Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease (NCT04475783) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease
Austria478 participantsStarted 2021-04-13
Plain-language summary
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial.
The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject age ≥ 18
✓. Subject has been informed on the nature of the study, the duration of the study, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.
✓. Rutherford category 2-4 according to the investigator's subjective evaluation
✓. Subject has a de novo or re-stenosed lesion with ≥ 70 % stenosis documented angiographically
✓. Target lesion length is ≥ 2 cm and ≤ 20 cm by visual estimate of the treating physician
✓. Multiple lesions with max. 3 cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 20 cm
✓. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
✓. Patency of P2 and P3 segment of the popliteal artery and at least one (1) infrapopliteal artery to the ankle (\< 50 % diameter stenosis) in continuity with the femoropopliteal artery
Exclusion criteria
✕. Failure to successfully cross the target lesion or subintimal target lesion guidewire crossing
✕. Flow-limiting dissection after pre-dilatation
✕. Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel)
What they're measuring
1
Patency rate (Absence of clinically driven target lesion revascularization)
Timeframe: one year after study procedure (PTA with medical product under investigation or comparator)