Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions

Inclusion criteria

• ✓. Subject must be between 21 and 85 years old;
• ✓. Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation;
• ✓. Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 4;
• ✓. Common femoral artery (CFA) stenosis (including CFA bifurcation) \>70% (visual estimate) or occlusion; Additional non-target lesion(s) in remaining non-target vessel(s), except ipsilateral iliac arteries, can be treated at the physician´s discretion;
• ✓. At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis \>50%).
• ✓. Endovascular Procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally);
• ✓. Non-target lesion interventions (TASC A and B) to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and successful;
• ✓. Willing to comply with the specified follow-up evaluation;

Exclusion criteria