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/NCT06027463</url>
    </required_header>
    <id_info>
      <org_study_id>liubei</org_study_id>
      <nct_id>NCT06027463</nct_id>
    </id_info>
    <brief_title>The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis</brief_title>
    <official_title>The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tang-Du Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tang-Du Hospital</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>
        Predicting relevant risk factors for patients with carotid artery stenosis after different&#xD;
        surgeries through machine learning&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 10, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>death</measure>
      <time_frame>two years</time_frame>
      <description>Patients who died after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>stroke</measure>
      <time_frame>half a year</time_frame>
      <description>Is there a recurrence of cerebral infarction within six months after surgery</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Postoperative Risk Factors for Patients With Carotid Artery Stenosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The target population of the study is adults aged 18-90 who have been diagnosed with head&#xD;
          and neck artery stenosis and risk events after head and neck revascularization and seek&#xD;
          medical treatment in neurosurgery departments of tertiary comprehensive hospitals.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1) All enrolled patients were diagnosed with clear head and neck artery stenosis and&#xD;
               a risk event after head and neck revascularization;&#xD;
  &#xD;
               (2) Location of lesion: origin of internal carotid artery, bifurcation of internal and&#xD;
               external carotid arteries;&#xD;
  &#xD;
               (3) Patients with symptomatic head and neck artery stenosis and dangerous events after&#xD;
               head and neck blood flow reconstruction, and with a degree of stenosis ≥ 70% on&#xD;
               non-invasive examination or stenosis ≥ 50% found on angiography;&#xD;
  &#xD;
               (4) Asymptomatic head and neck artery stenosis and risk events after head and neck&#xD;
               revascularization, with a degree of stenosis ≥ 70% on non-invasive examination or&#xD;
               stenosis ≥ 60% found on angiography;&#xD;
  &#xD;
               (5) Asymptomatic head and neck artery stenosis and dangerous events after head and&#xD;
               neck blood flow reconstruction, with a non-invasive examination of stenosis degree&#xD;
               less than 70%, but angiography or other examinations indicate that the stenosis lesion&#xD;
               is in an unstable state;&#xD;
  &#xD;
               (6) Symptomatic head and neck artery stenosis and risk events after head and neck&#xD;
               revascularization, non-invasive examination of head and neck artery stenosis and risk&#xD;
               event degree after head and neck revascularization at 50% to 69%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) Patients with poor overall condition and intolerance to general anesthesia;&#xD;
  &#xD;
               (2) Patients with mental illness or severe mental illness;&#xD;
  &#xD;
               (3) Severe respiratory system diseases;&#xD;
  &#xD;
               (4) Pregnant and lactating women;&#xD;
  &#xD;
               (5) Participating in another clinical study;&#xD;
  &#xD;
               (6) Patients with advanced tumors or those who are expected to die within one year;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Bei Liu, Doctor</last_name>
      <phone>18192823069</phone>
      <email>liubei206@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tangdu Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710038</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bei Liu, Doctor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>Carotid Stenosis</mesh_term>
      <mesh_term>Constriction, Pathologic</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/NCT06027463
  org study id: liubei
  nct id: NCT06027463
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Predicting relevant risk factors for patients with carotid artery stenosis after different
        surgeries through machine learning
  observational model: Other
  time perspective: Prospective
  measure: death
  time frame: two years
  description: Patients who died after surgery
  measure: stroke
  time frame: half a year
  description: Is there a recurrence of cerebral infarction within six months after surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  last name: Bei Liu, Doctor
  phone: 18192823069
  email: liubei206@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carotid Stenosis
  mesh term: Constriction, Pathologic