<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/NCT03753061</url>
  </required_header>
  <id_info>
    <org_study_id>HEMO-CS1802</org_study_id>
    <nct_id>NCT03753061</nct_id>
  </id_info>
  <brief_title>Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)</brief_title>
  <official_title>The Safety and Efficacy of Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy- A Prospective, Multicenter, Open Label, Blinded, Randomized Controlled, Non-inferiority Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Science and Technology of the People´s Republic of China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Science and Technology of the People´s Republic of China</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>
      This study is a prospective, multi-center, open-label, end-point blinded, randomized,&#xD;
      parallel positive control, non-inferiority clinical trial, with a purpose to evaluate the&#xD;
      safety and efficacy of Hemo Jirui intracranial thrombus aspiration catheter system for&#xD;
      endovascular treatment of acute ischemic stroke by comparison with stent retriever (Solitaire&#xD;
      FR). The trial is anticipated to last from November 2018 to May 2019, with 204 subjects&#xD;
      recruited from 15-20 clinical trial centers in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, multi-center, open-label, end-point blinded, parallel positive&#xD;
      controlled, non-inferiority clinical trial. Patients with acute ischemic stroke (AIS) who&#xD;
      meet inclusion criteria would be enrolled in this study. Led by Beijing Tiantan Hospital&#xD;
      affiliated to Capital Medical University, this study is planned to be carried out in 15-20&#xD;
      clinical trial institutions in China. There will be 102 patients enrolled in each group.&#xD;
      Patients in the experimental group will be treated with the intracranial thrombus aspiration&#xD;
      catheter, product of Hemo Jirui. Patients in the control group will be treated with stent&#xD;
      retriever (Solitaire FR).&#xD;
&#xD;
      In this trial, relevant examinations of safety and efficacy assessments were performed&#xD;
      immediately after the procedure, at 24 hours, 7 days, 30 days, and 90 days. Primary efficacy&#xD;
      endpoint will be the immediate recanalization rate (mTICI 2b-3) of target vessel after the&#xD;
      procedure. Secondary efficacy endpoints will include: (1) Proportion of functional&#xD;
      independence (mRS 0-2) at 90 days; (2) ordinal shift analysis of mRS at 90 days; (3)&#xD;
      immediate recanalization rate (mTICI 2b-3) of the first pass of thrombectomy device; (4)&#xD;
      immediate recanalization rate (mTICI 2b-3) of the last pass of thrombectomy device;&#xD;
      (5)procedure time (randomization to recanalization); (6) Change in NIHSS score at 24hours;&#xD;
      (7) Change in NIHSS score at 7 days or discharge (whichever comes first); (8) mTICI grading&#xD;
      of target vessel revealed by CTA or MRA at 22-36 hours; (9) The extent of anterior&#xD;
      circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI. Safety endpoints&#xD;
      will include: (1) All-cause mortality at 90 days; (2) stroke-related mortality at 90 days;&#xD;
      (3) stroke recurrence rate within 90 days; (4) any type of intracranial hemorrhagic&#xD;
      transformation within 22-36 hours, including parenchymal, subarachnoid or ventricular&#xD;
      hemorrhage; (5) symptomatic intracranial hemorrhage (sICH) within 22-36 hours, as confirmed&#xD;
      by any intracranial hemorrhage on CT or MRI associated with ≥ 4 points of worsening on NIHSS&#xD;
      or even contributing to death; (5) procedural complications or serious adverse events&#xD;
      procedural complications or serious adverse events (SAEs) within 90 days.&#xD;
&#xD;
      The trial is anticipated to last from November 2018 to May 2019, all the related&#xD;
      investigative organization and individuals will obey the Declaration of Helsinki and Chinese&#xD;
      Good Clinical Practice standard. The trial has been approved by Institutional Review Board&#xD;
      (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Anticipated">March 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 20, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure</measure>
    <time_frame>immediate</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of functional independence (mRS 0-2) at 90 days</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ordinal shift analysis of mRS at 90 days</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instant recanalization rate (mTICI 2b-3) after the first thrombectomy</measure>
    <time_frame>immediate</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instant recanalization rate (mTICI 2b-3) after the last thrombectomy</measure>
    <time_frame>immediate</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time (randomization to recanalization)</measure>
    <time_frame>procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NIHSS score at 24±2 hours</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NIHSS score at 7±1 days or discharge (whichever comes first)</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours</measure>
