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Intravascular Ultrasound Imaging for Leg Artery Treatment

This study is testing whether using Intravascular Ultrasound (IVUS) imaging during minimally invasive procedures to treat blocked leg arteries in people with Peripheral Arterial Disease (PAD) leads to better outcomes. PAD is a condition where narrowed arteries reduce blood flow to your limbs. You might be able to join if you are 18 or older, have symptomatic PAD (Rutherford Class 2-5), and have significant narrowing in your leg arteries. The study will compare IVUS-guided treatment to standard angiography-guided treatment. Success will be measured by how well your arteries remain open (primary patency) for up to 6 months after the procedure. The study plans to enroll 350 participants, but its current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to one of two treatment groups. It plans to enroll 350 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure how well their arteries remain open for up to 6 months after the procedure.

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NCT07353905

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

Recruiting
NAAges 18+InterventionalTreatment
Baylor Research Institute
~350 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Intravascular Ultrasound (IVUS)Angiographic-guided Intervention

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Patency
Measured over From enrollment to 6 months

Conditions

Peripheral Arterial Disease
Lower Extremity Arterial Disease

Explore related trials

Peripheral Artery Disease

Where it's being run

6 sites across 1 states
Texas6

Study leadership

  • Subhash Banerjee, MD · PRINCIPAL_INVESTIGATOR · Baylor Scott & White Research Institute

Who to contact

Sarah Hale
[email protected]
469-814-4845
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Prior intervention at the target lesion within 6 months
Target lesion is abdominal aorta or inframalleolar BTK arteries

What this trial measures

  • Primary PatencyFrom enrollment to 6 months

    Freedom from restenosis ≥50% or an increase in Duplex Ultrasound peak systolic velocity ≥2.5 times reference proximal segment or target lesion revascularization (TLR).