Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-02 @ 1:36 PM
Study NCT ID:
NCT03920358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
Sponsor:
Microvention-Terumo, Inc.
Organization:
Study Overview
Official Title:
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
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:
FRITS
Brief Summary:
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
Detailed Description:
This is a multi-center observational study. Treatment and follow-up visits will be performed as per standard of care. The purpose of this study is to demonstrate that use of the FRED/ FRED Jr/ FRED X Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure.
150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.
150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: