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The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
NCT06321575 · View on ClinicalTrials.gov ↗
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
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avantec Vascular, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06321575 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Louisiana, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06321575?
The interventions under investigation include: Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06321575?
This trial is sponsored by Avantec Vascular, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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