Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)

Inclusion Criteria

• •Clinical Criteria
• •1. Non-pregnant female ≥18 years of age;
• •2. Rutherford Clinical Category 2-4;
• •3. Patient is willing to provide informed consent, is geographically stable, comply with the required follow up visits and testing schedule;
• •Angiographic Criteria
• •4. De novo or restenotic lesion(s) in native superficial femoral or popliteal arteries;
• •5. Lesion ≥70% stenosis by visual estimate;
• •6. Target reference vessel diameter of 4-7 mm;
• •7. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography; (Treatment of target lesion acceptable after successful treatment of inflow artery lesions. Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.)
• •8. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography after successful vessel preparation;
• •9. Successful antegrade wire crossing and vessel preparation (may include pre-dilatation) of the target lesion. Successful vessel preparation is defined by residual stenosis ≤30% without any major vascular complications;
• •10. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment except for remote common femoral patch angioplasty separated by at least 2 cm from the lesion(s).