An interventional study of Intravascular Ultrasound (IVUS) and Angiographic-guided Intervention in Peripheral Arterial Disease and Lower Extremity Arterial Disease, sponsored by Baylor Research Institute. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Baylor Research Institute · Not applicable, Interventional, and Treatment
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.
This is a U.S. prospective multicenter randomized controlled trial to evaluate the clinical outcomes of Intravascular ultrasound (IVUS) guided Lower Extremity (LE) endovascular intervention in patients with symptomatic peripheral artery disease (PAD) (Rutherford class 2-5).
Exclusion Criteria:
Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion.
Device: Intravascular Ultrasound (IVUS)
Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.
Device: Angiographic-guided Intervention
pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement
Standard angiography-guided intervention without IVUS.
Primary Patency
Freedom from restenosis ≥50% or an increase in Duplex Ultrasound peak systolic velocity ≥2.5 times reference proximal segment or target lesion revascularization (TLR).
Time frame: From enrollment to 6 months
Technical Success
Technical success is defined as less than 30% residual stenosis in the target lesion following the index procedure. Residual stenosis determined by operator visual estimation.
Time frame: Collected from index procedure
Procedural Success
Procedural success is technical success (less than 30 % residual stenosis in the target lesion) without the occurrence of procedural complications during the index procedure. Residual stenosis determined by operator visual estimation.
Time frame: Collected from Index procedure
Clinically driven-TLR (CD-TLR)
Clinically driven-target limb revascularization. Information collected from the medical record.
Time frame: From enrollment to 12 months
Amputation-free Survival
Defined as no evidence of amputation. Information is collected from the medical record
Time frame: From enrollment to 12 months
Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6))
Vascular Quality of Life Questionnaire (VascuQoL-6) collected at index procedure and 12 months.
Time frame: From enrollment to 12 months
Functional Status Improvement (Rutherford Class Improvement)
Rutherford class determined by physician and collected from the medical record.
Time frame: From enrollment to 12 months
Cost Effectiveness
This analysis will calculate total cost-effectiveness by comparing costs between the two groups. Total cost will include the initial procedural cost, costs related to complications, and costs of any repeat reinterventions during follow-up.
Time frame: Evaluated at 12 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We will need to get Information Security and sponsor approval before sharing our data. Any data shared would be aggregate, de-identified data shared in accordance with Baylor Scott \& White Research Institute's policies and procedures.
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