Trials Sponsors Conditions Drugs Pricing

Conditions

Intracranial Aneurysm Subarachnoid Hemorrhage

Keywords

intracranial aneurysmendovascular therapydetachable coilrecanalization

Outcome Measures

Primary Outcomes (1)

recanalization within 1 year after embolization
1 year

Secondary Outcomes (8)

aneurysmal rupture within 1 year after embolization
1 year
any event within 30 days after embolization
30 days
aneurysmal retreatment within 1 year after embolization
1 year
aneurysmal rupture and any death within 1 year after embolization
1 year
any stroke within 1 year after embolization
1 year
+3 more secondary outcomes

Study Arms (2)

Hydrogel coil group

EXPERIMENTAL

use Hydrogel Coil as much as be able to use

Device: Hydrogel coil

Bare platinum coil group

ACTIVE COMPARATOR

use only bare platinum coil

Device: Bare platinum coil

Interventions

Hydrogel coilDevice

at least one Hydrogel coil have to use for embolization

Also known as: Hydrocoil, HydroSoft, HydroFrame

Hydrogel coil group

Bare platinum coilDevice

only bare platinum coil have to use for embolization

Also known as: detachable coil, GDC, Microvention

Eligibility Criteria

Age20 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

saccular intracranial aneurysm
endovascular treatment scheduled within 60days after consent

Sponsors & Collaborators

Kobe City General Hospital
Otherlead
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Othercollaborator

Study Sites (2)

Nakamura Memorial Hospital

Sapporo, Hokkaido, Japan

Kobe City General Hospital

Kobe, Hyōgo, Japan

MeSH Terms

Conditions

Intracranial AneurysmSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Nobuyuki Sakai, MD, DMSc
Kobe City Medical Center General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

431 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of Neurosurgery

Study Record Dates

First Submitted

November 29, 2011

First Posted

January 25, 2012

Study Start

June 2012

Actual (reported)

HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Hydrogel coil group

Bare platinum coil group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Hydrogel coil group

Bare platinum coil group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations