Using Intravascular Ultrasound to Guide Peripheral Artery Disease Treatment in Adults with Chronic Limb Threatening Ischemia A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating whether using intravascular ultrasound IVUS during percutaneous revascularization can better prevent major adverse limb events MALE or significant artery narrowing restenosis compared to using angiography alone in adults with chronic limb threatening ischemia CLTI caused by peripheral arterial disease PAD. The study aims to understand if IVUS guidance improves outcomes after artery treatment in this population. Participants will be randomly assigned to one of two groups one receiving percutaneous revascularization guided by IVUS, where operators use ultrasound to optimize treatment of arteries hardened by calcium, and the other receiving standard care guided by angiography alone without IVUS. The procedures focus on unblocking arteries affected by PAD and CLTI. The study will follow participants for up to 5 years after treatment. Throughout the study, researchers will monitor participants regularly to track the time until the first major adverse limb event, including unplanned above-ankle amputations, need for additional artery treatment, or restenosis. They will also assess mortality, wound healing using the WIFI scale, walking ability, and vascular quality of life. Data will be collected up to five years post-randomization to evaluate long-term safety and effectiveness of the treatment strategies.

Intravascular Ultrasound for Peripheral Artery Disease Revascularization