Status:
COMPLETED
HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
Lead Sponsor:
Kobe City General Hospital
Collaborating Sponsors:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Conditions:
Intracranial Aneurysm
Subarachnoid Hemorrhage
Eligibility:
All Genders
20-79 years
Phase:
NA
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 endpoin...
Eligibility Criteria
Inclusion
- 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
- previous endovascular treated
- additional aneurysm scheduled of endovascular treatment
- pregnant
- ineligible for study
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT01516658
Start Date
June 1 2012
End Date
June 1 2019
Last Update
October 16 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
2
Kobe City General Hospital
Kobe, Hyōgo, Japan