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HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study — HYBRID  

Subarachnoid Hemorrhage Clinical Trial

Official title:
Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01516658
Study type Interventional
Source Kobe City General Hospital
Contact
Status Completed
Phase N/A
Start date June 2012
Completion date June 2019
View Details
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