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

NCT06321575 | Recruiting DMC FDA Device

• 1 other identifier: AVA-CL-5000
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Symptomatic Infrainguinal Peripheral Arterial Disease; Endovascular Intervention

Outcome Measures

Primary Outcomes (2)

• Freedom from major adverse events (MAE)

  MAE is defined as: * Clinically-driven target lesion revascularization (CD-TLR) * Cardiovascular-related deaths * Unplanned major target limb amputation (above the ankle) * Perforations or dissections grade C or greater in the target vessel that require intervention * Symptomatic distal emboli requiring intervention * Pseudoaneurysm requiring intervention

  Index procedure through 30-day follow-up

• Technical success

  Defined as the percent of target lesions that have a residual diameter stenosis ≤50% after atherectomy with the Golazo Peripheral AS and prior to adjunctive therapy

  During surgery/procedure

Secondary Outcomes (11)

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

  During surgery/procedure

• Procedural Success Rate

  End of surgery/procedure

• Clinical Success Rate

  30-day and 6-month follow-up

• Rates of all adverse events classified as MAEs

  30-day and 6-month follow-up

• Incidence of minor target limb amputation

  30-day and 6-month follow-up

Study Arms (1)

Golazo® Peripheral Atherectomy System

EXPERIMENTAL

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

Device: Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)

Interventions

Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) DEVICE

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.

Golazo® Peripheral Atherectomy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Candidate for atherectomy of the peripheral vasculature in the lower limbs
• Life expectancy \>1 year in the opinion of the investigator
• 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.
• Target limb Rutherford clinical classification category 3 to 5
• Suitable candidate for angiography and endovascular intervention in the opinion of the investigator
• Willing and able to comply with the protocol-specified procedures and assessments
• Informed consent granted
• Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation
• Total treated lesion length ≤20 cm by angiographic visual estimation
• Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation
• Target limb will have a minimum of one patent (less than 50% stenosis) below the knee (BTK) vessel crossing the ankle, distal to any target lesion, providing perfusion to the foot at baseline

You may not qualify if:

• Active infection in the target limb
• History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days
• Planned surgical or interventional procedure within 30 days after the index procedure
• Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days
• Critical limb ischemia (CLI) with Rutherford clinical classification category 6
• Significant acute or chronic kidney disease with a GFR \<30 and/or requiring dialysis
• Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator
• Myocardial infarction (MI) or stroke within two months of baseline evaluation
• Pregnant or lactating
• 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)
• Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \<125,000/microliter, known coagulopathy, or international normalized ratio (INR) \>1.5
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated
• History of heparin-induced thrombocytopenia (HIT)
• Any thrombolytic therapy within two weeks of enrollment

Sponsors & Collaborators

• Avantec Vascular: lead
• Bright Research Partners: collaborator
• Yale Cardiovascular Research Group: collaborator

Study Sites (20)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251, United States

RECRUITING

Pulse Cardiovascular Institute

Scottsdale, Arizona, 85251, United States

RECRUITING

Merced Vascular

Merced, California, 95340, United States

RECRUITING

Palm Vascular Center

Fort Lauderdale, Florida, 33312, United States

RECRUITING

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

RECRUITING

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, 33801, United States

COMPLETED

Amavita Research Services

Miami, Florida, 33137, United States

RECRUITING

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, 31792, United States

RECRUITING

Pacific Vascular Institute

‘Aiea, Hawaii, 96701, United States

RECRUITING

Baton Rouge General Hospital

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Cardiovascular Institute of the South - Houma

Houma, Louisiana, 70360, United States

RECRUITING

Cardiovascular Institute of the South - Lafayette

Lafayette, Louisiana, 70506, United States

RECRUITING

Vascular Breakthroughs

Plymouth, Massachusetts, 02360, United States

RECRUITING

Advanced Heart and Vascular Institute

Flemington, New Jersey, 08822, United States

RECRUITING

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, 37388, United States

RECRUITING

Nextstage Clinical Research - Beaumont

Beaumont, Texas, 77702, United States

RECRUITING

Hope Vascular & Podiatry

Houston, Texas, 77054, United States

RECRUITING

Nextstage Clinical Research - Waco

Waco, Texas, 76712, United States

RECRUITING

Bellin Health

Green Bay, Wisconsin, 54301, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Matthew Finn, MD

  Cardiovascular Institute of the South

  PRINCIPAL INVESTIGATOR

• Craig Walker, MD

  Cardiovascular Institute of the South

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gene Reu

CONTACT

858-945-0007; GReu@avantecvascular.com

Jessi Maumee

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)