<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/NCT03781622</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN 0001-CAN</org_study_id>
    <nct_id>NCT03781622</nct_id>
  </id_info>
  <brief_title>WOLF - Feasibility Neurothrombectomy Study in Acute Ischemic Stroke Patients</brief_title>
  <acronym>WOLF</acronym>
  <official_title>WOLF - Prospective Feasibility Clinical Investigation to Evaluate the Safety and Technical Performance of the WOLF Thrombectomy Device in Acute Ischemic Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>880 Medical, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>880 Medical, LLC</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>
      This study is being conducted as a feasibility clinical investigation to collect safety and&#xD;
      technical performance data of the WOLF Thrombectomy Device for the removal of thrombus in the&#xD;
      neurovasculature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has been designed as a prospective, non-randomized, multi-center, feasibility&#xD;
      clinical investigation to evaluate the safety and device technical performance of the WOLF&#xD;
      Thrombectomy Device in removing thrombus from an occluded large intracranial vessel(s) in&#xD;
      patients with acute ischemic stroke. The device may be used alone or as an adjunct to&#xD;
      intravenous tissue plasminogen activator (tPA) and/or to other traditional, thrombectomy&#xD;
      modalities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Poor enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">June 13, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>
    <intervention_model_description>A prospective, non-randomized, multi-center, feasibility clinical investigation to evaluate the safety and device technical performance of the WOLF Thrombectomy Device in removing thrombus from an occluded large intracranial vessel(s) in patients with acute ischemic stroke. The device may be used alone or as an adjunct to intravenous tissue plasminogen activator (tPA) and/or to other traditional, thrombectomy modalities.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Technical Success Endpoint</measure>
    <time_frame>At index procedure</time_frame>
    <description>Technical Success defined as the ability to achieve a revascularization rate (Thrombolysis in cerebral infarction [TICI] 2b/3) of ≥50% with the first pass of the WOLF Thrombectomy device. Revascularization is assessed by the investigator using fluoroscopy and after the first pass of the device is assessed using the TICI scale. Additional passes will be performed as necessary and the total number of attempts to achieve revascularization documented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Endpoint</measure>
    <time_frame>At index procedure and through 24 hours post procedure.</time_frame>
    <description>WOLF device-related adverse events (incidence, relationship to device and severity) at index procedure and through 24 hours post procedure.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>WOLF Thrombectomy Device Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients enrolled in the study who received the treatment and who met all Inclusion and Exclusion Criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WOLF Thrombectomy Device</intervention_name>
    <description>Mechanical thrombectomy for the neurovasculature</description>
    <arm_group_label>WOLF Thrombectomy Device Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects age ≥18 years (no upper limit).&#xD;
&#xD;
          2. NIHSS &gt; 6 at the time of baseline neuro imaging.&#xD;
&#xD;
          3. Endovascular treatment intended to be initiated within 60 minutes of qualifying&#xD;
             neuroimaging and intended vessel recanalization within 90 minutes of qualifying&#xD;
             neuroimaging.&#xD;
&#xD;
          4. Stroke symptom onset within 24hrs of when groin puncture can be obtained.&#xD;
&#xD;
          5. Anterior and posterior circulation large vessel occlusion as confirmed through neuro&#xD;
             imaging (CT/CTA/mCTA/MRI/MRA).&#xD;
&#xD;
          6. Neurovascular imaging (CTA/mCTA and or MRA) must include the aortic arch, cervical&#xD;
             vessels and intracranial circulation.&#xD;
&#xD;
          7. Advanced neurovascular imaging is required for patients when groin puncture can be&#xD;
             obtained after 6 hours and before 24 hours (multiphase CTA, CT Perfusion or perfusion&#xD;
             diffusion imaging).&#xD;
&#xD;
          8. The occlusion is located in a proximal intracranial artery (carotid artery, M1 segment&#xD;
             of the MCA, or proximal M2 divisions) of the anterior circulation for patients after 6&#xD;
             hours and before 24 hours.&#xD;
&#xD;
          9. There is imaging and clinical evidence of small core and large areas at risk, defined&#xD;
             in the previous trials (DAWN &amp; DEFUSE 3) as either:&#xD;
&#xD;
             i. NIHSS ≥10 and either 0-21 ml core infarct (≥80 years old) or 0-31 ml core infarct&#xD;
             (&lt;80 years old), or NIHSS≥20 and 31 to &lt;51ml core infarct and &lt;80 years old (DAWN&#xD;
             trial criteria).&#xD;
&#xD;
             OR ii. Ischemic core volume is &lt; 70 ml, mismatch ratio is &gt;/= 1.8 and mismatch volume*&#xD;
             is &gt;/= 15 ml (DEFUSE 3 trial criteria).&#xD;
