Using Intravascular Ultrasound Imaging to Improve Treatment of Leg Arteries in Patients with Peripheral Artery Disease

What this Trial Is About

Researchers are evaluating whether using ultrasound imaging inside blood vessels during minimally invasive treatment of leg arteries improves outcomes for patients with symptomatic peripheral artery disease PAD classified as Rutherford class 2-5. This prospective, multicenter randomized controlled trial in the U.S. aims to compare clinical results between ultrasound-guided and standard angiography-guided interventions. The study is led by the Baylor Research Institute and focuses on lower extremity arterial disease affecting several specific artery locations. Participants will receive one of two treatments either intravascular ultrasound IVUS guidance during their endovascular intervention or a standard angiographic-guided procedure without IVUS. The IVUS is used before and after procedures like atherectomy, balloon angioplasty, or stent placement to guide treatment. The trial follows participants through these treatments to assess outcomes over time. During the study, participants will be monitored for clinical success and functional improvements using questionnaires and classifications over 12 months, with primary patency assessed at 6 months. Researchers will also evaluate technical and procedural success during the initial procedure, survival without amputation, the need for repeat interventions, and cost effectiveness. The total study duration extends to July 2028, with ongoing assessments to measure the impact of ultrasound guidance on treatment results.

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries