Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014