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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03064126
Other study ID # S2062
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2, 2017
Est. completion date October 25, 2023

Study information

Verified date April 2024
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 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.


Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date October 25, 2023
Est. primary completion date November 18, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Intervention

Device:
RANGER™ Paclitaxel Coated Balloon
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.
Drug:
Paclitaxel
The RANGER™ Balloon is coated with the drug Paclitaxel.
Procedure:
Standard Balloon Angioplasty
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.

Locations

Country Name City State
Austria Medizinische Univ.-Kliniken Graz Graz
Austria Allgemeines Krankenhaus AKH Vienna
Austria Hanusch-Krankenhaus Vienna
Belgium Ziekenhuis Oost Limburg Genk
Belgium Universitair Ziekenhuis Gent Gent
Belgium Regionaal Ziekenhuis Heilig Hart Tienen Tienen
Canada Peter Lougheed Centre Calgary Alberta
Canada Hamilton General Hospital Hamilton Ontario
Canada Hopital Saint - Francois d'Assise Quebec
Canada Fleurimont Hospital Sherbrooke Quebec
Japan Kansai Rosai Hospital Amagasaki Hyogo-ken
Japan Iwaki City Medical Center Iwaki Fukushima
Japan Kasukabe Chuo General Hospital Kasukabe Saitama
Japan Kishiwada Tokushukai Hospital Kishiwada Osaka
Japan Kokura Memorial Hospital Kitakyushu Fukuoka
Japan Kyoto Katsura Hospital Kyoto
Japan Saiseikai Central Hospital Minato Tokyo
Japan Morinomiya Hospital Osaka
Japan Osaka Saiseikai Nakatsu Hospital Osaka
Japan Tokeidai Memorial Hospital Sapporo Hokkaido
Japan Sendai Kousei Hospital Sendai Miyagi
Japan Saiseikai Yokohama-City Eastern Hospital Yokohama Kanagawa
New Zealand Auckland City Hospital Auckland
New Zealand Clinical Trials NZ Hamilton
New Zealand Middlemore Hospital Otahuhu
United States King's Daughters Medical Center - Kentucky Heart Institute Ashland Kentucky
United States Rocky Mountain Regional VA Medical Center Aurora Colorado
United States St. Charles Medical Center Bend Oregon
United States Bethesda North Hospital Cincinnati Ohio
United States South Florida Vascular Associates Coconut Creek Florida
United States Ohio State University Medical Center Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States North Park Heart & Vascular Center Dallas Texas
United States Premier Cardiovascular Institute Dayton Ohio
United States Thomas Hospital Fairhope Alabama
United States St. Joseph Hospital Fort Wayne Indiana
United States North Florida Regional Medical Center Gainesville Florida
United States University Medical Center-Greenville Memorial Hospital Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Kaiser Foundation Hospitals Honolulu Hawaii
United States Terrebonne General Medical Center Houma Louisiana
United States Turkey Creek Medical Center Knoxville Tennessee
United States Davis Hospital and Medical Center Layton Utah
United States Cardiology Clinic of San Antonio Live Oak Texas
United States Texas Tech University Health Sciences Center Lubbock Texas
United States Wellstar Hospitals Marietta Georgia
United States North Dallas Research Associates McKinney Texas
United States Mount Sinai Medical Center Miami Beach Florida
United States West Virginia University Hospitals Morgantown West Virginia
United States Community Hospital Munster Indiana
United States Jersey Shore University Medical Center Neptune New Jersey
United States Mount Sinai Medical Center New York New York
United States Christiana Hospital Newark Delaware
United States AdventHealth Orlando Orlando Florida
United States Temple University Philadelphia Pennsylvania
United States The Heart Hospital Baylor Plano Plano Texas
United States THR Presbyterian Plano Plano Texas
United States Rex Hospital Raleigh North Carolina
United States United Heart and Vascular Clinic Saint Paul Minnesota
United States AdventHealth Sebring Sebring Florida
United States Staten Island University Hospital Staten Island New York
United States The Vascular Experts Stratford Connecticut
United States Tyler Cardiac and Endovascular Center Tyler Texas
United States Washington Hospital Center Washington District of Columbia
United States Aspirus Heart and Vascular Institute Wausau Wisconsin
United States Northeast Ohio Vascular Associates, Inc. Willoughby Ohio
United States Coastal Carolina Surgical Associates Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Japan,  New Zealand, 

References & Publications (5)

Kakkar AM, Abbott JD. Percutaneous versus surgical management of lower extremity peripheral artery disease. Curr Atheroscler Rep. 2015;17(2):479. doi: 10.1007/s11883-014-0479-0. — View Citation

Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18. — View Citation

Litsky J, Chanda A, Stilp E, Lansky A, Mena C. Critical evaluation of stents in the peripheral arterial disease of the superficial femoral artery - focus on the paclitaxel eluting stent. Med Devices (Auckl). 2014 May 28;7:149-56. doi: 10.2147/MDER.S45472. eCollection 2014. — View Citation

Razavi MK, Mustapha JA, Miller LE. Contemporary systematic review and meta-analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic disease. J Vasc Interv Radiol. 2014 Oct;25(10):1489-96, 1496.e1-3. doi: 10.1016/j.jvir.2014.06.018. Epub 2014 Aug 15. — View Citation

Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Primary Lesion Patency RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) = 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR >2.4 suggests >50% stenosis.
LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) = 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure.
PK Substudy not analyzed for primary patency.
12 months (6 months for LB substudy)
Primary Major Adverse Events (MAEs) (Primary Safety Endpoint) RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months.
LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure.
PK Substudy: Not analyzed for primary safety endpoint.
12 months (6 months for LB substudy)
Secondary Number of Participants With Technical Success of Angioplasty Procedure Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure. Day 0
Secondary Number of Participants With Procedural Success of Angioplasty Procedure Procedural success defined as residual stenosis of less than or equal to 50% (non-stented subjects) or less than or equal to 30% (stented subjects) by core laboratory evaluation. Day 0
Secondary Number of Participants With Clinical Success Rate Assessment Clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge. Day 0
Secondary Number of Major Adverse Event (MAE) Assessment MAEs defined as all-cause of death post-index procedure, target limb major amputation, and/or target lesion revascularization (TLR). 12 months (6 months for LB substudy)
Secondary Number of CEC Adjudicated Events Through 12 Months Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window. 12 months (6 Months for LB Substudy)
Secondary Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR 12 months (6 months for LB substudy)
Secondary Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR 12 months (6 months for LB substudy)
Secondary Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) Improvement of ABI by = 0.1 or to an ABI = 0.90 as compared to the pre-procedure value without the need for repeat revascularization. 12 months (6 months for LB substudy)
Secondary Walking Improvement (Distance) Assessed by Change in Six Minute Walk Test (6MWT) The 6MWT measure the maximal walking distance that a patient achieves on a flat, hard surface within a period of 6 minutes. It evaluates the global and integrated responses of all physiological systems involved during exercise including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular units and muscle metabolism. Change in distance walked from baseline to 12 months. 12 months
Secondary Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline to 12 months. 12 months
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