    <time_frame>22-36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI</measure>
    <time_frame>22-36 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">204</enrollment>
  <condition>Large Vessel Occlusion</condition>
  <condition>Acute Ischemic Stroke</condition>
  <condition>Cerebrovascular Disorders</condition>
  <arm_group>
    <arm_group_label>Aspiration Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mechanical thrombectomy with Aspiration Catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stent Retriever (Solitaire FR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mechanical thrombectomy with Solitaire FR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aspiration Catheter</intervention_name>
    <description>Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.</description>
    <arm_group_label>Aspiration Catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Solitaire FR</intervention_name>
    <description>Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.</description>
    <arm_group_label>Stent Retriever (Solitaire FR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years.&#xD;
&#xD;
          2. Symptoms and signs in accordance with anterior circulation ischemia and large vessel&#xD;
             occlusion (ICA, MCA-M1 or M2) confirmed by CTA/MRA/DSA.&#xD;
&#xD;
          3. Pre-stroke Modified Rankin Scale（mRS）0-1.&#xD;
&#xD;
          4. NIHSS score ≥ 6 points at time of randomization.&#xD;
&#xD;
          5. The patients should receive endovascular treatment within 8 hours of estimated time of&#xD;
             large vessel occlusion (LVO) onset, and have an ASPECTS ≥ 6 points on non-enhanced CT.&#xD;
&#xD;
          6. If intravenous thrombolysis with tPA (IVT) is considered as part of standard medical&#xD;
             management, IVT should be started within 4.5 hours of estimated time of LVO.&#xD;
             Furthermore, in AIS patients with an unknown time of onset, IVT guided by a mismatch&#xD;
             between DWI and FLAIR in the region of ischemia is also recommended.&#xD;
&#xD;
          7. Written informed consent obtained from patient or patient's legally authorized&#xD;
             representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute posterior circulation cerebral infarction comfirmed by CT or MRI.&#xD;
&#xD;
          2. Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging.&#xD;
&#xD;
          3. Large (more than one-third of the MCA) regions of clear hypodensity on the baseline CT&#xD;
             scan or ASPECTS &lt; 7 points or significant mass effect with midline shift.&#xD;
&#xD;
          4. Proven occlusion of the common carotid artery.&#xD;
&#xD;
          5. Known or suspected chronic occlusion of target vessel.&#xD;
&#xD;
          6. Known life threatening allergy (more than rash) to iodinated contrast agent.&#xD;
&#xD;
          7. Arterial tortuosity and other problems that would prevent the device from reaching the&#xD;
             target vessel.&#xD;
&#xD;
          8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency.&#xD;
&#xD;
          9. Baseline platelet count &lt; 50000/µL.&#xD;
&#xD;
         10. Severe heart, liver or kidney failure and other serious or terminal illness.&#xD;
&#xD;
         11. Major surgery within the past 2 weeks&#xD;
&#xD;
         12. Haemorrhage of the gastrointestinal or urinary tract within the past 3 weeks.&#xD;
&#xD;
         13. Baseline blood glucose &lt; 2.7 or &gt; 22.2 mmol/L.&#xD;
&#xD;
         14. Baseline blood pressure &gt; 185/110 mmHg, or aggressive treatment (intravenous&#xD;
             medication) necessary to reduce blood pressure to these limits&#xD;
&#xD;
         15. Pregnant or lactating or positive pregnancy test on admission.&#xD;
&#xD;
         16. Dementia or psychiatric disease that would confound the neurological or functional&#xD;
             evaluations.&#xD;
&#xD;
         17. Life expectancy less than 1 year.&#xD;
&#xD;
         18. Current participation in another drug or device research.&#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_contact>
    <last_name>Zhongrong Miao, MD</last_name>
    <phone>86-010-67098857</phone>
    <email>13601243293@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yan Lin, Master</last_name>
    <phone>86-13911573513</phone>
    <email>yan.lin@hemochina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Quanshan Ai</last_name>
    </contact>
    <investigator>
      <last_name>Quanshan Ai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Luhe Hospital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaokun Geng</last_name>
    </contact>
    <investigator>
      <last_name>Xiaokun Geng</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100070</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhongrong Miao, MD</last_name>
    </contact>
    <investigator>
      <last_name>Zhongrong Miao, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhou Xing</last_name>
    </contact>
    <investigator>
      <last_name>Zhou Xing</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xinguang Yang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Hebei University</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhiqiang Li</last_name>
    </contact>
    <investigator>
      <last_name>Zhiqiang Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tangshan People's Hospital</name>
      <address>
        <city>Tangshan</city>
        <state>Hebei</state>
        <zip>063000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Wang</last_name>
    </contact>
    <investigator>
      <last_name>Yan Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Luoyang Central Hospital</name>
      <address>
        <city>Luoyang</city>
        <state>Henan</state>
        <zip>471000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liping Wei</last_name>
    </contact>
    <investigator>
      <last_name>Liping Wei</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henan Province People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tianxiao Li</last_name>
    </contact>
    <investigator>
      <last_name>Tianxiao Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheng Guan</last_name>
    </contact>
    <investigator>
      <last_name>Sheng Guan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhengzhou Central Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haibo Wang</last_name>
    </contact>
    <investigator>
      <last_name>Haibo Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Taihe Hospital</name>
      <address>
        <city>Shiyan</city>
        <state>Hubei</state>
        <zip>442000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhibing Ai</last_name>
    </contact>
    <investigator>
      <last_name>Zhibing Ai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Xuzhou Medical University</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinchun Ye</last_name>
    </contact>
    <investigator>
      <last_name>Xinchun Ye</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baotou Central Hospital</name>
      <address>
        <city>Baotou</city>
        <state>Neimenggu</state>
        <zip>014000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changchun Jiang</last_name>
    </contact>
    <investigator>
      <last_name>Changchun Jiang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenwei Zhao</last_name>
    </contact>
    <investigator>
      <last_name>Zhenwei Zhao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianfeng Han</last_name>
    </contact>
    <investigator>
      <last_name>Jianfeng Han</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Wu</last_name>
    </contact>
    <investigator>
      <last_name>Wei Wu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liaocheng People's Hospital</name>
      <address>
        <city>Liaocheng</city>
        <state>Shandong</state>
        <zip>252000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liyong Zhang</last_name>
    </contact>
    <investigator>
      <last_name>Liyong Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Qingdao Central Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haicheng Yuan</last_name>
    </contact>
    <investigator>
      <last_name>Haicheng Yuan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Weihai Central Hospital</name>
      <address>
        <city>Weihai</city>
        <state>Shandong</state>
        <zip>264400</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongjun Hou</last_name>
    </contact>
    <investigator>
      <last_name>Hongjun Hou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yantaishan Hospital</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <zip>264000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dianjing Sun</last_name>
    </contact>
    <investigator>
      <last_name>Dianjing Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>First Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Zhang</last_name>
    </contact>
    <investigator>
      <last_name>Jin Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin First Central Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Binge Chang</last_name>
    </contact>
    <investigator>
      <last_name>Binge Chang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Yang</last_name>
    </contact>
    <investigator>
      <last_name>Li Yang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Zhongrong Miao</investigator_full_name>
    <investigator_title>Chief of the Department of Interventional Neurology in Beijing Tiantan Hopital</investigator_title>
  </responsible_party>
  <keyword>Large vessel occlusion</keyword>
  <keyword>Acute ischemic stroke</keyword>
  <keyword>Endovascular treatment</keyword>
  <keyword>Mechanical thrombectomy</keyword>
  <keyword>Aspiration Catheter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Intracranial Thrombosis</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Ischemia</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/NCT03753061
org study id: HEMO-CS1802
nct id: NCT03753061
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, multi-center, open-label, end-point blinded, randomized,
      parallel positive control, non-inferiority clinical trial, with a purpose to evaluate the
      safety and efficacy of Hemo Jirui intracranial thrombus aspiration catheter system for
      endovascular treatment of acute ischemic stroke by comparison with stent retriever (Solitaire
      FR). The trial is anticipated to last from November 2018 to May 2019, with 204 subjects
      recruited from 15-20 clinical trial centers in China.
