Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01516658
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2011-11-29
Brief Title:
HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
Sponsor:
Kobe City General Hospital
Organization:
Kobe City General Hospital
Study Overview
Official Title:
Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms Multi-center Prospective Randomized Open-label Blind-endpoint Trial
Status:
COMPLETED
Status Verified Date:
2019-10
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:
HYBRID
Brief Summary:
HYBRID study is prospective randomized open label controlled multi center trial to compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms
Detailed Description:
At least one Hydrocoil have to use in Hydrocoil arm and only bare platinum coil have to use in Control arm
Primary endpoint is recanalization within 1 year after embolization and secondary endpoint are
1 aneurysmal rupture within 1 year after embolization
2 any event within 30 days after embolization
3 recanalization within 6 months after embolization
4 aneurysmal retreatment within 1 year after embolization
5 aneurysmal rupture and any death within 1 year after embolization
6 any stroke within 1 year after embolization
7 any stroke death hemorrhagic event aneurysmal recanalization or retreatment within 1 year after embolization
8 change in aneurysmal occlusion
9 any comlicaion within 1 year after embolization
10 length of Hydrocoil maximum diameter of aneurysm volume embolization ratio
Primary endpoint is recanalization within 1 year after embolization and secondary endpoint are
1 aneurysmal rupture within 1 year after embolization
2 any event within 30 days after embolization
3 recanalization within 6 months after embolization
4 aneurysmal retreatment within 1 year after embolization
5 aneurysmal rupture and any death within 1 year after embolization
6 any stroke within 1 year after embolization
7 any stroke death hemorrhagic event aneurysmal recanalization or retreatment within 1 year after embolization
8 change in aneurysmal occlusion
9 any comlicaion within 1 year after embolization
10 length of Hydrocoil maximum diameter of aneurysm volume embolization ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMIN000006748 | OTHER | UMIN Japan | None |