Peripheral Arterial DiseaseINVIGORNCT07353905

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

A study testing Intravascular Ultrasound (IVUS) and Angiographic-guided Intervention in people with Peripheral Arterial Disease and Lower Extremity Arterial Disease, run by Baylor Research Institute at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease, Lower Extremity Arterial Disease
What is being tested?: Intravascular Ultrasound (IVUS) and Angiographic-guided Intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 6 sitesUnited States
Study dates: 12 Dec 2025to Jul 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

Prior intervention at the target lesion within 6 months
Target lesion is abdominal aorta or inframalleolar BTK arteries

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sarah Hale contact

469-814-4845

sarah.hale@bswhealth.org

Sarah Weideman contact

214-820-2927

sarah.weideman@bswhealth.org

City, postcode or hospital

Sites recruiting now only

6 sites in 1 country

United States6 sites, 6 recruiting

Baylor Scott & White The Heart Hospital - Dallas
Dallas, Texas, 75226
Sarah Hale, 469-814-4845, sarah.hale@bswhealth.org
Sarah Weideman, 214-820-2927, sarah.weideman@bswhealth.org
Recruiting
Baylor Scott & White The Heart Hospital - Fort Worth
Fort Worth, Texas, 76104
Theresa Cheyne, 817-922-2579, Theresa.Cheyne@BSWHealth.org
Mohammad Alqaim, MD
Not yet recruiting
Baylor Scott & White The Heart Hospital - Mckinney
McKinney, Texas, 75071
Denise Espinoza, (469) 814-4783, Denise.Espinoza@BSWHealth.org
Erisa Stokes, BS, erisa.stokes@bswhealth.org
Recruiting
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Osniel Gonzalez Ramos, BS, 469-814-4862, osniel.gonzalezramos@bswhealth.org
Erisa Stokes, BS, 469-814-4819, erisa.stokes@bswhealth.org
Recruiting
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
Margarite Grable, 254-724-5861, Margarite.Grable@BSWHealth.org
Christian Wintz, christian.wintz@bswhealth.org
Not yet recruiting
Baylor Scott & White The Heart Hospital - Waxahachie
Waxahachie, Texas, 75165
Sarah Hale, 469-814-4845, sarah.hale@bswhealth.org
Sarah Weideman, 214-820-2927, sarah.weideman@bswhealth.org
Recruiting

Other trials in United States

About this study

Read the 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).

Conditions: Peripheral Arterial Disease, Lower Extremity Arterial Disease
Being tested: Intravascular Ultrasound (IVUS), Angiographic-guided Intervention
Keywords: Intravascular Ultrasound, Angioplasty, Endovascular Treatment
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07353905
Study group	Role	What they receive
Intravascular Ultrasound (IVUS)	Active comparator	Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion. Receives: Device: Intravascular Ultrasound (IVUS)
Non-Intravascular Ultrasound (IVUS)	Active comparator	Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion. Receives: Device: Angiographic-guided Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: From enrollment to 6 months

Secondary outcomes (7)

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.
Measured: 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.
Measured: Collected from Index procedure
Clinically driven-TLR (CD-TLR)
Clinically driven-target limb revascularization. Information collected from the medical record.
Measured: From enrollment to 12 months
Amputation-free Survival
Defined as no evidence of amputation. Information is collected from the medical record
Measured: 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.
Measured: From enrollment to 12 months
Functional Status Improvement (Rutherford Class Improvement)
Rutherford class determined by physician and collected from the medical record.
Measured: 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.
Measured: Evaluated at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 2025Jul 2028

First posted21 Jan 2026
Study start12 Dec 2025
Primary completionJan 2028 (estimated)
Study completionJul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
More trials run by Baylor Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective randomized controlled study.
Masking: Single blind
Who is masked: Participant
Enrolment: 350 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07353905
Sponsor's protocol ID: 025-412
Acronym: INVIGOR
Status last verified: Jan 2026
First submitted: 9 Dec 2025
Last updated: 9 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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.

Publications

PASS 2025 Power Analysis and Sample Size Software (2025). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
Divakaran 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.
PubMed 36265940
Rymer 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.
PubMed 37071719
Shin 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.
PubMed 40792582
Allan 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.
PubMed 35272779
Meng 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.
PubMed 37688486
Jang 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.
PubMed 39674438
Lee 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.
PubMed 39846915
Soney 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.
PubMed 37210800

Interested in taking part?

Sarah Hale

469-814-4845

sarah.hale@bswhealth.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
ClinicalTrials.gov ID: NCT07353905
Acronym / sponsor ID: INVIGOR / 025-412
Conditions: Peripheral Arterial Disease, Lower Extremity Arterial Disease
Keywords: Intravascular Ultrasound, Angioplasty, Endovascular Treatment
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 350 participants (estimated)
Lead sponsor: Baylor Research InstituteUniversity, hospital or other
Collaborators: Philips Healthcare
Study start: 12 Dec 2025 (actual)
Primary completion: Jan 2028 (estimated)
Study completion: Jul 2028 (estimated)
First posted: 21 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Prospective randomized controlled study.

Arm	Type	Receives
Intravascular Ultrasound (IVUS)	Active comparator	Device: Intravascular Ultrasound (IVUS)Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion.
Non-Intravascular Ultrasound (IVUS)	Active comparator	Device: Angiographic-guided InterventionIntravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (2 listed)

Prior intervention at the target lesion within 6 months
Target lesion is abdominal aorta or inframalleolar BTK arteries

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravascular Ultrasound (IVUS)pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement	Device	Intravascular Ultrasound (IVUS)
Angiographic-guided InterventionStandard angiography-guided intervention without IVUS.	Device	Non-Intravascular Ultrasound (IVUS)

Primary outcome

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).

7 secondary outcomes

Technical Success
Time frame: Collected from index procedure
Procedural Success
Time frame: Collected from Index procedure
Clinically driven-TLR (CD-TLR)
Time frame: From enrollment to 12 months
Amputation-free Survival
Time frame: From enrollment to 12 months
Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6))
Time frame: From enrollment to 12 months
Functional Status Improvement (Rutherford Class Improvement)
Time frame: From enrollment to 12 months
Cost Effectiveness
Time frame: Evaluated at 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
BackgroundPASS 2025 Power Analysis and Sample Size Software (2025). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
Background: PubMed 36265940Divakaran 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.
Background: PubMed 37071719Rymer 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.
Background: PubMed 40792582Shin 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.
Background: PubMed 35272779Allan 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.
Background: PubMed 37688486Meng 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.
Background: PubMed 39674438Jang 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.
Background: PubMed 39846915Lee 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.
Background: PubMed 37210800Soney 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.
Individual participant dataSharing planned: 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.

Related trials for Peripheral Arterial Disease

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Sarah Hale contact

469-814-4845

sarah.hale@bswhealth.org

Sarah Weideman contact

214-820-2927

sarah.weideman@bswhealth.org

Subhash Banerjee, MD principal investigator

Baylor Scott & White Research Institute

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Hale (469-814-4845, sarah.hale@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Patency (time frame: From enrollment to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07353905, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.