RANGER II SFARANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA)

Fecha de inicio: 2 de marzo de 2017

Inclusion Criteria: 1. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits; 2. Subject at least 20 years of age; 3. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4; 4. Target lesion is in the native SFA and/or PPA down to the P1 segment; 5. Patent popliteal and infrapopliteal arteries, i.e., single vessel runoff or better with at least one of three vessels patent (less than 50 % stenosis) to the ankle or foot; 6. Reference vessel diameter ≥ 4 mm and ≤ 8 mm by visual estimate; 7. Angiographic evidence that target lesion consists of a single de novo, non-stented and non-atherectomy treated or restenotic lesion (or tandem lesions or a combination lesion as defined below) that is: * ≥ 70%-99% stenotic with total lesion length up to 180 mm by visual estimate. * Occluded with total lesion length ≤ 100 mm by visual estimate. * If lesion is restenotic, most recent PTA treatment must be \> 3 months prior to enrollment. Exclusion Criteria: 1. Life expectancy, documented in the Investigator's opinion, of less than 12 months; 2. Hemorrhagic stroke or cardiac event (e.g. STEMI, unstable angina) within 6 months prior to enrollment; 3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel; 4. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated; 5. Chronic renal insufficiency with serum creatinine \> 2.0 mg/dL within 30 days of index procedure or treatment with dialysis; 6. Platelet count \< 80,000 mm 3 or \> 600,000 mm 3 or history of bleeding diathesis; 7. Receiving immunosuppressive therapy; 8. Septicemia at the time of enrollment; 9. Any major intervention planned within 30 days post index procedure; 10. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of enrollment; 11. Failure to successfully cross the target lesion with a guidewire; 12. Failure to successfully pre-dilate the target vessel; 13. Patient has lesion that requires the use of adjunctive primary treatment modalities (i.e. laser, atherectomy, scoring/cutting balloon, other debulking devices, etc.) during the index procedure; 14. History of major amputation in the target limb; 15. Target lesion or vessel has ever been previously treated with stent (e.g. in-stent restenosis) or surgery. Target lesion or vessel has been treated with atherectomy or a DCB in the past 12 months; 16. Pregnant or breast feeding; 17. Presence of aneurysm in the target vessel; 18. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment; 19. Patient has significant inflow disease which cannot be treated prior to the target lesion treatment; 20. Patient has perforated targeted vessel as evidenced by extravasation of contrast media; 21. Patient has severe calcification that renders the lesion undilatable; 22. Current participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints.