<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/NCT02977520</url>
  </required_header>
  <id_info>
    <org_study_id>TWKY-2016-ZD-01-10</org_study_id>
    <nct_id>NCT02977520</nct_id>
  </id_info>
  <brief_title>Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms</brief_title>
  <acronym>PAOCA</acronym>
  <official_title>Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Luhe Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Luhe Hospital</source>
  <brief_summary>
    <textblock>
      Cerebral aneurysm is one of the main diseases that seriously affect human health. The most&#xD;
      important treatment method is surgical clipping and endovascular embolization. Not complete&#xD;
      occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This&#xD;
      study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined&#xD;
      with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of&#xD;
      aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In&#xD;
      addition, the model can also be used to the young doctor's training, and the patient and&#xD;
      their families can be convenient and intuitive understanding of the disease, so as to form a&#xD;
      good communication between doctors and patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">May 2017</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>time of operation</measure>
    <time_frame>1 to 3 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Printing, Three-Dimensional, Simulation Training</condition>
  <arm_group>
    <arm_group_label>Interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Obtain the CTA data of cerebral aneurysms and built the 3D printing models. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Printing, Three-Dimensional</intervention_name>
    <description>To establish 3D model of cerebral aneurysms and have preoperative evaluation.</description>
    <arm_group_label>Interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years-80 years;&#xD;
&#xD;
          -  Hunt-Hess grade: 0-4;&#xD;
&#xD;
          -  Without other stroke, brain trauma and other neurological disease;&#xD;
&#xD;
          -  Without cerebral hernia;&#xD;
&#xD;
          -  Cystic aneurysm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age: less than 18 years or above 80 years;&#xD;
&#xD;
          -  Hunt-Hess grade is 5;&#xD;
&#xD;
          -  With serious previous disorder of multiple organ;&#xD;
&#xD;
          -  Acute cerebral hernia;&#xD;
&#xD;
          -  Aneurysms were fusiform or serpentine expansion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>QING HUANG, M.D.</last_name>
    <phone>86-10-69543901</phone>
    <phone_ext>2053</phone_ext>
    <email>huangqing@ccmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>YANLONG HU, M.D.</last_name>
    <phone>86-10-69543901</phone>
    <phone_ext>2055</phone_ext>
    <email>doctor_yanlonghu@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Luhe hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>QING HUANG, M.D.</last_name>
      <phone>86-10-69543901</phone>
      <phone_ext>2053</phone_ext>
      <email>huangqing@ccmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>QING HUANG, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02977520
org study id: TWKY-2016-ZD-01-10
nct id: NCT02977520
lead sponsor: 
Cerebral aneurysm is one of the main diseases that seriously affect human health. The most
      important treatment method is surgical clipping and endovascular embolization. Not complete
      occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This
      study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined
      with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of
      aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In
      addition, the model can also be used to the young doctor's training, and the patient and
      their families can be convenient and intuitive understanding of the disease, so as to form a
      good communication between doctors and patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time of operation
time frame: 1 to 3 hours
arm group label: Interventional group
arm group type: Experimental
description: Obtain the CTA data of cerebral aneurysms and built the 3D printing models. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.
arm group label: general group
arm group type: No Intervention
description: Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms.
intervention type: Procedure
intervention name: Printing, Three-Dimensional
description: To establish 3D model of cerebral aneurysms and have preoperative evaluation.
arm group label: Interventional group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: QING HUANG, M.D.
phone: 86-10-69543901
phone ext: 2053
email: huangqing@ccmu.edu.cn
last name: YANLONG HU, M.D.
phone: 86-10-69543901
phone ext: 2055
email: doctor_yanlonghu@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm