<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/NCT04466033</url>
  </required_header>
  <id_info>
    <org_study_id>C14-CLN002</org_study_id>
    <nct_id>NCT04466033</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Performance of Magneto Microcatheter</brief_title>
  <official_title>Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Magneto Thrombectomy Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Magneto Thrombectomy Solutions</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>
      A prospective, open label single arm feasibility study to evaluate the safety and performance&#xD;
      of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for&#xD;
      thrombectomy procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</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>Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure</measure>
    <time_frame>24 hours</time_frame>
    <description>Occurrence of device related Serious Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure</measure>
    <time_frame>90 days</time_frame>
    <description>Occurrence of device related Serious Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use</measure>
    <time_frame>During Procedure</time_frame>
    <description>Assessment of device performance in clot removal (TICI scale to evaluate revascularization) and ease of use (questionnaire that will be completed by the treating physician post procedure)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Magneto Microcatheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magneto Microcatheter</intervention_name>
    <description>All patients will be treated with Magneto Microcatheter</description>
    <arm_group_label>Magneto Microcatheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical signs consistent with acute ischemic stroke&#xD;
&#xD;
          2. Patient with Acute Ischemic Stroke within 24 hours from symptoms o&#xD;
&#xD;
          3. Age 18-85 years old&#xD;
&#xD;
          4. Consent process is completed per international and local regulations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known use of cocaine or other vasoactive substance&#xD;
&#xD;
          2. Known bleeding diathesis&#xD;
&#xD;
          3. Any known hemorrhagic or coagulation deficiency.&#xD;
&#xD;
          4. Current use of oral anticoagulants with International Normalized Ratio (INR) &gt; 3;&#xD;
&#xD;
          5. PTT (Partial Thromboplastin Time)&gt;2 at screening&#xD;
&#xD;
          6. Uncontrolled hypertension (Systolic blood pressure&gt;185 or Diastolic blood&#xD;
             pressure&gt;110) refractory to pharmacological management&#xD;
&#xD;
          7. Pregnant or lactating female&#xD;
&#xD;
          8. CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score&lt;6, mass&#xD;
             effect and/or intracranial tumor&#xD;
&#xD;
          9. Angiographic evidence of either carotid dissection or vasculitis at the target site or&#xD;
             any condition that may limit device access to the target site (i.e high grade&#xD;
             stenosis) per the treating physician's discretion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Marzelik</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr.Amsalem</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaare Zedek, Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shelly Sharon</last_name>
    <phone>0765300768</phone>
    <email>shelly@magts.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shaare Zedek</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yaakov Amsalem, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oleg Merzlyak, Dr.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>June 24, 2021</last_update_submitted>
  <last_update_submitted_qc>June 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</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>


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/NCT04466033
org study id: C14-CLN002
nct id: NCT04466033
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A prospective, open label single arm feasibility study to evaluate the safety and performance
      of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for
      thrombectomy procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure
time frame: 24 hours
description: Occurrence of device related Serious Adverse Events
measure: Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure
time frame: 90 days
description: Occurrence of device related Serious Adverse Events
measure: Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use
time frame: During Procedure
description: Assessment of device performance in clot removal (TICI scale to evaluate revascularization) and ease of use (questionnaire that will be completed by the treating physician post procedure)
arm group label: Magneto Microcatheter
arm group type: Experimental
intervention type: Device
intervention name: Magneto Microcatheter
description: All patients will be treated with Magneto Microcatheter
arm group label: Magneto Microcatheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Dr. Marzelik
role: Principal Investigator
affiliation: Sheba Medical Center
last name: Dr.Amsalem
role: Principal Investigator
affiliation: Shaare Zedek, Israel
last name: Shelly Sharon
phone: 0765300768
email: shelly@magts.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Ischemic Stroke
sharing ipd: No