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Clinical trials
catalyst calendar across sponsors →Studies where PEN 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.
15 interventional · 18 observational · 15 with posted results
Held by 21 tracked-famous managers (Balyasny Asset Management L.P., MILLENNIUM MANAGEMENT LLC, CITADEL ADVISORS LLC, TWO SIGMA INVESTMENTS, LP, Hudson Bay Capital Management LP, +16 more) · FINRA short interest 4.2 days to cover (settled 2026-07-31) · government filings 180d: 0 congress / 2 executive
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 OcclusionsNCT07749170observationalChange in NIHSS at 24 hours | — | Recruiting | Device: Endovascular Thrombectomy · Other: Medical Management | Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion | 250 | Sep 2028 | ≤ 773 d | 2026-08-06 |
| A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)NCT06747117observationalTarget Limb Salvage Rate | — | Recruiting | Device: Indigo Aspiration System | Lower Extremity Acute Limb Ischemia, LE ALI | 300 | Jun 2028 | ≤ 681 d | 2026-08-07 |
| Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).NCT07107022observationalOutcomes: | — | Recruiting | Device: Penumbra System ® | Acute Ischemic Stroke (AIS) | 200 | Jan 2028 | ≤ 530 d | 2026-07-27 |
| Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration SystemNCT04798261observationalSafety: Composite of major adverse events | — | Recruiting | Device: Indigo Aspiration System | Pulmonary Embolism | 1,500 | Dec 2026 | ≤ 134 d | 2026-07-06 |
| BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein ThrombosisNCT05003843Composite of Major Adverse EventsOpen-label · Treatment | Not applicable | Active, not recruiting | Device: Indigo Aspiration System | Deep Vein Thrombosis, DVT | 229 | 2025-11-18actual | — | 2026-05-29 |
| Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in JapanNCT06446024observationalALI: Target Limb Salvage | — | Completed | Device: Mechanical aspiration thrombectomy | Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior, Acute DVT of Lower Extremity | 500 | 2025-07-25actual | — | 2026-02-04 |
| Comparison of Two Pulmonary Embolism TreatmentsNCT05684796results2026-08-18Change in RV/LV RatioRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Drug: Anticoagulation · Device: mechanical aspiration thrombectomy | Pulmonary Embolism Acute | 100 | 2025-06-12actual | — | 2026-08-18 |
| THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration TubingNCT05437055Efficacy Endpoint: Angiographic RevascularizationOpen-label · Treatment | Not applicable | Completed | Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt) | Acute Ischemic Stroke, Large Vessel Occlusion | 216 | 2024-09-23actual | — | 2026-06-30 |
| MIND: Artemis in the Removal of Intracerebral HemorrhageNCT03342664results2026-01-30Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)Randomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Artemis + Medical Management · Other: Best Medical Management Alone (MM) | Cerebral Hemorrhage, Brain Hemorrhage, Cerebral Parenchymal Hemorrhage, Intracerebral Hemorrhage | 236 | 2024-02-20actual | — | 2026-01-30 |
| Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging ModalitiesNCT04106583results2025-03-04observationalEfficacy: Adequate OcclusionStudy Protocol and Statistical Analysis Plan ↗ | — | Completed | Device: WAVE, as part of the SMART COIL System | Aneurysm, Brain | 572 | 2023-08-02actual | — | 2025-03-04 |
| A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration SystemNCT04144959results2025-06-27observationalTarget Limb Salvage RateStudy Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Device: Indigo Aspiration System | Lower Extremity Acute Limb Ischemia, LE ALI | 119 | 2023-01-02actual | — | 2025-06-27 |
| Investigation of Clot in Ischemic Stroke and Hematoma EvacuationNCT04693767results2024-10-23observationalClot Specimen HistologyStudy Protocol and Statistical Analysis Plan ↗ | — | Completed | Device: Mechanical thrombectomy · Other: Minimally invasive surgery | Ischemic Stroke, Intracranial Hematoma | 400 | 2022-07-22actual | — | 2024-10-23 |
| PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute PhaseNCT04178746observationalEfficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours | — | Terminatedsponsor's stated reason: Business decision to focus on other studies. No safety concern. | Device: Artemis Neuro Evacuation Device | Intracerebral Hemorrhage, Brain Hemorrhage, Intraventricular Hemorrhage | 4 | 2021-06-02actual | — | 2022-09-14 |
| LOTUS: Global Acute Stroke Study Utilizing Penumbra SystemNCT04157270observationalmTICI Score | — | Terminatedsponsor's stated reason: Business decision to focus on other studies. No safety concern | Device: Penumbra System | Stroke, Ischemic | 23 | 2021-05-10actual | — | 2021-06-25 |
| Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary ArteriesNCT03957473results2023-10-10observationalComposite of:Study Protocol and Statistical Analysis Plan ↗ | — | Completed | Device: Indigo Aspiration System | Coronary Vessel Occlusion | 400 | 2021-01-18actual | — | 2023-10-10 |
| COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization DeviceNCT03464565observationalmTICI Score | — | Completed | Device: Penumbra System | Stroke, Ischemic | 650 | 2020-01-17actual | — | 2020-12-22 |
| Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart CoilNCT02729740results2021-03-01Number of Participants Achieving Adequate Occlusion Immediate Post ProcedureOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Penumbra Smart Coil, Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) | Intracranial Aneurysm | 995 | 2019-12-27actual | — | 2021-03-01 |
| Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary EmbolismNCT03218566results2020-08-03Right Ventricle/Left Ventricle (RV:LV) RatioOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Indigo Aspiration System | Pulmonary Embolism | 119 | 2019-03-10actual | — | 2020-08-03 |
| Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil SystemNCT020798181. Packing density with the number of coils implantedOpen-label · Treatment | Phase 4 | Withdrawnsponsor's stated reason: The study was never initiated. | Device: Penumbra Ruby Coil System | Visceral Artery Aneurysms, Arteriovenous Malformations | 0 | Sep 2018 | — | 2019-04-12 |
| European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic StrokeNCT02678169observationalAngiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score. | — | Completed | Device: Penumbra Aspiration System | Ischemic Stroke | 204 | Nov 2017actual | — | 2018-01-17 |
| A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM SystemNCT01754051observationalPacking density with the number of coils implanted | — | Completed | Device: PC 400 coils | Intracranial Aneurysms | 100 | 2017-10-03actual | — | 2018-05-17 |
| Study of the Penumbra Coil 400 System to Treat AneurysmNCT01465841results2020-07-07Packing Density With the Number of Coils ImplantedOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: PC 400 coils (Penumbra ) | Intracranial Aneurysms, Peripheral Aneurysms | 517 | Jun 2017actual | — | 2020-07-07 |
| A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic StrokeNCT01584609results2018-09-13Number of Participants With Angiographic Revascularization of the Occluded Target VesselRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Penumbra System with Separator 3D, Penumbra System alone | Acute Ischemic Stroke From Large Vessel Occlusion | 198 | Jun 2017actual | — | 2018-09-13 |
| Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial AneurysmsNCT01753388Aneurysmal occlusion of the treated target lesion on 6-month angiography as defined by the method of Roy et al. (Stroke 2001;32:1998-2004).Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: The study was never initiated | Device: Liberty Stent | Wide Neck Intracranial Aneurysms | 0 | Jun 2017 | — | 2019-04-12 |
| The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial AneurysmsNCT01636453results2018-08-23Number of Participants With Raymond Class I Complete Obliteration at 12 MonthsOpen-label · Treatment | Not applicable | Completed | Device: Stent assisted coiling with the Liberty Stent | Wide-neck, Saccular Intracranial Aneurysms | 120 | Dec 2016actual | — | 2018-08-23 |
| A Study of Survival and Outcome After StrokeNCT01193569observationalProportion of patients with a modified Rankin score of 2 or less | — | Completed | — | Ischemic Stroke | 142 | 2016-12-22actual | — | 2018-04-12 |
| Assess the Penumbra System in the Treatment of Acute StrokeNCT01429350results2020-09-22Good Functional Outcome as Defined by a Modified Rankin Score of 0-2Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA) · Device: Penumbra System | Ischemic Stroke | 108 | Oct 2016actual | — | 2020-09-22 |
| CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400NCT02122133observational1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time]. | — | Terminatedsponsor's stated reason: Business decision to focus on other studies. No safety concern. | Device: PC 400 | Intracranial Aneurysms | 67 | 2016-10-19actual | — | 2019-04-12 |
| Imaging Guided Patient Selection for Interventional Revascularization TherapyNCT00963989results2021-11-23Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedureOpen-label · Treatment | Not applicable | Completed | Device: Penumbra System | Acute Ischemic Stroke | 146 | Sep 2016actual | — | 2021-11-23 |
| Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the PeripheryNCT02085551results2020-06-22Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI ScoresOpen-label · Treatment | Not applicable | Completed | Device: Mechanical Thrombectomy by the Indigo System | Peripheral Arterial Occlusion or Emboli | 85 | Sep 2015actual | — | 2020-06-22 |
| A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST TrialNCT01092819observationalFunctional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2. | — | Completed | Other: Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies | Stroke | 150 | Dec 2013actual | — | 2019-04-12 |
| Penumbra Imaging Collaborative Study (PICS)NCT00785161observationalProportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. | — | Completed | Device: Penumbra System | Stroke | 289 | Dec 2010actual | — | 2018-04-12 |
| Study to Assess the Safety and Effectiveness of the Penumbra SystemNCT00334061results2009-01-12Percentage of Participants With Revascularization of the Occluded Target VesselNon-randomized · Open-label · Treatment | Phase 2 | Completed | Device: Penumbra System | Stroke | 125 | Jun 2007actual | — | 2019-09-18 |
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