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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03064126




Registration number
NCT03064126
Ethics application status
Date submitted
13/01/2017
Date registered
24/02/2017

Titles & IDs
Public title
RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
Scientific 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)
Secondary ID [1] 0 0
S2062
Universal Trial Number (UTN)
Trial acronym
RANGER II SFA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 0 0
Atherosclerosis 0 0
Artery Diseases, Peripheral 0 0
Plaque, Atherosclerotic 0 0
Occlusive Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - RANGER™ Paclitaxel Coated Balloon
Treatment: Drugs - Paclitaxel
Treatment: Surgery - Standard Balloon Angioplasty

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.

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.


Treatment: Devices: 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.

Treatment: Drugs: Paclitaxel
The RANGER™ Balloon is coated with the drug Paclitaxel.

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Primary Lesion Patency
Timepoint [1] 0 0
12 months (RCT); 6 months (LB substudy)
Primary outcome [2] 0 0
Major Adverse Events (MAEs) (Primary Safety Endpoint)
Timepoint [2] 0 0
Primary safety endpoint assessed at 12 months for RCT study and at both 6 and 12 months for LB substudy.
Secondary outcome [1] 0 0
Number of Participants With Technical Success of Angioplasty Procedure
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 0
Number of Participants With Procedural Success of Angioplasty Procedure
Timepoint [2] 0 0
Day 0
Secondary outcome [3] 0 0
Number of Participants With Clinical Success Rate Assessment
Timepoint [3] 0 0
Day 0
Secondary outcome [4] 0 0
Number of Major Adverse Event (MAE) Assessment
Timepoint [4] 0 0
60-months (RCT); 12-months (LB substudy).
Secondary outcome [5] 0 0
Number of Clinical Events Committee (CEC) Adjudicated Events
Timepoint [5] 0 0
1, 6, 12, 24, 36, 48 and 60 months (RCT and PK substudy); 1, 6 and 12 months (LB substudy)
Secondary outcome [6] 0 0
Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline
Timepoint [6] 0 0
1, 6, 12, 24 and 36 months post-procedure (RCT); 1, 6 and 12 months post-procedure (LB substudy).
Secondary outcome [7] 0 0
Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline.
Timepoint [7] 0 0
1, 6, 12, 24 and 36 months post-procedure (RCT): 1, 6, and 12 months post-procedure (LB substudy)
Secondary outcome [8] 0 0
Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline.
Timepoint [8] 0 0
1, 6, 12, 24, and 36 months post-procedure (RCT); 1, 6, and 12 months post-procedure (LB substudy)
Secondary outcome [9] 0 0
Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline
Timepoint [9] 0 0
6 and 12 months post-procedure (RCT)
Secondary outcome [10] 0 0
Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline.
Timepoint [10] 0 0
1, 6, 12, 24 and 36 months post-procedure (RCT)
Secondary outcome [11] 0 0
Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion
Timepoint [11] 0 0
1, 6, 12, 24, and 36-months post-procedure (RCT); 1, 6, and 12-months post-procedure (LB substudy)
Secondary outcome [12] 0 0
Patient Utility Values as Assessed by Change in EQ-5D From Baseline.
Timepoint [12] 0 0
1, 6, 12, 24 and 36-months post-procedure (RCT).
Secondary outcome [13] 0 0
Changes in Healthcare Utilization Over Time
Timepoint [13] 0 0
1, 6, 12, 24, 36, 48 and 60-months post-procedure (RCT); 1, 6, 12-months post-procedure (LB substudy)
Secondary outcome [14] 0 0
PK Parameters Paclitaxel (PTx) Dose
Timepoint [14] 0 0
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.
Secondary outcome [15] 0 0
PK Parameters - Maximum Plasma Concentration
Timepoint [15] 0 0
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.
Secondary outcome [16] 0 0
PK Parameters - Tmax
Timepoint [16] 0 0
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.
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
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.

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Life expectancy, documented in the Investigator's opinion, of less than 12 months;
2. Hemorrhagic stroke or cardiac event (e.g. STEMI, unstable angina) within 6 months prior to enrollment;
3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
4. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated;
5. Chronic renal insufficiency with serum creatinine > 2.0 mg/dL within 30 days of index procedure or treatment with dialysis;
6. Platelet count < 80,000 mm 3 or > 600,000 mm 3 or history of bleeding diathesis;
7. Receiving immunosuppressive therapy;
8. Septicemia at the time of enrollment;
9. Any major intervention planned within 30 days post index procedure;
10. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of enrollment;
11. Failure to successfully cross the target lesion with a guidewire;
12. Failure to successfully pre-dilate the target vessel;
13. Patient has lesion that requires the use of adjunctive primary treatment modalities (i.e. laser, atherectomy, scoring/cutting balloon, other debulking devices, etc.) during the index procedure;
14. History of major amputation in the target limb;
15. Target lesion or vessel has ever been previously treated with stent (e.g. in-stent restenosis) or surgery. Target lesion or vessel has been treated with atherectomy or a DCB in the past 12 months;
16. Pregnant or breast feeding;
17. Presence of aneurysm in the target vessel;
18. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment;
19. Patient has significant inflow disease which cannot be treated prior to the target lesion treatment;
20. Patient has perforated targeted vessel as evidenced by extravasation of contrast media;
21. Patient has severe calcification that renders the lesion undilatable;
22. Current participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2023
Sample size
Target
Accrual to date
Final
440
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
West Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Austria
State/province [25] 0 0
Graz
Country [26] 0 0
Austria
State/province [26] 0 0
Vienna
Country [27] 0 0
Belgium
State/province [27] 0 0
Genk
Country [28] 0 0
Belgium
State/province [28] 0 0
Gent
Country [29] 0 0
Belgium
State/province [29] 0 0
Tienen
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Japan
State/province [33] 0 0
Fukuoka
Country [34] 0 0
Japan
State/province [34] 0 0
Fukushima
Country [35] 0 0
Japan
State/province [35] 0 0
Hokkaido
Country [36] 0 0
Japan
State/province [36] 0 0
Hyogo-ken
Country [37] 0 0
Japan
State/province [37] 0 0
Kanagawa
Country [38] 0 0
Japan
State/province [38] 0 0
Miyagi
Country [39] 0 0
Japan
State/province [39] 0 0
Osaka
Country [40] 0 0
Japan
State/province [40] 0 0
Saitama
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo
Country [42] 0 0
Japan
State/province [42] 0 0
Kyoto
Country [43] 0 0
New Zealand
State/province [43] 0 0
Auckland
Country [44] 0 0
New Zealand
State/province [44] 0 0
Hamilton
Country [45] 0 0
New Zealand
State/province [45] 0 0
Otahuhu

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Zeller, MD
Address 0 0
Universitaets-Herzzentrum
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03064126