Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
NCT ID: NCT02063672
Last Updated: 2019-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2014-03-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
PTA Catheter
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter
PTA Catheter
Interventions
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Lutonix DCB
Standard Uncoated Balloon Angioplasty Catheter
PTA Catheter
Eligibility Criteria
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Inclusion Criteria
2. Rutherford Clinical Category 2-4
3. Significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery
4. Lesion measures between 4 and 18 cm
5. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix
6. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography
7. Successful crossing and predilatation of the target lesion with a guidewire
8. 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
9. No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment
Exclusion Criteria
2. 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
3. History of stroke within 3 months
4. History of MI, thrombolysis or angina within 2 weeks of enrollment
5. 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
6. Target lesion involves a previously placed covered stent or drug-eluting stent
7. Grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent
8. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
9. 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
10. Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)
18 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Carlos Mena, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Cardiology Associates
Fairhope, Alabama, United States
Yale University
New Haven, Connecticut, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Radiology and Imaging Specialists of Lakeland, P.A.
Lakeland, Florida, United States
Mount Sinai Medical Center
Miami, Florida, United States
Northwestern University
Evanston, Illinois, United States
William Beaumont Hospital Research Institute
Royal Oak, Michigan, United States
Metropolitan Hospital d/b/a Metro Health Hospital
Wyoming, Michigan, United States
Minneapolis Radiology and Vascular Research Foundation
Plymouth, Minnesota, United States
Hattiesburg Clinic, PA
Hattiesburg, Mississippi, United States
Jackson Heart Clinic, P.A.
Jackson, Mississippi, United States
Kansas City Vascular Foundation
North Kansas City, Missouri, United States
Hunterdon Cardiovascular Associates
Flemington, New Jersey, United States
Rex Hospital, Inc.
Raleigh, North Carolina, United States
TriHealth, Inc.
Cincinnati, Ohio, United States
The Miriam Hospital - A Lifespan Partner
Providence, Rhode Island, United States
Wellmont Cardiology Services, Inc.
Kingsport, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CL0018-01
Identifier Type: -
Identifier Source: org_study_id
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