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NCT06321575

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

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy
Avantec Vascular·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Peripheral Arterial Disease
Drug/Device/Intervention
Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Avantec Vascular
Location
Houma, United States of America
Timeline & enrollment
Phase
N/A
Start date
Apr 25, 2024
End date
Nov 01, 2026
Enrollment
159 participants
Primary outcome

Freedom from major adverse events (MAE),Technical success

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 15 investigational sites
 in the U.S.

ICD-10 classifications
Peripheral vascular disease, unspecifiedOther peripheral vascular diseasesOther specified peripheral vascular diseasesPeripheral angiopathy in diseases classified elsewhereOther congenital malformations of peripheral vascular system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06321575
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06321575 through Pure Global AI's free database. This phase not specified trial is sponsored by Avantec Vascular and is currently Recruiting. The study focuses on Peripheral Arterial Disease. Target enrollment is 159 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.