RecruitingNot ApplicableNCT06321575

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

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


Sponsor

Avantec Vascular

Enrollment

159 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) for people with peripheral arterial disease. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGolazo® Peripheral Atherectomy System (Golazo® Peripheral AS)

Golazo® Peripheral AS is a sterile, single-use percutaneous device that has two main components: 1) the Golazo® Accustrike atherectomy catheter, and 2) the Golazo® motorized drive unit (MDU) and is intended for use in atherectomy of the peripheral vasculature.


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

Cardiovascular Institute of the South - Houma

Houma, Louisiana, United States

Cardiovascular Institute of the South - Lafayette

Lafayette, Louisiana, United States

Vascular Breakthroughs

Plymouth, Massachusetts, United States

Advanced Heart and Vascular Institute

Flemington, New Jersey, United States

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

Nextstage Clinical Research - Beaumont

Beaumont, Texas, United States

Hope Vascular & Podiatry

Houston, Texas, United States

Nextstage Clinical Research - Waco

Waco, Texas, United States

Bellin Health

Green Bay, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06321575


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