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

NCT06321575 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2026-02-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Avantec Vascular

    lead INDUSTRY

Principal Investigators

  • Matthew Finn, MD · Cardiovascular Institute of the South

  • Craig Walker, MD · Cardiovascular Institute of the South

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06321575 on ClinicalTrials.gov