NCT07353905

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Peripheral Arterial Disease
• Lower Extremity Arterial Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-12
• Primary completion: 2028-01-01
• Completion: 2028-07-01
• First posted: 2026-01-21
• Last updated: 2026-03-19

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study