350 Participants Needed

Intravascular Ultrasound for Peripheral Artery Disease

(INVIGOR Trial)

Recruiting at 5 trial locations
SH
SW
Overseen BySarah Weideman
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special type of ultrasound, called intravascular ultrasound (IVUS), can improve outcomes for people with peripheral artery disease (PAD) during leg artery treatment. Peripheral artery disease narrows the arteries in the legs, causing pain and difficulty walking. The study compares two groups: one receives the ultrasound treatment, and the other does not. It seeks patients with PAD symptoms and more than 50% artery narrowing, as shown on an angiogram, who are candidates for minimally invasive artery treatment. As an unphased trial, this study allows patients to contribute to innovative research that could enhance PAD treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that intravascular ultrasound is safe for peripheral artery disease treatment?

Research has shown that Intravascular Ultrasound (IVUS) is generally safe. One study found no major differences in safety outcomes, such as death or major bleeding, when comparing IVUS to other methods. Another large study demonstrated that IVUS improved long-term results for treating blood vessel problems in the legs. These findings suggest that IVUS is well-tolerated and beneficial in medical procedures. Overall, IVUS has been used safely and effectively in similar treatments, making it a promising option for patients considering joining a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about using Intravascular Ultrasound (IVUS) for treating Peripheral Artery Disease (PAD) because it offers a unique approach to visualizing and targeting artery blockages. Unlike traditional imaging techniques, IVUS provides real-time, detailed images from inside the blood vessels, potentially leading to more accurate and effective treatment decisions. This could result in better patient outcomes by precisely locating and assessing the severity of blockages, allowing for more tailored interventions.

What evidence suggests that intravascular ultrasound is effective for peripheral artery disease?

Research has shown that using intravascular ultrasound (IVUS) during treatments for peripheral artery disease (PAD) can lead to better outcomes. In this trial, one group of participants will receive treatment with IVUS, while another group will receive treatment without it. One study found that patients who had IVUS experienced a much lower rate of arteries narrowing again, at 22%, compared to 57% for those without IVUS. Another large study demonstrated a 32% reduction in major limb events, such as amputations, when IVUS was used. These findings suggest that IVUS improves the success of PAD treatments by providing clearer images inside the blood vessels.36789

Who Is on the Research Team?

SB

Subhash Banerjee, MD

Principal Investigator

Baylor Scott & White Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with symptomatic peripheral artery disease (PAD) in the leg, confirmed by angiography showing more than 50% blockage. It's not open to those who've had previous treatments on the affected area within six months or are participating in other PAD drug/device trials.

Inclusion Criteria

I am 18 years old or older.
I am a candidate for treatment involving the inside of my blood vessels.
I have leg pain due to a significant artery blockage.

Exclusion Criteria

I have not had any treatments on the target lesion in the last 6 months.
I am part of a trial for leg artery disease treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intravascular ultrasound (IVUS) guided Femoropopliteal (FP) endovascular intervention is performed on patients with symptomatic peripheral artery disease

1 day
1 visit (in-person)

Follow-up

Participants are monitored for primary patency and other outcomes, including technical and procedural success, from enrollment to 6 months

6 months
Multiple visits (in-person and virtual)

Extended Follow-up

Participants are monitored for clinically driven-target limb revascularization, amputation-free survival, and functional status improvement up to 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Intravascular Ultrasound (IVUS)

Trial Overview

The study is examining if using intravascular ultrasound (IVUS) guidance during minimally invasive procedures improves outcomes for patients with PAD compared to standard angiographic-guided interventions.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Intravascular Ultrasound (IVUS)Active Control1 Intervention
Group II: Non-Intravascular Ultrasound (IVUS)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+

Philips Healthcare

Industry Sponsor

Trials
127
Recruited
200,000+
Roy Jakobs profile image

Roy Jakobs

Philips Healthcare

Chief Executive Officer since 2022

Master's in Business Administration from Radboud University Nijmegen and Università degli Studi di Bologna

Dr. Roy Jakobs profile image

Dr. Roy Jakobs

Philips Healthcare

Chief Medical Officer

MD from McGill University

Citations

The Impact of Intravascular Ultrasound Use on 1-Year ...

At 1 year, cases with IVUS utilization had significantly lower rates of binary restenosis (22% vs 57%; P = .004) and substantially lower rates ...

Intravascular Ultrasound Use in Peripheral Arterial and ...

Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease ...

IVUS in Peripheral Endovascular Interventions: A ...

Observational and randomized data involving PCI have demonstrated that IVUS improves procedural and clinical outcomes, including reduction in ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40311752/

Use of Intravascular Ultrasound during Peripheral Vascular ...

The use of IVUS for the treatment of claudication is rapidly increasing, without clear benefits in outcomes. The role of IVUS in treating claudication ...

IVUS Improved Outcomes in Largest Real-world Analysis ...

Peripheral artery disease (PAD): a 32% reduction in major adverse limb events, including amputations, during lower extremity arterial interventions. The study ...

Twenty‐Four–Month Outcomes of Intravascular Ultrasound ...

There were no significant differences in safety outcomes between groups, including all‐cause death, cardiovascular death, and major bleeding.

Intravascular Ultrasound Use in Peripheral Arterial and ...

IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support ...

Short-and long-term clinical impact of intravascular ultrasound ...

IVUS usage for EVT did not improve MACCE or limb events over 2-years. However, IVUS usage improved procedural success rate and contributed less MALE when ...

Intravascular Ultrasound Use in Peripheral Arterial and ...

IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits.