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

BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery Comparing a Stent-avoiding (Study Arm) Versus Stent-preferred (Control Arm) Approach Within a Prospective, Randomized, Multi-center Trial

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).

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 study, each strata will include 60 patients.

All enrolled patients will be followed up for 24 month to asses the incidence of restenosis by duplex ultrasound and major adverse events.

Follow-up visits occur at 6, 12 and 24 month intervals as well as telephone visit after 1,36, 48 and 60 month.

Inclusion Criteria:

1. Subject age ≥ 18
2. 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.
3. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
4. Rutherford Becker Classification 2-4
5. Both treatment options seem feasible at the operator's discretion
6. Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤ 30cm not involving the infrageniculate popliteal artery are eligible.
7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
8. 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
9. A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria:

1. Failure to successfully cross the target lesion
2. Angiographic evidence of severe calcification that makes a stent-avoiding approach not feasible at the operator's discretion.
3. Femoropopliteal lesions classified as TASC II Typ A (single stenosis >=10cm and single occlusion >=5cm)
4. Presence of fresh thrombus in the lesion.
5. Presence of aneurysm in the target vessel/s
6. Presence of a stent in the target lesion
7. Prior vascular surgery of the target lesion.
8. Stroke or heart attack within 3 months prior to enrollment
9. Any planned surgical procedure or intervention performed within 30 days prior to or post index procedure
10. SFA or PPA disease in the opposite leg that requires treatment at the index procedure
11. Enrolled in another investigational drug, device or biologic study that interferes with the study
12. Life expectancy of less than one year
13. 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
14. Rutherford classification of 0, 1, 5 or 6.
15. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
16. Platelet count <100,000 mm3 or >600,000 mm3
17. Receiving dialysis or immunosuppressant therapy
18. Pregnant or lactating females.
19. History of major amputation in the same limb as the target lesion
20. Chronic kidney disease (serum creatinine > 3 mg/dL)