RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
Condition: Peripheral Artery Disease; Atherosclerosis; Artery Diseases, Peripheral; Plaque, Atherosclerotic; Occlusive Arterial Disease
MeSH terms: Atherosclerosis; Peripheral Arterial Disease; Arterial Occlusive Diseases; Plaque, Atherosclerotic
Intervention: RANGER™ Paclitaxel Coated Balloon; Paclitaxel; Standard Balloon Angioplasty
Intervention description: A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.; The RANGER™ Balloon is coated with the drug Paclitaxel.; A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The RANGER™ investigational device is coated with the drug paclitaxel.
Masking: Single (Participant)
Masking description: Subjects will be blinded to treatment assigned and treatment received until completion of all 12 month follow-up visits (primary endpoint).
Enrollment: 440.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Artery; Atherosclerosis; Arterial; Peripheral; Plaque; Angioplasty; PTA

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.
    

Eligibility 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.