HYdrogel Coil Versus Bare Platinum Coil in Recanalization... | NCT01516658

Studies
HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

NCT01516658

Sponsor

Kobe City General Hospital

Status

Completed

Last Update Posted

Oct 16, 2019Actual

Enrollment

431Actual

Phase

Not Applicable

Conditions

Intracranial Aneurysm
Subarachnoid Hemorrhage

Interventions

Hydrogel coil
Bare platinum coil

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UMIN000006748	Other Identifier	UMIN Japan

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Jun 2019Actual

First Submitted Date

Nov 29, 2011

First Submission Date that Met QC Criteria

Jan 24, 2012

First Posted Date

Jan 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2019

Last Update Posted Date

Oct 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nobuyuki Sakai, Director of Neurosurgery, Kobe City General HospitalPrincipal Investigator

Lead Sponsor

Kobe City General HospitalOTHER

Collaborators

Name	Class
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

431Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hydrogel coil	Device	at least one Hydrogel coil have to use for embolization	Hydrogel coil group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recanalization within 1 year after embolization		1 year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nobuyuki Sakai, MD, DMSc	Kobe City Medical Center General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nakamura Memorial Hospital		Sapporo	Hokkaido		Japan
Kobe City General Hospital

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm
D013345	Subarachnoid Hemorrhage

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided