- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02013193
Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries (RANGER-SFA)
December 20, 2019 updated by: Hemoteq AG
Prospective, Randomized, Multicentre Clinical Study of the Hemoteq Ranger™ Paclitaxel-Coated PTA Balloon Catheter (Ranger DCB) in Comparison to Uncoated PTA Balloons in Femoropopliteal Lesions
The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL).
Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Medical University, AKH
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Caen, France, 14000
- CHU Caen Côte de Nacre
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Paris, France, 75908
- Hôpital Européen Georges-Pompidou (HEGP)
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Toulouse, France, 31076
- Clinique Pasteur Toulouse
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Arnsberg, Germany, 59759
- Klinikum Arnsberg
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Bad Segeberg, Germany, 23795
- Segeberger Kliniken
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Darmstadt, Germany, 64283
- Klinikum Darmstadt GmbH
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Frankfurt, Germany, 60389
- Cardiovascular Center
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Leipzig, Germany, 04103
- Universitätsklinikum Leipzig
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Leipzig, Germany, 04289
- Park-Krankenhaus
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Marburg, Germany, 35043
- Universitätsklinikum
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must be age 18 or older
- Subject is willing and able to provide informed consent
- Subject is available to attend all required follow-up visits
- Subject has a clinically significant symptomatic leg ischemia requiring treatment
- Subject has a Rutherford clinical category of 2-4
- If the index lesion is restenotic, the prior PTA must have been >30 days prior to treatment in the current study
- Only one lesion per limb can be treated under this protocol.
- Successful intraluminal wire crossing of the target lesion
- Index lesion is a clinically and hemodynamically significant stenotic or restenotic lesion located in the native nonstented superficial femoral artery or proximal popliteal artery
- Degree of stenosis 70% or more, by visual assessment
- Lesion length between 20 mm and 150 mm
- At least one patent infrapopliteal artery to the foot of the index limb
Exclusion Criteria:
- Subjects who have undergone prior vascular surgery of the femoropopliteal artery in the index limb to treat atherosclerotic disease
- History of major amputation in the same limb as the target lesion
- Presence of aneurysm in the target vessel
- Acute ischemia and/or acute thrombosis in any artery of the lower limbs
- Acute Myocardial Infarction within 30 days before the index procedure
- Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
- Known hypersensitivity or contraindication to contrast dye that cannot be adequately pre-medicated
- Known allergies against Paclitaxel or other components of the used medical devices
- Intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial
- Platelet count <100,000 mm3 or >600,000 mm3
- Concomitant renal failure with a serum creatinine >2.0 mg/dL
- Receiving dialysis or immunosuppressant therapy
- Life expectancy of less than one year
- Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.
- Woman who is pregnant or nursing.
- Previously planned stenting of the index lesion
- Use of adjunctive therapies (debulking, laser, cryoplasty, re-entry devices)
- Planned or expected procedures (cardiac, aorta, peripheral) within 30 days after the index procedure
- Presence of outflow lesions requiring intervention within 30 days of the index procedure
- Perforated vessel as evidenced by extravasation of contrast media
- Heavily calcified target lesions resistant to PTA
- Current participation in another drug or device trial that has not completed the primary endpoint, that may potentially confound the results of this trial, or that would limit the subject's compliance with the follow-up requirements
- Current participation in any study using drug-coated/drug-eluting technologies
- Current participation in any study using drug-coated/drug-eluting technologies
- Target lesion with in-stent restenosis (any stent or stent-graft)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ranger(TM) Paclitaxel-coated balloon
Index lesion treated with Ranger(TM) Paclitaxel-coated PTA balloon catheter (Ranger DCB)
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After successful pre-dilatation the index lesion is treated with one or two Ranger DCB devices that completely cover the lesion.
If two devices are deployed, overlap shall be minimal.
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Active Comparator: uncoated PTA balloon
Index lesion treated with an uncoated standard PTA dilatation balloon catheter selected upon investigator´s discretion
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The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
in-segment late lumen loss
Time Frame: six months
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In-segment late lumen loss (LLL) of the treated segment after PTA using the Ranger™ paclitaxel-coated PTA balloon, in comparison to the LLL after PTA using an uncoated balloon, as observed by angiography at six months post-index procedure.
