xml: <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/NCT06042335</url>
    </required_header>
    <id_info>
      <org_study_id>102699</org_study_id>
      <nct_id>NCT06042335</nct_id>
    </id_info>
    <brief_title>A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific</brief_title>
    <official_title>A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is a prospective, multi-center, single arm, feasibility study that will enroll a&#xD;
        maximum of 20 subjects. A maximum of 5 investigational centers in Australia will participate.&#xD;
        Enrollment is expected to take about 4 months, subject participation will last about 3&#xD;
        months.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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</measure>
      <time_frame>Procedure</time_frame>
      <description>Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure</measure>
      <time_frame>12-36 hours</time_frame>
      <description>Defined as proportion of subjects with Symptomatic intracranial haemorrhage (sICH) at 24 hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Acute Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>DAISe EZ</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DAISe EZ</intervention_name>
      <description>DAISe Thrombectomy System for mechanical thrombectomy</description>
      <arm_group_label>DAISe EZ</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Age 18 years or older. 2. Pre-stroke (24 hours prior to stroke onset) independent&#xD;
               functional status in activities of daily living with modified Rankin Score 0-2.&#xD;
  &#xD;
               3. Diagnosis of acute ischemic stroke with study enrollment time &lt; 24 hours from onset&#xD;
               of symptoms.&#xD;
  &#xD;
               4. Disabling stroke defined as a baseline NIHSS &gt; 6. 5. Confirmed symptomatic, large&#xD;
               vessel occlusion of the intracranial internal carotid artery (ICA), MCA-M1 or MCA-M2.&#xD;
  &#xD;
               6. The following imaging criteria must also be met:&#xD;
  &#xD;
                 -  For subjects 0-6hrs onset:&#xD;
  &#xD;
                      -  MRI criterion: volume of diffusion restriction as assessed by automated core&#xD;
                         volume software ≤50 mL OR&#xD;
  &#xD;
                      -  CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images or,&#xD;
                         computed tomography perfusion (CPT) core as assessed by automated core&#xD;
                         volume software ≤50 mL.&#xD;
  &#xD;
                 -  For subjects 6-24hrs onset:&#xD;
  &#xD;
                      -  ≤20mL ischemic core volume if age &gt;80&#xD;
  &#xD;
                      -  ≤30mL ischemic core volume if age &lt;80 and NIHSS 10-20&#xD;
  &#xD;
                 -  The following imaging criteria must also be met:&#xD;
  &#xD;
                      -  ≤50mL ischemic core volume if age &lt;80 and NIHSS &gt;20 7. Signed informed&#xD;
                         consent from patient or legal representative&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh&#xD;
               hemorrhage on presentation.&#xD;
  &#xD;
            2. Clinical history, past imaging or clinical judgment suggests that the intracranial&#xD;
               occlusion is chronic.&#xD;
  &#xD;
            3. Rapidly improving neurological deficits based on the investigator's clinical&#xD;
               judgement.&#xD;
  &#xD;
            4. Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test&#xD;
               is positive.&#xD;
  &#xD;
            5. Severe contrast allergy or absolute contraindication to iodinated contrast.&#xD;
  &#xD;
            6. Difficult endovascular access, difficult aortic arch or severe neurovascular&#xD;
               tortuosity that will result in an inability to deliver endovascular therapy.&#xD;
  &#xD;
            7. Evidence of dissection in the carotid or target artery for treatment.&#xD;
  &#xD;
            8. Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or&#xD;
               stenting at time of the procedure.&#xD;
  &#xD;
            9. Renal failure (on dialysis).&#xD;
  &#xD;
           10. Severe, sustained hypertension resistant to treatment (SBP &gt;185 mmHg or DBP &gt;110&#xD;
               mmHg).&#xD;
  &#xD;
           11. 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;
           12. Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin&#xD;
               time (PTT) &gt; 2.0 times the normal prior to procedure.&#xD;
  &#xD;
           13. Cerebral vasculitis or evidence of active systemic infection.&#xD;
  &#xD;
           14. Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial&#xD;
               endocarditis.&#xD;
  &#xD;
           15. Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular&#xD;
               territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).&#xD;
  &#xD;
           16. 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;
               -&#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>Stephanie Cihlar</last_name>
      <phone>763-227-7833</phone>
      <email>scihlar@mivineuroscience.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</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 18, 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>Ischemic Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042335
  org study id: 102699
  nct id: NCT06042335
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  The study is a prospective, multi-center, single arm, feasibility study that will enroll a
        maximum of 20 subjects. A maximum of 5 investigational centers in Australia will participate.
        Enrollment is expected to take about 4 months, subject participation will last about 3
        months.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Successful revascularization
  time frame: Procedure
  description: Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.
  measure: Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
  time frame: 12-36 hours
  description: Defined as proportion of subjects with Symptomatic intracranial haemorrhage (sICH) at 24 hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4.
  arm group label: DAISe EZ
  arm group type: Experimental
  description: Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.
  intervention type: Device
  intervention name: DAISe EZ
  description: DAISe Thrombectomy System for mechanical thrombectomy
  arm group label: DAISe EZ
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephanie Cihlar
  phone: 763-227-7833
  email: scihlar@mivineuroscience.com
  responsible party type: Sponsor
  mesh term: Ischemic Stroke
  sharing ipd: No