Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT07353905
Status
Recruiting
Apply to this trial

Conditions

  • Lower Extremity Arterial Disease
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravascular Ultrasound (IVUS) — DEVICE
    pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement
  • Angiographic-guided Intervention — DEVICE
    Standard angiography-guided intervention without IVUS.

Study Details

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.

Key Dates

Start date
Dec 12, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Baylor Scott & White The Heart Hospital - DallasDallasTexas75226
Sarah Hale
[email protected]
469-814-4845
Sarah Weideman
[email protected]
214-820-2927
Subhash Banerjee, MD (PRINCIPAL_INVESTIGATOR)
Zachary Rosol, MD (SUB_INVESTIGATOR)
Javier Vasquez, MD (SUB_INVESTIGATOR)
Georges Feghali, MD (SUB_INVESTIGATOR)
Baylor Scott & White The Heart Hospital - Fort WorthFort WorthTexas76104
Theresa Cheyne
[email protected]
817-922-2579
Mohammad Alqaim, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White The Heart Hospital - MckinneyMcKinneyTexas75071
Denise Espinoza
[email protected]
(469) 814-4783
Erisa Stokes, BS
[email protected]
Robert Widmer, MD (PRINCIPAL_INVESTIGATOR)
Arash Shirvani, MD (SUB_INVESTIGATOR)
Joseph Liechty, MD (SUB_INVESTIGATOR)
Sanjeev Trehan, MD (SUB_INVESTIGATOR)
The Heart Hospital Baylor PlanoPlanoTexas75093
Osniel Gonzalez Ramos, BS
[email protected]
469-814-4862
Erisa Stokes, BS
[email protected]
469-814-4819
Sameh Sayfo, MD (PRINCIPAL_INVESTIGATOR)
Chadi Dib, MD (SUB_INVESTIGATOR)
John Kedora, MD (SUB_INVESTIGATOR)
Mazin Foteh, MD (SUB_INVESTIGATOR)
Srinivasa Potluri, MD (SUB_INVESTIGATOR)
Dennis Gable, MD (SUB_INVESTIGATOR)
Baylor Scott & White Medical Center - TempleTempleTexas76508
Margarite Grable
[email protected]
254-724-5861
Christian Wintz
[email protected]
Timothy Mixon, MD (PRINCIPAL_INVESTIGATOR)
Clint Malone, MD (SUB_INVESTIGATOR)
Baylor Scott & White The Heart Hospital - WaxahachieWaxahachieTexas75165
Sarah Hale
[email protected]
469-814-4845
Sarah Weideman
[email protected]
214-820-2927
Christopher Henry, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By research site
Baylor Scott & White The Heart Hospital - Dallas· Dallas, TXBaylor Scott & White The Heart Hospital - Fort Worth· Fort Worth, TXBaylor Scott & White The Heart Hospital - Mckinney· McKinney, TXThe Heart Hospital Baylor Plano· Plano, TXBaylor Scott & White Medical Center - Temple· Temple, TXBaylor Scott & White The Heart Hospital - Waxahachie· Waxahachie, TX

Related Studies