01161589observationalCollection of simultaneous cardiac signals representing S-ICD and ICD sensing vectors—Completed—Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation142Nov 2008actual—2017-02-16
Electrocardiogram (ECG) Recordings in Paediatric PopulationNCT00399386observational—CompletedProcedure: EP, ICD, AblationArrhythmia62Oct 2008actual—2017-02-16
Spinal Cord Stimulation for Painful Diabetic NeuropathyNCT00487981results2012-03-13Pain Rating at 6 Months Post Activation Compared to BaselineOpen-label · TreatmentPhase 4Terminatedsponsor's stated reason: Insufficient Data CollectedDevice: Precision Spinal Cord StimulationDiabetic Neuropathy, Pain, Peripheral Neuropathy1Sep 2008actual—2012-03-13
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) SystemNCT00853645results2021-06-29Number of Participants With a Successful Induced Ventricular Fibrillation ConversionOpen-label · Device feasibilityNot applicableCompletedDevice: Subcutaneous Implantable Defibrillator (S-ICD) SystemVentricular Tachyarrhythmias6Sep 2008actual—2021-07-06
Asthma Intervention Research 2 (AIR2) TrialNCT00231114results2010-11-29Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)Randomized · Double-masked · TreatmentNot applicableCompletedDevice: Alair System, Alair SystemAsthma297Aug 2008actual—2017-07-27
Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle ElectrodeNCT00386724results2020-12-17Reduction in Baseline Back Pain Severity as Measured at 3 Months Post-activationOpen-label · TreatmentNot applicableTerminatedsponsor's stated reason: Insufficient Data CollectedDevice: Precision Spinal Cord Stimulation System, Artisan Surgical LeadBack Pain, Chronic Pain, Pain in Leg, Unspecified8Aug 2008actual—2020-12-17
An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge IncontinenceNCT00080470results2013-10-10Number of Leaks Per DayRandomized · Single-masked · TreatmentPhase 3CompletedDevice: bionUrinary Incontinence148Jul 2008actual—2013-11-19
RAPID-RF: Remote Active Monitoring in Patients With Heart FailureNCT00334451observational—Completed—Heart Failure891Jul 2008actual—2014-02-24
Spinal Cord Stimulation for Chronic and Intractable Back PainNCT00370695results2020-12-17The Primary Objective of This Study is to Evaluate Back Pain Severity at 12 Weeks Post-activation as Compared to Baseline.Open-label · TreatmentNot applicableTerminatedsponsor's stated reason: Insufficient Data CollectedDevice: Precision Spinal Cord Stimulation SystemBack Pain15Jul 2008actual—2020-12-17
Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent SystemNCT00497367Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVRNon-randomized · Open-labelPhase 1CompletedDevice: Percutaneous Coronary Intervention (PCI) TAXUS PetalCardiovascular Diseases28Jul 2008actual—2015-03-26
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) SystemNCT00399217observational—CompletedDevice: Subcutaneous Implantable Defibrillator (S-ICD) system, ICDVentricular Fibrillation, Ventricular Tachycardia55Jun 2008actual—2017-02-16
Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac ShuntNCT00442364results2014-02-26Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological EffectsNon-randomized · Open-label · TreatmentPhase 2CompletedDrug: Polidocanol (1%) Microfoam (Varisolve) · Procedure: Endovenous Microfoam OcclusionVaricose Veins60Jun 2008actual—2021-04-21
Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower ExtremityNCT00399841results2020-12-19The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation.Randomized · Open-label · TreatmentNot applicableTerminatedsponsor's stated reason: Investigator ResignedDevice: Precision for Spinal Cord StimulationIntractable Neuropathic Pain, Pain, Back Pain, Lower Extremity Pain13May 2008actual—2020-12-19
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct ObstructionNCT00433771results2010-02-09Adequate Clinical Palliation of the Biliary ObstructionNon-randomized · Open-label · TreatmentPhase 3CompletedDevice: WallFlex™ Biliary Fully Covered Metal Stent placementCholestasis, Extrahepatic74May 2008actual—2010-06-29
