Peripheral Artery DiseasePhase 3RANGER II SFANCT03064126
RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
A Phase 3 study testing RANGER™ Paclitaxel Coated Balloon, Paclitaxel and Standard Balloon Angioplasty in people with Peripheral Artery Disease and Atherosclerosis, run by Boston Scientific Corporation at 67 sites in 6 countries.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral
- What is being tested?
- RANGER™ Paclitaxel Coated Balloon, Paclitaxel and Standard Balloon Angioplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 67 sitesin 6 countries
- Study dates
- 2 Mar 2017to 25 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
67 sites in 6 countries.
67 sites in 6 countries
United States42 sites
King's Daughters Medical Center - Kentucky Heart Institute
Ashland, Kentucky, 41101
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
St. Charles Medical Center
Bend, Oregon, 97701
Bethesda North Hospital
Cincinnati, Ohio, 45220
South Florida Vascular Associates
Coconut Creek, Florida, 33073
Ohio State University Medical Center
Columbus, Ohio, 20161
Mercy Hospital
Coon Rapids, Minnesota, 55433
North Park Heart & Vascular Center
Dallas, Texas, 75321
Premier Cardiovascular Institute
Dayton, Ohio, 45406
Thomas Hospital
Fairhope, Alabama, 36532
St. Joseph Hospital
Fort Wayne, Indiana, 46802
North Florida Regional Medical Center
Gainesville, Florida, 32605
University Medical Center-Greenville Memorial Hospital
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Kaiser Foundation Hospitals
Honolulu, Hawaii, 96819
Terrebonne General Medical Center
Houma, Louisiana, 70360
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Davis Hospital and Medical Center
Layton, Utah, 84041
Cardiology Clinic of San Antonio
Live Oak, Texas, 78233
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Wellstar Hospitals
Marietta, Georgia, 30060
North Dallas Research Associates
McKinney, Texas, 75069
Mount Sinai Medical Center
Miami Beach, Florida, 33140
West Virginia University Hospitals
Morgantown, West Virginia, 26506
Community Hospital
Munster, Indiana, 46321
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Mount Sinai Medical Center
New York, New York, 10029
Christiana Hospital
Newark, Delaware, 19718
AdventHealth Orlando
Orlando, Florida, 32803
Temple University
Philadelphia, Pennsylvania, 19140
The Heart Hospital Baylor Plano
Plano, Texas, 75093
THR Presbyterian Plano
Plano, Texas, 75093
Rex Hospital
Raleigh, North Carolina, 27607
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
AdventHealth Sebring
Sebring, Florida, 33872
Staten Island University Hospital
Staten Island, New York, 10305
The Vascular Experts
Stratford, Connecticut, 06612
Tyler Cardiac and Endovascular Center
Tyler, Texas, 75701
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Aspirus Heart and Vascular Institute
Wausau, Wisconsin, 54401
Northeast Ohio Vascular Associates, Inc.
Willoughby, Ohio, 44094
Coastal Carolina Surgical Associates
Wilmington, North Carolina, 28401
Japan12 sites
Kansai Rosai Hospital
Amagasaki, Hyōgo
Iwaki City Medical Center
Iwaki, Fukushima
Kasukabe Chuo General Hospital
Kasukabe, Saitama
Kishiwada Tokushukai Hospital
Kishiwada, Osaka
Kokura Memorial Hospital
Kitakyushu, Fukuoka
Kyoto Katsura Hospital
Kyoto
Saiseikai Central Hospital
Minato, Tokyo
Morinomiya Hospital
Osaka
Osaka Saiseikai Nakatsu Hospital
Osaka
Tokeidai Memorial Hospital
Sapporo, Hokkaido
Sendai Kousei Hospital
Sendai, Miyagi
Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa
Canada4 sites
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Hopital Saint - Francois d'Assise
Québec, G1L 3L2
Fleurimont Hospital
Sherbrooke, Quebec, J1H 5N4
Austria3 sites
Medizinische Univ.-Kliniken Graz
Graz, 8036
Allgemeines Krankenhaus AKH
Vienna, 1090
Hanusch-Krankenhaus
Vienna, 1140
Belgium3 sites
Ziekenhuis Oost Limburg
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, 9000
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, 3300
New Zealand3 sites
Auckland City Hospital
Auckland, 1010
Clinical Trials NZ
Hamilton, 3204
Middlemore Hospital
Otahuhu, 1640
About this study
Official title: 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.
