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RECRUITINGOBSERVATIONAL

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes

Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to: 1. Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint) 2. Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint) 3. Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint) Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient.

Who May Be Eligible (Plain English)

Who May Qualify: - Underwent Endovascular Intervention - Treated Iliac, Common or Superficial Femoral, Popliteal, Peroneal, Anterior Tibial, or Posterior Tibial Arteries Who Should NOT Join This Trial: - Surgical Bypass Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Underwent Endovascular Intervention * Treated Iliac, Common or Superficial Femoral, Popliteal, Peroneal, Anterior Tibial, or Posterior Tibial Arteries Exclusion Criteria: * Surgical Bypass

Locations (20)

Arkansas Heart Institute
Little Rock, Arkansas, United States
Denver VAMC
Denver, Colorado, United States
Emory University
Atlanta, Georgia, United States
Loyola University Medical Center
Chicago, Illinois, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States
Mid West Cardiovascular Research Foundation
Davenport, Iowa, United States
VA Boston Healthcare System
Boston, Massachusetts, United States
Detroit Medical Center
Detroit, Michigan, United States
St. Louis University Medical Center
St Louis, Missouri, United States
Carolina East Health System
New Bern, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Harrington Heart and Vascular Institute, University Hospitals
Cleveland, Ohio, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
Integris Heart Hospital
Oklahoma City, Oklahoma, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Seton Heart Institute/ UT Austin
Austin, Texas, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States
Christus Sphon Hospital Corpus Christi-Shoreline
Corpus Christi, Texas, United States
North Texas Veteran Affairs Medical Center
Dallas, Texas, United States