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice InfestationNCT00528021results2010-12-28Clinical CureRandomized · Double-masked · TreatmentPhase 2CompletedDrug: Placebo, BGC20-0582Pediculus Humanus Capitis, Head Lice230May 2008actual—2022-06-28
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct ObstructionNCT00713427results2021-06-04Number of Participants With Absence of Recurrent Biliary ObstructionOpen-label · TreatmentNot applicableCompletedDevice: WallFlex™ Biliary Partially-Covered StentBiliary Strictures Caused by Malignant Neoplasms70May 2008actual—2021-07-30
MODULA Modul 7 VRRNCT00180414results2022-03-29Percentage of Biventricular PacingRandomized · Single-masked · TreatmentNot applicableTerminatedsponsor's stated reason: low enrolment rateDevice: CRT devices with ventricular rate regulation [VRR] (CE labeled)Atrial Fibrillation82008-05-07actual—2022-06-24
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed ArteriesNCT00114972results2010-06-23Primary Clinical Endpoint of 12-Month Binary MACCE.Randomized · Open-label · TreatmentPhase 3Unknown statusDevice: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent · Procedure: Coronary Artery Bypass SurgeryCoronary Artery Disease1,800Apr 2008actual—2010-06-23
Efficacy of the Spinal Cord Stimulation System as Salvage TherapyNCT00387244results2020-12-17Percent of Subjects With a Significant Reduction in Pain During the Temporary TrialOpen-label · TreatmentNot applicableTerminatedsponsor's stated reason: Insufficient Data CollectedDevice: Precision for Spinal Cord StimulationPain, Intractable Pain, Chronic Pain7Apr 2008actual—2020-12-17
Spy II Clinical RegistryNCT00751998results2011-04-12observationalProcedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.—CompletedDevice: SpyGlassBiliary Tract Diseases297Apr 2008actual—2021-08-19
An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency SyndromeNCT00131573results2013-11-19Average Number of Voids Per DayRandomized · Single-masked · TreatmentPhase 3CompletedDevice: bionOveractive Bladder118Mar 2008actual—2013-11-19
Decompensation Detection StudyNCT00583089observationalData collection and analysis.—Completed—Heart Failure699Mar 2008actual—2017-02-06
Electronic Repositioning With Acuity and Easytrak LeadsNCT00610116results2021-02-09Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)Open-label · TreatmentNot applicableCompletedDevice: Electronic RepositioningHeart Failure305Mar 2008actual—2021-04-21
The EASYTRAK EPI Clinical InvestigationNCT00158925results2017-04-28Chronic Pacing Thresholds at 3 MonthsOpen-label · TreatmentNot applicableCompletedDevice: EASYTRAK EPI leadBradycardia, Congestive Heart Failure100Feb 2008actual—2017-05-31
Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead EmbolisationNCT00261378Objective response rate measured according to RECIST and EASLRandomized · Double-masked · TreatmentPhase 2CompletedDevice: Transarterialchemoembolisation (TACE), DC Bead with DoxorubicinPrimary Liver Cancer212Jan 2008actual—2021-07-21
ECG Signal Collection From Long QT Syndrome, Wide QRS Complexes, Heart Failure, and Cardiac Resynchronization PatientsNCT00399412observational—CompletedDevice: subcutaneous ICDLong QT Syndrome, Wide QRS Complexes, Heart Failure, Cardiac Resynchronisation86Dec 2007actual—2017-02-16
Spinal Cord Stimulation for Low Back PainNCT00205868results2021-06-18Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.Non-randomized · Open-label · TreatmentPhase 4CompletedDevice: Precision Spinal Cord Stimulation SystemChronic Pain304Nov 2007actual—2021-06-18
Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -NCT00848445To compare the occurrence of AF (>350 bpm) during a period when AF pacing therapies are programmed on (APP and VRR) and during when AF therapies are programmed off.Randomized · Open-label · PreventionPhase 4CompletedDevice: Guidant Pulsar Max II or Insignia Plus DR, Atrial pacing preference turned on or offAtrial Fibrillation270Nov 2007actual—2021-05-12
