- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02063672
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis (SFA ISR)
A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Fairhope, Alabama, United States, 36532
- Cardiology Associates
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale University
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Health Research Institute
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Florida
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Lakeland, Florida, United States, 33805
- Radiology and Imaging Specialists of Lakeland, P.A.
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Miami, Florida, United States, 33140
- Mount Sinai Medical Center
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Illinois
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Evanston, Illinois, United States, 60208
- Northwestern University
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Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital Research Institute
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Wyoming, Michigan, United States, 49519
- Metropolitan Hospital d/b/a Metro Health Hospital
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Minnesota
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Plymouth, Minnesota, United States, 55441
- Minneapolis Radiology and Vascular Research Foundation
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Mississippi
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Hattiesburg, Mississippi, United States, 39401
- Hattiesburg Clinic, PA
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Jackson, Mississippi, United States, 39216
- Jackson Heart Clinic, P.A.
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Missouri
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North Kansas City, Missouri, United States, 64116
- Kansas City Vascular Foundation
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New Jersey
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Flemington, New Jersey, United States, 08822
- Hunterdon Cardiovascular Associates
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North Carolina
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Raleigh, North Carolina, United States, 27607
- Rex Hospital, Inc.
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Ohio
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Cincinnati, Ohio, United States, 45220
- TriHealth, Inc.
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Rhode Island
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Providence, Rhode Island, United States, 02906
- The Miriam Hospital - A Lifespan Partner
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Tennessee
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Kingsport, Tennessee, United States, 37660
- Wellmont Cardiology Services, Inc.
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Texas
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch
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Virginia
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Richmond, Virginia, United States, 23219
- Virginia Commonwealth University
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Wisconsin
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Milwaukee, Wisconsin, United States, 53215
- Aurora Medical Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Male or non-pregnant female ≥18 years of age
- Rutherford Clinical Category 2-4
- Significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery
- Lesion measures between 4 and 18 cm
- Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix
- A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography
- Successful crossing and predilatation of the target lesion with a guidewire
- At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been (nor planned to be) revascularized
- No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment
Key Exclusion Criteria:
- Life expectancy of <1 year
- Patient is currently participating in an investigational drug or other device study or previously enrolled in this study NOTE: Enrollment in another drug or device clinical trial during the follow up period is not allowed
- History of stroke within 3 months
- History of MI, thrombolysis or angina within 2 weeks of enrollment
- Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion
- Target lesion involves a previously placed covered stent or drug-eluting stent
- Grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent
- Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
- Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion
- Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)
Study Plan
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 |
---|---|
Experimental: Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
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Active Comparator: PTA Catheter
Standard Uncoated Balloon Angioplasty Catheter
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PTA Catheter
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Primary Patency at 1 Year
Time Frame: 12 Months
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Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.
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12 Months
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Percentage of Participants Without Primary Safety Events
Time Frame: 12 Months
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Primary Safety Events include: All Cause Perioperative (≤30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year
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12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Device Success
Time Frame: During the Index Procedure (90 mins)
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Device success is defined as, on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.
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During the Index Procedure (90 mins)
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Percentage of Participants With Technical Success
Time Frame: During the Index Procedure (90 mins)
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Technical success of the balloon procedure is defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion and a successful withdrawal of the study system with the achievement of < 30% residual percent stenosis without deployment of a bail-out stent.
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During the Index Procedure (90 mins)
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Percentage of Participants With Procedural Success
Time Frame: During the Index Procedure (90 mins)
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Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without major adverse events (defined as occurrence of death, amputation of the target limb, or repeat revascularization of the target lesion) during the index procedure and through the hospital stay.
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During the Index Procedure (90 mins)
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Percentage of Participants With Primary Patency at 6 and 12 Months
Time Frame: 6 months and 12 months
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Primary Patency is defined as Freedom from CEC-adjudicated Clinically-Driven TLR and from Core laboratory-adjudicated Binary Restenosis.
