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NCT06321575 · ClinicalTrials.gov registry record · NA

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

A NA study of Peripheral Arterial Disease, sponsored by Avantec Vascular.

Recruiting
Registry status
NA
Development phase
159
Enrollment target
20
Study locations

NCT06321575 is a NA study of Peripheral Arterial Disease that is actively recruiting participants, run by Avantec Vascular. The registered enrollment target is 159 participants, below the 4,204-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT06321575, a NA study of Peripheral Arterial Disease, is actively recruiting participants, sponsored by Avantec Vascular.

RECRUITING
Registry status
NA
Development phase
159 participants
Enrollment target
20
Study locations

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 Studied

Peripheral Arterial Disease

Interventions

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

Study Locations (20)

Florida

  • Palm Vascular Center - Fort Lauderdale
  • First Coast Cardiovascular Institute - Jacksonville
  • Radiology and Imaging Specialists of Lakeland - Lakeland
  • Amavita Research Services - Miami

Louisiana

  • Baton Rouge General Hospital - Baton Rouge
  • Cardiovascular Institute of the South - Houma - Houma
  • Cardiovascular Institute of the South - Lafayette - Lafayette

Texas

  • Nextstage Clinical Research - Beaumont - Beaumont
  • Hope Vascular & Podiatry - Houston
  • Nextstage Clinical Research - Waco - Waco

Arizona

  • HonorHealth Scottsdale Osborn Medical Center - Scottsdale
  • Pulse Cardiovascular Institute - Scottsdale

California

  • Merced Vascular - Merced

Georgia

  • Cardiovascular Consultants of South Georgia - Thomasville

Hawaii

  • Pacific Vascular Institute - ‘Aiea

Massachusetts

  • Vascular Breakthroughs - Plymouth

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2024-06-20
Est. Completion 2026-11
Phase NA

Sponsor

Avantec Vascular

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06321575

The ClinicalTrials.gov registry entry for NCT06321575 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,204-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (96% lower). The listed sponsor is Avantec Vascular, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) is the first listed.

NCT06321575 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Louisiana, Texas.

Frequently Asked Questions

What is clinical trial NCT06321575 about?

NCT06321575 is a clinical study titled "The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)". 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.

What is the current status of trial NCT06321575?

This trial is currently recruiting. It is a NA study. The enrollment target is 159 participants. The study started on 2024-06-20. Estimated completion is 2026-11.

What conditions does trial NCT06321575 study?

This clinical trial studies the following conditions: Peripheral Arterial Disease.

What interventions are being tested in trial NCT06321575?

The interventions under investigation include: Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) (DEVICE).

Who is sponsoring clinical trial NCT06321575?

This trial is sponsored by Avantec Vascular, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06321575 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.