RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty (RANGER II SFA)

RANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA)

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Peripheral Artery Disease; Plaque, Atherosclerotic; Artery Diseases, Peripheral; Occlusive Arterial Disease
• Intervention / Treatment: Device: RANGER™ Paclitaxel Coated Balloon; Drug: Paclitaxel; Procedure: Standard Balloon Angioplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Univ.-Kliniken Graz
  • Vienna, Austria, 1140
    • Hanusch-Krankenhaus
  • Vienna, Austria, 1090
    • Allgemeines Krankenhaus AKH
• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Tienen, Belgium, 3300
    • Regionaal Ziekenhuis Heilig Hart Tienen
• Canada
  • Quebec, Canada, G1L 3L2
    • Hopital Saint - Francois d'Assise
  • Alberta
    • Calgary, Alberta, Canada, T1Y 6J4
      • Peter Lougheed Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Fleurimont Hospital
• Japan
  • Kyoto, Japan
    • Kyoto Katsura Hospital
  • Osaka, Japan
    • Morinomiya Hospital
  • Osaka, Japan
    • Osaka Saiseikai Nakatsu Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan
      • Kokura Memorial Hospital
  • Fukushima
    • Iwaki, Fukushima, Japan
      • Iwaki City Medical Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Tokeidai Memorial Hospital
  • Hyogo-ken
    • Amagasaki, Hyogo-ken, Japan
      • Kansai Rosai Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan
      • Saiseikai Yokohama-City Eastern Hospital
  • Miyagi
    • Sendai, Miyagi, Japan
      • Sendai Kousei Hospital
  • Osaka
    • Kishiwada, Osaka, Japan
      • Kishiwada Tokushukai Hospital
  • Saitama
    • Kasukabe, Saitama, Japan
      • Kasukabe Chuo General Hospital
  • Tokyo
    • Minato, Tokyo, Japan
      • Saiseikai Central Hospital
• New Zealand
  • Auckland, New Zealand, 1010
    • Auckland City Hospital
  • Hamilton, New Zealand, 3204
    • Clinical Trials NZ
  • Otahuhu, New Zealand, 1640
    • Middlemore Hospital
• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Thomas Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center
  • Connecticut
    • Stratford, Connecticut, United States, 06612
      • The Vascular Experts
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Coconut Creek, Florida, United States, 33073
      • South Florida Vascular Associates
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Medical Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Sebring, Florida, United States, 33872
      • Adventhealth Sebring
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar Hospitals
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Foundation Hospitals
  • Indiana
    • Fort Wayne, Indiana, United States, 46802
      • St. Joseph Hospital
    • Munster, Indiana, United States, 46321
      • Community Hospital
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • King's Daughters Medical Center - Kentucky Heart Institute
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Terrebonne General Medical Center
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Saint Paul, Minnesota, United States, 55102
      • United Heart and Vascular Clinic
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital
    • Wilmington, North Carolina, United States, 28401
      • Coastal Carolina Surgical Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Bethesda North Hospital
    • Columbus, Ohio, United States, 20161
      • Ohio State University Medical Center
    • Dayton, Ohio, United States, 45406
      • Premier Cardiovascular Institute
    • Willoughby, Ohio, United States, 44094
      • Northeast Ohio Vascular Associates, Inc.
  • Oregon
    • Bend, Oregon, United States, 97701
      • St. Charles Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • University Medical Center-Greenville Memorial Hospital
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Turkey Creek Medical Center
  • Texas
    • Dallas, Texas, United States, 75321
      • North Park Heart & Vascular Center
    • Live Oak, Texas, United States, 78233
      • Cardiology Clinic of San Antonio
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • Plano, Texas, United States, 75093
      • THR Presbyterian Plano
    • Tyler, Texas, United States, 75701
      • Tyler Cardiac and Endovascular Center
  • Utah
    • Layton, Utah, United States, 84041
      • Davis Hospital and Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospitals
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Percutaneous Transluminal Angioplasty (PTA); Drug: Paclitaxel; The RANGER™ Balloon is coated with the drug Paclitaxel.
Active Comparator: 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.	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.; Other Names: Percutaneous Transluminal Angioplasty (PTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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. RCT Standard Balloon Angioplasty: Device deficiency data is only collected for Ranger DCB; data not collected for Standard PTA group; there is no pre-specified analysis of this outcome for the Standard PTA group.	Day 0
Number of Major Adverse Event (MAE) Assessment	MAEs defined as all-cause of death post-index procedure (30-days), target limb major amputation, and/or target lesion revascularization (TLR) through 60-months in RCT. MAEs defined as all-cause of death post-index procedure (30-days), target limb major amputation, and/or target lesion revascularization (TLR) through 12-months in LB substudy. PK Substudy: There was no prespecified analysis of MAEs for PK substudy.	60-months (RCT); 12-months (LB substudy).
