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Massive PAD registry aims to settle stent vs Non-Stent debate

NCT ID NCT01904851

Knowledge-focused Sponsor: Baylor Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is creating a large registry of 14,000 people with peripheral artery disease (PAD) to compare the long-term results of treatments that use stents versus those that do not. Researchers will track outcomes like repeat procedures, amputations, and walking ability over 12 months. The goal is to learn which approach works better in real-world practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 14,000 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jan 2013

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with diagnosed peripheral arterial disease who underwent endovascular intervention, and received either a stent or non-stent based treatment.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albert Einstein Healthcare Network

    COMPLETED

    Philadelphia, Pennsylvania, 19141, United States

  • Arkansas Heart Institute

    COMPLETED

    Little Rock, Arkansas, 72211, United States

  • Baylor Scott & White Research Institute

    RECRUITING

    Dallas, Texas, 75226, United States

  • Cardiothoracic and Vascular Surgeons

    COMPLETED

    Austin, Texas, 78756, United States

  • Carolina East Health System

    COMPLETED

    New Bern, North Carolina, 28560, United States

  • Christus Sphon Hospital Corpus Christi-Shoreline

    COMPLETED

    Corpus Christi, Texas, 78404, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 38732, United States

  • Denver VAMC

    COMPLETED

    Denver, Colorado, 80220, United States

  • Detroit Medical Center

    RECRUITING

    Detroit, Michigan, 48201, United States

  • El Paso Cardiovascular Care

    COMPLETED

    El Paso, Texas, 79925, United States

  • Emory University

    COMPLETED

    Atlanta, Georgia, 30322, United States

  • Harrington Heart and Vascular Institute, University Hospitals

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Indiana University Health Ball Memorial Hospital

    COMPLETED

    Muncie, Indiana, 47303, United States

  • Integris Heart Hospital

    COMPLETED

    Oklahoma City, Oklahoma, 73109, United States

  • Loyola University Medical Center

    COMPLETED

    Chicago, Illinois, 60153, United States

  • Mid West Cardiovascular Research Foundation

    COMPLETED

    Davenport, Iowa, 52803, United States

  • North Dallas Research Associates

    COMPLETED

    McKinney, Texas, 75069, United States

  • North Texas Veteran Affairs Medical Center

    RECRUITING

    Dallas, Texas, 75216, United States

  • Oklahoma University Health Science Center

    COMPLETED

    Oklahoma City, Oklahoma, 73104, United States

  • Seton Heart Institute/ UT Austin

    RECRUITING

    Austin, Texas, 78705, United States

  • St. Louis University Medical Center

    COMPLETED

    St Louis, Missouri, 63104, United States

  • UT Health Sciences Center

    COMPLETED

    San Antonio, Texas, 78229, United States

  • VA Boston Healthcare System

    COMPLETED

    Boston, Massachusetts, 02301, United States

  • Wellmont CVA Heart Institute

    RECRUITING

    Kingsport, Tennessee, 37663, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.