Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:March 2014
End Date:March 2019

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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

To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of
femoropopliteal artery (SFA) in-stent restenosis (ISR).


Key Inclusion Criteria:

1. Male or non-pregnant female ≥18 years of age

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

Key Exclusion Criteria:

1. Life expectancy of <1 year

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.)
We found this trial at
20
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Mark Levy, MD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Michael Silva, MD
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Cincinnati, Ohio 45220
Principal Investigator: Patrick Muck, MD
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Evanston, Illinois 60208
Principal Investigator: Andrew Hoel, MD
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Fairhope, Alabama 36532
Principal Investigator: Frank Bunch, MD
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Flemington, New Jersey 08822
Principal Investigator: Andrey Espinoza, MD
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Hattiesburg, Mississippi 39401
Principal Investigator: Robert Wilkins, MD
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Jackson, Mississippi 39216
Principal Investigator: James Bennett, MD
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Kingsport, Tennessee 37660
Principal Investigator: D. Christopher Metzger, MD
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Lakeland, Florida 33805
Principal Investigator: Fakhir Elmasri, MD
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Miami, Florida 33140
Principal Investigator: Robert Beasley, MD
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Milwaukee, Wisconsin 14450
Principal Investigator: Mark Mewissen, MD
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: S. Elissa Altin, MD
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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North Kansas City, Missouri 64116
Principal Investigator: Scott Kujath, MD
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Plymouth, Minnesota 55441
Principal Investigator: Troy Long, MD
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Providence, Rhode Island 02906
Principal Investigator: Peter Soukas, MD
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Raleigh, North Carolina 27607
Principal Investigator: George Adams, MD
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Royal Oak, Michigan 48073
Principal Investigator: Amr Abbas, MD
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Washington, District of Columbia 20010
Principal Investigator: Nelson Bernardo, MD
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Wyoming, Michigan 49519
Principal Investigator: Jihad Mustapha, MD
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