RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty (RANGER II SFA)
Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral
About this trial
This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Artery, Atherosclerosis, Arterial, Peripheral, Plaque, Angioplasty, PTA
Eligibility Criteria
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 < 80,000 mm 3 or > 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.
Sites / Locations
- Thomas Hospital
- Rocky Mountain Regional VA Medical Center
- The Vascular Experts
- Christiana Hospital
- Washington Hospital Center
- South Florida Vascular Associates
- North Florida Regional Medical Center
- Mount Sinai Medical Center
- AdventHealth Orlando
- AdventHealth Sebring
- Wellstar Hospitals
- Kaiser Foundation Hospitals
- St. Joseph Hospital
- Community Hospital
- King's Daughters Medical Center - Kentucky Heart Institute
- Terrebonne General Medical Center
- Mercy Hospital
- United Heart and Vascular Clinic
- Hackensack University Medical Center
- Jersey Shore University Medical Center
- Mount Sinai Medical Center
- Staten Island University Hospital
- Rex Hospital
- Coastal Carolina Surgical Associates
- Bethesda North Hospital
- Ohio State University Medical Center
- Premier Cardiovascular Institute
- Northeast Ohio Vascular Associates, Inc.
- St. Charles Medical Center
- Temple University
- University Medical Center-Greenville Memorial Hospital
- Turkey Creek Medical Center
- North Park Heart & Vascular Center
- Cardiology Clinic of San Antonio
- Texas Tech University Health Sciences Center
- North Dallas Research Associates
- The Heart Hospital Baylor Plano
- THR Presbyterian Plano
- Tyler Cardiac and Endovascular Center
- Davis Hospital and Medical Center
- West Virginia University Hospitals
- Aspirus Heart and Vascular Institute
- Medizinische Univ.-Kliniken Graz
- Allgemeines Krankenhaus AKH
- Hanusch-Krankenhaus
- Ziekenhuis Oost Limburg
- Universitair Ziekenhuis Gent
- Regionaal Ziekenhuis Heilig Hart Tienen
- Peter Lougheed Centre
- Hamilton General Hospital
- Fleurimont Hospital
- Hopital Saint - Francois d'Assise
- Kokura Memorial Hospital
- Iwaki City Medical Center
- Tokeidai Memorial Hospital
- Kansai Rosai Hospital
- Saiseikai Yokohama-City Eastern Hospital
- Sendai Kousei Hospital
- Kishiwada Tokushukai Hospital
- Kasukabe Chuo General Hospital
- Saiseikai Central Hospital
- Kyoto Katsura Hospital
- Morinomiya Hospital
- Osaka Saiseikai Nakatsu Hospital
- Auckland City Hospital
- Clinical Trials NZ
- Middlemore Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
RANGER™ Paclitaxel Coated Balloon
Standard Balloon Angioplasty
RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.
Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.