Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
INVIGOR
1 other identifier
interventional
350
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2025
CompletedStudy Start
First participant enrolled
December 12, 2025
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
July 9, 2026
January 1, 2026
2.1 years
December 9, 2025
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
From enrollment to 6 months
Secondary Outcomes (7)
Technical Success
Collected from index procedure
Procedural Success
Collected from Index procedure
Clinically driven-TLR (CD-TLR)
From enrollment to 12 months
Amputation-free Survival
From enrollment to 12 months
Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6))
From enrollment to 12 months
- +2 more secondary outcomes
Study Arms (2)
Intravascular Ultrasound (IVUS)
ACTIVE COMPARATORIntravascular Ultrasound (IVUS) is used during the treatment of the target lesion.
Non-Intravascular Ultrasound (IVUS)
ACTIVE COMPARATORIntravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.
Interventions
pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement
Standard angiography-guided intervention without IVUS.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Prior intervention at the target lesion within 6 months
- Target lesion is abdominal aorta or inframalleolar BTK arteries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philips Healthcarecollaborator
- Baylor Research Institutelead
Study Sites (6)
Baylor Scott & White The Heart Hospital - Dallas
Dallas, Texas, 75226, United States
Baylor Scott & White The Heart Hospital - Fort Worth
Fort Worth, Texas, 76104, United States
Baylor Scott & White The Heart Hospital - Mckinney
McKinney, Texas, 75071, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508, United States
Baylor Scott & White The Heart Hospital - Waxahachie
Waxahachie, Texas, 75165, United States
Related Publications (9)
PASS 2025 Power Analysis and Sample Size Software (2025). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
BACKGROUNDDivakaran S, Parikh SA, Hawkins BM, Chen S, Song Y, Banerjee S, Rosenfield K, Secemsky EA. Temporal Trends, Practice Variation, and Associated Outcomes With IVUS Use During Peripheral Arterial Intervention. JACC Cardiovasc Interv. 2022 Oct 24;15(20):2080-2090. doi: 10.1016/j.jcin.2022.07.050.
PMID: 36265940BACKGROUNDRymer JA, Secemsky EA. Use of Intravascular Ultrasound to Optimize Peripheral Vascular Interventions: How Do We Optimize Outcomes and Improve Uptake? Circ Cardiovasc Interv. 2023 Apr;16(4):e013016. doi: 10.1161/CIRCINTERVENTIONS.123.013016. Epub 2023 Apr 18. No abstract available.
PMID: 37071719BACKGROUNDShin J, Ahn CM, Lee SJ, Lee SH, Lee YJ, Kim BK, Hong MK, Jang Y, Kim TH, Park HW, Jang JY, Lee JH, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS-DCB investigators. Twenty-Four-Month Outcomes of Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease. J Am Heart Assoc. 2025 Aug 19;14(16):e041564. doi: 10.1161/JAHA.125.041564. Epub 2025 Aug 12.
PMID: 40792582BACKGROUNDAllan RB, Puckridge PJ, Spark JI, Delaney CL. The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial. JACC Cardiovasc Interv. 2022 Mar 14;15(5):536-546. doi: 10.1016/j.jcin.2022.01.001.
PMID: 35272779BACKGROUNDMeng W, Guo J, Pan D, Guo L, Gu Y. Intravascular Ultrasound-Guided Versus Angiography-Guided Endovascular Therapy for Femoropopliteal Artery Disease: A Scoping Review. J Endovasc Ther. 2025 Jun;32(3):627-634. doi: 10.1177/15266028231197396. Epub 2023 Sep 9.
PMID: 37688486BACKGROUNDJang JS, Jin HY, Park YA, Yang TH, Seo JS, Kim DK, Wi JH. Meta-Analysis of Intravascular Ultrasound-Guided Versus Angiography-Guided Endovascular Treatment in Lower Extremity Artery Disease. Am J Cardiol. 2025 Mar 15;239:8-17. doi: 10.1016/j.amjcard.2024.12.012. Epub 2024 Dec 12.
PMID: 39674438BACKGROUNDLee SJ, Kim TH, Lee JH, Ahn CM, Lee SH, Lee YJ, Kim BK, Hong MK, Jang Y, Park HW, Jang JY, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS-DCB Investigators. Intravascular Ultrasound-Guided vs Angiography-Guided Drug-Coated Balloon Angioplasty in Patients With Complex Femoropopliteal Artery Disease. JACC Cardiovasc Interv. 2025 Mar 10;18(5):558-569. doi: 10.1016/j.jcin.2024.10.052. Epub 2025 Jan 22.
PMID: 39846915BACKGROUNDSoney H, Kakkilaya A, Vazquez DF, Banerjee R, Rosol Z, Tsai S, Banerjee S. Reproducibility of Femoropopliteal Artery Intravascular Ultrasound Imaging in Patients With Peripheral Artery Disease. Am J Cardiol. 2023 Jul 15;199:1-6. doi: 10.1016/j.amjcard.2023.04.026. Epub 2023 May 19.
PMID: 37210800BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Subhash Banerjee, MD
Baylor Scott & White Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2025
First Posted
January 21, 2026
Study Start
December 12, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
July 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
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.