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

Primary Purpose

Intracranial Aneurysm, Subarachnoid Hemorrhage

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Hydrogel coil

Bare platinum coil

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring intracranial aneurysm, endovascular therapy, detachable coil, recanalization

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Nakamura Memorial Hospital
Kobe City General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrogel coil group

Bare platinum coil group

Arm Description

use Hydrogel Coil as much as be able to use

use only bare platinum coil

Outcomes

Primary Outcome Measures

recanalization within 1 year after embolization

Secondary Outcome Measures

aneurysmal rupture within 1 year after embolization

any event within 30 days after embolization

aneurysmal retreatment within 1 year after embolization

aneurysmal rupture and any death within 1 year after embolization

any stroke within 1 year after embolization

any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization

change in aneurysmal occlusion

any complicaion within 1 year after embolization

Full Information

NCT ID

NCT01516658

First Posted

November 29, 2011

Last Updated

October 14, 2019

Sponsor

Kobe City General Hospital

Collaborators

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

1. Study Identification

Unique Protocol Identification Number

NCT01516658

Brief Title

HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

Acronym

HYBRID

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 2012 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kobe City General Hospital

Collaborators

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: aneurysmal rupture within 1 year after embolization any event within 30 days after embolization recanalization within 6 months after embolization aneurysmal retreatment within 1 year after embolization aneurysmal rupture and any death within 1 year after embolization any stroke within 1 year after embolization any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization change in aneurysmal occlusion any comlicaion within 1 year after embolization %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysm, Subarachnoid Hemorrhage

Keywords

intracranial aneurysm, endovascular therapy, detachable coil, recanalization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

431 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrogel coil group

Arm Type

Experimental

Arm Description

use Hydrogel Coil as much as be able to use

Arm Title

Bare platinum coil group

Arm Type

Active Comparator

Arm Description

use only bare platinum coil

Intervention Type

Device

Intervention Name(s)

Hydrogel coil

Other Intervention Name(s)

Hydrocoil, HydroSoft, HydroFrame

Intervention Description

at least one Hydrogel coil have to use for embolization

Intervention Type

Device

Intervention Name(s)

Bare platinum coil

Other Intervention Name(s)

detachable coil, GDC, Microvention

Intervention Description

only bare platinum coil have to use for embolization

Primary Outcome Measure Information:

Title

recanalization within 1 year after embolization

Time Frame

1 year

Secondary Outcome Measure Information:

Title

aneurysmal rupture within 1 year after embolization

Time Frame

1 year

Title

any event within 30 days after embolization

Time Frame

30 days

Title

aneurysmal retreatment within 1 year after embolization

Time Frame

1 year

Title

aneurysmal rupture and any death within 1 year after embolization

Time Frame

1 year

Title

any stroke within 1 year after embolization

Time Frame

1 year

Title

any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization

Time Frame

1 year

Title

change in aneurysmal occlusion

Time Frame

1 year

Title

any complicaion within 1 year after embolization

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nobuyuki Sakai, MD, DMSc

Organizational Affiliation

Kobe City Medical Center General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nakamura Memorial Hospital

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

Kobe City General Hospital

City

Kobe

State/Province

Hyogo

Country

Japan

12. IPD Sharing Statement

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HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

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