NCT01516658

HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Kobe City General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm
• Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DEVICE	Hydrogel coil	at least one Hydrogel coil have to use for embolization
DEVICE	Bare platinum coil	only bare platinum coil have to use for embolization

Timeline

• Start date: 2012-06-01
• Primary completion: 2018-03-01
• Completion: 2019-06-01
• First posted: 2012-01-25
• Last updated: 2019-10-16

Locations

2 sites across 1 country: Japan