RecruitingNot ApplicableNCT07353905
Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
Sponsor
Baylor Research Institute
Enrollment
350 participants
Start Date
Dec 12, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria2
- Prior intervention at the target lesion within 6 months
- Target lesion is abdominal aorta or inframalleolar BTK arteries
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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)
View Full Details on ClinicalTrials.gov
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NCT07353905
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