<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/NCT04437862</url>
  </required_header>
  <id_info>
    <org_study_id>101773</org_study_id>
    <nct_id>NCT04437862</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke</brief_title>
  <acronym>EvaQ</acronym>
  <official_title>A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MIVI Neuroscience, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MIVI Neuroscience, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the safety and efficacy of the Q Revascularization System to remove thrombi and emboli&#xD;
      from the neurovasculature in patients experiencing an acute ischemic stroke&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2020</start_date>
  <completion_date type="Actual">August 2, 2023</completion_date>
  <primary_completion_date type="Actual">April 21, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful revascularization rate</measure>
    <time_frame>Procedure end</time_frame>
    <description>Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptomatic intracranial haemorrhage rate</measure>
    <time_frame>36 hours post procedure</time_frame>
    <description>Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful revascularization rate with study device</measure>
    <time_frame>Procedure</time_frame>
    <description>Successful revascularization defined as mTICI 2b-3 flow after all aspiration attempts with the study device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful revascularization rate on the first attempt with study device</measure>
    <time_frame>Procedure</time_frame>
    <description>Successful revascularization defined as mTICI 2b-3 flow after the first aspiration attempt with the study device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Time</measure>
    <time_frame>Procedure</time_frame>
    <description>Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ENT rate</measure>
    <time_frame>Procedure</time_frame>
    <description>Embolization to a new vascular territory (ENT) during procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Complications</measure>
    <time_frame>Procedure through 90 days</time_frame>
    <description>Rate of procedure related complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICH</measure>
    <time_frame>36 hours post procedure</time_frame>
    <description>Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Good functional outcome</measure>
    <time_frame>90 days post procedure</time_frame>
    <description>Good functional outcome measured by Modified Rankin Score (mRS) defined as a value of 0-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days post procedure</time_frame>
    <description>All cause mortality</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Acute Stroke</condition>
  <condition>Cerebral Ischemia</condition>
  <arm_group>
    <arm_group_label>Q Revascularization System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Q Revascularization System</intervention_name>
    <description>Q Revascularization System for mechanical thrombectomy</description>
    <arm_group_label>Q Revascularization System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Pre-stroke independent functional status in activities of daily living with mRS 0-1.&#xD;
&#xD;
          -  A disabling stroke defined as NIHSS ≥ 6&#xD;
&#xD;
          -  In USA thrombolytic therapy (IV tPA) received within 3 hours of onset/ last known&#xD;
             well, in Europe treatment with IV tPA received within 4.5 hours from onset/ last known&#xD;
             well OR ineligibility for thrombolytic therapy&#xD;
&#xD;
          -  Endovascular treatment intended to be initiated &lt; 8 hours from onset of symptoms or&#xD;
             last known well time&#xD;
&#xD;
          -  Confirmed symptomatic large vessel occlusion of the intracranial internal carotid&#xD;
             artery, middle cerebral artery, M1, M2, basilar or intracerebral vertebral artery by&#xD;
             baseline neuroimaging CTA/MRA and angiographic imaging with a mTICI Score 0-1&#xD;
&#xD;
          -  For strokes in the anterior circulation the following imaging criteria should also be&#xD;
             met: MRI criterion of volume of diffusion restriction visually assessed ≤50 mL OR CT&#xD;
             criterion of ASPECTS 6 to 10 on baseline CT or CTA-source images or, significantly&#xD;
             lowered cerebral blood volume (CBV) ≤50 mL&#xD;
&#xD;
          -  For strokes in the basilar or vertebral artery, the following imaging criterion should&#xD;
             also be met: pc-ASPECTS score 8 to 10 on baseline CT, CTA-source images, or MRI&#xD;
&#xD;
          -  Signed informed consent from subject, acceptable person responsible (e.g. LAR) and/or&#xD;
             according to County specific regulatory requirements and local ethical committee or&#xD;
             review board requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CT or MRI evidence of intracranial hemorrhage on presentation&#xD;
&#xD;
          -  CT or MRI showing mass effect or intracranial tumor (meningioma &gt; 2 cm in diameter).&#xD;
&#xD;
          -  Previous stroke within the past 3 months&#xD;
&#xD;
          -  Rapidly improving neurological status as determined by Investigator/Neurologist&#xD;
&#xD;
          -  Renal failure/insufficiency with &gt;3.0 mg/dL creatinine prior to procedure&#xD;
&#xD;
          -  Severe, sustained hypertension resistant to treatment (SBP &gt;185 mmHg or DBP &gt;110 mmHg)&#xD;
