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Golazo® Peripheral Atherectomy System for Peripheral Arterial Disease (GREAT Trial)

N/A

Recruiting

Led By Craig Walker, MD

Research Sponsored by Avantec Vascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Candidate for atherectomy of the peripheral vasculature in the lower limbs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

GREAT Trial Summary

This trial aims to determine if the Golazo® Peripheral Atherectomy System is safe and effective for treating peripheral arterial disease in 159 patients across 15 sites in the U.S.

Who is the study for?

This trial is for adults over 18 with symptomatic peripheral arterial disease affecting the legs. Participants must have a specific range of artery narrowing and be able to undergo an atherectomy, which is a procedure to remove plaque from arteries. They should not have had previous treatments that would affect the study's outcome.Check my eligibility

What is being tested?

The Golazo® Peripheral Atherectomy System is being tested in patients with narrowed leg arteries due to plaque buildup. The goal is to see if this system can safely and effectively clear these blockages in up to 159 subjects across multiple U.S. sites.See study design

What are the potential side effects?

While not explicitly stated, side effects may include discomfort at the site of intervention, bleeding, risk of infection, potential damage to blood vessels or surrounding tissues during the procedure.

GREAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a candidate for a procedure to remove plaque from my leg arteries.

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My blood vessel blockage is severe but treatable, and I have good blood flow in at least one leg artery.

GREAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom from major adverse events (MAE)

Technical success

Secondary outcome measures

Change in % stenosis in target lesion after treatment with Golazo Peripheral AS

Clinical Success Rate

Incidence of angiographic procedural distal embolization in the target limb

+8 more

GREAT Trial Design

1Treatment groups

Experimental Treatment

Group I: Golazo® Peripheral Atherectomy SystemExperimental Treatment1 Intervention

Treatment atherectomy of the peripheral vasculature with the Golazo® Peripheral Atherectomy System.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bright Research PartnersIndustry Sponsor

13 Previous Clinical Trials

1,595 Total Patients Enrolled

Yale Cardiovascular Research GroupOTHER

7 Previous Clinical Trials

2,767 Total Patients Enrolled

1 Trials studying Peripheral Arterial Disease

271 Patients Enrolled for Peripheral Arterial Disease

Avantec VascularLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for patients to participate in this ongoing clinical trial?

"Indeed, as per the details available on clinicaltrials.gov, this research endeavor is actively seeking individuals to partake. Initially made public on April 25th, 2024 and subsequently revised on April 30th, 2024, it aims to enroll a total of 159 patients from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

2024. "The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06321575.

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