This study is a prospective, multi-center, open-label, end-point blinded, parallel positive
      controlled, non-inferiority clinical trial. Patients with acute ischemic stroke (AIS) who
      meet inclusion criteria would be enrolled in this study. Led by Beijing Tiantan Hospital
      affiliated to Capital Medical University, this study is planned to be carried out in 15-20
      clinical trial institutions in China. There will be 102 patients enrolled in each group.
      Patients in the experimental group will be treated with the intracranial thrombus aspiration
      catheter, product of Hemo Jirui. Patients in the control group will be treated with stent
      retriever (Solitaire FR).

      In this trial, relevant examinations of safety and efficacy assessments were performed
      immediately after the procedure, at 24 hours, 7 days, 30 days, and 90 days. Primary efficacy
      endpoint will be the immediate recanalization rate (mTICI 2b-3) of target vessel after the
      procedure. Secondary efficacy endpoints will include: (1) Proportion of functional
      independence (mRS 0-2) at 90 days; (2) ordinal shift analysis of mRS at 90 days; (3)
      immediate recanalization rate (mTICI 2b-3) of the first pass of thrombectomy device; (4)
      immediate recanalization rate (mTICI 2b-3) of the last pass of thrombectomy device;
      (5)procedure time (randomization to recanalization); (6) Change in NIHSS score at 24hours;
      (7) Change in NIHSS score at 7 days or discharge (whichever comes first); (8) mTICI grading
      of target vessel revealed by CTA or MRA at 22-36 hours; (9) The extent of anterior
      circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI. Safety endpoints
      will include: (1) All-cause mortality at 90 days; (2) stroke-related mortality at 90 days;
      (3) stroke recurrence rate within 90 days; (4) any type of intracranial hemorrhagic
      transformation within 22-36 hours, including parenchymal, subarachnoid or ventricular
      hemorrhage; (5) symptomatic intracranial hemorrhage (sICH) within 22-36 hours, as confirmed
      by any intracranial hemorrhage on CT or MRI associated with ≥ 4 points of worsening on NIHSS
      or even contributing to death; (5) procedural complications or serious adverse events
      procedural complications or serious adverse events (SAEs) within 90 days.

      The trial is anticipated to last from November 2018 to May 2019, all the related
      investigative organization and individuals will obey the Declaration of Helsinki and Chinese
      Good Clinical Practice standard. The trial has been approved by Institutional Review Board
      (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure
time frame: immediate
measure: Proportion of functional independence (mRS 0-2) at 90 days
time frame: 90 days
measure: Ordinal shift analysis of mRS at 90 days
time frame: 90 days
measure: Instant recanalization rate (mTICI 2b-3) after the first thrombectomy
time frame: immediate
measure: Instant recanalization rate (mTICI 2b-3) after the last thrombectomy
time frame: immediate
measure: Procedure time (randomization to recanalization)
time frame: procedure
measure: Change in NIHSS score at 24±2 hours
time frame: 24 hours
measure: Change in NIHSS score at 7±1 days or discharge (whichever comes first)
time frame: 7 days
measure: mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours
time frame: 22-36 hours
measure: The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI
time frame: 22-36 hours
arm group label: Aspiration Catheter
arm group type: Experimental
description: Mechanical thrombectomy with Aspiration Catheter.
arm group label: Stent Retriever (Solitaire FR)
arm group type: Active Comparator
description: Mechanical thrombectomy with Solitaire FR.
intervention type: Device
intervention name: Aspiration Catheter
description: Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.
arm group label: Aspiration Catheter
intervention type: Device
intervention name: Solitaire FR
description: Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.
arm group label: Stent Retriever (Solitaire FR)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhongrong Miao, MD
phone: 86-010-67098857
email: 13601243293@163.com
last name: Yan Lin, Master
phone: 86-13911573513
email: yan.lin@hemochina.com
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country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Zhongrong Miao
investigator title: Chief of the Department of Interventional Neurology in Beijing Tiantan Hopital
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Cerebrovascular Disorders
mesh term: Intracranial Thrombosis
mesh term: Thrombosis
mesh term: Ischemia