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
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.
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.
;
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