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Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes

Key facts

Who runs it
Baylor Research Institute
Where
Atlanta, Austin, Boston, Chicago, Cleveland, Corpus Christi, Dallas, Davenport, Denver, Detroit, El Paso, Kingsport, Little Rock, McKinney, Muncie, New Bern, Oklahoma City, Philadelphia, San Antonio, and St Louis, United StatesSee the 24 sites
Trial code
Status
Recruiting
People taking part
14,000 people, planned
Started
Jan 2013
Expected to end
Jan 2033
Type of study
Observational, 2 groups
Record updated
6 February 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • Underwent Endovascular Intervention
  • Treated Iliac, Common or Superficial Femoral, Popliteal, Peroneal, Anterior Tibial, or Posterior Tibial Arteries

Who cannot take part

  • Surgical Bypass

Where in United States

  • Emory UniversityAtlanta, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Seton Heart Institute/ UT AustinAustin, United StatesContact: Sarah J BenedictTaking people
  • Cardiothoracic and Vascular SurgeonsAustin, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • VA Boston Healthcare SystemBoston, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Loyola University Medical CenterChicago, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Cleveland ClinicCleveland, United StatesContact: Aravinda Nanjundappa, MD (principal investigator)Taking people
  • Harrington Heart and Vascular Institute, University HospitalsCleveland, United StatesContact: Mehdi Shishehbor, MD (principal investigator)Taking people
  • Christus Sphon Hospital Corpus Christi-ShorelineCorpus Christi, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Baylor Scott & White Research InstituteDallas, United StatesContact: David Fernandez Vazquez, MDTaking people
  • North Texas Veteran Affairs Medical CenterDallas, United StatesContact: Shirling Tsai, MD (principal investigator)Taking people
  • Mid West Cardiovascular Research FoundationDavenport, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Denver VAMCDenver, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Detroit Medical CenterDetroit, United StatesContact: Chadi Alraies, MD (principal investigator)Taking people
  • El Paso Cardiovascular CareEl Paso, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Wellmont CVA Heart InstituteKingsport, United StatesContact: Gaurav Rana, MD (principal investigator)Taking people
  • Arkansas Heart InstituteLittle Rock, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • North Dallas Research AssociatesMcKinney, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Indiana University Health Ball Memorial HospitalMuncie, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Carolina East Health SystemNew Bern, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Integris Heart HospitalOklahoma City, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Oklahoma University Health Science CenterOklahoma City, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • Albert Einstein Healthcare NetworkPhiladelphia, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • UT Health Sciences CenterSan Antonio, United StatesContact: David Fernandez Vazquez, MDNo longer taking part
  • St. Louis University Medical CenterSt Louis, United StatesContact: David Fernandez Vazquez, MDNo longer taking part

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease
Record updated
6 February 2026