Read the 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
- Being tested
- RANGER™ Paclitaxel Coated Balloon, Paclitaxel, Standard Balloon Angioplasty
- Keywords
- Artery, Atherosclerosis, Arterial, Peripheral, Plaque, Angioplasty, PTA
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis, Plaque, Atherosclerotic, Arterial Occlusive Diseases, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RANGER™ Paclitaxel Coated BalloonDevice
Also called Percutaneous Transluminal Angioplasty (PTA)
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.
PaclitaxelDrug
The RANGER™ Balloon is coated with the drug Paclitaxel.
Standard Balloon AngioplastyProcedure or surgery
Also called Percutaneous Transluminal Angioplasty (PTA)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Day 0
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start2 Mar 2017
- Primary completion18 Nov 2019
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The RANGER™ investigational device is coated with the drug paclitaxel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, MD, Principal investigator, Universitaets-HerzzentrumRavish Sachar, MD, Principal investigator, University of North Carolina - Rex Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064126
- Sponsor's protocol ID
- S2062
- Acronym
- RANGER II SFA
- Status last verified
- Oct 2024
- First submitted
- 13 Jan 2017
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24920940Kakkar 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.
PubMed 25612856Razavi 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.
PubMed 25130307Laird 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.
PubMed 20484101Scheinert 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.
PubMed 24456716Schroe 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.
PubMed 35943120Soga 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.
PubMed 34557931Sachar 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.
PubMed 34016410
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03064126
- Acronym / sponsor ID
- RANGER II SFA / S2062
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral, Plaque, Atherosclerotic, Occlusive Arterial Disease
- Keywords
- Artery, Atherosclerosis, Arterial, Peripheral, Plaque, Angioplasty, PTA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 15 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The RANGER™ investigational device is coated with the drug paclitaxel.
| Arm | Type | Receives |
|---|---|---|
| RANGER™ Paclitaxel Coated Balloon | Experimental | Device: RANGER™ Paclitaxel Coated Balloon, Drug: PaclitaxelRANGER™ 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 Angioplasty | Active comparator | Procedure: Standard Balloon AngioplastyStandard 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RANGER™ Paclitaxel Coated BalloonAlso: Percutaneous Transluminal Angioplasty (PTA)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. | Device | RANGER™ Paclitaxel Coated Balloon |
| PaclitaxelThe RANGER™ Balloon is coated with the drug Paclitaxel. | Drug | RANGER™ Paclitaxel Coated Balloon |
| Standard Balloon AngioplastyAlso: Percutaneous Transluminal Angioplasty (PTA)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. | Procedure or surgery | Standard Balloon Angioplasty |
Primary outcome
Number of Participants With Primary Lesion Patency
Time frame: 12 months (RCT); 6 months (LB substudy)
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.
Major Adverse Events (MAEs) (Primary Safety Endpoint)
Time frame: Primary safety endpoint assessed at 12 months for RCT study and at both 6 and 12 months for LB substudy.
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.
17 secondary outcomes
Number of Participants With Technical Success of Angioplasty Procedure
Time frame: Day 0
Number of Participants With Procedural Success of Angioplasty Procedure
Time frame: Day 0
Number of Participants With Clinical Success Rate Assessment
Time frame: Day 0
Number of Major Adverse Event (MAE) Assessment
Time frame: 60-months (RCT); 12-months (LB substudy).
Number of Clinical Events Committee (CEC) Adjudicated Events
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 6 and 12 months post-procedure (RCT)
Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline.
Time frame: 1, 6, 12, 24 and 36 months post-procedure (RCT)
Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion
Time frame: 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.
Time frame: 1, 6, 12, 24 and 36-months post-procedure (RCT).
Changes in Healthcare Utilization Over Time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24920940Litsky 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.
- Background: PubMed 25612856Kakkar 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.
- Background: PubMed 25130307Razavi 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.
- Background: PubMed 20484101Laird 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.
- Background: PubMed 24456716Scheinert 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.
- Derived from this study: PubMed 35943120Schroe 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.
- Derived from this study: PubMed 34557931Soga 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.
- Derived from this study: PubMed 34016410Sachar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Zeller, MD principal investigator
Universitaets-Herzzentrum
Ravish Sachar, MD principal investigator
University of North Carolina - Rex Hospital
67 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RANGER™ Paclitaxel Coated Balloon, Paclitaxel and Standard Balloon Angioplasty in people with Peripheral Artery Disease and Atherosclerosis, run by Boston Scientific Corporation at 67 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Japan, Canada, Austria, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Primary Lesion Patency (time frame: 12 months (RCT); 6 months (LB substudy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064126, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.