IVUS-guided revascularization of leg arteries
Official title: Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
Run by Baylor Research Institute · NCT07353905 · Data updated 2026-11-12
This trial will test whether using ultrasound inside the blood vessels during minimally invasive treatment of leg arteries improves outcomes for adults with symptomatic peripheral artery disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 6 sites (Dallas, Texas and 5 other locations) |
| Status | Recruiting |
| Started | December 12, 2025 |
| Main results expected | January 2028 |
| Study ends | July 2028 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07353905 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with symptomatic lower extremity PAD (Rutherford class 2–5), angiographic >50% stenosis, and a planned endovascular intervention at an eligible target lesion are ideal candidates.
✕Probably not a fit
Patients with a prior intervention at the target lesion within 6 months or whose target lesion is the abdominal aorta or inframalleolar below-the-knee arteries are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a U.S. prospective multicenter randomized controlled trial comparing intravascular ultrasound (IVUS)-guided versus angiographic-guided lower extremity endovascular intervention in patients with symptomatic peripheral artery disease (Rutherford class 2–5). Participants with target lesions in the iliac, femoropopliteal, profunda, or supramalleolar below-the-knee arteries and angiographic stenosis >50% will be randomized to guidance strategies during intervention. The trial will track clinical outcomes including technical success, vessel patency, limb-related events, and need for repeat procedures over follow-up. The lead sites are Baylor Scott & White Heart Hospitals in Texas in collaboration with Philips Healthcare.
Why it matters
Potential benefit: If successful, using IVUS during leg artery procedures could improve vessel repair accuracy, increase durable patency, and reduce the need for repeat procedures.
How similar studies have gone: IVUS guidance has shown procedural benefits in coronary interventions and some smaller peripheral studies, but large multicenter randomized data for lower extremity PAD are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Baylor Scott & White The Heart Hospital - Dallas
Dallas, Texas, United States Recruiting -
Baylor Scott & White The Heart Hospital - Mckinney
McKinney, Texas, United States Recruiting -
The Heart Hospital Baylor Plano
Plano, Texas, United States Recruiting -
Baylor Scott & White The Heart Hospital - Waxahachie
Waxahachie, Texas, United States Recruiting -
Baylor Scott & White The Heart Hospital - Fort Worth
Fort Worth, Texas, United States Not yet recruiting -
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States Not yet recruiting
Study contacts
- Principal investigator: Subhash Banerjee, MD — Baylor Scott & White Research Institute
- Study coordinator: Sarah Hale
- Email: sarah.hale@bswhealth.org
- Phone: 469-814-4845
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.