Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05563051
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-09-28
Brief Title:
Kaneka Endovascular Embolization and Protection
Sponsor:
Kaneka Medical America LLC
Organization:
Kaneka Medical America LLC
Study Overview
Official Title:
Kaneka Endovascular Embolization and Protection
Status:
RECRUITING
Status Verified Date:
2024-03
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:
KEEP
Brief Summary:
Prospective multi-center non-randomized registry study up to 164 patients enrolled and followed at 180 days - 45 days and again at 365 days - 90 days post procedure
Detailed Description:
Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive devices
Study Duration
Anticipated timeline for study
Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled
Study Duration
Anticipated timeline for study
Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled
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?:
False
Is an FDA AA801 Violation?:
None