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RECRUITINGINTERVENTIONAL

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - Prior intervention at the target lesion within 6 months - Target lesion is abdominal aorta or inframalleolar BTK arteries Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Intravascular Ultrasound (IVUS)

pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement

DEVICE

Angiographic-guided Intervention

Standard angiography-guided intervention without IVUS.

Locations (6)

Baylor Scott & White The Heart Hospital - Dallas
Dallas, Texas, United States
Baylor Scott & White The Heart Hospital - Fort Worth
Fort Worth, Texas, United States
Baylor Scott & White The Heart Hospital - Mckinney
McKinney, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States
Baylor Scott & White The Heart Hospital - Waxahachie
Waxahachie, Texas, United States