Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In… (NCT02063672) | Clinical Trial Compass
CompletedNot Applicable
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
United States82 participantsStarted 2014-03
Plain-language summary
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
What they're measuring
1
Percentage of Participants With Primary Patency at 1 Year
Timeframe: 12 Months
2
Percentage of Participants Without Primary Safety Events
. 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