<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/NCT03820882</url>
  </required_header>
  <id_info>
    <org_study_id>JSSKBMCT001</org_study_id>
    <nct_id>NCT03820882</nct_id>
  </id_info>
  <brief_title>Stent Retriever for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke(Catfish)</brief_title>
  <official_title>Catfish Flow Restoration Device for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke: a Randomised, Parallel-group, Non-inferiority Trial</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>
      The study is a randomized, prospective, parallel-group, multicenter, open-label,&#xD;
      non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(Catfish) or&#xD;
      Solitaire for endovascular therapy for acute ischemic stroke. The study aims to evaluate the&#xD;
      benefit and safety of stent retriever(Catfish) for acute ischemic stroke therapy, as compared&#xD;
      to Solitaire FR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective is to determine whether stent retriever(Catfish) will have non-inferior&#xD;
      successful recanalization rate compared to Solitaire in patients with acute ischemic stroke&#xD;
      caused by large vessel occlusion.&#xD;
&#xD;
      The secondary objectives is to verify whether there is significant differences in time from&#xD;
      artery puncture to successful recanalization (mTICI 2b or greater), NIHSS score at 24 hours&#xD;
      and at 7 days or discharge if earlier, good clinical outcomes at 90 days (defined as mRS&#xD;
      score ≤2) between stent retriever(Catfish) and Solitaire in patients with acute ischemic&#xD;
      stroke caused by large vessel occlusion.&#xD;
&#xD;
      The third objectives is to compare the rate of symptomatic intracranial hemorrhage, serious&#xD;
      adverse event(SAE), all cause of mortality with 90 days after operation, between stent&#xD;
      retriever (Catfish) and Solitaire in patients with acute ischemic stroke due to large vessel&#xD;
      occlusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2019</start_date>
  <completion_date type="Actual">June 5, 2021</completion_date>
  <primary_completion_date type="Actual">January 5, 2021</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>
    <intervention_model_description>prospective, randomized, open-label, parallel assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</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>
    <description>Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA(digital subtraction angiography ) intraoperative immediately in both treatment groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to achieve recanalization</measure>
    <time_frame>intraprocedure immediate</time_frame>
    <description>The period from femoral artery puncture to successful recanalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS score at 24±2 hours</measure>
    <time_frame>24±2 hours</time_frame>
    <description>National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS score at 7±1 days or discharge</measure>
    <time_frame>7±1 days</time_frame>
    <description>National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients who got a mRS 0-2 at 90±14 days</measure>
    <time_frame>90±14 days</time_frame>
    <description>The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment.the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptomatic intracranial hemorrhage after procedure</measure>
    <time_frame>24±2 hours</time_frame>
    <description>sICH was defined as any type of ICH on neuroimaging after the treatment within 24±2 hours after procedure with increasing of ≥4 points on NIHSS, National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serious adverse event(SAE) within 90±14 days after procedure</measure>
    <time_frame>90±14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all cause of mortality within 90±14 days after procedure</measure>
    <time_frame>90±14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>stent retriever(Catfish)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mechanical thrombectomy with Catfish flow restoration device</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 flow restoration device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Catfish</intervention_name>
    <description>Patients will be treated for mechanical recanalization with Catfish within 8 hours after stroke onset plus standard medical management.</description>
    <arm_group_label>stent retriever(Catfish)</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. 18≤ages≤80;&#xD;
&#xD;
          2. mRS score must lower than 2 Pre-AIS(acute ischemic stroke).&#xD;
&#xD;
          3. Baseline NIHSS score obtained prior to randomization must be between 8 and 25;&#xD;
&#xD;
          4. Symptoms and signs in accordance with Large vessel occlusion, confirmed by CTA(CT&#xD;
             angiogram)/MRA(magnetic resonance angiography )/DSA;&#xD;
&#xD;
          5. Patient treatable within 8 hours of symptom onset (symptoms onset is defined as point&#xD;
             in time the patient was last seen well (at baseline)) can accept the complete femoral&#xD;
             artery puncture;&#xD;
&#xD;
          6. Baseline Alberta stroke program early CT score (ASPECTS) or posterior circulation&#xD;
             Alberta stroke program early CT score (pc-ASPECTS)≥ 6 on Computed tomography (CT) or&#xD;
             magnetic resonance imaging(MRI).&#xD;
&#xD;
          7. The patient or relative give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of stroke in past 3 months.&#xD;
&#xD;
          2. Presumed septic embolus, or suspicion of bacterial endocarditis.&#xD;
&#xD;
          3. Evidence of tortuosity of cervical vessels precluding device delivery/deployment;&#xD;
&#xD;
          4. Hypertension (Systolic blood pressure(SBP)&gt;185 mmHg or diastolic blood&#xD;
             pressure(DBP)&gt;110 mm Hg) after using drug;&#xD;
&#xD;
          5. Platelet count&lt;30,000/μL and use of Novel Anticoagulant with International Normalized&#xD;
             Ratio(INR)&gt;3.0;&#xD;
&#xD;
          6. Random blood glucose of&lt;2.7mmol/L or&gt;22.2mmol/L;&#xD;
&#xD;
          7. Patients with heart or lung or liver or renal failure or other sever disease&#xD;
             (intracranial tumors, cerebral arteriovenous malformation (AVM), systemic infection,&#xD;