Binary restenosis is based on threshold Doppler peak systolic velocity ratio (PSVR) ≥ 2.5 (together with waveform analysis & color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol).
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6 months and 12 months
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Percentage of Participants With Secondary Patency at 6 Months and 12 Months
Time Frame: 6 months and 12 months
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Secondary patency is defined as the absence of Binary Restenosis as adjudicated by the blinded, independent core laboratory, independent of whether or not patency is re-established via an endovascular procedure.
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6 months and 12 months
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Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)
Time Frame: 6 months and 12 months
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Clinically-driven TLR is defined as revascularization of the target vessel with evidence of target vessel diameter stenosis >50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms), OR revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms.
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6 months and 12 months
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Percentage of Participants Without Target Lesion Revascularization (TLR)
Time Frame: 6 months and 12 months
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TLR is defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.
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6 months and 12 months
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Percentage of Participants With Sustained Clinical Benefit Compared to Baseline
Time Frame: 6 months and 12 months
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Sustained clinical benefit is defined as an improvement in Rutherford Classification compared to baseline and freedom from target vessel revascularization.
The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene.
A decrease in units on the scale represents improvement in clinical symptoms.
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6 months and 12 months
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Change of Rutherford Classification From Baseline
Time Frame: 6 months and 12 months
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The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene.
A decrease in units on the scale represents improvement in clinical symptoms.
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6 months and 12 months
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Change of Resting Ankle Brachial Index (ABI) From Baseline
Time Frame: 6 months and 12 months
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The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium).
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6 months and 12 months
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Change in Walking Impairment Questionnaire From Baseline
Time Frame: 6 months and 12 months
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The Walking Impairment Questionnaire (WIQ) is a validated questionnaire that evaluates walking ability with a focus on walking distance, walking speed, and the ability to climb stairs.
Participants answer each item on a Likert scale from 0 for "unable to do" to 4 for "no difficulty", and each response is weighted based on the difficulty of the task.
The overall score is determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100.
The overall score ranges from 0-100 with lower scores indicating lower performance.
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6 months and 12 months
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Change in Quality of Life From Baseline
Time Frame: 6 months and 12 Months
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EQ-5D is a standardized tool to assess patient-reported mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, or slight, moderate, severe, or extreme problems. Patients choose the appropriate level in each of the 5 dimensions, which results in a 1-digit number for each dimension. The digits for the 5 dimensions are converted into a single EQ-5D™ index score based on a set of population-based preference weights. For the U.S. general population, possible EQ-5D™ index scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. A downloadable scoring file is available at: https://www.ahrq.gov/rice/EQ5Dscore.htm. The EQ VAS records a patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). A higher VAS value indicates a higher quality of life. |
6 months and 12 Months
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Percentage of Participants Without Major Vascular Complications (≤30 Day)
Time Frame: 30 Days
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Freedom from major vascular complications at 30 days follow-up
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30 Days
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Percentage of Participants Without All-Cause Death
Time Frame: 1 month, 6 months, and 12 months
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Mortality from any cause.
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1 month, 6 months, and 12 months
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Percentage of Participants Without Major Limb Amputation
Time Frame: 1 month, 6 months, and 12 months
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Major limb amputation is defined as amputation of the lower limb above the ankle.
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1 month, 6 months, and 12 months
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Percentage of Participants Without Minor Limb Amputation
Time Frame: 1 month, 6 months, and 12 months
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Minor limb amputation is defined as amputation of a part of the foot below the ankle.
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1 month, 6 months, and 12 months
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Percentage of Participants Without Target Vessel Revascularizations (TVR)
Time Frame: 1 month, 6 months, and 12 months
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A TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel.
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1 month, 6 months, and 12 months
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Percentage of Participants Without Any Target Limb Reinterventions
Time Frame: 1 month, 6 months, and 12 months
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Any surgical intervention in the target limb.
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1 month, 6 months, and 12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CL0018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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