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Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

NCT07353905 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease
  • Lower Extremity Arterial Disease

Interventions

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.

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY

  • Baylor Research Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2028-01-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07353905 on ClinicalTrials.gov