Effect of Pulse Width With Spinal Cord StimulationNCT00399516results2012-04-04Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)Non-randomized · Open-label · DiagnosticPhase 4CompletedDevice: PrecisionPain, Chronic Pain, Back Pain21Oct 2007actual—2012-04-04
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality DefibrillatorNCT00180375observationalTime to first appropriate therapy—CompletedDevice: Prizm, Vitality, RenewalVentricular Tachycardia, Ventricular Fibrillation636Aug 2007actual—2017-02-23
Bion for Occipital Nerve StimulationNCT00205829Demonstrate acceptable rate of adverse events.Non-randomized · Open-label · TreatmentPhase 1/2CompletedDevice: battery-powered bion(R) microstimulator systemChronic Headaches10Aug 2007actual—2012-08-02
TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting StentNCT00292474The primary objective of this study is to evaluate the safety and effectiveness of the TAXUS Stent System with 1 ug/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a slow rate-release formulation of a triblock copolymer carrier systRandomized · Double-masked · TreatmentPhase 2/3CompletedDevice: percutaneous coronary interventionCoronary Artery Disease1,326Aug 2007actual—2008-10-08
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance ProgramNCT00569491Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events CommitteeNon-randomized · Open-label · TreatmentPhase 4CompletedDevice: TAXUS Express 2™Coronary Artery Disease2,585Apr 2007actual—2008-09-25
CRT RENEWAL RegistryNCT00146874observational—CompletedDevice: cardiac resynchronization therapyHeart Failure1,000Mar 2007actual—2010-08-18
Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary IncontinenceNCT00688298Measuring the amount of time to complete successful pre-pubic delivery approach and placement of the mesh in the mid-urethra and the number of difficulties associated with the placementOpen-label · TreatmentNot applicableCompletedDevice: Prefyx PPS™ System, Advantage ™ SystemStress Urinary Incontinence, Intrinsic Sphincter Deficiency100Mar 2007actual—2020-11-12
A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery LesionsNCT00371475Percent diameter stenosis of the analysis segment at 9-monthsNon-randomized · Open-label · TreatmentPhase 3CompletedDevice: TAXUS Liberté-SR, TAXUS™ ExpressCoronary Artery Disease150Feb 2007actual—2012-02-02
Guidant Microwave Ablation System for the Treatment of Atrial FibrillationNCT00111488Freedom from atrial fibrillation at six monthsRandomized · Single-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Slow enrollmentDevice: Flex 4 and GeneratorAtrial Fibrillation200Dec 2006actual—2016-01-06
Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column StimulationNCT00370773The primary objective of this study is to compare subthreshold intraspinal nerve root stimulation (INRS) with subthreshold and suprathreshold dorsal column stimulation (DCS).Randomized · Open-label · DiagnosticPhase 4Terminatedsponsor's stated reason: Slow EnrollingDevice: Precision Spinal Cord Stimulation SystemBack Pain4Dec 2006actual—2008-09-05
A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small VesselsNCT00371748Percent diameter stenosis - analysis segment at 9 monthsNon-randomized · Open-label · TreatmentPhase 3CompletedDevice: TAXUS Liberté-SR, TAXUS™ Express2, Express2Coronary Artery Disease261Dec 2006actual—2012-02-02
TAXUS ARRIVE 2: A Multi-Center Safety Surveillance ProgramNCT00569751Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).Non-randomized · Open-label · TreatmentPhase 4CompletedDevice: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent SystemCardiovascular Disease, de Novo Coronary Lesions5,016Nov 2006actual—2008-09-29
