<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/NCT03754738</url>
  </required_header>
  <id_info>
    <org_study_id>2018-ESCAPE</org_study_id>
    <nct_id>NCT03754738</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients</brief_title>
  <acronym>ESCAPE</acronym>
  <official_title>Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</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>
      With mechanical thrombectomy now representing standard of care for treatment of acute&#xD;
      ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that&#xD;
      result in improved outcomes for patients with LVO has become an issue of increasing&#xD;
      importance. A number of retrospective studies have demonstrated that flow arrest during the&#xD;
      clot retrieval process results in less clot fragmentation, lower rates of distal emboli,&#xD;
      higher revascularization rates and improved rates of good neurological outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">November 25, 2018</start_date>
  <completion_date type="Anticipated">February 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 25, 2019</primary_completion_date>
  <phase>Phase 2</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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distal embolization,</measure>
    <time_frame>After mechanical thrombectomy, usually within 3 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified thrombolysis in cerebral infarction 2b/3,</measure>
    <time_frame>After mechanical thrombectomy, usually within 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified thrombolysis in cerebral infarction</measure>
    <time_frame>After mechanical thrombectomy, usually within 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified thrombolysis in cerebral infarction 2b/3 after the first pass</measure>
    <time_frame>After the first pass, , usually within 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First pass recanalization rate</measure>
    <time_frame>After the first pass, , usually within 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of passes</measure>
    <time_frame>After mechanical thrombectomy, usually within 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>From the procedure start to the end, usually within 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institutes of Health Stroke Scale</measure>
    <time_frame>7 days or discharge</time_frame>
    <description>Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic intracranial hemorrhage</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>90 days</time_frame>
    <description>Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety (occurrence of adverse events and serious adverse events)</measure>
    <time_frame>7 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">155</enrollment>
  <condition>Mechanical Thrombectomy</condition>
  <condition>Stroke</condition>
  <condition>Balloon Guide Catheter</condition>
  <arm_group>
    <arm_group_label>Balloon guide catheter group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mechanical thrombectomy with a balloon guide catheter group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-balloon guide catheter group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mechanical thrombectomy with a non-balloon guide catheter group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Balloon guide catheter</intervention_name>
    <description>Use a balloon guide catheter in the mechanical thrombectomy</description>
    <arm_group_label>Balloon guide catheter group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-balloon guide catheter</intervention_name>
    <description>Use a non-balloon guide catheter in the mechanical thrombectomy</description>
    <arm_group_label>Non-balloon guide catheter group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  A clinical diagnosis of acute stroke, with a deficit on the NIHSS of 2 points or more.&#xD;
&#xD;
          -  Intracranial arterial occlusion of the distal intracranial carotid artery or middle&#xD;
             (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, or DSA.&#xD;
&#xD;
          -  Treatment can be initiated (groin puncture) within 6 hours of symptom onset.&#xD;
&#xD;
          -  Planning to mechanical thrombectomy with a stenting retriever.&#xD;
&#xD;
          -  Signed informed consent prior to entering study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate stenosis, severe stenosis, or occlusion of the ipsilateral extracranial&#xD;
             carotid artery.&#xD;
&#xD;
          -  Previously deployed stents in the ipsilateral carotid artery.&#xD;
&#xD;
          -  Dissections of the ipsilateral carotid artery.&#xD;
&#xD;
          -  Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant&#xD;
             therapy with INR &gt; 3.0.&#xD;
&#xD;
          -  Baseline platelet count &lt; 50.000/µL.&#xD;
&#xD;
          -  Baseline blood glucose of &lt; 50mg/dL or &gt;400mg/dl.&#xD;
&#xD;
          -  Severe, sustained hypertension (SBP &gt; 220 mm Hg or DBP &gt; 110 mm Hg).&#xD;
&#xD;
          -  Renal insufficiency with creatinine ≥ 3 mg/dl.&#xD;
&#xD;
          -  Patients in sedation and intubated patients could not be included if baseline NIHSS is&#xD;
             not obtained by a neurologist or emergency physician prior to sedation or intubation.&#xD;
&#xD;
          -  Seizures at stroke onset which would preclude obtaining a baseline NIHSS.&#xD;
&#xD;
          -  Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor&#xD;
             from overseas).&#xD;
&#xD;
          -  Subject participating in a study involving an investigational drug or device that&#xD;
             would impact this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Suzhou Municipal Hoapital</name>
      <address>
        <city>Suzhou</city>
        <state>An Hui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhengfei Ma, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xuan Wu Hospital，Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xunming ji</last_name>
      <phone>861013120136877</phone>
      <email>jixunming@vip.163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lu He hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaokun Geng, MD</last_name>
      <phone>18311055270</phone>
      <email>xgeng@ccmu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shengli Oilfield Central Hospital</name>
      <address>
        <city>Dongying</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zongen Gao</last_name>
    </contact>
    <investigator>
      <last_name>Zongen Gao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nanyang City Center Hospital</name>
      <address>
        <city>Nanyang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changming Wen</last_name>
      <phone>13838729696</phone>
      <email>wenchangming9587@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yajun Lian</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Ji Xunming,MD,PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03754738
org study id: 2018-ESCAPE
nct id: NCT03754738
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
With mechanical thrombectomy now representing standard of care for treatment of acute
      ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that
      result in improved outcomes for patients with LVO has become an issue of increasing
      importance. A number of retrospective studies have demonstrated that flow arrest during the
      clot retrieval process results in less clot fragmentation, lower rates of distal emboli,
      higher revascularization rates and improved rates of good neurological outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Distal embolization,
time frame: After mechanical thrombectomy, usually within 3 hours
measure: Modified thrombolysis in cerebral infarction 2b/3,
time frame: After mechanical thrombectomy, usually within 3 hours
measure: Modified thrombolysis in cerebral infarction
time frame: After mechanical thrombectomy, usually within 3 hours
measure: Modified thrombolysis in cerebral infarction 2b/3 after the first pass
time frame: After the first pass, , usually within 3 hours
measure: First pass recanalization rate
time frame: After the first pass, , usually within 3 hours
measure: Number of passes
time frame: After mechanical thrombectomy, usually within 3 hours
measure: Procedure time
time frame: From the procedure start to the end, usually within 3 hours
measure: National Institutes of Health Stroke Scale
time frame: 7 days or discharge
description: Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
measure: Symptomatic intracranial hemorrhage
time frame: 24 hours
measure: Modified Rankin Scale
time frame: 90 days
description: Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
measure: Mortality
time frame: 90 days
measure: Safety (occurrence of adverse events and serious adverse events)
time frame: 7 days
arm group label: Balloon guide catheter group
arm group type: Experimental
description: mechanical thrombectomy with a balloon guide catheter group
arm group label: Non-balloon guide catheter group
arm group type: Active Comparator
description: mechanical thrombectomy with a non-balloon guide catheter group
intervention type: Device
intervention name: Balloon guide catheter
description: Use a balloon guide catheter in the mechanical thrombectomy
arm group label: Balloon guide catheter group
intervention type: Device
intervention name: Non-balloon guide catheter
description: Use a non-balloon guide catheter in the mechanical thrombectomy
arm group label: Non-balloon guide catheter group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming,MD,PhD
investigator title: Principal Investigator