Clinical trial NCT01516658: HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
Official title: Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Subarachnoid Hemorrhage
Keywords: intracranial aneurysm
endovascular therapy
detachable coil
recanalization
Lead sponsor: Kobe City General Hospital
Sponsor class: OTHER
Collaborators: name: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
First posted: 2012-01-25
Enrollment: 431
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: recanalization within 1 year after embolization
timeFrame: 1 year
Secondary outcomes:
measure: aneurysmal rupture within 1 year after embolization
timeFrame: 1 year
measure: any event within 30 days after embolization
timeFrame: 30 days
measure: aneurysmal retreatment within 1 year after embolization
timeFrame: 1 year
measure: aneurysmal rupture and any death within 1 year after embolization
timeFrame: 1 year
measure: any stroke within 1 year after embolization
timeFrame: 1 year
measure: any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
timeFrame: 1 year
measure: change in aneurysmal occlusion
timeFrame: 1 year
measure: any complicaion within 1 year after embolization
timeFrame: 1 year
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City General Hospital
state: Hyogo
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Nobuyuki Sakai, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: