RANGERâ„¢ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

ID: NCT03064126
Status: Recruiting
Phase: Phase 3
Start Date: March 02, 2017
First Submitted: January 13, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Boston Scientific Corporation
Location: Austria, Belgium, Canada, Germany, Japan, New Zealand, United States
Conditions: Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral, Plaque, Atherosclerotic, Occlusive Arterial Disease
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Study Description

Brief Summary

To evaluate the safety and effectiveness of the Rangerâ„¢ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).

Detailed Description

The RANGER II SFA is a global, prospective, multi-center clinical trial. Approximately 396 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.
Condition or disease Intervention/treatment Phase

Artery Diseases, Peripheral

Atherosclerosis

Occlusive Arterial Disease

Peripheral Artery Disease

Plaque, Atherosclerotic

Device: RANGERâ„¢ Paclitaxel Coated Balloon
Other Names
Percutaneous Transluminal Angioplasty (PTA)
Drug: Paclitaxel
Other Names
Procedure: Standard Balloon Angiplasty
Other Names
Percutaneous Transluminal Angioplasty (PTA)
Phase 3

Tracking Information

First Submitted DateJanuary 13, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateMarch 02, 2017
Anticipated Completion DateJune 01, 2023
Actual Primary Completion DateJune 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Primary Lesion Patency [Time Frame: 12 months]

    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.

  • Major Adverse Events (MAEs) [Time Frame: 12 months]

    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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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.

  • 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.

  • 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.

  • Major Adverse Events (MAE) assessment [Time Frame: 1 month, 6 months, 12 months, 24 months, 36 months, 48 month and 60 months]

    MAEs are defined as all-cause death post-index procedure, TLR, and major target limb amputation.

  • Assessment of Death occurrence from any cause [Time Frame: 1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months]

    Analysis of the number of deaths from any cause

  • Clinically-driven Target Vessel Revascularization (TVR) rates [Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months]

    Clinically-driven TVR is defined as any surgical or percutaneous rate of target vessel revascularizations that occur will be reported throughout the 60 month study follow up.

  • Clinically-driven Target Lesion revascularization (TLR) rates [Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months]

    Clinically-driven TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure. Analysis of the number of TLR that occur will be reported throughout the 60 month study follow up.

  • Rate of Primary Sustained Clinical Improvement as assessed by changes in Rutherford Classification [Time Frame: 1 month, 6 months, 12 months, 24 months and 36 months]

    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

  • Rate of Secondary Sustained Clinical Improvement as assessed by changes in Rutherford Classification [Time Frame: 1 month, 6 months, 12 months, 24 months and 36 months]

    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

  • Rate of Hemodynamic Improvement as assessed by changes in Ankle Brachial Index (ABI) [Time Frame: 1 month, 6 months, 12 months, 24 months, and 36 months]

    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.

  • Target Lesion Restenosis rate [Time Frame: 1 month, 6 months, 12 months, 24 months, and 36 months]

    Restenosis is defined as DUS peak systolic velocity ratio (SVR) > 2.4 which suggests stenosis >50%. Duplex-defined binary restenosis of the target lesion rates will be reported as the number of evaluable participants with TLR through 36 months.

  • Walking Improvement assessed by change in Six Minute Walk Test (6MWT) [Time Frame: Screening, 6 months and 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. Comparison results will be reported through the 12 month follow up.

  • Walking Improvement assessed by change in Walking Impairment Questionnaire (WIQ) [Time Frame: 1 month, 6 months, 12 months, 24 months and 36 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). Scores will be reported though 36 month follow up.

  • Patient Utility Values by change in EQ-5D [Time Frame: 1 month, 6 months, 12 months, 24 months and 36 months]

    The EQ-5D questionnaire is a descriptive system of health-related quality of life questions that consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity within each EQ-5D dimension. Results of responses will be reported through 36 months.

  • Changes in healthcare utilization over time rates [Time Frame: Index Procedure (Day 0), 1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months]

    Investigators are asked to document any use of the healthcare system that occurs throughout the study. Reports of hospitalizations, re-hospitalizations, overall time spent hospitalized, treatment in hospitals (outpatient clinics) will occur with all enrolled patients through 60 month follow up.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleRANGERâ„¢ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
Official TitleRANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGERâ„¢ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA)
Brief Summary

To evaluate the safety and effectiveness of the Rangerâ„¢ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).

Detailed Description

The RANGER II SFA is a global, prospective, multi-center clinical trial. Approximately 396 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.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
396
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Artery Diseases, Peripheral
Atherosclerosis
Occlusive Arterial Disease
Peripheral Artery Disease
Plaque, Atherosclerotic
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Device: RANGERâ„¢ Paclitaxel Coated Balloon

A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.

Other Names
Percutaneous Transluminal Angioplasty (PTA)
Drug: Paclitaxel

The RANGERâ„¢ Balloon is coated with the drug Paclitaxel.

Other Names
Procedure: Standard Balloon Angiplasty

A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.

Other Names
Percutaneous Transluminal Angioplasty (PTA)
Study Groups/Cohorts
RANGERâ„¢ Paclitaxel Coated Balloon
RANGERâ„¢ 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
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.

Study Arms
Experimental RANGERâ„¢ Paclitaxel Coated Balloon
RANGERâ„¢ 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 : RANGERâ„¢ 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.

Experimental RANGERâ„¢ Paclitaxel Coated Balloon
RANGERâ„¢ 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.
Drug : Paclitaxel
The RANGERâ„¢ 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 Angiplasty
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.

Arm Intervention/Treatment
Experimental RANGERâ„¢ Paclitaxel Coated Balloon
RANGERâ„¢ 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 : RANGERâ„¢ Paclitaxel Coated Balloon
Experimental RANGERâ„¢ Paclitaxel Coated Balloon
RANGERâ„¢ 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.
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 Angiplasty

Recruitment Information

Recruitment Status:Recruiting
Enrollment396
Completion DateJune 01, 2023
Eligibility 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.
GenderAll
Age20 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Austria
Belgium
Canada
Germany
Japan
New Zealand
United States

Administrative Information

NCT Number:NCT03064126
Other Study ID Numbers
S2062
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Boston Scientific Corporation
Collaborators
Not Available
Investigators
Principal Investigator
Ravish Sachar, MD
University of North Carolina - Rex Hospital
Principal Investigator
Thomas Zeller, MD
Universitaets-Herzzentrum

Publications