Intravascular Ultrasound for Peripheral Artery Disease

(INVIGOR Trial)

Recruiting at 5 trial locations

Overseen By Sarah Weideman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Prior intervention, Enrolled in trial

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Subhash Banerjee, MD

Principal Investigator

Baylor Scott & White Research Institute

Are You a Good Fit for This Trial?

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)

How Is the Trial Designed?

Group I: Intravascular Ultrasound (IVUS) Active Control 1 Intervention

Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion.

Group II: Non-Intravascular Ultrasound (IVUS) Active Control 1 Intervention

Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.

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

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

Philips Healthcare

Chief Medical Officer

MD from McGill University