Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities

• Status: Completed
• Trial end date: 2020-01-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at end of study treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

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 <90,000 mm3 or >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