Ultrasound inside arteries could boost leg treatment success
NCT ID NCT07353905
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Baylor Scott & White Medical Center - Temple
NOT_YET_RECRUITINGTemple, Texas, 76508, United States
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Baylor Scott & White The Heart Hospital - Dallas
RECRUITINGDallas, Texas, 75226, United States
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Baylor Scott & White The Heart Hospital - Fort Worth
NOT_YET_RECRUITINGFort Worth, Texas, 76104, United States
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Baylor Scott & White The Heart Hospital - Mckinney
RECRUITINGMcKinney, Texas, 75071, United States
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Baylor Scott & White The Heart Hospital - Waxahachie
RECRUITINGWaxahachie, Texas, 75165, United States
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The Heart Hospital Baylor Plano
RECRUITINGPlano, Texas, 75093, United States
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