NCT07353905NARecruiting

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

Baylor Research Institute

Start Date

12/12/2025

Completion Date

7/1/2028

Summary

This study will test whether using ultrasound imaging within blood vessels during minimally invasive treatment of leg arteries in patients with peripheral artery disease leads to better clinical outcomes.

Detailed Description

This is a U.S. prospective multicenter randomized controlled trial to evaluate the clinical outcomes of Intravascular ultrasound (IVUS) guided Lower Extremity (LE) endovascular intervention in patients with symptomatic peripheral artery disease (PAD) (Rutherford class 2-5).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Intravascular Ultrasound (IVUS)

DEVICE

Angiographic-guided Intervention

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Conditions

Peripheral Arterial DiseaseLower Extremity Arterial Disease

Locations

Baylor Scott & White The Heart Hospital - Dallas

Dallas, Texas 75226

United States

Baylor Scott & White The Heart Hospital - Fort Worth

Fort Worth, Texas 76104

United States

Baylor Scott & White The Heart Hospital - Mckinney

McKinney, Texas 75071

United States

The Heart Hospital Baylor Plano

Plano, Texas 75093

United States

Baylor Scott & White Medical Center - Temple

Temple, Texas 76508

United States

Baylor Scott & White The Heart Hospital - Waxahachie

Waxahachie, Texas 75165

United States