RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

NCT03064126 | Completed Phase 3 Results DMC FDA Device

• 1 other identifier: S2062
• Study Type: interventional
• Target: 440
• Locations: 6 countries
• Sites: 67

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.

Conditions

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

Keywords

Artery; Atherosclerosis; Arterial; Peripheral; Plaque; Angioplasty; PTA

Outcome Measures

Primary Outcomes (2)

• 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: There was no prespecified analysis of primary lesion patency.

  12 months (RCT); 6 months (LB substudy)

• 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: There was no prespecified analysis of primary safety endpoint.

  Primary safety endpoint assessed at 12 months for RCT study and at both 6 and 12 months for LB substudy.

Secondary Outcomes (17)

• Number of Participants With Technical Success of Angioplasty Procedure

  Day 0

• Number of Participants With Procedural Success of Angioplasty Procedure

  Day 0

• Number of Participants With Clinical Success Rate Assessment

  Day 0

• Number of Major Adverse Event (MAE) Assessment

  60-months (RCT); 12-months (LB substudy).

• Number of Clinical Events Committee (CEC) Adjudicated Events

  1, 6, 12, 24, 36, 48 and 60 months (RCT and PK substudy); 1, 6 and 12 months (LB substudy)

Study Arms (2)

RANGER™ Paclitaxel Coated Balloon

EXPERIMENTAL

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.

Device: RANGER™ Paclitaxel Coated Balloon; Drug: Paclitaxel

Standard Balloon Angioplasty

ACTIVE COMPARATOR

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.

Procedure: Standard Balloon Angioplasty

Interventions

RANGER™ Paclitaxel Coated Balloon 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.

Also known as: Percutaneous Transluminal Angioplasty (PTA)

RANGER™ Paclitaxel Coated Balloon

Paclitaxel DRUG

The RANGER™ Balloon is coated with the drug Paclitaxel.

RANGER™ Paclitaxel Coated Balloon

Standard Balloon Angioplasty 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.

Also known as: Percutaneous Transluminal Angioplasty (PTA)

Standard Balloon Angioplasty

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (67)

Thomas Hospital

Fairhope, Alabama, 36532, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

The Vascular Experts

Stratford, Connecticut, 06612, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

South Florida Vascular Associates

Coconut Creek, Florida, 33073, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

AdventHealth Sebring

Sebring, Florida, 33872, United States

Location

Wellstar Hospitals

Marietta, Georgia, 30060, United States

Location

Kaiser Foundation Hospitals

Honolulu, Hawaii, 96819, United States

Location

St. Joseph Hospital

Fort Wayne, Indiana, 46802, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

King's Daughters Medical Center - Kentucky Heart Institute

Ashland, Kentucky, 41101, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

United Heart and Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Coastal Carolina Surgical Associates

Wilmington, North Carolina, 28401, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45220, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 20161, United States

Location

Premier Cardiovascular Institute

Dayton, Ohio, 45406, United States

Location

Northeast Ohio Vascular Associates, Inc.

Willoughby, Ohio, 44094, United States

Location

St. Charles Medical Center

Bend, Oregon, 97701, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University Medical Center-Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

North Park Heart & Vascular Center

Dallas, Texas, 75321, United States

Location

Cardiology Clinic of San Antonio

Live Oak, Texas, 78233, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

North Dallas Research Associates

McKinney, Texas, 75069, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

THR Presbyterian Plano

Plano, Texas, 75093, United States

Location

Tyler Cardiac and Endovascular Center

Tyler, Texas, 75701, United States

Location

Davis Hospital and Medical Center

Layton, Utah, 84041, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

Aspirus Heart and Vascular Institute

Wausau, Wisconsin, 54401, United States

Location

Medizinische Univ.-Kliniken Graz

Graz, 8036, Austria

Location

Allgemeines Krankenhaus AKH

Vienna, 1090, Austria

Location

Hanusch-Krankenhaus

Vienna, 1140, Austria

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, 3300, Belgium

Location

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Fleurimont Hospital

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Hopital Saint - Francois d'Assise

Québec, G1L 3L2, Canada

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Location

Iwaki City Medical Center

Iwaki, Fukushima, Japan

Location

Tokeidai Memorial Hospital

Sapporo, Hokkaido, Japan

Location

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Location

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Location

Kasukabe Chuo General Hospital

Kasukabe, Saitama, Japan

Location

Saiseikai Central Hospital

Minato, Tokyo, Japan

Location

Kyoto Katsura Hospital

Kyoto, Japan

Location

Morinomiya Hospital

Osaka, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, Japan

Location

Auckland City Hospital

Auckland, 1010, New Zealand

Location

Clinical Trials NZ

Hamilton, 3204, New Zealand

Location

Middlemore Hospital

Otahuhu, 1640, New Zealand

Location

Related Publications (8)

• 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.

  PMID: 24920940 BACKGROUND

• 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.

  PMID: 25612856 BACKGROUND

• 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.

  PMID: 25130307 BACKGROUND

• 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.

  PMID: 20484101 BACKGROUND

• 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.

  PMID: 24456716 BACKGROUND

• 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.

  PMID: 35943120 DERIVED

• 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.

  PMID: 34557931 DERIVED

• 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.

  PMID: 34016410 DERIVED

MeSH Terms

Conditions

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

Interventions

Angioplasty; Paclitaxel

Condition Hierarchy (Ancestors)

Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Cynthia Peterson
• Organization: Boston Scientific

Cynthia.Peterson@bsci.com

763-955-8233

Study Officials

• Thomas Zeller, MD

  Universitaets-Herzzentrum

  PRINCIPAL INVESTIGATOR

• Ravish Sachar, MD

  University of North Carolina - Rex Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to treatment assigned and treatment received until completion of all 12 month follow-up visits (primary endpoint).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The RANGER™ investigational device is coated with the drug paclitaxel.

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: February 24, 2017
• Study Start: March 2, 2017
• Primary Completion: November 18, 2019
• Study Completion: October 25, 2023
• Last Updated: October 29, 2024
• Results First Posted: July 15, 2020

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (42); JP (12); AU (3); NZ (3); CA (4); BE (3)