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

February 9, 2026 updated by: Avantec Vascular

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • HonorHealth Scottsdale Osborn Medical Center
        • Principal Investigator:
          • Hasan Aldailami, MD
        • Contact:
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • Pulse Cardiovascular Institute
        • Principal Investigator:
          • Venkatesh Ramaiah, MD
        • Contact:
          • Anita Ramaiah, MD
          • Phone Number: 480-600-0600
    • California
      • Merced, California, United States, 95340
        • Recruiting
        • Merced Vascular
        • Principal Investigator:
          • Mani Nallasivan, MD
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
        • Recruiting
        • Palm Vascular Center
        • Principal Investigator:
          • Robert Beasley, MD
        • Contact:
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • First Coast Cardiovascular Institute
        • Principal Investigator:
          • Vaqar Ali, MD
        • Contact:
        • Sub-Investigator:
          • Yazan Khatib, MD
      • Lakeland, Florida, United States, 33801
        • Completed
        • Radiology and Imaging Specialists of Lakeland
      • Miami, Florida, United States, 33137
    • Georgia
      • Thomasville, Georgia, United States, 31792
        • Recruiting
        • Cardiovascular Consultants of South Georgia
        • Contact:
        • Contact:
          • Lauren Montgomery
          • Phone Number: 229-584-5575
        • Principal Investigator:
          • B. Clay Sizemore, MD
    • Hawaii
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Baton Rouge General Hospital
        • Contact:
          • Jamie Mooney
          • Phone Number: 225-237-1673
        • Contact:
          • Mary Hamilton
          • Phone Number: 225-237-1673
        • Principal Investigator:
          • Joseph Griffin, MD
      • Houma, Louisiana, United States, 70360
      • Lafayette, Louisiana, United States, 70506
        • Recruiting
        • Cardiovascular Institute of the South - Lafayette
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amit Amin, MD
    • Massachusetts
      • Plymouth, Massachusetts, United States, 02360
        • Recruiting
        • Vascular Breakthroughs
        • Contact:
          • Elizabeth Gagne
          • Phone Number: 203-548-7860
        • Contact:
          • Maria Myslinski
          • Phone Number: 203-548-7860
        • Principal Investigator:
          • Scott James, DO
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Recruiting
        • Advanced Heart and Vascular Institute
        • Contact:
          • Alexis Bellafiore
          • Phone Number: 908-237-3405
        • Contact:
          • Erin Squindo
          • Phone Number: 908-237-3405
        • Principal Investigator:
          • Andrey Espinoza, MD
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Regional Medical Center
        • Principal Investigator:
          • Brian Brown, MD
        • Contact:
        • Contact:
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Recruiting
        • Tennessee Center for Clinical Trials
        • Principal Investigator:
          • Dinesh Gupta, MD
    • Texas
      • Beaumont, Texas, United States, 77702
        • Recruiting
        • Nextstage Clinical Research - Beaumont
        • Principal Investigator:
          • Jorge Hernandez, MD
      • Houston, Texas, United States, 77054
        • Recruiting
        • Hope Vascular & Podiatry
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Montero-Backer, MD
      • Waco, Texas, United States, 76712
        • Recruiting
        • NextStage Clinical Research - Waco
        • Principal Investigator:
          • Donald S Cross, MD
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Bellin Health
        • Principal Investigator:
          • Jason Ricci, MD
        • Contact:
          • Katherine Guilliams
          • Phone Number: 920-617-2060
        • Contact:
          • Christen Piaskowski
          • Phone Number: 920-617-2060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

General 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

    Angiographic inclusion criteria:

  9. Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation
  10. Total treated lesion length ≤20 cm by angiographic visual estimation
  11. Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation
  12. 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

General 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)
  11. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy
  12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count <125,000/microliter, known coagulopathy, or international normalized ratio (INR) >1.5
  13. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated
  14. History of heparin-induced thrombocytopenia (HIT)
  15. Any thrombolytic therapy within two weeks of enrollment
  16. Target lesion(s) within a native vessel graft or synthetic graft
  17. Significant stenosis or occlusion of inflow not successfully treated before the index procedure
  18. Any evidence or history of intracranial or gastrointestinal bleeding or intracranial aneurysm
  19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

  20. One or more of the following complications of the foot:

    1. Osteomyelitis that extends to the metatarsal bones.
    2. Gangrene involving the plantar skin of the forefoot, midfoot or heel
    3. Deep ulcer or large shallow ulcer (>3cm) involving the plantar skin of the forefoot, midfoot, or heel
    4. Any heel ulcer with/without calcaneal involvement
    5. Any wound with calcaneal bone involvement
    6. Wounds that are deemed to be neuropathic or non-ischemic in nature
    7. Wounds that require flap coverage or complete wound management for large soft tissue defect

  21. Congestive heart failure with a NYHA functional classification of III or higher

    Angiographic exclusion criteria:

  22. More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single tandem lesion
  23. Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device
  24. In-stent restenosis within the target lesion(s)
  25. Potentially unstable or flow-limiting dissection, type C or greater
  26. Clinical/angiographic evidence of distal embolization
  27. Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Golazo® Peripheral Atherectomy System
Treatment atherectomy of the peripheral vasculature with the Golazo® Peripheral Atherectomy System.
Device: Golazo® 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from major adverse events (MAE)
Time Frame: Index procedure through 30-day follow-up

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
Time Frame: During surgery/procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success Rate
Time Frame: 30-day and 6-month follow-up
Defined as the proportion of subjects who have procedural success in all target lesions with at least one grade of improvement in the Rutherford clinical classification
30-day and 6-month follow-up
Rates of all adverse events classified as MAEs
Time Frame: 30-day and 6-month follow-up
As adjudicated by the CEC and presented by seriousness and causality (procedure and device relatedness)
30-day and 6-month follow-up
Change in % stenosis in target lesion after treatment with Golazo Peripheral AS
Time Frame: During surgery/procedure
Determined after atherectomy and prior to other adjunctive therapies
During surgery/procedure
Procedural Success Rate
Time Frame: End of surgery/procedure
Defined as the proportion of the target lesion in which the final stenosis is ≤30% after treatment with atherectomy and any other adjunctive therapy
End of surgery/procedure
Incidence of minor target limb amputation
Time Frame: 30-day and 6-month follow-up
As adjudicated by the CEC
30-day and 6-month follow-up
Incidence of myocardial infarction
Time Frame: 30-day and 6-month follow-up
As adjudicated by the CEC
30-day and 6-month follow-up
Incidence of target vessel revascularization (TVR) in the target limb
Time Frame: 30-day and 6-month follow-up
As adjudicated by the CEC
30-day and 6-month follow-up
Incidence of angiographic procedural distal embolization in the target limb
Time Frame: During surgery/procedure
As reported by the angiographic core laboratory
During surgery/procedure
Time to primary patency of the target lesion(s)
Time Frame: 6 months
Primary patency is the interval from the time of the index procedure until the time of any intervention designed to maintain or reestablish patency of the target vessels, the time significant stenosis or total occlusion is confirmed, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
6 months
Time to assisted primary patency of the target lesion(s)
Time Frame: 6 months
Assisted primary patency is the interval from the time of the index procedure until the time significant stenosis is confirmed, including interventions designed to maintain patency of a vessel with significant stenosis, the time total occlusion is confirmed, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
6 months
Time to secondary patency of the target lesion(s)
Time Frame: 6 months
Secondary patency is the interval from the time of the index procedure until the time total occlusion is confirmed in a target vessel, including interventions designed to reestablish patency in a total occluded vessel, or the time of measurement of patency. Determined by duplex ultrasound/doppler (DUS) or angiography.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avantec Vascular

Collaborators

Bright Research Partners
Yale Cardiovascular Research Group

Investigators

  • Principal Investigator: Matthew Finn, MD, Cardiovascular Institute of the South
  • Principal Investigator: Craig Walker, MD, Cardiovascular Institute of the South

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVA-CL-5000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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