Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-30 @ 7:13 AM
Study NCT ID:
NCT04663867
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)
Sponsor:
AngioSafe, Inc.
Organization:
Study Overview
Official Title:
Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTOR-1
Brief Summary:
The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.
Detailed Description:
The purpose of the study is to demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System. The system facilitates the crossing of chronic total occlusions (CTOs) in the peripheral arteries of lower limbs. A minimum of 70 subjects will be treated across selected study enters within the U.S. and followed for 30 days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: