HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

Subarachnoid Hemorrhage Clinical Trial

— HYBRID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516658
• Other study ID #: TRIBRAIN1119
• Secondary ID: UMIN000006748
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: June 2019

Study information

• Verified date: October 2019
• Source: Kobe City General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: June 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Intracranial Aneurysm
• Subarachnoid Hemorrhage

Intervention

Device:
• Hydrogel coil
at least one Hydrogel coil have to use for embolization
• Bare platinum coil
only bare platinum coil have to use for embolization

Locations

Country	Name	City	State
Japan	Kobe City General Hospital	Kobe	Hyogo
Japan	Nakamura Memorial Hospital	Sapporo	Hokkaido

Sponsors (2)

Lead Sponsor	Collaborator
Kobe City General Hospital	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recanalization within 1 year after embolization		1 year
Secondary	aneurysmal rupture within 1 year after embolization		1 year
Secondary	any event within 30 days after embolization		30 days
Secondary	aneurysmal retreatment within 1 year after embolization		1 year
Secondary	aneurysmal rupture and any death within 1 year after embolization		1 year
Secondary	any stroke within 1 year after embolization		1 year
Secondary	any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization		1 year
Secondary	change in aneurysmal occlusion		1 year
Secondary	any complicaion within 1 year after embolization		1 year