RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

Inclusion Criteria

• 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;
• Subject at least 20 years of age;
• Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4;
• Target lesion is in the native SFA and/or PPA down to the P1 segment;
• 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;
• Reference vessel diameter ≥ 4 mm and ≤ 8 mm by visual estimate;
• 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

• Life expectancy, documented in the Investigator's opinion, of less than 12 months;
• Hemorrhagic stroke or cardiac event (e.g. STEMI, unstable angina) within 6 months prior to enrollment;
• Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated;
• Chronic renal insufficiency with serum creatinine > 2.0 mg/dL within 30 days of index procedure or treatment with dialysis;
• Platelet count 600, 000 mm 3 or history of bleeding diathesis;
• Receiving immunosuppressive therapy;
• Septicemia at the time of enrollment;
• Any major intervention planned within 30 days post index procedure;
• Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of enrollment;
• Failure to successfully cross the target lesion with a guidewire;
• Failure to successfully pre-dilate the target vessel;
• 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;
• History of major amputation in the target limb;
• 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;
• Pregnant or breast feeding;
• Presence of aneurysm in the target vessel;
• Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment;
• Patient has significant inflow disease which cannot be treated prior to the target lesion treatment;
• Patient has perforated targeted vessel as evidenced by extravasation of contrast media;
• Patient has severe calcification that renders the lesion undilatable;
• 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.