Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

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.

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).

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