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

Who can take part

• 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

Who cannot take part

• 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
• Enrolled in another investigational drug, device or biologic study that interferes with the study
• 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
• Receiving dialysis or immunosuppressant therapy
• Failure to successfully cross the target lesion
• SFA or PPA disease in the opposite leg that requires treatment at the index procedure
• History of major amputation in the same limb as the target lesion
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Platelet count <100,000 mm3 or >600,000 mm3
• Chronic kidney disease (serum creatinine > 3 mg/dL)
• 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
• Life expectancy of less than one year
• Rutherford classification of 0, 1, 5 or 6
• Pregnant or lactating females