Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries (INVIGOR)

Baylor Scott and White Health (BSWH)

Status: Enrolling

Conditions: Peripheral Arterial Disease; Femoropopliteal Disease

Treatments: Device: Intravascular Ultrasound (IVUS); Device: Angiographic-guided Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07353905

025-412

Details and patient eligibility

About

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.

Full description

This is a U.S. prospective multicenter randomized controlled trial to evaluate the clinical outcomes of Intravascular ultrasound (IVUS) guided Femoropopliteal (FP) endovascular intervention in patients with symptomatic peripheral artery disease (PAD) (Rutherford class 2-5).

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age ≥18 years
• Symptomatic FP PAD with angiographic evidence of >50% stenosis
• Candidates for endovascular therapy

Exclusion criteria

• Prior intervention at the target lesion within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

350 participants in 2 patient groups

Intravascular Ultrasound (IVUS)

Active Comparator group

Description:

Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion.

Treatment:

Device: Intravascular Ultrasound (IVUS)

Non-Intravascular Ultrasound (IVUS)

Active Comparator group

Description:

Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.

Treatment:

Device: Angiographic-guided Intervention