&#xD;
         10. Pre-stroke disability limited to patients with mRS ≤ 2.&#xD;
&#xD;
         11. Written informed consent to participate given by subject or legal / authorized&#xD;
             representative per local ethics committee requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subject is known to be pregnant.&#xD;
&#xD;
          2. Absence of large vessel occlusion on neuro imaging.&#xD;
&#xD;
          3. Presence of existing or preexisting large vessel infarction.&#xD;
&#xD;
          4. Angiographic evidence of excessive arterial tortuosity or access that precludes the&#xD;
             WOLF device from reaching the thrombus.&#xD;
&#xD;
          5. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant&#xD;
             therapy with INR &gt;2.5.&#xD;
&#xD;
          6. Patient has a known hypersensitivity to contrast media.&#xD;
&#xD;
          7. Medical reasons the procedure cannot be performed (i.e. patient is experiencing&#xD;
             active, uncontrolled bleeding, etc.)&#xD;
&#xD;
          8. Subject is known to be currently enrolled in another investigational trial that could&#xD;
             interfere with the endpoint analysis of this trial.&#xD;
&#xD;
          9. ASPECT &lt; 5 or &gt; 1/3 MCA vascular territory compromised as evidenced by CT or MRI.&#xD;
&#xD;
         10. Significant mass effect and mid-line shift.&#xD;
&#xD;
         11. Any evidence of intracranial hemorrhage on imaging.&#xD;
&#xD;
         12. For posterior circulation large vessel occlusion evidence of completed significant&#xD;
             brain stem infarction.&#xD;
&#xD;
         13. Posterior circulation after 6 hours.&#xD;
&#xD;
         14. Patients are known to have severe psychiatric disorders, substance abuse, or other&#xD;
             reason for being unable to follow trial follow-up instructions.&#xD;
&#xD;
         15. Subject has a known significant concomitant illness with a life expectancy of &lt;6&#xD;
             months.&#xD;
&#xD;
         16. Subject has a known allergy to nickel.&#xD;
&#xD;
         17. Subject has a known history of severe intracranial atherosclerotic disease (ICAD).&#xD;
&#xD;
         18. Subject is unlikely to be able and willing to comply with site standard medical follow&#xD;
             up to 90 days.&#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>Brian van Adel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamilton General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal University Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N5A2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</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>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/NCT03781622
org study id: CLIN 0001-CAN
nct id: NCT03781622
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
This study is being conducted as a feasibility clinical investigation to collect safety and
      technical performance data of the WOLF Thrombectomy Device for the removal of thrombus in the
      neurovasculature.
This study has been designed as a prospective, non-randomized, multi-center, feasibility
      clinical investigation to evaluate the safety and device technical performance of the WOLF
      Thrombectomy Device in removing thrombus from an occluded large intracranial vessel(s) in
      patients with acute ischemic stroke. The device may be used alone or as an adjunct to
      intravenous tissue plasminogen activator (tPA) and/or to other traditional, thrombectomy
      modalities.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective, non-randomized, multi-center, feasibility clinical investigation to evaluate the safety and device technical performance of the WOLF Thrombectomy Device in removing thrombus from an occluded large intracranial vessel(s) in patients with acute ischemic stroke. The device may be used alone or as an adjunct to intravenous tissue plasminogen activator (tPA) and/or to other traditional, thrombectomy modalities.
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Technical Success Endpoint
time frame: At index procedure
description: Technical Success defined as the ability to achieve a revascularization rate (Thrombolysis in cerebral infarction [TICI] 2b/3) of ≥50% with the first pass of the WOLF Thrombectomy device. Revascularization is assessed by the investigator using fluoroscopy and after the first pass of the device is assessed using the TICI scale. Additional passes will be performed as necessary and the total number of attempts to achieve revascularization documented.
measure: Primary Safety Endpoint
time frame: At index procedure and through 24 hours post procedure.
description: WOLF device-related adverse events (incidence, relationship to device and severity) at index procedure and through 24 hours post procedure.
arm group label: WOLF Thrombectomy Device Arm
arm group type: Experimental
description: Patients enrolled in the study who received the treatment and who met all Inclusion and Exclusion Criteria
intervention type: Device
intervention name: WOLF Thrombectomy Device
description: Mechanical thrombectomy for the neurovasculature
arm group label: WOLF Thrombectomy Device Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian van Adel, MD
role: Principal Investigator
affiliation: Hamilton General Hospital
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No