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

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.)