<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/NCT03007082</url>
  </required_header>
  <id_info>
    <org_study_id>CHEC2016-119</org_study_id>
    <nct_id>NCT03007082</nct_id>
  </id_info>
  <brief_title>Revive AIS Patients ImmeDiately</brief_title>
  <acronym>RAPID</acronym>
  <official_title>A Multicenter, Prospective Registry Clinical Study of the Effectiveness and Safety of ReVive SE Thrombectomy for Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, prospective registry clinical study to evaluate the real-world&#xD;
      efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE&#xD;
      device on the basis of standardised medical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, prospective, single-arm observational study to evaluate the&#xD;
      real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke patients&#xD;
      using Revive SE device on the basis of standardised medical treatment.The device selection&#xD;
      before treatment is based upon doctors who are blinded to the protocol. The primary outcomes&#xD;
      are reperfusion rate immediately after intervention (mTICI score ≥II b ) and mRS Score at 90&#xD;
      days after intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reperfusion rate (mTICI≥2b)</measure>
    <time_frame>immediately after thrombectomy procedure</time_frame>
    <description>The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>3 months after thrombectomy procedure</time_frame>
    <description>the percentage of functional independence as assessed by mRS (modified Rankin Scale) score&lt;3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>within 3 hours after groin puncture</time_frame>
    <description>the time take to achieve successful reperfusion (from groin puncture to reperfusion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of passes of ReVive SE for each patient</measure>
    <time_frame>within 3 hours after groin puncture</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of downstream embolization</measure>
    <time_frame>within 3 hours after groin puncture</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of embolization into new territories during intervention</measure>
    <time_frame>within 3 hours after groin puncture</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of symptomatic intracranial hemorrhage</measure>
    <time_frame>within 24 hours after operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device or intervention related adverse events</measure>
    <time_frame>within 90 days after intervention</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Occlusion, Cerebrovascular</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Revive SE intracranial thrombectomy device</intervention_name>
    <description>Intra-arterial mechanical thrombectomy with Revive SE；&#xD;
According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute ischemic stroke patients in a time window of 6 hours and received thrombectomy&#xD;
        treatment using Revive SE device&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age over 18 years;&#xD;
&#xD;
          2. clinical diagnosis should be acute ischaemic stroke;&#xD;
&#xD;
          3. no more than 6 hours after onset;&#xD;
&#xD;
          4. IV tPA thrombolysis, if needed, should start within 4.5 hours after onset；&#xD;
&#xD;
          5. Pre-stroke mRS ≤2;&#xD;
&#xD;
          6. ICA/M1/M2/A1/A2/VA/BA occlusion confirmed by CTA/MRA/DSA;'&#xD;
&#xD;
          7. written informed consent form given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. . history of intracranial hemorrhage.&#xD;
&#xD;
          2. . life expectancy &lt;90 days;&#xD;
&#xD;
          3. . history of major surgery or severe trauma in the past 10 days;&#xD;
&#xD;
          4. . Uncontrolled hypertension (defined as: SBP&gt;185mmHg or DBP ≥110 mm Hg at 3 continuous&#xD;
             measurements with interval of at least 10 minutes confirm the SBP&gt;185mmHg or DBP ≥110&#xD;
             mm Hg)&#xD;
&#xD;
          5. . PLT&lt;40*10^9/L；&#xD;
&#xD;
          6. . blood glucose &lt;2.7mmol /L or &gt;22. 2 mmol /L；&#xD;
&#xD;
          7. . concomitant use of oral anticoagulation drugs, and INR &gt;3.0；&#xD;
&#xD;
          8. . ASPECTS score ≤5；&#xD;
&#xD;
          9. . conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).&#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>Jian-min Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurosurgery, Changhai hospital, Shanghai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peng-fei Yang, MD</last_name>
    <phone>15921196312</phone>
    <phone_ext>+86</phone_ext>
    <email>15921196312@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wan-ling Wen, MD</last_name>
    <phone>15721571004</phone>
    <phone_ext>+86</phone_ext>
    <email>wwljoy00@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Changhai hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peng-fei Yang, MD</last_name>
      <phone>15921196312</phone>
      <email>15921196312@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Jian-min Liu</investigator_full_name>
    <investigator_title>Department of Neurosurgery, Changhai hospital</investigator_title>
  </responsible_party>
  <keyword>endovascular treatment</keyword>
  <keyword>mechanical thrombectomy</keyword>
  <keyword>stent retriever</keyword>
  <keyword>human</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03007082
org study id: CHEC2016-119
nct id: NCT03007082
lead sponsor: 
has dmc: Yes
This is a multicenter, prospective registry clinical study to evaluate the real-world
      efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE
      device on the basis of standardised medical treatment.
This is a multi-center, prospective, single-arm observational study to evaluate the
      real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke patients
      using Revive SE device on the basis of standardised medical treatment.The device selection
      before treatment is based upon doctors who are blinded to the protocol. The primary outcomes
      are reperfusion rate immediately after intervention (mTICI score ≥II b ) and mRS Score at 90
      days after intervention.
observational model: Case-Only
time perspective: Prospective
measure: Reperfusion rate (mTICI≥2b)
time frame: immediately after thrombectomy procedure
description: The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory
measure: Functional outcome
time frame: 3 months after thrombectomy procedure
description: the percentage of functional independence as assessed by mRS (modified Rankin Scale) score<3
measure: Procedure time
time frame: within 3 hours after groin puncture
description: the time take to achieve successful reperfusion (from groin puncture to reperfusion)
measure: Number of passes of ReVive SE for each patient
time frame: within 3 hours after groin puncture
measure: Incidence of downstream embolization
time frame: within 3 hours after groin puncture
measure: Incidence of embolization into new territories during intervention
time frame: within 3 hours after groin puncture
measure: Incidence of symptomatic intracranial hemorrhage
time frame: within 24 hours after operation
measure: Mortality
time frame: 3 months
measure: Device or intervention related adverse events
time frame: within 90 days after intervention
intervention type: Device
intervention name: Revive SE intracranial thrombectomy device
description: Intra-arterial mechanical thrombectomy with Revive SE；
According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jian-min Liu, MD
role: Principal Investigator
affiliation: Department of Neurosurgery, Changhai hospital, Shanghai
last name: Peng-fei Yang, MD
phone: 15921196312
phone ext: +86
email: 15921196312@163.com
last name: Wan-ling Wen, MD
phone: 15721571004
phone ext: +86
email: wwljoy00@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Jian-min Liu
investigator title: Department of Neurosurgery, Changhai hospital
mesh term: Ischemic Stroke
mesh term: Cerebrovascular Disorders
sharing ipd: Undecided