Condition: Peripheral Arterial Disease · Sponsor: Baylor Research Institute
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…
This description comes directly from the study's public registry record.
David Fernandez Vazquez, MD · 2148202928 · david.fernandezvazquez@bswhealth.org
Always discuss trial participation with your own doctor first.
| Arkansas Heart Institute | Little Rock, Arkansas, United States | Completed |
| Denver VAMC | Denver, Colorado, United States | Completed |
| Emory University | Atlanta, Georgia, United States | Completed |
| Loyola University Medical Center | Chicago, Illinois, United States | Completed |
| Indiana University Health Ball Memorial Hospital | Muncie, Indiana, United States | Completed |
| Mid West Cardiovascular Research Foundation | Davenport, Iowa, United States | Completed |
| VA Boston Healthcare System | Boston, Massachusetts, United States | Completed |
| Detroit Medical Center | Detroit, Michigan, United States | Recruiting |
| St. Louis University Medical Center | St Louis, Missouri, United States | Completed |
| Carolina East Health System | New Bern, North Carolina, United States | Completed |
| Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| Harrington Heart and Vascular Institute, University Hospitals | Cleveland, Ohio, United States | Recruiting |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT01904851