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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
431
at least one Hydrogel coil have to use for embolization
only bare platinum coil have to use for embolization
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
Kobe City General Hospital
Kobe, Hyōgo, Japan
recanalization within 1 year after embolization
Time frame: 1 year
aneurysmal rupture within 1 year after embolization
Time frame: 1 year
any event within 30 days after embolization
Time frame: 30 days
aneurysmal retreatment within 1 year after embolization
Time frame: 1 year
aneurysmal rupture and any death within 1 year after embolization
Time frame: 1 year
any stroke within 1 year after embolization
Time frame: 1 year
any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
Time frame: 1 year
change in aneurysmal occlusion
Time frame: 1 year
any complicaion within 1 year after embolization
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.