Recruiting

Ultrasound Imaging

Sponsor:

Baylor Research Institute

Code:

NCT07353905

Conditions

Peripheral Arterial Disease

Lower Extremity Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intravascular Ultrasound (IVUS)

Angiographic-guided Intervention

Study Details

Brief 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

Study ID

NCT07353905

Start date

Dec 12, 2025

Status verified date

Jan, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intravascular Ultrasound (IVUS)

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

active comparator: Non-Intravascular Ultrasound (IVUS)

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

Interventions

Intravascular Ultrasound (IVUS)

pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement

Angiographic-guided Intervention

Standard angiography-guided intervention without IVUS.

Primary outcome measure

  • Primary Patency [ Time Frame: From enrollment to 6 months ]

Central Contacts and Locations

Central contacts

Sarah Hale

469-814-4845sarah.hale@bswhealth.org

Sarah Weideman

214-820-2927sarah.weideman@bswhealth.org

Locations

Baylor Scott & White The Heart Hospital - Dallas

Recruiting

Dallas, Texas, United States, 75226

Contacts

Sarah Hale

469-814-4845sarah.hale@bswhealth.org

Sarah Weideman

214-820-2927sarah.weideman@bswhealth.org

Principal Investigator:

Subhash Banerjee, MD

Baylor Scott & White The Heart Hospital - Mckinney

Recruiting

McKinney, Texas, United States, 75071

Contacts

Denise Espinoza

(469) 814-4783Denise.Espinoza@BSWHealth.org

Erisa Stokes, BS

erisa.stokes@bswhealth.org

Principal Investigator:

Robert Widmer, MD

The Heart Hospital Baylor Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Osniel Gonzalez Ramos, BS

469-814-4862osniel.gonzalezramos@bswhealth.org

Erisa Stokes, BS

469-814-4819erisa.stokes@bswhealth.org

Principal Investigator:

Sameh Sayfo, MD

Baylor Scott & White The Heart Hospital - Waxahachie

Recruiting

Waxahachie, Texas, United States, 75165

Contacts

Sarah Hale

469-814-4845sarah.hale@bswhealth.org

Sarah Weideman

214-820-2927sarah.weideman@bswhealth.org

Principal Investigator:

Christopher Henry, MD

More Information

Sponsor

Baylor Research Institute

Last update posted

Jul 9, 2026

Last verified

Jan, 2026

Keywords

  • Intravascular Ultrasound
  • Angioplasty
  • Endovascular Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-07-09.