Serranator Recoil Study

This is an interventional treatment trial for Peripheral Arterial Disease Read More

Inclusion Criteria:

1. Male or female of >18 years old.
2. Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure.
3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and comply, and has signed the consent form.
4. Subject has Rutherford Clinical Category 3, 4, 5, or 6.

Angiographic Inclusion Criteria:

1. Target lesion(s) has stenosis >70% by visual assessment;
2. De-novo, or non-stented re-stenotic lesions;
3. Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
4. Target lesions involve infrapopliteal tibial arteries including pedal;
5. A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length;
6. If a second lesion is identified in another vessel, the second lesion can also be treated and if treated will be treated with the alternate treatment.

Exclusion Criteria:

1. Evidence of aneurysm or acute thrombus in the target vessel.
2. Subject has an allergy to contrast medium that cannot be pretreated.
3. Subject is pregnant or breastfeeding.

Angiographic Exclusion Criteria:

1. Acute Total Occlusions; evidence of acute thrombus formation by angiography.
2. In-stent restenotic lesions.
3. Inability to cross the lesion with the assigned study device.
4. Treatment of target lesion with atherectomy.