IVUS-guided revascularization of leg arteries

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

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

• Phase: NA
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baylor Research Institute (other)
• Locations: 6 sites (Dallas, Texas and 5 other locations)
• Trial ID: NCT07353905 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Dallas, Texas and 5 other locations

• Baylor Scott & White The Heart Hospital - Dallas — Dallas, Texas, United States (RECRUITING)
• Baylor Scott & White The Heart Hospital - Fort Worth — Fort Worth, Texas, United States (NOT_YET_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 Medical Center - Temple — Temple, Texas, United States (NOT_YET_RECRUITING)
• Baylor Scott & White The Heart Hospital - Waxahachie — Waxahachie, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Subhash Banerjee, MD — Baylor Scott & White Research Institute
• Study coordinator: Sarah Hale

Conditions: Peripheral Arterial Disease, Lower Extremity Arterial Disease, Intravascular Ultrasound, Angioplasty, Endovascular Treatment