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

Primary Purpose

Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RANGER™ Paclitaxel Coated Balloon
Paclitaxel
Standard Balloon Angioplasty
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Artery, Atherosclerosis, Arterial, Peripheral, Plaque, Angioplasty, PTA

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thomas Hospital
  • Rocky Mountain Regional VA Medical Center
  • The Vascular Experts
  • Christiana Hospital
  • Washington Hospital Center
  • South Florida Vascular Associates
  • North Florida Regional Medical Center
  • Mount Sinai Medical Center
  • AdventHealth Orlando
  • AdventHealth Sebring
  • Wellstar Hospitals
  • Kaiser Foundation Hospitals
  • St. Joseph Hospital
  • Community Hospital
  • King's Daughters Medical Center - Kentucky Heart Institute
  • Terrebonne General Medical Center
  • Mercy Hospital
  • United Heart and Vascular Clinic
  • Hackensack University Medical Center
  • Jersey Shore University Medical Center
  • Mount Sinai Medical Center
  • Staten Island University Hospital
  • Rex Hospital
  • Coastal Carolina Surgical Associates
  • Bethesda North Hospital
  • Ohio State University Medical Center
  • Premier Cardiovascular Institute
  • Northeast Ohio Vascular Associates, Inc.
  • St. Charles Medical Center
  • Temple University
  • University Medical Center-Greenville Memorial Hospital
  • Turkey Creek Medical Center
  • North Park Heart & Vascular Center
  • Cardiology Clinic of San Antonio
  • Texas Tech University Health Sciences Center
  • North Dallas Research Associates
  • The Heart Hospital Baylor Plano
  • THR Presbyterian Plano
  • Tyler Cardiac and Endovascular Center
  • Davis Hospital and Medical Center
  • West Virginia University Hospitals
  • Aspirus Heart and Vascular Institute
  • Medizinische Univ.-Kliniken Graz
  • Allgemeines Krankenhaus AKH
  • Hanusch-Krankenhaus
  • Ziekenhuis Oost Limburg
  • Universitair Ziekenhuis Gent
  • Regionaal Ziekenhuis Heilig Hart Tienen
  • Peter Lougheed Centre
  • Hamilton General Hospital
  • Fleurimont Hospital
  • Hopital Saint - Francois d'Assise
  • Kokura Memorial Hospital
  • Iwaki City Medical Center
  • Tokeidai Memorial Hospital
  • Kansai Rosai Hospital
  • Saiseikai Yokohama-City Eastern Hospital
  • Sendai Kousei Hospital
  • Kishiwada Tokushukai Hospital
  • Kasukabe Chuo General Hospital
  • Saiseikai Central Hospital
  • Kyoto Katsura Hospital
  • Morinomiya Hospital
  • Osaka Saiseikai Nakatsu Hospital
  • Auckland City Hospital
  • Clinical Trials NZ
  • Middlemore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RANGER™ Paclitaxel Coated Balloon

Standard Balloon Angioplasty

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Primary Lesion Patency
RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR >2.4 suggests >50% stenosis. LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure. PK Substudy not analyzed for primary patency.
Major Adverse Events (MAEs) (Primary Safety Endpoint)
RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months. LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure. PK Substudy: Not analyzed for primary safety endpoint.

Secondary Outcome Measures

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.
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.
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.
Number of Major Adverse Event (MAE) Assessment
MAEs defined as all-cause of death post-index procedure, target limb major amputation, and/or target lesion revascularization (TLR).
Number of CEC Adjudicated Events Through 12 Months
Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window.
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
Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification
Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR
Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI)
Improvement of ABI by ≥ 0.1 or to an ABI ≥ 0.90 as compared to the pre-procedure value without the need for repeat revascularization.
Walking Improvement (Distance) Assessed by Change in Six Minute Walk Test (6MWT)
The 6MWT measure the maximal walking distance that a patient achieves on a flat, hard surface within a period of 6 minutes. It evaluates the global and integrated responses of all physiological systems involved during exercise including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular units and muscle metabolism. Change in distance walked from baseline to 12 months.
Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline
The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline to 12 months.

