Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions (PESTO-AFC)

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring common femoral artery, drug-coated balloon, surgical endarterectomy Read More

Inclusion Criteria:

1. Subject must be between 21 and 85 years old;
2. 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;
3. Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 4;
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;
5. At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis >50%).
6. Endovascular Procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally);
7. 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;
8. Willing to comply with the specified follow-up evaluation;
9. Written informed consent prior to any study procedures.

Exclusion Criteria:

1. Ipsilateral significant (>50%) stenosis of the iliac arteries.
2. Significant (>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot.
3. Angiographic evidence of thrombus within target vessel;
4. Thrombolysis within 72 hours prior to the index procedure;
5. In-Stent restenosis or restenosis of the native common femoral artery.
6. Aneurysm in the abdominal aorta or iliac arteries;
7. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
8. Recent MI or stroke < 30 days prior to the index procedure;
9. Life expectancy less than 24 months;
10. Known or suspected active infection at the time of the index procedure;
11. Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent;
12. Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study;
13. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.