Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries (INVIGOR)

March 17, 2026 updated by: Baylor Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Scott & White The Heart Hospital - Dallas
        • Contact:
        • Principal Investigator:
          • Subhash Banerjee, MD
        • Contact:
        • Sub-Investigator:
          • Zachary Rosol, MD
        • Sub-Investigator:
          • Javier Vasquez, MD
        • Sub-Investigator:
          • Georges Feghali, MD
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • Baylor Scott & White The Heart Hospital - Fort Worth
        • Contact:
        • Principal Investigator:
          • Mohammad Alqaim, MD
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Baylor Scott & White The Heart Hospital - Mckinney
        • Principal Investigator:
          • Robert Widmer, MD
        • Contact:
        • Sub-Investigator:
          • Arash Shirvani, MD
        • Sub-Investigator:
          • Joseph Liechty, MD
        • Contact:
        • Sub-Investigator:
          • Sanjeev Trehan, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • The Heart Hospital Baylor Plano
        • Principal Investigator:
          • Sameh Sayfo, MD
        • Sub-Investigator:
          • Chadi Dib, MD
        • Contact:
        • Sub-Investigator:
          • John Kedora, MD
        • Sub-Investigator:
          • Mazin Foteh, MD
        • Sub-Investigator:
          • Srinivasa Potluri, MD
        • Sub-Investigator:
          • Dennis Gable, MD
        • Contact:
      • Temple, Texas, United States, 76508
        • Not yet recruiting
        • Baylor Scott & White Medical Center - Temple
        • Contact:
        • Principal Investigator:
          • Timothy Mixon, MD
        • Sub-Investigator:
          • Clint Malone, MD
        • Contact:
      • Waxahachie, Texas, United States, 75165
        • Recruiting
        • Baylor Scott & White The Heart Hospital - Waxahachie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Henry, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravascular Ultrasound (IVUS)
Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion.
Device: Intravascular Ultrasound (IVUS)
pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement
Active Comparator: Non-Intravascular Ultrasound (IVUS)
Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.
Device: Angiographic-guided Intervention
Standard angiography-guided intervention without IVUS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Patency
Time Frame: From enrollment to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: Collected from index procedure
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.
Collected from index procedure
Procedural Success
Time Frame: Collected from Index procedure
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.
Collected from Index procedure
Clinically driven-TLR (CD-TLR)
Time Frame: From enrollment to 12 months
Clinically driven-target limb revascularization. Information collected from the medical record.
From enrollment to 12 months
Amputation-free Survival
Time Frame: From enrollment to 12 months
Defined as no evidence of amputation. Information is collected from the medical record
From enrollment to 12 months
Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6))
Time Frame: From enrollment to 12 months
Vascular Quality of Life Questionnaire (VascuQoL-6) collected at index procedure and 12 months.
From enrollment to 12 months
Functional Status Improvement (Rutherford Class Improvement)
Time Frame: From enrollment to 12 months
Rutherford class determined by physician and collected from the medical record.
From enrollment to 12 months
Cost Effectiveness
Time Frame: Evaluated at 12 months
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.
Evaluated at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

Philips Healthcare

Investigators

  • Principal Investigator: Subhash Banerjee, MD, Baylor Scott & White Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 025-412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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