HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

Not Applicable

Completed

• Conditions: Subarachnoid Hemorrhage; Intracranial Aneurysm
• Interventions: Device: Hydrogel coil; Device: Bare platinum coil

• Registration Number: NCT01516658
• Lead Sponsor: Kobe City General Hospital

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.

Study Timeline

• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Study Start: 2012-06
• Primary Completion: 2018-03
• Study Completion: 2019-06
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 431

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrogel coil group	Hydrogel coil	use Hydrogel Coil as much as be able to use
Bare platinum coil group	Bare platinum coil	use only bare platinum coil

Primary Outcome Measures

Name	Time	Method
recanalization within 1 year after embolization	1 year

Secondary Outcome Measures

Name	Time	Method
aneurysmal rupture and any death within 1 year after embolization	1 year
aneurysmal retreatment 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
aneurysmal rupture within 1 year after embolization	1 year
any event within 30 days after embolization	30 days
change in aneurysmal occlusion	1 year
any complicaion within 1 year after embolization	1 year

Trial Locations

Locations (2)

Nakamura Memorial Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Kobe City General Hospital; 🇯🇵 Kobe, Hyogo, Japan