<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/NCT03786666</url>
  </required_header>
  <id_info>
    <org_study_id>VUS-CAS</org_study_id>
    <nct_id>NCT03786666</nct_id>
  </id_info>
  <brief_title>Ultrasound Evaluation of Carotid Artery Atherosclerotic Plaques and Recanalization</brief_title>
  <official_title>Vascular Ultrasound Evaluation of Atherosclerotic Plaques and the Success of Recanalization in Patients With Carotid Artery Stenosis and Occlusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Shanxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second People's Hospital of Liaocheng</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaocheng Brains Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lanzhou university second hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Hospital of China Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalian Municipal Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Inner Mongolia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shengli Oilfield Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhengzhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weihai Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</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 purpose of this multiple-center study are: 1) To establish the ultrasound criteria for&#xD;
      evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA&#xD;
      (carotid artery endarterectomy) and plaque specimen after CEA.&#xD;
&#xD;
      2) To establish the carotid artery recanalization strategies based on the evaluation results&#xD;
      of carotid artery and intracranial artery by color doppler flow imaging and TCCS/TCD&#xD;
      (transcranial color coded sonography/transcranial doppler).&#xD;
&#xD;
      3) To compare the success rate and the incidence of restenosis between CEA and carotid artery&#xD;
      stenting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, a total of 1000-1200 patients with carotid artery moderate (50-69%, with&#xD;
      symptoms), severe (70-99%) stenosis (with or without symptoms) or occlusion who received&#xD;
      either CEA or stenting are to recruited. Before carotid artery recanalization, CDFI (color&#xD;
      duplex flow imaging) and TCCS/TCD are used to evaluate the structures and hemodynamic of&#xD;
      carotid artery and intracranial artery. In addition, patients are to be followed up by&#xD;
      ultrasound 1 week, 3 month, 6month and 1 year after recanalization.&#xD;
&#xD;
        1. Ultrasound examinations procedures: According to the guidelines of vascular&#xD;
           ultrasonography published by the Stroke Prevention Engineering Committee, the National&#xD;
           Health Commission of China in 2015. The plaque characteristics, stenosis degrees of&#xD;
           carotid artery and intracranial arteries, and collateral circulation are evaluated by&#xD;
           CDFI and TCCS/TCD.&#xD;
&#xD;
        2. Radiology examination procedures: Before recanalization, enrolled patients receive MRI&#xD;
           examinations to determine the presence and the location of cerebral infarction. If&#xD;
           necessary, patients receive CT angiography (CTA) , MRI angiography (MRA) or Digital&#xD;
           subtraction angiography (DSA) to confirm the degrees of vessel stenosis and occlusion.&#xD;
           One week after recanalization, CT and MRI are used to identify the cerebral hemorrhage&#xD;
           and newly cerebral infarction.&#xD;
&#xD;
        3. The data collected in this study including:&#xD;
&#xD;
      1) The general information of enrolled subjects, which include age, gender, resident address&#xD;
      and telephone number, the history of hypertension, coronary artery diseases, dyslipidemia,&#xD;
      diabetes mellitus and smoking.&#xD;
&#xD;
      2. The primary endpoints are: The combination endpoints events of death, cerebral hemorrhage&#xD;
      , newly cerebral infarction, hyperperfusion syndrome, residual sternosis≥50% within 30-day&#xD;
      after recanalization. The secondary endpoints are the re-current cerebral artery events and&#xD;
      the occurence of restenosis during the at least 1 year follow-up period.&#xD;
&#xD;
      4. Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0)&#xD;
      software are used for statistical analysis.&#xD;
&#xD;
      1) Diagnostic test are used to test the sensitivity, specificity and accuracy of ultrasound&#xD;
      for evaluating vulnerable plaque by using plaque specimen after CEA as the &quot;gold&quot; standard.&#xD;
&#xD;
      2) The Chi-square test are used to compare the success rate of stenting and CEA. The Cox&#xD;
      regression analysis are used to compare the restenosis rate of stenting and CEA.&#xD;
&#xD;
      3) A P&lt;0.05 was considered statistically significance. 5. Quality assurance plan:&#xD;
&#xD;
        1. The medical centers implement the projects are the stroke center awarded by the Stroke&#xD;
           Prevention Engineering Committee, the National Health Commission of China. The medical&#xD;
           centers have the instruments required in this study.&#xD;
&#xD;
        2. Neurologists, neurosurgeons and vascular ultrasound physicians have received standard&#xD;
           training hosted by the Stroke Prevention Engineering Committee, the National Health&#xD;
           Commission of China and obtained excellent records.&#xD;
&#xD;
        3. All the centers conduct the project followed the uniform implementation plans and each&#xD;
           center guarantee the data input in time and accurately.&#xD;
&#xD;
        4. The project has the unique database and data input in uniform format.&#xD;
&#xD;
        5. There are specific staffs to check the accuracy and completeness of data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>The rate of combination endpoints events including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome,and residual sternosis≥50%.</measure>
    <time_frame>within 30-day after recanalization.</time_frame>
    <description>The rate of combination endpoints events, including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, and residual sternosis≥50%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the rate of re-current cerebral artery events and the occurence of restenosis</measure>
    <time_frame>during the at least 1 year follow-up period</time_frame>
    <description>the rate of re-current cerebral artery events and the occurence of restenosis</description>
  </secondary_outcome>
  <enrollment type="Actual">1213</enrollment>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Carotid artery recanalization CEA or carotid artery stenting</intervention_name>
    <description>Carotid artery recanalization CEA or carotid artery stenting</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Carotid artery plaques removed by CEA.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with carotid artery moderate (50-69%), severe (70-99%) stenosis or occlusion, who&#xD;
        needs recanalization by CEA or stenting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Patients with carotid artery moderate (50-69%, with symptoms), severe (70-99%, with&#xD;
             or without symptoms) stenosis or occlusion diagnosed by CDFI and confirmed by CTA or&#xD;
             DSA.&#xD;
&#xD;
             2) Patient has the indications for carotid artery stenting or CEA according to the&#xD;
             guidelines published by the Stroke Prevention Engineering Committee, the National&#xD;
             Health Commission of China.&#xD;
&#xD;
             3) Patient with complete imaging evaluation and can be followed up to at least 1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - 1) Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as&#xD;
        dissection, aneurysm, arteritis, cardiac embolism and et al.&#xD;
&#xD;
        2) Patients with cerebral hemorrhage. 3) Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yang Hua, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>No.45 Changchun Road, Beijing,100053, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xuanwu Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Ischemia</keyword>
  <keyword>Carotid artery Stenosis</keyword>
  <keyword>CEA</keyword>
  <keyword>Stenting</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Vulnerable plaque</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plaque, Atherosclerotic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03786666
org study id: VUS-CAS
nct id: NCT03786666
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this multiple-center study are: 1) To establish the ultrasound criteria for
      evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA
      (carotid artery endarterectomy) and plaque specimen after CEA.

      2) To establish the carotid artery recanalization strategies based on the evaluation results
      of carotid artery and intracranial artery by color doppler flow imaging and TCCS/TCD
      (transcranial color coded sonography/transcranial doppler).

      3) To compare the success rate and the incidence of restenosis between CEA and carotid artery
      stenting.
In this study, a total of 1000-1200 patients with carotid artery moderate (50-69%, with
      symptoms), severe (70-99%) stenosis (with or without symptoms) or occlusion who received
      either CEA or stenting are to recruited. Before carotid artery recanalization, CDFI (color
      duplex flow imaging) and TCCS/TCD are used to evaluate the structures and hemodynamic of
      carotid artery and intracranial artery. In addition, patients are to be followed up by
      ultrasound 1 week, 3 month, 6month and 1 year after recanalization.

        1. Ultrasound examinations procedures: According to the guidelines of vascular
           ultrasonography published by the Stroke Prevention Engineering Committee, the National
           Health Commission of China in 2015. The plaque characteristics, stenosis degrees of
           carotid artery and intracranial arteries, and collateral circulation are evaluated by
           CDFI and TCCS/TCD.

        2. Radiology examination procedures: Before recanalization, enrolled patients receive MRI
           examinations to determine the presence and the location of cerebral infarction. If
           necessary, patients receive CT angiography (CTA) , MRI angiography (MRA) or Digital
           subtraction angiography (DSA) to confirm the degrees of vessel stenosis and occlusion.
           One week after recanalization, CT and MRI are used to identify the cerebral hemorrhage
           and newly cerebral infarction.

        3. The data collected in this study including:

      1) The general information of enrolled subjects, which include age, gender, resident address
      and telephone number, the history of hypertension, coronary artery diseases, dyslipidemia,
      diabetes mellitus and smoking.

      2. The primary endpoints are: The combination endpoints events of death, cerebral hemorrhage
      , newly cerebral infarction, hyperperfusion syndrome, residual sternosis≥50% within 30-day
      after recanalization. The secondary endpoints are the re-current cerebral artery events and
      the occurence of restenosis during the at least 1 year follow-up period.

      4. Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0)
      software are used for statistical analysis.

      1) Diagnostic test are used to test the sensitivity, specificity and accuracy of ultrasound
      for evaluating vulnerable plaque by using plaque specimen after CEA as the "gold" standard.

      2) The Chi-square test are used to compare the success rate of stenting and CEA. The Cox
      regression analysis are used to compare the restenosis rate of stenting and CEA.

      3) A P<0.05 was considered statistically significance. 5. Quality assurance plan:

        1. The medical centers implement the projects are the stroke center awarded by the Stroke
           Prevention Engineering Committee, the National Health Commission of China. The medical
           centers have the instruments required in this study.

        2. Neurologists, neurosurgeons and vascular ultrasound physicians have received standard
           training hosted by the Stroke Prevention Engineering Committee, the National Health
           Commission of China and obtained excellent records.

        3. All the centers conduct the project followed the uniform implementation plans and each
           center guarantee the data input in time and accurately.

        4. The project has the unique database and data input in uniform format.

        5. There are specific staffs to check the accuracy and completeness of data.
observational model: Cohort
time perspective: Prospective
measure: The rate of combination endpoints events including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome,and residual sternosis≥50%.
time frame: within 30-day after recanalization.
description: The rate of combination endpoints events, including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, and residual sternosis≥50%
measure: the rate of re-current cerebral artery events and the occurence of restenosis
time frame: during the at least 1 year follow-up period
description: the rate of re-current cerebral artery events and the occurence of restenosis
intervention type: Procedure
intervention name: Carotid artery recanalization CEA or carotid artery stenting
description: Carotid artery recanalization CEA or carotid artery stenting
Carotid artery plaques removed by CEA.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yang Hua, MD
role: Principal Investigator
affiliation: No.45 Changchun Road, Beijing,100053, China
facility: 
country: China
responsible party type: Sponsor
mesh term: Plaque, Atherosclerotic
sharing ipd: No