Number of Clinical Events Committee (CEC) Adjudicated Events	CEC adjudicated events including death of any cause, target lesion revascularization (TLR), target vessel revascularization (TVR) and target limb amputation (TLA). 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. LB substudy follow-up through 12 month.	1, 6, 12, 24, 36, 48 and 60 months (RCT and PK substudy); 1, 6 and 12 months (LB substudy)
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. LB Substudy: Follow-up through 12-month. PK Substudy: There was no prespecified analysis of Rate of Primary Sustained Clinical Improvement for PK substudy.	1, 6, 12, 24 and 36 months post-procedure (RCT); 1, 6 and 12 months post-procedure (LB substudy).
Number of Participants With Rate of Secondary 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 including those subjects with repeat TLR. LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Secondary Sustained Clinical Improvement for PK substudy.	1, 6, 12, 24 and 36 months post-procedure (RCT): 1, 6, and 12 months post-procedure (LB substudy)
Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline.	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. LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Hemodynamic Improvement for PK substudy.	1, 6, 12, 24, and 36 months post-procedure (RCT); 1, 6, and 12 months post-procedure (LB substudy)
Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline	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. LB Substudy: There was no prespecified analysis of Walking Improvement (distance) for the LB substudy. PK Substudy: There was no prespecified analysis of Walking Improvement (distance) for PK substudy.	6 and 12 months post-procedure (RCT)
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. LB Substudy: There was no prespecified analysis of Walking Improvement for the LB substudy. PK Substudy: There was no prespecified analysis of Walking Improvement for the PK substudy.	1, 6, 12, 24 and 36 months post-procedure (RCT)
Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion	Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 1, 6, 12, 24 and 36 Months (RCT) Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 1, 6, and 12 (LB Substudy) PK Substudy: There was no prespecified analysis of duplex defined binary restenosis of the target lesion	1, 6, 12, 24, and 36-months post-procedure (RCT); 1, 6, and 12-months post-procedure (LB substudy)
Patient Utility Values as Assessed by Change in EQ-5D From Baseline.	Patient Utility Values as assessed by change in EQ-5D from baseline at 1, 6, 12, 24 and 36-months post-procedure. The EuroQOL (EQ)-5D is a multi-attribute health classification system. The EQ-5D uses a 5-dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) descriptive system, which each consisting of 5 response options (no problems, slight problems, moderate problems, severe problems, or extreme problems/inability to perform). Outcomes reported as "Improvement" defined as improving at least one category from baseline. LB Substudy: There was no prespecified analysis of Patient Utility Values for the LB Substudy. PK Substudy: There was no prespecified analysis of Patient Utility Values for the PK Substudy.	1, 6, 12, 24 and 36-months post-procedure (RCT).
Changes in Healthcare Utilization Over Time	Changes in healthcare utilization over time as measured by hospitalization readmission. Readmission Rate represents (# of subjects/Total enrolled subjects) who were hospitalized due to TLR/TVR or due to Procedure/Device related AE. LB Substudy: Follow-up through 12 Month. PK Substudy: There was no prespecified analysis of healthcare utilization over time for the PK Substudy.	1, 6, 12, 24, 36, 48 and 60-months post-procedure (RCT); 1, 6, 12-months post-procedure (LB substudy)
PK Parameters Paclitaxel (PTx) Dose	Summary of Pharmacokinetic Parameters in PK substudy. Paclitaxel (PTx) Dose PK parameter data not collected or analyzed in RCT or LB substudy.	Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
PK Parameters - Maximum Plasma Concentration	Summary of Pharmacokinetic Parameters in PK substudy. cmax (ng/mL) = Maximum plasma concentration PK data not collected or analyzed in RCT or LB substudy.	Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
PK Parameters - Tmax	Summary of Pharmacokinetic Parameters in PK substudy. - Tmax Tmax (h) = The timepoint where cmax is reached PK parameter data not collected or analyzed in RCT or LB substudy.	Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
PK Parameters - Area Under the Blood Concentration Versus Time Curve From Time Zero up to the Time of the Last Quantifiable Concentration, Calculated by Trapezoidal Methods.	Summary of Pharmacokinetic Parameters in PK substudy. AUC0-t (ng*h/mL) = Area under the blood concentration versus time curve from time zero up to the time of the last quantifiable concentration, calculated by trapezoidal methods. PK parameter data not collected or analyzed in RCT or LB substudy.	Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Thomas Zeller, MD, Universitaets-Herzzentrum; Principal Investigator: Ravish Sachar, MD, University of North Carolina - Rex Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): November 18, 2019
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Atherosclerosis; Angioplasty; Peripheral; Plaque; Artery; Arterial; PTA
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arteriosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Plaque, Atherosclerotic; Atherosclerosis; Arterial Occlusive Diseases; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Albumin-Bound Paclitaxel; Paclitaxel
• Other Study ID Numbers: S2062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes