HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study (HYBRID)

Kobe City General Hospital

Status: Completed

Conditions: Subarachnoid Hemorrhage; Intracranial Aneurysm

Treatments: Device: Bare platinum coil; Device: Hydrogel coil

Study type: Interventional

Funder types: Other

Identifiers

NCT01516658

TRIBRAIN1119

UMIN000006748 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 431 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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431 participants in 2 patient groups

Hydrogel coil group

Experimental group

Description:

use Hydrogel Coil as much as be able to use

Treatment:

Device: Hydrogel coil

Bare platinum coil group

Active Comparator group

Description:

use only bare platinum coil

Treatment:

Device: Bare platinum coil