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six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
technical success
Time Frame: during index procedure, less 1 hour
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The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
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during index procedure, less 1 hour
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procedural success
Time Frame: within 24 hours of index procedure
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Technical success with no MAE noted within 24 hours of the index procedure.
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within 24 hours of index procedure
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primary patency
Time Frame: six months
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Percentage of lesions that reach endpoint without a hemodynamically significant stenosis on duplex ultrasound (DUS) and without target lesion revascularization (TLR) or bypass of the target lesion to maintain or restore patency.
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six months
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primary patency
Time Frame: twelve months
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Percentage of lesions that reach endpoint without a hemodynamically significant stenosis on DUS and without TLR or bypass of the target lesion to maintain or restore patency.
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twelve months
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assisted primary patency
Time Frame: six months
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Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.
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six months
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assisted primary patency
Time Frame: twelve months
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Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.
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twelve months
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secondary patency
Time Frame: six months
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Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.
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six months
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secondary patency
Time Frame: twelve months
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Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.
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twelve months
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binary restenosis rate
Time Frame: six months
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Binary restenosis defined as > 50% diameter stenosis via peak systolic velocity ratio (PSVR) > 2.4 via duplex ultrasound and assessed by the core lab.
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six months
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binary restenosis rate
Time Frame: twelve months
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Binary restenosis defined as > 50% diameter stenosis via peak systolic velocity ratio (PSVR) > 2.4 via duplex ultrasound and assessed by the core lab.
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twelve months
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clinical success
Time Frame: pre-discharge, estim. 1-2 days post-index procedure
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Positive change (by +1 or more) of Rutherford category at pre-discharge post-index-procedure as compared to baseline.
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pre-discharge, estim. 1-2 days post-index procedure
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clinical success
Time Frame: six months
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Positive change (by +1 or more) of Rutherford category at six months (plus or minus 30 days) post-index-procedure as compared to baseline.
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six months
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clinical success
Time Frame: twelve months
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Positive change (by +1 or more) of Rutherford category at twelve months (plus or minus 30 days) post-index-procedure as compared to baseline.
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twelve months
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hemodynamic success
Time Frame: pre-discharge, estim. 1-2 days post-index procedure
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positive change in Ankle-Brachial Index (ABI) at pre-discharge as compared to baseline
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pre-discharge, estim. 1-2 days post-index procedure
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hemodynamic success
Time Frame: six months
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positive change in ABI at six months (plus or minus 30 days) as compared to baseline
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six months
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hemodynamic success
Time Frame: twelve months
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positive change in ABI at twelve months (plus or minus 30 days) as compared to baseline
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twelve months
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change in quality of life
Time Frame: six months
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Change in functional status measured by changes in the Walking Impairment Questionnaire (WiQ) and general health-related quality of life measured by changes in SF-12 and EQ5D scores at six months (plus or minus 30 days) as compared to baseline.
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six months
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change in quality of life
Time Frame: twelve months
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Change in functional status measured by changes in the Walking Impairment Questionnaire (WiQ) and general health-related quality of life measured by changes in SF-12 and EQ5D scores at twelve months (plus or minus 30 days) as compared to baseline.
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twelve months
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change in quality of life
Time Frame: 24 months
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Change in general health-related quality of life measured by changes in SF-12 and EQ5D scores at 24 months (plus or minus 30 days) as compared to baseline.
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24 months
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change in quality of life
Time Frame: 36 months
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Change in general health-related quality of life measured by changes in SF-12 and EQ5D scores at 36 months (plus or minus 30 days) as compared to baseline.
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36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dierk Scheinert, M.D., University Leipzig
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2014
Primary Completion (Actual)
June 16, 2016
Study Completion (Actual)
March 15, 2019
Study Registration Dates
First Submitted
December 11, 2013
First Submitted That Met QC Criteria
December 16, 2013
First Posted (Estimate)
December 17, 2013
Study Record Updates
Last Update Posted (Actual)
December 23, 2019
Last Update Submitted That Met QC Criteria
December 20, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTQ001-RangerSFA
- CIV-13-07-011514 (Other Identifier: EUDAMED)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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