CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Ar… (NCT05734157) | Clinical Trial Compass
CompletedNot Applicable
CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
France, Germany75 participantsStarted 2022-02-17
Plain-language summary
The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must be at least 18 years of age.
✓. Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
✓. Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations.
✓. Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery.
✓. De novo or restenotic lesion(s) \>70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). Lesion must be at least 2 cm from any stented area.
✓. Subject is willing to comply with the required follow up visits, testing schedule and medication regimen.
✓. Successful wire crossing of lesion.
✓. Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation).
Exclusion criteria
✕. Pregnant or lactating females.
✕. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries.
✕. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
What they're measuring
1
Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate
Timeframe: 6 months post procedure
2
The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR)