<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/NCT03269942</url>
  </required_header>
  <id_info>
    <org_study_id>SCAT</org_study_id>
    <nct_id>NCT03269942</nct_id>
  </id_info>
  <brief_title>Study of Complex Intracranial Aneurysm Treatment</brief_title>
  <acronym>SCAT</acronym>
  <official_title>Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator expects that endovascular flow-diversion is superior over revascularization&#xD;
      by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open, prospective, controlled randomized superiority trial is conducted. The hypothesis is&#xD;
      that endovascular flow-diversion is better than revascularization in treatment of complex&#xD;
      intracranial aneurysms by postoperative modified Rankin Scale (mRS). Sample size was measured&#xD;
      by Fisher exact test. Depending on a type of the procedure, the patients are divided into two&#xD;
      groups: Endovascular Flow Diversion Procedure (include 55 patients) and Revascularization&#xD;
      Procedure (include 55 patients). Randomization is performed by random number generation.The&#xD;
      study was approved by Institutional Review Board&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 14, 2015</start_date>
  <completion_date type="Anticipated">June 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mRS</measure>
    <time_frame>6, 12 months after procedure</time_frame>
    <description>Change from baseline modified Rankin Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete aneurysm occlusion</measure>
    <time_frame>6, 12 months after procedure</time_frame>
    <description>Measured as: complete occlusion or residual aneurysm (included neck remnant)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm</measure>
    <time_frame>6, 12 months after procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Intracranial Aneurysm</condition>
  <arm_group>
    <arm_group_label>Endovascular Flow-Diversion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation of flow-diversion device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cerebral Revascularization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cerebral revascularization procedure with trapping of aneurysm</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endovascular Flow-Diversion</intervention_name>
    <description>Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.</description>
    <arm_group_label>Endovascular Flow-Diversion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cerebral Revascularization</intervention_name>
    <description>Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.</description>
    <arm_group_label>Cerebral Revascularization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  anterior circulation complex intracranial aneurysm&#xD;
&#xD;
          -  neck is more than 4 mm wide&#xD;
&#xD;
          -  dome/neck ratio of aneurysm equals or less than 2:1&#xD;
&#xD;
          -  age less than 75 years&#xD;
&#xD;
          -  ability to give informed consent (subject or legally authorized representative)&#xD;
&#xD;
          -  aneurysm is suitable for treatment to both procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subarachnoid hemorrhage less than 30 days ago&#xD;
&#xD;
          -  contraindications to endovascular treatment&#xD;
&#xD;
          -  atypical aneurysms (mycotic, flow-related in patients with AVM, traumatic, false)&#xD;
&#xD;
          -  informed consent refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novosibirsk Research Institution of Circulation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intracranial Aneurysm</keyword>
  <keyword>Flow Diverter</keyword>
  <keyword>Cerebral Revascularization</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/NCT03269942
org study id: SCAT
nct id: NCT03269942
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigator expects that endovascular flow-diversion is superior over revascularization
      by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.
Open, prospective, controlled randomized superiority trial is conducted. The hypothesis is
      that endovascular flow-diversion is better than revascularization in treatment of complex
      intracranial aneurysms by postoperative modified Rankin Scale (mRS). Sample size was measured
      by Fisher exact test. Depending on a type of the procedure, the patients are divided into two
      groups: Endovascular Flow Diversion Procedure (include 55 patients) and Revascularization
      Procedure (include 55 patients). Randomization is performed by random number generation.The
      study was approved by Institutional Review Board
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: mRS
time frame: 6, 12 months after procedure
description: Change from baseline modified Rankin Scale
measure: Complete aneurysm occlusion
time frame: 6, 12 months after procedure
description: Measured as: complete occlusion or residual aneurysm (included neck remnant)
measure: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
time frame: 6, 12 months after procedure
arm group label: Endovascular Flow-Diversion
arm group type: Active Comparator
description: Implantation of flow-diversion device
arm group label: Cerebral Revascularization
arm group type: Active Comparator
description: Cerebral revascularization procedure with trapping of aneurysm
intervention type: Procedure
intervention name: Endovascular Flow-Diversion
description: Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
arm group label: Endovascular Flow-Diversion
intervention type: Procedure
intervention name: Cerebral Revascularization
description: Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.
arm group label: Cerebral Revascularization
criteria: 
gender: All
minimum age: N/A
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm