HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

Study Overview
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Brief Summary
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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
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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: aneurysmal rupture within 1 year after embolization any event within 30 days after embolization recanalization within 6 months after embolization aneurysmal retreatment within 1 year after embolization aneurysmal rupture and any death within 1 year after embolization any stroke within 1 year after embolization any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization change in aneurysmal occlusion any comlicaion within 1 year after embolization %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.

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

Conditions
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Intracranial Aneurysm, Subarachnoid Hemorrhage

Intervention / Treatment
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* Device: Hydrogel coil
* Device: Bare platinum coil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogel coil group<br>use Hydrogel Coil as much as be able to use | Device: Hydrogel coil<br>* at least one Hydrogel coil have to use for embolization<br>* Other names: HydroFrame;|
| Active Comparator: Bare platinum coil group<br>use only bare platinum coil | Device: Bare platinum coil<br>* only bare platinum coil have to use for embolization<br>* Other names: Microvention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recanalization within 1 year after embolization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aneurysmal rupture within 1 year after embolization |  | 1 year | 
| 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 | 
| any stroke 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial aneurysm, endovascular therapy, detachable coil, recanalization