Clinical Trial

BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery

Active, Not Recruiting
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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).
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2018-12-12; most recent amendment 2026-04-30.
Status change: Recruiting → Active, Not Recruiting 2021-12-13
Status change: Not Yet Recruiting → Recruiting 2019-01-18
Trial Details
NCT Number NCT03776799
Lead Sponsor University of Leipzig
Conditions Peripheral Arterial Disease
Enrollment 120 participants
Start Date 2019-01-01
Primary Completion 2022-08-24 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-06