&#xD;
          -  Use of warfarin anticoagulation with International Normalized Ratio (INR) &gt; 3.0 at the&#xD;
             time of the procedure or any known hemorrhagic or coagulation deficiency&#xD;
&#xD;
          -  For patients who have received a direct thrombin inhibitor within the last 48 hours;&#xD;
             partial thromboplastin time (PTT) &gt; 2.0 times the normal prior to procedure&#xD;
&#xD;
          -  Platelet count &lt; 50,000 mm3&#xD;
&#xD;
          -  Cerebral vasculitis or evidence of active systemic infection&#xD;
&#xD;
          -  Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial&#xD;
             endocarditis&#xD;
&#xD;
          -  Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular&#xD;
             territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)&#xD;
&#xD;
          -  Seizure due to stroke&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe contrast allergy or absolute contraindication to iodinated contrast&#xD;
&#xD;
          -  Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or&#xD;
             stenting at time of the procedure&#xD;
&#xD;
          -  Difficult endovascular access or difficult aortic arch or severe neurovascular&#xD;
             tortuosity that will result in an inability to deliver endovascular therapy&#xD;
&#xD;
          -  Evidence of dissection in the carotid or target artery for treatment&#xD;
&#xD;
          -  Clinical history, past imaging or clinical judgment suggests that the intracranial&#xD;
             occlusion is chronic&#xD;
&#xD;
          -  Active participation in another study involving an investigational drug or device&#xD;
&#xD;
          -  A severe or fatal comorbid illness that will prevent improvement or follow-up or that&#xD;
             will render the procedure unlikely to benefit the patient&#xD;
&#xD;
          -  Unwillingness to complete follow up visits&#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>Christopher Cognard, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Purpan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lucas Elijovich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee Health Sciences Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian Jankowitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Medicine at the University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper University Health Care</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University at Buffalo Neurosurgery</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Urbains</name>
      <address>
        <city>Nancy</city>
        <zip>54035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bicetre Paris</name>
      <address>
        <city>Paris</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Purpan</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Brain Ischemia</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04437862
org study id: 101773
nct id: NCT04437862
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Assess the safety and efficacy of the Q Revascularization System to remove thrombi and emboli
      from the neurovasculature in patients experiencing an acute ischemic stroke
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful revascularization rate
time frame: Procedure end
description: Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure
measure: Symptomatic intracranial haemorrhage rate
time frame: 36 hours post procedure
description: Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4
measure: Successful revascularization rate with study device
time frame: Procedure
description: Successful revascularization defined as mTICI 2b-3 flow after all aspiration attempts with the study device
measure: Successful revascularization rate on the first attempt with study device
time frame: Procedure
description: Successful revascularization defined as mTICI 2b-3 flow after the first aspiration attempt with the study device
measure: Procedure Time
time frame: Procedure
description: Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow
measure: ENT rate
time frame: Procedure
description: Embolization to a new vascular territory (ENT) during procedure
measure: Procedure Complications
time frame: Procedure through 90 days
description: Rate of procedure related complications
measure: ICH
time frame: 36 hours post procedure
description: Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification.
measure: Good functional outcome
time frame: 90 days post procedure
description: Good functional outcome measured by Modified Rankin Score (mRS) defined as a value of 0-2
measure: Mortality
time frame: 90 days post procedure
description: All cause mortality
arm group label: Q Revascularization System
arm group type: Experimental
intervention type: Device
intervention name: Q Revascularization System
description: Q Revascularization System for mechanical thrombectomy
arm group label: Q Revascularization System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher Cognard, PhD, MD
role: Principal Investigator
affiliation: Hôpital Purpan
last name: Lucas Elijovich, MD
role: Principal Investigator
affiliation: University of Tennessee Health Sciences Center
last name: Brian Jankowitz, MD
role: Principal Investigator
affiliation: School of Medicine at the University of Pennsylvania
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Brain Ischemia
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No