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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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)
. Presence of fresh thrombus in the lesion.
. Presence of aneurysm in the target vessel/s
. Presence of a stent in the target lesion
. Prior vascular surgery of the target lesion.
. Stroke or heart attack within 3 months prior to enrollment