             active disseminated intravascular coagulation, history of sever psychosis);&#xD;
&#xD;
          8. Patients with Dementia or psychiatric disease that would confound the neurological or&#xD;
             functional evaluations.&#xD;
&#xD;
          9. Anticipated life expectancy of less than 6 months;&#xD;
&#xD;
         10. Known serious sensitivity to contrast medium and nitinol metal;&#xD;
&#xD;
         11. Females who are pregnant or breastfeeding;&#xD;
&#xD;
         12. Current participation in any other clinical trial;&#xD;
&#xD;
         13. The patient or the patient's legally authorized representative hasn't signed and dated&#xD;
             an informed consent form;&#xD;
&#xD;
         14. Rapidly improving neurologic examination.&#xD;
&#xD;
         15. Excessive vascular access tortuosity that will likely result in unstable access&#xD;
             platform.&#xD;
&#xD;
         16. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.&#xD;
&#xD;
         17. Suspected intracranial dissection or cerebral vasculitis.&#xD;
&#xD;
         18. Evidence of tandem cervical occlusion, or stenosis requiring treatment.&#xD;
&#xD;
         19. Major surgery or significant trauma in the past 30 days or plan to have surgery in&#xD;
             next 3 months after enrolled.&#xD;
&#xD;
         20. CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma)&#xD;
&#xD;
         21. Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging&#xD;
&#xD;
         22. The subject is not appropriate for mechanical thrombectomy intervention in the opinion&#xD;
             of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhongrong Miao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tiantan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tiantan hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>10000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>September 23, 2022</last_update_submitted>
  <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Science and Technology of the People´s Republic of China</investigator_affiliation>
    <investigator_full_name>Zhongrong Miao</investigator_full_name>
    <investigator_title>Director, Head of Neurointerventional, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <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>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/NCT03820882
org study id: JSSKBMCT001
nct id: NCT03820882
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is a randomized, prospective, parallel-group, multicenter, open-label,
      non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(Catfish) or
      Solitaire for endovascular therapy for acute ischemic stroke. The study aims to evaluate the
      benefit and safety of stent retriever(Catfish) for acute ischemic stroke therapy, as compared
      to Solitaire FR.
The main objective is to determine whether stent retriever(Catfish) will have non-inferior
      successful recanalization rate compared to Solitaire in patients with acute ischemic stroke
      caused by large vessel occlusion.

      The secondary objectives is to verify whether there is significant differences in time from
      artery puncture to successful recanalization (mTICI 2b or greater), NIHSS score at 24 hours
      and at 7 days or discharge if earlier, good clinical outcomes at 90 days (defined as mRS
      score ≤2) between stent retriever(Catfish) and Solitaire in patients with acute ischemic
      stroke caused by large vessel occlusion.

      The third objectives is to compare the rate of symptomatic intracranial hemorrhage, serious
      adverse event(SAE), all cause of mortality with 90 days after operation, between stent
      retriever (Catfish) and Solitaire in patients with acute ischemic stroke due to large vessel
      occlusion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized, open-label, parallel assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure
time frame: immediate
description: Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA(digital subtraction angiography ) intraoperative immediately in both treatment groups
measure: Time to achieve recanalization
time frame: intraprocedure immediate
description: The period from femoral artery puncture to successful recanalization
measure: NIHSS score at 24±2 hours
time frame: 24±2 hours
description: National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits
measure: NIHSS score at 7±1 days or discharge
time frame: 7±1 days
description: National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits
measure: proportion of patients who got a mRS 0-2 at 90±14 days
time frame: 90±14 days
description: The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment.the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)
measure: symptomatic intracranial hemorrhage after procedure
time frame: 24±2 hours
description: sICH was defined as any type of ICH on neuroimaging after the treatment within 24±2 hours after procedure with increasing of ≥4 points on NIHSS, National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits
measure: serious adverse event(SAE) within 90±14 days after procedure
time frame: 90±14 days
measure: all cause of mortality within 90±14 days after procedure
time frame: 90±14 days
arm group label: stent retriever(Catfish)
arm group type: Experimental
description: Mechanical thrombectomy with Catfish flow restoration device
arm group label: stent retriever(Solitaire FR)
arm group type: Active Comparator
description: Mechanical thrombectomy with Solitaire FR flow restoration device
intervention type: Device
intervention name: Catfish
description: Patients will be treated for mechanical recanalization with Catfish within 8 hours after stroke onset plus standard medical management.
arm group label: stent retriever(Catfish)
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: 80 Years
healthy volunteers: No
last name: Zhongrong Miao, MD
role: Principal Investigator
affiliation: Beijing Tiantan Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ministry of Science and Technology of the People´s Republic of China
investigator full name: Zhongrong Miao
investigator title: Director, Head of Neurointerventional, Principal Investigator, Clinical Professor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia