<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/NCT03256513</url>
  </required_header>
  <id_info>
    <org_study_id>D161100003816002</org_study_id>
    <nct_id>NCT03256513</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization</brief_title>
  <official_title>The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization for Ischemic Cerebral Vascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The 306 Hospital of People's Liberation Army</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</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>
      Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood&#xD;
      flow monitoring and blood pressure, and combining patient demographics and preoperative risk&#xD;
      factors to establish an applicable individual blood pressure controlling model. By comparing&#xD;
      with routine antihypertensive strategies through prospective randomized controlled trials ,&#xD;
      to provide the best perioperative blood pressure control standards and strategies for each&#xD;
      patient ,thus better ensuring the safety and efficacy of CEA .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>death</measure>
    <time_frame>30 days</time_frame>
    <description>all cause death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ischemic stroke</measure>
    <time_frame>30 days</time_frame>
    <description>Ischemic stroke is defined as an acute episode of neurological events with focal symptoms and signs, with a duration of more than 24h and confirmed by imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cardiovascular events</measure>
    <time_frame>30 days</time_frame>
    <description>Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>transient ischemic attack,TIA</measure>
    <time_frame>30 days</time_frame>
    <description>transient ischemic attack, TIA is defined as: Patients with new onset of neurological symptoms and / or signs, duration &lt; 24 hours, MRI diffusion weighted imaging (DWI) did not find new infarcts. If MRI DWI showed new lesion, ischemic stroke was defined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral hemorrhage</measure>
    <time_frame>30 days</time_frame>
    <description>cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hyperperfusion syndrome</measure>
    <time_frame>30 days</time_frame>
    <description>Hyperfusion Syndrome is defined as : 30 days after operation, new onset headache, vomiting, mental symptoms, macular edema, focal seizures, neurological dysfunction, or imaging brain edema, visible bleeding, and exception of new ischemic cerebral infarction or other causes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>epilepsy</measure>
    <time_frame>30 days</time_frame>
    <description>epilepsy is defined as focal onset, with or without evolution to a bilateral tonic-clonic seizure, confirmed by EEG findings including interictal epileptiform discharges (IEDs), lateralized periodic discharges (LPDs; previously known as periodic lateralized epileptiform discharges [PLEDs]), and generalized periodic discharges (GPDs)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2270</enrollment>
  <condition>Cerebral Revascularization</condition>
  <condition>Ischemic Cerebrovascular Disease</condition>
  <arm_group>
    <arm_group_label>model controlling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>an statistical model for periprocedural blood pressure control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional controlling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>an conventional strategy for periprocedural blood pressure control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>model controlling</intervention_name>
    <description>control blood pressure by statistical l model with anticipate lowest peri-procedure risk</description>
    <arm_group_label>model controlling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional controlling</intervention_name>
    <description>control blood pressure by conventional strategy</description>
    <arm_group_label>conventional controlling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  symptomatic patient with carotid artery stenosis&gt;=50% or asymptomatic patient with&#xD;
             carotid artery stenosis&gt;=70%, according to DSA or CTA;&#xD;
&#xD;
          -  without massive cerebral infarction(infarction area &gt;1/2 territory of middle cerebral&#xD;
             artery) confirmed by CT or MRI;&#xD;
&#xD;
          -  informed consent acquired.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lesion beyond range limit of procedure (higher than C2);&#xD;
&#xD;
          -  target vascular complete occlusion or ipsilateral intracranial artery severe stenosis&#xD;
             or complete occlusion cannot be revascularized via CEA procedure&#xD;
&#xD;
          -  nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital&#xD;
             vascular malformation;&#xD;
&#xD;
          -  history of instable angina pectoris, myocardial infarction or congestive heart failure&#xD;
