Absolute Pro® MOMENTUM™

General Clinical Inclusion Criteria:

• Subject is ≥ 18 years of age.
• Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
• Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
• Subject is diagnosed as having moderate to severe claudication (Rutherford-Becker Clinical Category 2-3) or ischemic rest pain (Rutherford-Becker Clinical Category 4).
• Female subject of childbearing potential must:
• have had a negative pregnancy test (serum HCG) within 14 days before treatment;
• not be nursing at the time of treatment; and
• agree at time of consent to use birth control during participation in this trial.
• Subject has life expectancy > 12 months.

Angiographic Inclusion Criteria:

• A single de novo or restenotic [not previously treated with stent, brachytherapy, laser, surgical bypass, or endarterectomy] native disease segment of the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) located within the following parameters: ≥1 cm below the femoral bifurcation in the SFA. ≥3 cm above the proximal margin of the intercondylar fossa.
• Disease segment length visually estimated to be ≤ 14 cm (140 mm) and can be treated with one stent.
• Disease segment visually estimated to be ≥ 50% stenosis or a total occlusion.
• Target vessel reference diameter visually estimated to be ≥ 4.0 mm and ≤ 7.0 mm.
• A patent ipsilateral iliac artery, defined as 2.5 mg/dl.
• Subject is on chronic hemodialysis.
• Subject has documented or suspected uncontrolled diabetes mellitus (DM), unless HbA1c has been assessed as 50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure within 30 days before or after the procedure.
• Target vessel has been previously treated at any location with a stent, or has been previously treated ≤ 5 cm from the proximal or distal margin of the target lesion with brachytherapy or laser.
• Target lesion is within or adjacent to an aneurysm.
• Target lesion or vessel has angiographic evidence of thrombus that is unresponsive to anti-thrombotic therapies.
• Subject has a contralateral superficial femoral or proximal popliteal artery lesion that requires treatment within 30 days before or after the procedure.
• Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3 cm.
• Subject has evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion.
• .Subject has any condition that precludes safe access to the target lesion or target vessel, e.g. severe calcification, excessive tortuosity.
• Target lesion requires use of re-entry, ablative, cutting balloon, atherectomy, or similar devices to cross or treat the lesion.