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Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

This study is currently recruiting participants.
Verified October 2012 by Kobe City General Hospital
Sponsor:
Information provided by (Responsible Party):
Nobuyuki Sakai, Kobe City General Hospital
ClinicalTrials.gov Identifier:
NCT01702584
First received: September 5, 2012
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
Stent Embolisation
 Procedure: stent assisted embolization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kobe City General Hospital:

Primary Outcome Measures:
  • any death, stroke and major hemorrhagic event [ Time Frame: 2 years after treatment ] [ Designated as safety issue: Yes ]
    any death, stroke and major hemorrhagic event within 2 years after treatment


Secondary Outcome Measures:
  • any adverse event [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1000
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
stent assisted embolization
stent assisted embolization of intracranial aneurysm
 Procedure: stent assisted embolization
stent assisted embolization and anti-thrombotic management
Other Name: Enterprise VRD

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

stent assisted embolization of intracranial aneurysm

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not determined
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702584

Contacts
Contact: Nobuyuki Sakai, MD, DMSc 81783024321 ext 080 n.sakai@siren.ocn.ne.jp

Locations
Japan
Kobe City Medical Center General Hospital Recruiting
Kobe, Hyogo, Japan, 650-0047
Contact: Nobuyuki Sakai, MD, DMSc     81783024321 ext 080     n.sakai@siren.ocn.ne.jp    
Sponsors and Collaborators
Kobe City General Hospital
Investigators
Principal Investigator: Nobuyuki Sakai, MD, DMSc Kobe City Medical Center General Hospital
  More Information

No publications provided

Responsible Party: Nobuyuki Sakai, Director of Neurosurgery, Kobe City General Hospital
ClinicalTrials.gov Identifier: NCT01702584     History of Changes
Other Study ID Numbers: TRIBRAIN1204, UMIN000010405
Study First Received: September 5, 2012
Last Updated: October 4, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kobe City General Hospital:
stent
intracranial aneurysm
embolization
adverse event

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013