Occipital Nerve Stimulation to Treat Chronic HeadachesNCT00205894The primary safety measure is the incidence of major complications, defined as device or procedure related major adverse events that require medical and surgical intervention.Non-randomized · Open-label · TreatmentPhase 1/2CompletedDevice: bion microstimulatorHeadache Disorders20Oct 2006actual—2008-09-05
Study of Cytrix Use in Pelvic Floor Prolapse TreatmentNCT01244165Number of patients reporting intra-operative complicationsNon-randomized · Open-label · TreatmentPhase 4CompletedDevice: Cytrix · Other: Other treatments for pelvic organ prolapseVaginal Vault Prolapse45Oct 2006actual—2010-11-19
EASYTRAK 3 Downsize LeadNCT00384722Lead-related complication-free rate at one-monthNon-randomized · Open-label · TreatmentPhase 2/3CompletedDevice: EASYTRAK 3 Downsize LeadHeart Failure70Jul 2006actual—2009-06-24
VENEK: Healing in Different Vein Harvesting Methods During Aortocoronary Coronary Artery Bypass Graft Surgery (CABG)NCT00180388Evaluation of the economic differences between methods of treatmentRandomized · Open-label · TreatmentPhase 4Terminatedsponsor's stated reason: terminated for logistical reasonsProcedure: endoscopic vein harvesting, open vein harvestingCoronary Artery Disease300Jun 2006actual—2016-09-01
Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery LesionsNCT00371423Analysis segment percent diameter stenosis at 9-monthsNon-randomized · Open-label · TreatmentPhase 3CompletedDevice: TAXUS Liberté™-SR, TAXUS Liberté™-SRCoronary Artery Disease247Jun 2006actual—2012-02-02
Research in Severe Asthma (RISA) TrialNCT00214539results2011-11-07Respiratory Adverse Events Per SubjectRandomized · Open-label · TreatmentNot applicableCompletedProcedure: Bronchial Thermoplasty with the Alair System · Drug: ControlAsthma34Feb 2006actual—2021-02-11
LIFE Study - Limiting Chronotropic Incompetence for Pacemaker RecipientsNCT00146861Determine the prevalence of CI among a general sample of pacemaker patients, compare differences in quality of life and physical activity between patients programmed to either blended sensor or accelerometerRandomized · Single-maskedPhase 4CompletedDevice: sensor programmingBradycardia1,500Jan 2006actual—2017-05-18
TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery LesionsNCT003717099-Month Target Vessel Revascularization (TVR)Non-randomized · Open-label · TreatmentPhase 3CompletedDevice: TAXUS Liberté-SR, TAXUS™ ExpressCoronary Artery Disease871Nov 2005actual—2012-02-02
Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac ArteriesNCT00352222Angiographic mean percent loss of luminal diameter at 6 months post-procedure defined as ((post-procedure MLD - Follow-up MLD)/Post-procedure MLD) X 100Non-randomized · Open-label · TreatmentPhase 3CompletedDevice: stent implantationArterial Occlusive Disease, Intermittent Claudication, Atherosclerotic Disease, Thrombosis150Jul 2005actual—2008-09-29
A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.NCT00597142Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.Open-label · TreatmentPhase 4CompletedDevice: Express™ Renal Premounted Stent SystemAtherosclerotic Lesions in the Aortorenal Ostium100Jul 2005actual—2014-11-21
SITELINE 2 PolyurethaneNCT00180284Pacing voltage threshold at 3 MonthsNon-randomized · Open-label · TreatmentPhase 3CompletedDevice: SITELINE 2 Polyurethane (pacing lead)Bradycardia200May 2005actual—2011-09-29
Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)NCT00316108The primary endpoint is one-year morbidity and mortality, defined as the cumulative incidence of any non Q-wave myocardial infarction within the 24 hours following carotid stentingNon-randomized · Open-label · TreatmentNot applicableCompletedDevice: WALLSTENT® Endoprosthesis™Carotid Artery Diseases, Stroke, Cerebral Arteriosclerosis747May 2005actual—2014-08-28

Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.

Source: ClinicalTrials.gov, retrieved 2026-08-19

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