Registry for evaluating treatments in patients with Peripheral Arterial Disease
Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease
This study is trying to see how well different treatments work for people with Peripheral Arterial Disease by looking at data from 14,000 patients who have had procedures to improve blood flow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 14000 (estimated) |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 24 sites (Little Rock, Arkansas and 23 other locations) |
| Trial ID | NCT01904851 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the effectiveness of stent and non-stent based therapies in patients with Peripheral Arterial Disease (PAD). It will collect comprehensive data on patient demographics, procedural details, and clinical outcomes through an online platform called REDCAP. The study will include data from 14,000 patients who have undergone endovascular interventions on specific arteries, allowing for a comparison of outcomes such as revascularization and complications over a 12-month period. The registry will also analyze historical data dating back to January 1, 2005.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients who have undergone endovascular interventions on the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries.
Not a fit: Patients who have had a failed revascularization attempt, surgical bypass, or only iliac artery treatment will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the best treatment options for patients with Peripheral Arterial Disease, potentially improving patient outcomes.
How similar studies have performed: Other studies have successfully utilized registry approaches to evaluate treatment outcomes in similar patient populations, indicating that this methodology is both tested and effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Underwent Endovascular Intervention * Treated Iliac, Common or Superficial Femoral, Popliteal, Peroneal, Anterior Tibial, or Posterior Tibial Arteries Exclusion Criteria: * Surgical Bypass
Where this trial is running
Little Rock, Arkansas and 23 other locations
- 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)
- Oklahoma University Health Science Center — Oklahoma City, Oklahoma, United States (Completed)
- Integris Heart Hospital — Oklahoma City, Oklahoma, United States (Completed)
- Albert Einstein Healthcare Network — Philadelphia, Pennsylvania, United States (Completed)
- Wellmont CVA Heart Institute — Kingsport, Tennessee, United States (Recruiting)
- Seton Heart Institute/ UT Austin — Austin, Texas, United States (Recruiting)
- Cardiothoracic and Vascular Surgeons — Austin, Texas, United States (Completed)
- Christus Sphon Hospital Corpus Christi-Shoreline — Corpus Christi, Texas, United States (Completed)
- North Texas Veteran Affairs Medical Center — Dallas, Texas, United States (Recruiting)
- Baylor Scott & White Research Institute — Dallas, Texas, United States (Recruiting)
- El Paso Cardiovascular Care — El Paso, Texas, United States (Completed)
- North Dallas Research Associates — McKinney, Texas, United States (Completed)
- UT Health Sciences Center — San Antonio, Texas, United States (Completed)
Study contacts
- Principal investigator: Subhash Banerjee, MD — Baylor Research Institute
- Study coordinator: David Fernandez Vazquez, MD
- Email: david.fernandezvazquez@bswhealth.org
- Phone: 2148202928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.