RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

RANGER 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)

To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).

Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

The RANGER II SFA is a global, prospective, multi-center clinical trial. Approximately 446 subjects will be enrolled at up to 80 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand.

The trial consists of a single-blind, superiority, 3:1 (Ranger Drug-Coated Balloon (DCB) vs. Standard PTA) randomized controlled trial (RCT) and a concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy, and a concurrent, non-blinded, non-randomized, Long balloon substudy.

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.