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NCT Number: NCT07353905

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Lower Extremity Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White The Heart Hospital - Dallas, Dallas, Texas, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. Clinically driven-TLR (CD-TLR)

    Time frame: From enrollment to 12 months

    Clinically driven-target limb revascularization. Information collected from the medical record.

  4. Amputation-free Survival

    Time frame: From enrollment to 12 months

    Defined as no evidence of amputation. Information is collected from the medical record

  5. 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.

  6. Functional Status Improvement (Rutherford Class Improvement)

    Time frame: From enrollment to 12 months

    Rutherford class determined by physician and collected from the medical record.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Hale

CONTACT

[email protected]

469-814-4845

Sarah Weideman

CONTACT

[email protected]

214-820-2927

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Philips Healthcare

Registry information

Acronym: INVIGOR

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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