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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: Recruiting NA study of Peripheral Arterial Disease, sponsored by Avantec Vascular.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2024-06-20 |
| Est. Completion | 2026-11 |
| Phase | NA |
What NCT06321575 shows while recruiting
NCT06321575 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 4,204-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (96% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Where NCT06321575's enrollment target sits among peer trials
159 30th of 79 higher than 50 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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