Efficacy and Safety of StENt-assisted Treatment for CEreb... | NCT01702584

Studies
Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

NCT01702584

Sponsor

Kobe City General Hospital

Status

Unknown status

Last Update Posted

Sep 9, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Stent Embolisation

Interventions

stent assisted embolization

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
UMIN000010405	Other Identifier	UMIN Japan

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2021Estimated

First Submitted Date

Sep 5, 2012

First Submission Date that Met QC Criteria

Oct 4, 2012

First Posted Date

Oct 8, 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

Sep 6, 2020

Last Update Posted Date

Sep 9, 2020Actual

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

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm.

Detailed Description

To evaluate stent assisted embolization of intracranial aneurysm, record information about treatment and any event (death, stroke, hemorrhagic event) prospectively.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stent assisted embolization		stent assisted embolization of intracranial aneurysm	Procedure: stent assisted embolization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stent assisted embolization	Procedure	stent assisted embolization and anti-thrombotic management	stent assisted embolization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
any death, stroke and major hemorrhagic event	any death, stroke and major hemorrhagic event within 2 years after treatment	2 years after treatment

Secondary Outcomes

Measure	Description	Time Frame
any adverse event	death, stroke, hemorrhagic event within 30days or between 31days to 2years after treatment any change of anti-thrombotic therapy within 2years after treatment recanalization or re-treatment within 2years after treatment stent stenosis or occlusion within 2years after treatment any adverse event within 2years after treatment	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stent assisted embolization of intracranial aneurysm
20 or more year old

Exclusion Criteria:

not determined

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

stent assisted embolization of intracranial aneurysm

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nobuyuki Sakai, MD, DMSc	Contact	81783024321	080	n.sakai@siren.ocn.ne.jp

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
Kobe City Medical Center General Hospital	Recruiting	Kobe	Hyōgo	650-0047	Japan

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm

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