Intracranial Aneurysm, Subarachnoid Hemorrhage
Conditions
Keywords
intracranial aneurysm, endovascular therapy, detachable coil, recanalization
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.
Interventions
DEVICEHydrogel coil
at least one Hydrogel coil have to use for embolization
DEVICEBare platinum coil
only bare platinum coil have to use for embolization
Sponsors
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* saccular intracranial aneurysm * endovascular treatment scheduled within 60days after consent * 20-79 years old * unruptured, chronic SAH or acurte SAH Grade 1-III * 7-20mm in size * 1 year follow up possibel * independent (mRS 0-2) * document consent
Exclusion criteria
* previous endovascular treated * additional aneurysm scheduled of endovascular treatment * pregnant * ineligible for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recanalization within 1 year after embolization | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| any event within 30 days after embolization | 30 days |
| aneurysmal retreatment within 1 year after embolization | 1 year |
| aneurysmal rupture and any death within 1 year after embolization | 1 year |
| aneurysmal rupture within 1 year after embolization | 1 year |
| any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization | 1 year |
| change in aneurysmal occlusion | 1 year |
| any complicaion within 1 year after embolization | 1 year |
| any stroke within 1 year after embolization | 1 year |
Countries
Japan
Outcome results
None listed