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

Status: Recruiting
Location: See all (24) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Underwent Endovascular Intervention

• Treated Superficial Femoral, Popliteal, Peroneal, Anterior Tibial, or Posterior Tibial Arteries

Locations
United States
Arkansas
Arkansas Heart Institute
COMPLETED
Little Rock
Colorado
Denver VAMC
COMPLETED
Denver
Georgia
Emory University
COMPLETED
Atlanta
Iowa
Mid West Cardiovascular Research Foundation
COMPLETED
Davenport
Illinois
Loyola University Medical Center
COMPLETED
Chicago
Indiana
Indiana University Health Ball Memorial Hospital
COMPLETED
Muncie
Massachusetts
VA Boston Healthcare System
COMPLETED
Boston
Michigan
Detroit Medical Center
RECRUITING
Detroit
Missouri
St. Louis University Medical Center
COMPLETED
St Louis
North Carolina
Carolina East Health System
COMPLETED
New Bern
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Harrington Heart and Vascular Institute, University Hospitals
RECRUITING
Cleveland
Oklahoma
Integris Heart Hospital
COMPLETED
Oklahoma City
Oklahoma University Health Science Center
COMPLETED
Oklahoma City
Pennsylvania
Albert Einstein Healthcare Network
COMPLETED
Philadelphia
Tennessee
Wellmont CVA Heart Institute
RECRUITING
Kingsport
Texas
Cardiothoracic and Vascular Surgeons
COMPLETED
Austin
Seton Heart Institute/ UT Austin
RECRUITING
Austin
Christus Sphon Hospital Corpus Christi-Shoreline
COMPLETED
Corpus Christi
Baylor Scott & White Research Institute
RECRUITING
Dallas
North Texas Veteran Affairs Medical Center
RECRUITING
Dallas
El Paso Cardiovascular Care
COMPLETED
El Paso
North Dallas Research Associates
COMPLETED
Mckinney
UT Health Sciences Center
COMPLETED
San Antonio
Contact Information
Primary
David Fernandez Vazquez, MD
david.fernandezvazquez@bswhealth.org
2148202928
Time Frame
Start Date: 2013-01
Estimated Completion Date: 2033-01
Participants
Target number of participants: 14000
Treatments
Stent
The patient received one or more stents to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries in AT LEAST one of the lesions treated during the course of the procedure.
Non-Stent
The patient did not receive a stent to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries in ANY of the lesions treated during the course of the procedure.
Sponsors
Leads: Baylor Research Institute

This content was sourced from clinicaltrials.gov

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