Full Information

First Posted
January 13, 2017
Last Updated
September 22, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03064126
Brief Title
RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
Acronym
RANGER II SFA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral, Plaque, Atherosclerotic, Occlusive Arterial Disease
Keywords
Artery, Atherosclerosis, Arterial, Peripheral, Plaque, Angioplasty, PTA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The RANGER™ investigational device is coated with the drug paclitaxel.
Masking
Participant
Masking Description
Subjects will be blinded to treatment assigned and treatment received until completion of all 12 month follow-up visits (primary endpoint).
Allocation
Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RANGER™ Paclitaxel Coated Balloon
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Balloon Angioplasty
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
RANGER™ Paclitaxel Coated Balloon
Other Intervention Name(s)
Percutaneous Transluminal Angioplasty (PTA)
Intervention Description
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
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
The RANGER™ Balloon is coated with the drug Paclitaxel.
Intervention Type
Procedure
Intervention Name(s)
Standard Balloon Angioplasty
Other Intervention Name(s)
Percutaneous Transluminal Angioplasty (PTA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Primary Lesion Patency
Description
RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR >2.4 suggests >50% stenosis. LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure. PK Substudy not analyzed for primary patency.
Time Frame
12 months (6 months for LB substudy)
Title
Major Adverse Events (MAEs) (Primary Safety Endpoint)
Description
RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months. LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure. PK Substudy: Not analyzed for primary safety endpoint.
Time Frame
12 months (6 months for LB substudy)
Secondary Outcome Measure Information:
Title
Number of Participants With Technical Success of Angioplasty Procedure
Description
Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure.
Time Frame
Day 0
Title
Number of Participants With Procedural Success of Angioplasty Procedure
Description
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.
Time Frame
Day 0
Title
Number of Participants With Clinical Success Rate Assessment
Description
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.
Time Frame
Day 0
Title
Number of Major Adverse Event (MAE) Assessment
Description
MAEs defined as all-cause of death post-index procedure, target limb major amputation, and/or target lesion revascularization (TLR).
Time Frame
12 months (6 months for LB substudy)
Title
Number of CEC Adjudicated Events Through 12 Months
Description
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.
Time Frame
12 months (6 Months for LB Substudy)
Title
Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline
Description
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
Time Frame
12 months (6 months for LB substudy)
Title
Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification
Description
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
Time Frame
12 months (6 months for LB substudy)
Title
Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI)
Description
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.
Time Frame
12 months (6 months for LB substudy)
Title
Walking Improvement (Distance) Assessed by Change in Six Minute Walk Test (6MWT)
Description
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.
Time Frame
12 months
Title
Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline
Description
The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline to 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Zeller, MD
Organizational Affiliation
Universitaets-Herzzentrum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ravish Sachar, MD
Organizational Affiliation
University of North Carolina - Rex Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Rocky Mountain Regional VA Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
The Vascular Experts
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
06612
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
South Florida Vascular Associates
City
Coconut Creek
State/Province
Florida
ZIP/Postal Code
33073
Country
United States
Facility Name
North Florida Regional Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
AdventHealth Sebring
City
Sebring
State/Province
Florida
ZIP/Postal Code
33872
Country
United States
Facility Name
Wellstar Hospitals
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Kaiser Foundation Hospitals
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
St. Joseph Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46802
Country
United States
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
King's Daughters Medical Center - Kentucky Heart Institute
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Terrebonne General Medical Center
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
United Heart and Vascular Clinic
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Coastal Carolina Surgical Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
20161
Country
United States
Facility Name
Premier Cardiovascular Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Northeast Ohio Vascular Associates, Inc.
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
St. Charles Medical Center
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University Medical Center-Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
North Park Heart & Vascular Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75321
Country
United States
Facility Name
Cardiology Clinic of San Antonio
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
North Dallas Research Associates
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
THR Presbyterian Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Tyler Cardiac and Endovascular Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Davis Hospital and Medical Center
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aspirus Heart and Vascular Institute
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Medizinische Univ.-Kliniken Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Allgemeines Krankenhaus AKH
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hanusch-Krankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Ziekenhuis Oost Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Regionaal Ziekenhuis Heilig Hart Tienen
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Fleurimont Hospital
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Hopital Saint - Francois d'Assise
City
Quebec
ZIP/Postal Code
G1L 3L2
Country
Canada
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Iwaki City Medical Center
City
Iwaki
State/Province
Fukushima
Country
Japan
Facility Name
Tokeidai Memorial Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kansai Rosai Hospital
City
Amagasaki
State/Province
Hyogo-ken
Country
Japan
Facility Name
Saiseikai Yokohama-City Eastern Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Kasukabe Chuo General Hospital
City
Kasukabe
State/Province
Saitama
Country
Japan
Facility Name
Saiseikai Central Hospital
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
Kyoto Katsura Hospital
City
Kyoto
Country
Japan
Facility Name
Morinomiya Hospital
City
Osaka
Country
Japan
Facility Name
Osaka Saiseikai Nakatsu Hospital
City
Osaka
Country
Japan
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Clinical Trials NZ
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Middlemore Hospital
City
Otahuhu
ZIP/Postal Code
1640
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24920940
Citation
Litsky J, Chanda A, Stilp E, Lansky A, Mena C. Critical evaluation of stents in the peripheral arterial disease of the superficial femoral artery - focus on the paclitaxel eluting stent. Med Devices (Auckl). 2014 May 28;7:149-56. doi: 10.2147/MDER.S45472. eCollection 2014.
Results Reference
background
PubMed Identifier
25612856
Citation
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.
Results Reference
background
PubMed Identifier
25130307
Citation
Razavi MK, Mustapha JA, Miller LE. Contemporary systematic review and meta-analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic disease. J Vasc Interv Radiol. 2014 Oct;25(10):1489-96, 1496.e1-3. doi: 10.1016/j.jvir.2014.06.018. Epub 2014 Aug 15.
Results Reference
background
PubMed Identifier
20484101
Citation
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
Results Reference
background
PubMed Identifier
24456716
Citation
Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.
Results Reference
background
PubMed Identifier
35943120
Citation
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.
Results Reference
derived
PubMed Identifier
34557931
Citation
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.
Results Reference
derived
PubMed Identifier
34016410
Citation
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.
Results Reference
derived

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RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

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