Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321575
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-14
Brief Title:
The Golazo Peripheral Atherectomy System for a Safe and Effective Atherectomy GREAT Trial
Sponsor:
Avantec Vascular
Organization:
Avantec Vascular
Study Overview
Official Title:
The Golazo Peripheral Atherectomy System for a Safe and Effective Atherectomy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GREAT
Brief 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 US
Detailed Description:
The investigation is a prospective multicenter non-randomized single-arm open-label pivotal clinical study Subjects will undergo atherectomy treatment with the Golazo Peripheral Atherectomy System and will then be followed 6-months post-procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None