<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702584</url>
  </required_header>
  <id_info>
    <org_study_id>TRIBRAIN1204</org_study_id>
    <secondary_id>UMIN000010405</secondary_id>
    <nct_id>NCT01702584</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms</brief_title>
  <official_title>Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kobe City General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kobe City General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective registry study to evaluate safety and efficacy of stent assisted embolization of&#xD;
      intracranial aneurysm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate stent assisted embolization of intracranial aneurysm, record information about&#xD;
      treatment and any event (death, stroke, hemorrhagic event) prospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>any death, stroke and major hemorrhagic event</measure>
    <time_frame>2 years after treatment</time_frame>
    <description>any death, stroke and major hemorrhagic event within 2 years after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>any adverse event</measure>
    <time_frame>2 years</time_frame>
    <description>death, stroke, hemorrhagic event within 30days or between 31days to 2years after treatment&#xD;
any change of anti-thrombotic therapy within 2years after treatment&#xD;
recanalization or re-treatment within 2years after treatment&#xD;
stent stenosis or occlusion within 2years after treatment&#xD;
any adverse event within 2years after treatment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Stent Embolisation</condition>
  <arm_group>
    <arm_group_label>stent assisted embolization</arm_group_label>
    <description>stent assisted embolization of intracranial aneurysm</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>stent assisted embolization</intervention_name>
    <description>stent assisted embolization and anti-thrombotic management</description>
    <arm_group_label>stent assisted embolization</arm_group_label>
    <other_name>Enterprise VRD</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        stent assisted embolization of intracranial aneurysm&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stent assisted embolization of intracranial aneurysm&#xD;
&#xD;
          -  20 or more year old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not determined&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nobuyuki Sakai, MD, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kobe City Medical Center General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nobuyuki Sakai, MD, DMSc</last_name>
    <phone>81783024321</phone>
    <phone_ext>080</phone_ext>
    <email>n.sakai@siren.ocn.ne.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nobuyuki Sakai, MD, DMSc</last_name>
      <phone>81783024321</phone>
      <phone_ext>080</phone_ext>
      <email>n.sakai@siren.ocn.ne.jp</email>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>September 6, 2020</last_update_submitted>
  <last_update_submitted_qc>September 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kobe City General Hospital</investigator_affiliation>
    <investigator_full_name>Nobuyuki Sakai</investigator_full_name>
    <investigator_title>Director of Neurosurgery</investigator_title>
  </responsible_party>
  <keyword>stent</keyword>
  <keyword>intracranial aneurysm</keyword>
  <keyword>embolization</keyword>
  <keyword>adverse event</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702584
org study id: TRIBRAIN1204
secondary id: UMIN000010405
nct id: NCT01702584
lead sponsor: 
has dmc: No
Prospective registry study to evaluate safety and efficacy of stent assisted embolization of
      intracranial aneurysm.
To evaluate stent assisted embolization of intracranial aneurysm, record information about
      treatment and any event (death, stroke, hemorrhagic event) prospectively.
observational model: Cohort
time perspective: Prospective
measure: any death, stroke and major hemorrhagic event
time frame: 2 years after treatment
description: any death, stroke and major hemorrhagic event within 2 years after treatment
measure: any adverse event
time frame: 2 years
description: death, stroke, hemorrhagic event within 30days or between 31days to 2years after treatment
any change of anti-thrombotic therapy within 2years after treatment
recanalization or re-treatment within 2years after treatment
stent stenosis or occlusion within 2years after treatment
any adverse event within 2years after treatment
arm group label: stent assisted embolization
description: stent assisted embolization of intracranial aneurysm
intervention type: Procedure
intervention name: stent assisted embolization
description: stent assisted embolization and anti-thrombotic management
arm group label: stent assisted embolization
other name: Enterprise VRD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Nobuyuki Sakai, MD, DMSc
role: Principal Investigator
affiliation: Kobe City Medical Center General Hospital
last name: Nobuyuki Sakai, MD, DMSc
phone: 81783024321
phone ext: 080
email: n.sakai@siren.ocn.ne.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kobe City General Hospital
investigator full name: Nobuyuki Sakai
investigator title: Director of Neurosurgery
mesh term: Intracranial Aneurysm
mesh term: Aneurysm