             within 6 months unable to accept systematic anesthesia;&#xD;
&#xD;
          -  history of severe injury, surgery or radiotherapy on neck;&#xD;
&#xD;
          -  with comorbid hemorrhagic cerebral disease such as intracranial aneurysm or vascular&#xD;
             malformation;&#xD;
&#xD;
          -  with comorbid blood system disease causing refractory coagulation dysfunction or&#xD;
             rejection to blood or blood products perfusion;&#xD;
&#xD;
          -  with other comorbidity, expected life &lt; 2 years;&#xD;
&#xD;
          -  severe diabetes mellitus difficult to control, blood sugar &gt;300mg/dl;&#xD;
&#xD;
          -  pregnancy or peri-natal period;&#xD;
&#xD;
          -  intolerance to systematic anesthesia or surgery after adequate preparation.&#xD;
&#xD;
          -  intolerance to peri-procedural drug possible to administrated;&#xD;
&#xD;
          -  not cooperating or rejecting to informed consent;&#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>Liqun Jiao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of neurosurgery, Xuanwu hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liqun Jiao, MD</last_name>
    <phone>86-10-83198899</phone>
    <phone_ext>8836</phone_ext>
    <email>jiaoliqun@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of neurosurgery, Xuanwu hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liqun Jiao, MD</last_name>
      <phone>86-10-83198899</phone>
      <phone_ext>8836</phone_ext>
      <email>jiaoliqun@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xuanwu Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>lingfeng</investigator_full_name>
    <investigator_title>clinical investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrovascular Disorders</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/NCT03256513
org study id: D161100003816002
nct id: NCT03256513
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood
      flow monitoring and blood pressure, and combining patient demographics and preoperative risk
      factors to establish an applicable individual blood pressure controlling model. By comparing
      with routine antihypertensive strategies through prospective randomized controlled trials ,
      to provide the best perioperative blood pressure control standards and strategies for each
      patient ,thus better ensuring the safety and efficacy of CEA .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: death
time frame: 30 days
description: all cause death
measure: ischemic stroke
time frame: 30 days
description: Ischemic stroke is defined as an acute episode of neurological events with focal symptoms and signs, with a duration of more than 24h and confirmed by imaging.
measure: cardiovascular events
time frame: 30 days
description: Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.
measure: transient ischemic attack,TIA
time frame: 30 days
description: transient ischemic attack, TIA is defined as: Patients with new onset of neurological symptoms and / or signs, duration < 24 hours, MRI diffusion weighted imaging (DWI) did not find new infarcts. If MRI DWI showed new lesion, ischemic stroke was defined.
measure: cerebral hemorrhage
time frame: 30 days
description: cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.
measure: hyperperfusion syndrome
time frame: 30 days
description: Hyperfusion Syndrome is defined as : 30 days after operation, new onset headache, vomiting, mental symptoms, macular edema, focal seizures, neurological dysfunction, or imaging brain edema, visible bleeding, and exception of new ischemic cerebral infarction or other causes.
measure: epilepsy
time frame: 30 days
description: epilepsy is defined as focal onset, with or without evolution to a bilateral tonic-clonic seizure, confirmed by EEG findings including interictal epileptiform discharges (IEDs), lateralized periodic discharges (LPDs; previously known as periodic lateralized epileptiform discharges [PLEDs]), and generalized periodic discharges (GPDs)
arm group label: model controlling
arm group type: Experimental
description: an statistical model for periprocedural blood pressure control
arm group label: conventional controlling
arm group type: Active Comparator
description: an conventional strategy for periprocedural blood pressure control
intervention type: Other
intervention name: model controlling
description: control blood pressure by statistical l model with anticipate lowest peri-procedure risk
arm group label: model controlling
intervention type: Other
intervention name: conventional controlling
description: control blood pressure by conventional strategy
arm group label: conventional controlling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Liqun Jiao, MD
role: Principal Investigator
affiliation: Department of neurosurgery, Xuanwu hospital
last name: Liqun Jiao, MD
phone: 86-10-83198899
phone ext: 8836
email: jiaoliqun@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xuanwu Hospital, Beijing
investigator full name: lingfeng
investigator title: clinical investigator
mesh term: Cerebrovascular Disorders