NCT01702584

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

5.5 years

First QC Date

September 5, 2012

Last Update Submit

September 6, 2020

Conditions

Stent Embolisation

Keywords

stentintracranial aneurysmembolizationadverse event

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • any adverse event

    2 years

Study Arms (1)

stent assisted embolization

stent assisted embolization of intracranial aneurysm

Procedure: stent assisted embolization

Interventions

stent assisted embolizationPROCEDURE

stent assisted embolization and anti-thrombotic management

Also known as: Enterprise VRD
stent assisted embolization

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stent assisted embolization of intracranial aneurysm

You may qualify if:

  • stent assisted embolization of intracranial aneurysm
  • or more year old

You may not qualify if:

  • not determined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Nobuyuki Sakai, MD, DMSc

    Kobe City Medical Center General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nobuyuki Sakai, MD, DMSc

CONTACT

81783024321n.sakai@siren.ocn.ne.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neurosurgery

Study Record Dates

First Submitted

September 5, 2012

First Posted

October 8, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2018

Study Completion

March 1, 2021

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

JP(1)