Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities

Inclusion Criteria

General:

• Signed informed consent
• At least 18 years old
• Documented symptomatic iliac, femoropopliteal (FP) or below-the knee artery (BTK) atherosclerotic disease (Rutherford/Becker category 2, 3 or ≥4)
• Undergone clinically indicated uncomplicated endovascular intervention to one or more locations of the iliac, femoropopliteal below-the knee arteries
• Estimated survival ≥1 year in the judgment of the primary operator
• Pre-index procedure use of ASA, clopidogrel or both at any dose

Angiographic:

• De novo or restenotic lesions in the common and/or external iliac artery, superficial femoral artery (SFA), popliteal artery, tibio-peroneal (TP) trunk, anterior tibial (AT) artery, peroneal artery (PA) or posterior tibial (PT) artery (applies to all target lesions if multiple)
• Subjects with multiple planned procedures can be enrolled after the completion of the last planned procedure.

Exclusion Criteria

General:

• Complicated qualifying procedure (perforation, flow limiting dissection, distal embolization requiring re-intervention, need for repeat endovascular, surgical revascularization, amputation or blood transfusion prior to hospital discharge following an index procedure
• Extended hospital stay >7 days following the index procedure
• Allergy to aspirin or clopidogrel
• Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
• Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
• Platelet count 600,000 mm3
• Serum creatinine >2.5 mg/dL
• Dialysis-dependent end stage renal disease
• Pregnancy
• Current participation in another drug or device trial that requires interruption of dual-antiplatelet therapy with aspirin or clopidogrel for the duration of the study
• Planned surgeries, endovascular or other non-vascular or cardiac procedures
• Concurrent warfarin or other chronic oral anticoagulant therapy
• Contraindication(s) to the use of AT (history of intra-cerebral bleed, presence of intra-cerebral mass, recent or <6 weeks gastrointestinal bleed, blood transfusion within the last 6 weeks, any trauma requiring surgery or blood transfusion within the last 4 weeks or any surgical procedure within the last 4 weeks.

Angiographic:

• Endovascular intervention to iliac, femoropopliteal or BTK artery bypass graft
• Persistent, intraluminal thrombus of the proposed target lesion at the completion of the index procedure
• Perforated vessel as evidenced by extravasation of contrast media
• Vascular graft, aneurysm or postsurgical stenosis of the target vessel