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The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial) | Clinical Trials | Clareo Health

RECRUITINGNA

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

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy

NCT06321575•Avantec Vascular

View on ClinicalTrials.gov

Summary

The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.

Detailed Description

The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study. Subjects will undergo atherectomy treatment with the Golazo® Peripheral Atherectomy System and will then be followed 6-months post-procedure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years
•2. Candidate for atherectomy of the peripheral vasculature in the lower limbs
•3. Life expectancy \>1 year in the opinion of the investigator
•4. Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise. Subjects with non-compressible arteries shall have a toe brachial index (TBI) assessment.
•5. Target limb Rutherford clinical classification category 3 to 5
•6. Suitable candidate for angiography and endovascular intervention in the opinion of the investigator
•7. Willing and able to comply with the protocol-specified procedures and assessments
•8. Informed consent granted
•9. Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation
•10. Total treated lesion length ≤20 cm by angiographic visual estimation
+2 more criteria

Exclusion Criteria

•1. Active infection in the target limb
•2. History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days
•3. Planned surgical or interventional procedure within 30 days after the index procedure
•4. Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days
•5. Critical limb ischemia (CLI) with Rutherford clinical classification category 6
•6. Significant acute or chronic kidney disease with a GFR \<30 and/or requiring dialysis
•7. Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator
•8. Myocardial infarction (MI) or stroke within two months of baseline evaluation
•9. Pregnant or lactating
•10. Subject is participating in another clinical investigation of a device, drug, or procedure that has not completed the study treatment or that clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)
+24 more criteria

Locations (20)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

Pulse Cardiovascular Institute

Scottsdale, Arizona, United States

Merced Vascular

Merced, California, United States

Palm Vascular Center

Fort Lauderdale, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, United States

Amavita Research Services

Miami, Florida, United States

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, United States

Pacific Vascular Institute

‘Aiea, Hawaii, United States

Baton Rouge General Hospital

Baton Rouge, Louisiana, United States

Key Dates

Start Date

June 20, 2024

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

February 10, 2026

Enrollment

159

ESTIMATED participants

Conditions

Peripheral Arterial Disease

Interventions

Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)

DEVICE

Contacts

Gene Reu

CONTACT

858-945-0007 GReu@avantecvascular.com

Jessi Maumee

CONTACT

612-345-4544 jessi.maumee@brightresearch.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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