BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral … (NCT03776799) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
Germany120 participantsStarted 2019-01-01
Plain-language summary
Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease) Type B-D (stenosis \>10cm, occlusions \>5cm).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject age ≥ 18
✓. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
✓. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
✓. Rutherford Becker Classification 2-4
✓. Both treatment options seem feasible at the operator's discretion
✓. Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤ 30cm not involving the infrageniculate popliteal artery are eligible.
✓. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
✓. Patency of at least one (1) infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery. The inflow artery(ies) cannot be treated using a drug eluting stent or drug coated balloon
Exclusion criteria
✕. Failure to successfully cross the target lesion
✕. Angiographic evidence of severe calcification that makes a stent-avoiding approach not feasible at the operator's discretion.
✕. Femoropopliteal lesions classified as TASC II Typ A (single stenosis \>=10cm and single occlusion \>=5cm)
What they're measuring
1
Primary patency - Absence of clinically-driven target lesion revascularization (CD-TLR) and/or restenosis defined as a peak systolic velocity ratio (PSVR) > 2.4 assessed by ultrasound