Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

September 6, 2020 updated by: Nobuyuki Sakai, Kobe City General Hospital
Prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

stent assisted embolization of intracranial aneurysm

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • not determined

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
stent assisted embolization
stent assisted embolization of intracranial aneurysm
Procedure: stent assisted embolization
stent assisted embolization and anti-thrombotic management
Other Names:
  • Enterprise VRD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kobe City General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

March 1, 2018

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 8, 2012

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 6, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIBRAIN1204
  • UMIN000010405 (Other Identifier: UMIN Japan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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