We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01702584
Recruitment Status : Unknown
Verified October 2012 by Nobuyuki Sakai, Kobe City General Hospital.
Recruitment status was:  Recruiting
First Posted : October 8, 2012
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
Nobuyuki Sakai, Kobe City General Hospital

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

Condition or disease Intervention/treatment
Stent Embolisation Procedure: stent assisted embolization

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
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Enterprise VRD



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nobuyuki Sakai, Director of Neurosurgery, Kobe City General Hospital
ClinicalTrials.gov Identifier: NCT01702584     History of Changes
Other Study ID Numbers: TRIBRAIN1204
UMIN000010405 ( Other Identifier: UMIN Japan )
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by Nobuyuki Sakai, 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