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Ultrasound inside arteries could boost leg treatment success

NCT ID NCT07353905

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This study tests whether using a tiny ultrasound camera inside the blood vessels during a minimally invasive leg artery procedure leads to better results for people with peripheral artery disease. About 350 adults with leg pain or wounds from blocked arteries will be randomly assigned to get the standard procedure with or without the extra ultrasound guidance. The goal is to see if the ultrasound helps keep arteries open longer and reduces the need for repeat treatments.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 350 people

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

Started

Dec 2025

Expected to finish

Jul 2028

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.

Ages

18 years and older

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: * Age ≥18 years * Symptomatic LE PAD - Rutherford Class 2-5 * Angiographic evidence of \>50% stenosis * Undergoing LE peripheral artery intervention * Target lesion is iliac, femoropopliteal, profunda or supramalleolar below-the-knee arteries (target lesions extending into the abdominal aorta and inframalleolar BTK may be included). Exclusion Criteria: * Prior intervention at the target lesion within 6 months * Target lesion is abdominal aorta or inframalleolar BTK arteries

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 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

  • Baylor Scott & White Medical Center - Temple

    NOT_YET_RECRUITING

    Temple, Texas, 76508, United States

  • Baylor Scott & White The Heart Hospital - Dallas

    RECRUITING

    Dallas, Texas, 75226, United States

  • Baylor Scott & White The Heart Hospital - Fort Worth

    NOT_YET_RECRUITING

    Fort Worth, Texas, 76104, United States

  • Baylor Scott & White The Heart Hospital - Mckinney

    RECRUITING

    McKinney, Texas, 75071, United States

  • Baylor Scott & White The Heart Hospital - Waxahachie

    RECRUITING

    Waxahachie, Texas, 75165, United States

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

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