RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

NCT ID: NCT03064126

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-02
• Study Completion Date: 2023-10-25

Brief 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.

Detailed 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 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.

Conditions

Peripheral Artery Disease; Atherosclerosis; Artery Diseases, Peripheral; Plaque, Atherosclerotic; Occlusive Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RANGER™ Paclitaxel Coated Balloon

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.

Group Type: EXPERIMENTAL

RANGER™ Paclitaxel Coated Balloon

Intervention Type: DEVICE

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.

Paclitaxel

Intervention Type: DRUG

The RANGER™ Balloon is coated with the drug Paclitaxel.

Standard Balloon Angioplasty

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.

Group Type: ACTIVE_COMPARATOR

Standard Balloon Angioplasty

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

Paclitaxel

The RANGER™ Balloon is coated with the drug Paclitaxel.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous Transluminal Angioplasty (PTA); Percutaneous Transluminal Angioplasty (PTA)

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaets-Herzzentrum

Ravish Sachar, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina - Rex Hospital

Locations

Thomas Hospital

Fairhope, Alabama, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

The Vascular Experts

Stratford, Connecticut, United States

Christiana Hospital

Newark, Delaware, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

South Florida Vascular Associates

Coconut Creek, Florida, United States

North Florida Regional Medical Center

Gainesville, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

AdventHealth Sebring

Sebring, Florida, United States

Wellstar Hospitals

Marietta, Georgia, United States

Kaiser Foundation Hospitals

Honolulu, Hawaii, United States

St. Joseph Hospital

Fort Wayne, Indiana, United States

Community Hospital

Munster, Indiana, United States

King's Daughters Medical Center - Kentucky Heart Institute

Ashland, Kentucky, United States

Terrebonne General Medical Center

Houma, Louisiana, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

United Heart and Vascular Clinic

Saint Paul, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Mount Sinai Medical Center

New York, New York, United States

Staten Island University Hospital

Staten Island, New York, United States

Rex Hospital

Raleigh, North Carolina, United States

Coastal Carolina Surgical Associates

Wilmington, North Carolina, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Premier Cardiovascular Institute

Dayton, Ohio, United States

Northeast Ohio Vascular Associates, Inc.

Willoughby, Ohio, United States

St. Charles Medical Center

Bend, Oregon, United States

Temple University

Philadelphia, Pennsylvania, United States

University Medical Center-Greenville Memorial Hospital

Greenville, South Carolina, United States

Turkey Creek Medical Center

Knoxville, Tennessee, United States

North Park Heart & Vascular Center

Dallas, Texas, United States

Cardiology Clinic of San Antonio

Live Oak, Texas, United States

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

North Dallas Research Associates

McKinney, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

THR Presbyterian Plano

Plano, Texas, United States

Tyler Cardiac and Endovascular Center

Tyler, Texas, United States

Davis Hospital and Medical Center

Layton, Utah, United States

West Virginia University Hospitals

Morgantown, West Virginia, United States

Aspirus Heart and Vascular Institute

Wausau, Wisconsin, United States

Medizinische Univ.-Kliniken Graz

Graz, , Austria

Allgemeines Krankenhaus AKH

Vienna, , Austria

Hanusch-Krankenhaus

Vienna, , Austria

Ziekenhuis Oost Limburg

Genk, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, , Belgium

Peter Lougheed Centre

Calgary, Alberta, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

Fleurimont Hospital

Sherbrooke, Quebec, Canada

Hopital Saint - Francois d'Assise

Québec, , Canada

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Iwaki City Medical Center

Iwaki, Fukushima, Japan

Tokeidai Memorial Hospital

Sapporo, Hokkaido, Japan

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Kasukabe Chuo General Hospital

Kasukabe, Saitama, Japan

Saiseikai Central Hospital

Minato, Tokyo, Japan

Kyoto Katsura Hospital

Kyoto, , Japan

Morinomiya Hospital

Osaka, , Japan

Osaka Saiseikai Nakatsu Hospital

Osaka, , Japan

Auckland City Hospital

Auckland, , New Zealand

Clinical Trials NZ

Hamilton, , New Zealand

Middlemore Hospital

Otahuhu, , New Zealand

Countries

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

References

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.

Reference Type: BACKGROUND

PMID: 24920940 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25612856 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25130307 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20484101 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24456716 (View on PubMed)

Schroe H, Sachar R, Keirse K, Soga Y, Brodmann M, Rao V, Werner M, Holden A, Lopez L, Krishnan P, Diaz-Cartelle J. The RANGER II superficial femoral artery trial: 1-year results of the long lesion cohort. Vasc Med. 2022 Oct;27(5):457-465. doi: 10.1177/1358863X221097164. Epub 2022 Aug 9.

Reference Type: DERIVED

PMID: 35943120 (View on PubMed)

Soga Y, Fujihara M, Yamamoto Y, Nakamura S, Iida O, Kawasaki D, Urasawa K, Ando H, Mori S, Suzuki K, Horie K, Diaz-Cartelle J, Kozuki A. One-year results for Japanese patients in RANGER II SFA. Heart Vessels. 2022 Apr;37(4):568-573. doi: 10.1007/s00380-021-01947-3. Epub 2021 Sep 23.

Reference Type: DERIVED

PMID: 34557931 (View on PubMed)

Sachar R, Soga Y, Ansari MM, Kozuki A, Lopez L, Brodmann M, Schroe H, Ramanath VS, Diaz-Cartelle J, Zeller T; RANGER II SFA Investigators. 1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon. JACC Cardiovasc Interv. 2021 May 24;14(10):1123-1133. doi: 10.1016/j.jcin.2021.03.021.

Reference Type: DERIVED

PMID: 34016410 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

S2062

Identifier Type: -

Identifier Source: org_study_id