HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
NCT ID: NCT01516658
Last Updated: 2019-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
431 participants
INTERVENTIONAL
2012-06-30
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hydrogel coil group
use Hydrogel Coil as much as be able to use
Hydrogel coil
at least one Hydrogel coil have to use for embolization
Bare platinum coil group
use only bare platinum coil
Bare platinum coil
only bare platinum coil have to use for embolization
Interventions
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Hydrogel coil
at least one Hydrogel coil have to use for embolization
Bare platinum coil
only bare platinum coil have to use for embolization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* additional aneurysm scheduled of endovascular treatment
* pregnant
* ineligible for study
20 Years
79 Years
ALL
No
Sponsors
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Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
OTHER
Kobe City General Hospital
OTHER
Responsible Party
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Nobuyuki Sakai
Director of Neurosurgery
Principal Investigators
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Nobuyuki Sakai, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Kobe City Medical Center General Hospital
Locations
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Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
Kobe City General Hospital
Kobe, Hyōgo, Japan
Countries
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Other Identifiers
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UMIN000006748
Identifier Type: OTHER
Identifier Source: secondary_id
TRIBRAIN1119
Identifier Type: -
Identifier Source: org_study_id
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