xml: <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/NCT05988125</url>
    </required_header>
    <id_info>
      <org_study_id>ETERNITY</org_study_id>
      <nct_id>NCT05988125</nct_id>
    </id_info>
    <brief_title>Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients</brief_title>
    <official_title>Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wen-huo Chen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhangzhou Municipal Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To investigate the real situation of assessment, diagnosis and treatment of acute ischemic&#xD;
        stroke patients with endovascular therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients is an&#xD;
        academic,independent, pragmatic , prospective, multicenter, observational registry study. The&#xD;
        acute ischemic stroke patients undergone endovascular therapy will be enrolled in stroke&#xD;
        centers. Baseline information and clinical follow-up information at 90 days of stroke onset&#xD;
        are collected. Data collected include demographics, comorbidities, pathogenesis, blood&#xD;
        pressures, stroke severity on admission, time intervals, reperfusion condition, and&#xD;
        functional outcome, et al. The study aims to investigate the real situation of assessment,&#xD;
        diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>90 Days</target_duration>
    <primary_outcome>
      <measure>The modified Rankin Scale score at 90 days</measure>
      <time_frame>90 days</time_frame>
      <description>The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome.&#xD;
  0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Successful reperfusion rate</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>symptomatic intracranial hemorrhage or death within 90 days after stroke onset.</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Endovascular Treatment</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Acute ischemic stroke patients receiving endovascular treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Acute ischemic stroke;&#xD;
  &#xD;
            2. Brain imaging confirmed intracranial large vessel occlusion: intracranial internal&#xD;
               carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery&#xD;
               (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral&#xD;
               artery (PCA P1);&#xD;
  &#xD;
            3. Initiation of any type of endovascular treatment, including mechanical thrombectomy,&#xD;
               aspiration, angioplasty, and stenting;&#xD;
  &#xD;
            4. Informed Consent as documented by signature or fulfilling the criteria for emergency&#xD;
               consent/ deferral consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Acute intracranial haemorrhage&#xD;
  &#xD;
            2. No evidence of large vessel occlusion on digital subtraction angiography.&#xD;
  &#xD;
            3. Patient bedridden or presenting from a nursing home&#xD;
  &#xD;
            4. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living&#xD;
               abroad) -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wen-huo Chen, bachelor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wen-huo Chen, bachelor</last_name>
      <phone>+86-05962082582</phone>
      <email>doctorwwenhuo@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhangzhou Municipal Hospital</name>
        <address>
          <city>Zhangzhou</city>
          <state>Fujian</state>
          <zip>36300</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenhuo Chen, MD</last_name>
        <phone>13806906089</phone>
        <email>13806906089@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Gansu provincial hospital of TCM</name>
        <address>
          <city>Lanzhou</city>
          <state>Gansu</state>
          <zip>730050</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hua Cao</last_name>
        <phone>18919810265</phone>
        <email>shaoya20042001@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiamusi Central Hospital</name>
        <address>
          <city>Jiamusi</city>
          <state>Heilongjiang</state>
          <zip>154000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lihua Xu, MD</last_name>
        <phone>13846178333</phone>
        <email>drxulihua@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Neurology, The First Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>xiao-bing Li, M.D.</last_name>
        <phone>13970935284</phone>
        <email>lxb0203208@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Songyuan Jilin Oilfield Hospital</name>
        <address>
          <city>SongYuan</city>
          <state>Jilin</state>
          <zip>138000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dong-sheng Ju, MD</last_name>
        <phone>13894158599</phone>
        <email>judongsheng_1981@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shenyang First People's Hospital</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110091</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yi Sui, MD</last_name>
        <phone>13998352587</phone>
        <email>tjyiia@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Zhangzhou Municipal Hospital</investigator_affiliation>
      <investigator_full_name>Wen-huo Chen</investigator_full_name>
      <investigator_title>Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China</investigator_title>
    </responsible_party>
    <keyword>acute Ischemic Stroke</keyword>
    <keyword>Endovascular Treatment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ischemic Stroke</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988125
  org study id: ETERNITY
  nct id: NCT05988125
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the real situation of assessment, diagnosis and treatment of acute ischemic
        stroke patients with endovascular therapy.
  Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients is an
        academic,independent, pragmatic , prospective, multicenter, observational registry study. The
        acute ischemic stroke patients undergone endovascular therapy will be enrolled in stroke
        centers. Baseline information and clinical follow-up information at 90 days of stroke onset
        are collected. Data collected include demographics, comorbidities, pathogenesis, blood
        pressures, stroke severity on admission, time intervals, reperfusion condition, and
        functional outcome, et al. The study aims to investigate the real situation of assessment,
        diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.
  observational model: Cohort
  time perspective: Prospective
  measure: The modified Rankin Scale score at 90 days
  time frame: 90 days
  description: The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome.
  0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.
  measure: Successful reperfusion rate
  time frame: 90 days
  measure: symptomatic intracranial hemorrhage or death within 90 days after stroke onset.
  time frame: 90 days
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wen-huo Chen, bachelor
  role: Principal Investigator
  affiliation: Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
  last name: Wen-huo Chen, bachelor
  phone: +86-05962082582
  email: doctorwwenhuo@126.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Zhangzhou Municipal Hospital
  investigator full name: Wen-huo Chen
  investigator title: Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China
  mesh term: Ischemic Stroke