RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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.