Status:
ACTIVE_NOT_RECRUITING
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
Lead Sponsor:
University of Leipzig
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) approa...
Detailed Description
Prospective, multi-center 1:1 randomized Study. Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred (control arm) In total 120 patient will be enrolled in this s...
Eligibility Criteria
Inclusion
- 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
- A guidewire has successfully traversed the target treatment segment.
Exclusion
- 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
- Any planned surgical procedure or intervention performed within 30 days prior to or post index procedure
- SFA or PPA disease in the opposite leg that requires treatment at the index procedure
- Enrolled in another investigational drug, device or biologic study that interferes with the study
- Life expectancy of less than one year
- Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
- Rutherford classification of 0, 1, 5 or 6.
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
- Platelet count \<100,000 mm3 or \>600,000 mm3
- Receiving dialysis or immunosuppressant therapy
- Pregnant or lactating females.
- History of major amputation in the same limb as the target lesion
- Chronic kidney disease (serum creatinine \> 3 mg/dL)
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03776799
Start Date
January 1 2019
End Date
July 1 2026
Last Update
December 9 2024
Active Locations (1)
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1
University Clinic Leipzig
Leipzig, Saxony, Germany, 04103