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

This is an interventional treatment trial for Femoral Artery Stenosis focused on measuring Legs, Drug Coated Angioplasty Balloon, Experimental, Standard Angioplasty Balloon Read More

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).

Exclusion Criteria

1. Life expectancy of <2 years;
2. Subject is currently participating in an investigational drug or device study, or previously enrolled in this study. Enrollment in another investigational drug or device study during the follow up period is not allowed;
3. History of stroke within 3 months;
4. History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of index procedure;
5. Renal failure or chronic kidney disease with serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis;
6. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel.