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Procedure
Atherectomy System for Peripheral Arterial Disease (GREAT Trial)
N/A
Recruiting
Led By Matthew Finn, 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
Must not have
Active infection in the target limb
History of an endovascular procedure or open vascular surgery on the target limb, including proximal inflow vessels within the last 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an infection in the limb that needs treatment.
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I had surgery or a procedure on my limb's blood vessels within the last month.
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I am scheduled for surgery or a medical procedure within 30 days after the initial treatment.
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I cannot take blood thinners or clot-dissolving drugs due to health reasons.
Select...
I do not have bleeding disorders or a platelet count below 125,000.
Select...
My target lesion is in a graft.
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I have a blockage in my blood vessels that hasn't been fixed.
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My condition is severe leg pain at rest due to poor blood flow, classified as the most severe.
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I have severe kidney disease or am on dialysis.
Select...
I have not had clot-dissolving treatments in the last two weeks.
Select...
I have never had bleeding in my brain or stomach, or a brain aneurysm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Freedom from major adverse events (MAE)
Technical success
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
Bright Research PartnersIndustry Sponsor
17 Previous Clinical Trials
2,518 Total Patients Enrolled
Yale Cardiovascular Research GroupOTHER
10 Previous Clinical Trials
3,801 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
771 Patients Enrolled for Peripheral Arterial Disease
Avantec VascularLead Sponsor
Matthew Finn, MDPrincipal InvestigatorCardiovascular Institute of the South
Craig Walker, MDPrincipal InvestigatorCardiovascular Institute of the South
3 Previous Clinical Trials
554 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
549 Patients Enrolled for Peripheral Arterial Disease