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Status:

COMPLETED

Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities

Lead Sponsor:

University of Texas Southwestern Medical Center

Conditions:

Peripheral Arterial Disease

Eligibility:

All Genders

18-90 years

Phase:

PHASE3

Brief 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 increas...

Detailed Description

Peripheral arterial disease (PAD) is extremely prevalent worldwide and affects over 206 million people. Over 36 million patients with PAD are estimated to be present in the United States. Percutaneous...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 30 2020

Estimated Enrollment :

159 Patients enrolled

Trial Details

Trial ID

NCT02217501

Start Date

November 1 2015

End Date

January 30 2020

Last Update

February 21 2021

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Denver VA Medical Center

Denver, Colorado, United States, 80220

2

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States, 52803

3

VA North Texas Health Care System

Dallas, Texas, United States, 75216

4

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390