Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
Baylor Research Institute
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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
- DeviceIntravascular Ultrasound (IVUS)
pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement
- DeviceAngiographic-guided Intervention
Standard angiography-guided intervention without IVUS.
Locations (6)
- Baylor Scott & White The Heart Hospital - DallasDallas, Texas
- Baylor Scott & White The Heart Hospital - Fort WorthFort Worth, Texas
- Baylor Scott & White The Heart Hospital - MckinneyMcKinney, Texas
- The Heart Hospital Baylor PlanoPlano, Texas
- Baylor Scott & White Medical Center - TempleTemple, Texas
- Baylor Scott & White The Heart Hospital - WaxahachieWaxahachie, Texas