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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03064126
Recruitment Status : Active, not recruiting
First Posted : February 24, 2017
Results First Posted : July 15, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Atherosclerosis Artery Diseases, Peripheral Plaque, Atherosclerotic Occlusive Arterial Disease Device: RANGER™ Paclitaxel Coated Balloon Drug: Paclitaxel Procedure: Standard Balloon Angioplasty Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The RANGER™ investigational device is coated with the drug paclitaxel.
Masking: Single (Participant)
Masking Description: Subjects will be blinded to treatment assigned and treatment received until completion of all 12 month follow-up visits (primary endpoint).
Primary Purpose: Treatment
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)
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : November 18, 2019
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

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 Name: 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 Name: Percutaneous Transluminal Angioplasty (PTA)




Primary Outcome Measures :
  1. Number of Participants With Primary Lesion Patency [ Time Frame: 12 months (6 months for 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 not analyzed for primary patency.


  2. Major Adverse Events (MAEs) (Primary Safety Endpoint) [ Time Frame: 12 months (6 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: Not analyzed for primary safety endpoint.



Secondary Outcome Measures :
  1. Number of Participants With Technical Success of Angioplasty Procedure [ Time Frame: Day 0 ]
    Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure.

  2. Number of Participants With Procedural Success of Angioplasty Procedure [ Time Frame: Day 0 ]
    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.

  3. Number of Participants With Clinical Success Rate Assessment [ Time Frame: Day 0 ]
    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.

  4. Number of Major Adverse Event (MAE) Assessment [ Time Frame: 12 months (6 months for LB substudy) ]
    MAEs defined as all-cause of death post-index procedure, target limb major amputation, and/or target lesion revascularization (TLR).

  5. Number of CEC Adjudicated Events Through 12 Months [ Time Frame: 12 months (6 Months for LB Substudy) ]
    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.

  6. Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline [ Time Frame: 12 months (6 months for LB substudy) ]
    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

  7. Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification [ Time Frame: 12 months (6 months for LB substudy) ]
    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

  8. Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) [ Time Frame: 12 months (6 months for LB substudy) ]
    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.

  9. Walking Improvement (Distance) Assessed by Change in Six Minute Walk Test (6MWT) [ Time Frame: 12 months ]
    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.

  10. Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits;
  2. Subject at least 20 years of age;
  3. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4;
  4. Target lesion is in the native SFA and/or PPA down to the P1 segment;
  5. Patent popliteal and infrapopliteal arteries, i.e., single vessel runoff or better with at least one of three vessels patent (less than 50 % stenosis) to the ankle or foot;
  6. Reference vessel diameter ≥ 4 mm and ≤ 8 mm by visual estimate;
  7. Angiographic evidence that target lesion consists of a single de novo, non-stented and non-atherectomy treated or restenotic lesion (or tandem lesions or a combination lesion as defined below) that is:

    • ≥ 70%-99% stenotic with total lesion length up to 180 mm by visual estimate.
    • Occluded with total lesion length ≤ 100 mm by visual estimate.
    • If lesion is restenotic, most recent PTA treatment must be > 3 months prior to enrollment.

Exclusion Criteria:

  1. Life expectancy, documented in the Investigator's opinion, of less than 12 months;
  2. Hemorrhagic stroke or cardiac event (e.g. STEMI, unstable angina) within 6 months prior to enrollment;
  3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
  4. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated;
  5. Chronic renal insufficiency with serum creatinine > 2.0 mg/dL within 30 days of index procedure or treatment with dialysis;
  6. Platelet count < 80,000 mm 3 or > 600,000 mm 3 or history of bleeding diathesis;
  7. Receiving immunosuppressive therapy;
  8. Septicemia at the time of enrollment;
  9. Any major intervention planned within 30 days post index procedure;
  10. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of enrollment;
  11. Failure to successfully cross the target lesion with a guidewire;
  12. Failure to successfully pre-dilate the target vessel;
  13. Patient has lesion that requires the use of adjunctive primary treatment modalities (i.e. laser, atherectomy, scoring/cutting balloon, other debulking devices, etc.) during the index procedure;
  14. History of major amputation in the target limb;
  15. Target lesion or vessel has ever been previously treated with stent (e.g. in-stent restenosis) or surgery. Target lesion or vessel has been treated with atherectomy or a DCB in the past 12 months;
  16. Pregnant or breast feeding;
  17. Presence of aneurysm in the target vessel;
  18. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment;
  19. Patient has significant inflow disease which cannot be treated prior to the target lesion treatment;
  20. Patient has perforated targeted vessel as evidenced by extravasation of contrast media;
  21. Patient has severe calcification that renders the lesion undilatable;
  22. Current participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064126


Locations
Show Show 67 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Thomas Zeller, MD Universitaets-Herzzentrum
Principal Investigator: Ravish Sachar, MD University of North Carolina - Rex Hospital
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Publications:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03064126    
Other Study ID Numbers: S2062
First Posted: February 24, 2017    Key Record Dates
Results First Posted: July 15, 2020
Last Update Posted: January 7, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Boston Scientific Corporation:
Artery
Atherosclerosis
Arterial
Peripheral
Plaque
Angioplasty
PTA
Additional relevant MeSH terms:
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Atherosclerosis
Peripheral Arterial Disease
Arterial Occlusive Diseases
Plaque, Atherosclerotic
Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Pathological Conditions, Anatomical
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action