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A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

← catalyst calendar

NCT05386342 · readout ≤ 315 d

Sponsored by LeMaitre Vascular (industry) · LMAT — their whole pipeline →. With Avania.

Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
112estimated
Sites
3
Countries
Germany, Switzerland

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

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

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-01-11actualWhen the study began enrolling
Primary completionJun 2027estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionJun 2027estimatedThe whole study's end, after follow-up
First posted2022-05-23actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2024-10-18actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Thrombus
  • Embolus
  • Occlusion; Vessel

Intervention

  • Device: TufTex Over-the-Wire Embolectomy Catheter

Primary outcomes

what the primary-completion date above is the date OF
Performance objective is the technical success being <30% residual stenosis
measured 1 month post index procedure
Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up
measured 1 month post index procedure

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