<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/NCT02982135</url>
  </required_header>
  <id_info>
    <org_study_id>BJTTH-003</org_study_id>
    <nct_id>NCT02982135</nct_id>
  </id_info>
  <brief_title>Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease</brief_title>
  <official_title>Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>liuxingju</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Science and Technology of the People´s Republic of China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators conducted a prospective multi-center study assessing the effect of direct&#xD;
      bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rebleeding events</measure>
    <time_frame>5-10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ischemic events</measure>
    <time_frame>5-10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative compilications</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Moyamoya Disease</condition>
  <arm_group>
    <arm_group_label>group 1 direct bypass</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>direct bypass : patients recieve direct bypass treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2 indirect bypass</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>indirect bypass: patients recieve indirect bypass treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>bypass surgery and indrect bypass surgery</intervention_name>
    <description>bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes</description>
    <arm_group_label>group 1 direct bypass</arm_group_label>
    <arm_group_label>group 2 indirect bypass</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. cerebral digital subtraction contrast angiography (DSA) revealed severe stenosis or&#xD;
             occlusion of the distal internal carotid or proximal middle and anterior cerebral&#xD;
             arteries with prominent lenticulostriate &quot;moyamoya collaterals&quot;&#xD;
&#xD;
          2. patients had experienced at least one intracranial hemorrhage which was verified by&#xD;
             computed tomography (CT) scanning, magnetic resonance imaging MRI), or lumbar&#xD;
             puncture.&#xD;
&#xD;
          3. Patients requiring surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient whose initial onset was marked by ischemia but subsequently suffered from&#xD;
             intracranial hemorrhage&#xD;
&#xD;
          2. patients refused to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>0086</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>liu xingju, MD</last_name>
      <phone>008615011476305</phone>
      <email>liuxingju006@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Science and Technology of the People´s Republic of China</investigator_affiliation>
    <investigator_full_name>liuxingju</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>hemorrhagic moyamoya disease</keyword>
  <keyword>bypass</keyword>
  <keyword>indirect bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moyamoya Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02982135
org study id: BJTTH-003
nct id: NCT02982135
lead sponsor: 
has dmc: Yes
The investigators conducted a prospective multi-center study assessing the effect of direct
      bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: rebleeding events
time frame: 5-10 years
measure: ischemic events
time frame: 5-10 years
measure: postoperative compilications
time frame: 30 days
arm group label: group 1 direct bypass
arm group type: Other
description: direct bypass : patients recieve direct bypass treatment
arm group label: group 2 indirect bypass
arm group type: Other
description: indirect bypass: patients recieve indirect bypass treatment
intervention type: Other
intervention name: bypass surgery and indrect bypass surgery
description: bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes
arm group label: group 1 direct bypass
arm group label: group 2 indirect bypass
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Ministry of Science and Technology of the People´s Republic of China
investigator full name: liuxingju
investigator title: Principal investigator
mesh term: Moyamoya Disease
sharing ipd: Yes