<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/NCT02994563</url>
  </required_header>
  <id_info>
    <org_study_id>AmGR01</org_study_id>
    <nct_id>NCT02994563</nct_id>
  </id_info>
  <brief_title>Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study</brief_title>
  <official_title>Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amnis Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amnis Therapeutics</source>
  <oversight_info>
    <has_dmc>No</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>
      Prospective, single-arm, open label, Safety and Performance clinical investigation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from&#xD;
      intracranial vessels in patients experiencing ischemic stroke. Pre-CE mark clinical&#xD;
      investigation. Population will be subjects with documented untreated, acute ischemic stroke&#xD;
      with large vessel occlusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Subject recruitment problem due to Covid pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">October 7, 2019</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 25, 2021</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>All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first).</measure>
    <time_frame>24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first.</time_frame>
    <description>It will investigate whether the application of Amnis Thrombectomy device is a safe method, in acute stroke therapy, for obtaining recanalization of large vessels and with favorable patient outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All cause mortality (90 days).</measure>
    <time_frame>3 months post-procedure</time_frame>
    <description>Determine the number of participants with treatment-related adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial recanalization of the occluded target vessel in the immediate post-procedure angiogram.</measure>
    <time_frame>Immediate post-procedure angiogram.</time_frame>
    <description>Arterial recanalization of the occluded target vessel as angiographically scored by a Thrombolysis in Cerebral Infarction (TICI) flow grade of 2b or greater in the immediate post-procedure angiogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with rapid neurological improvement as determined by a NIHSS ≤4.</measure>
    <time_frame>First 24 hours after treatment</time_frame>
    <description>Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS or NIHSS ≤4) during the first 24 hours after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Good functional clinical outcome as determine by a modified Rankin Scale score of 0-2.</measure>
    <time_frame>First 24 hours after treatment.</time_frame>
    <description>Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS or NIHSS ≤4) during the first 24 hours after treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Open arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thrombectomy device to be used to retrieve clot and restore blood flow.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thrombectomy Device</intervention_name>
    <description>The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke</description>
    <arm_group_label>Open arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged18-85years.&#xD;
&#xD;
          2. Subject who is contraindicated or failed (when the physician withdraws the tPA per&#xD;
             physician discretion) intravenous tissue plasminogen activator (t-PA) therapy given at&#xD;
             local institutions or within national practice. Failed means that the physician does&#xD;
             not continue with IV tPA after thrombolysis; there is still an occlusion with TICI&#xD;
             that is &lt;/= 1 as the relevant inclusion criteria.&#xD;
&#xD;
          3. Subject is able to be treated within 8 hours of stroke symptoms onset with minimum of&#xD;
             one deployment of the Amnis Thrombectomy Device.&#xD;
&#xD;
          4. NIHSS score ≥8.&#xD;
&#xD;
          5. Pre-stroke mRS (modified Rankin Scale) score of 0 to 1.&#xD;
&#xD;
          6. Thrombolysis in cerebral infarction (TICI) ≤1 and causative occlusion of the M1 or M2&#xD;
             portion of the MCAs, anterior cerebral arteries, vertebral arteries, basilar artery&#xD;
             ,or posterior cerebral arteries (P1 o rP2), confirmed by CT or MR angiography that is&#xD;
             accessible to the Amnis thrombectomy device (i.e. according to IFU; 2-5.5 mm).&#xD;
&#xD;
          7. ASPECTS of ≥6 based on CT or MRI that was performed within 60 min prior to the start&#xD;
             of endovascular procedure.&#xD;
&#xD;
          8. Subject or subject's legal guardian where regulations permit, signs the Patient&#xD;
             Informed Consent and agrees that subject will attend follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Rapid neurological improvement prior to or at time of treatment suggesting resolution&#xD;
             of signs/symptoms of stroke.&#xD;
&#xD;
          2. Estimated time of symptom onset.&#xD;
&#xD;
          3. Baseline NIHSS score &lt;8.&#xD;
&#xD;
          4. BaselineNIHSS score ≥30 or state of coma.&#xD;
&#xD;
          5. Baseline pre-stroke mRS score &gt;1.&#xD;
&#xD;
          6. Baseline Thrombolysis in cerebral infarction (TICI) &gt; 2a.&#xD;
&#xD;
          7. Known serious sensitivity to radiographic contrast agent.&#xD;
&#xD;
          8. Arterial tortuosity, pre-existing stent and/o rother arterial disease that would&#xD;
             prevent the device from reaching the target vessel.&#xD;
&#xD;
          9. Evidence of a moderate/large core defined as extensive early ischemic changes of&#xD;
             Alberta Stroke Program Early CT score (ASPECTS) &lt;6.&#xD;
&#xD;
             Co-morbid conditions:&#xD;
&#xD;
         10. Elevated blood pressure(systolic&gt;185 mm Hg or diastolic &gt;110 mm Hg)&#xD;
&#xD;
         11. Use of warfarin anticoagulation with INR &gt;3.0.&#xD;
&#xD;
         12. Platelet count &lt;30,000/mm³.&#xD;
&#xD;
         13. Blood glucose concentration &lt;50 mg/dL (2.7 mmol/L).&#xD;
&#xD;
         14. CT/MRI imaging demonstrate smultilobar infarction (hypodensity &gt;1/3 cerebral&#xD;
             hemisphere).&#xD;
&#xD;
         15. CT or MRI evidence of mass effect, signs of hemorrhage, arteriovenous malformation or&#xD;
             aneurysm or intra-cranial tumor (except small meningioma).&#xD;
&#xD;
         16. Angiographic evidence of carotid dissection, complete cervical carotid occlusions or&#xD;
             vasculitis.&#xD;
&#xD;
         17. Clinical Symptoms or CT/MRI imaging suggest subarachnoid hemorrhage.&#xD;
&#xD;
         18. Imaging evidence that suggests, in the opinion of the investigator, the subject is not&#xD;
             appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to&#xD;
             target lesion, moderate/large infarct with poor collateral circulation, etc.).&#xD;
&#xD;
             General - related to the protocol or device:&#xD;
&#xD;
         19. Known sensitivity to nickel, titanium metals or their alloys.&#xD;
&#xD;
         20. Subject who requires hemodialysis or peritoneal dialysis, or who has a&#xD;
             contraindication to an angiogram for whatever reason.&#xD;
&#xD;
         21. Current participation in another investigational drug or device study.&#xD;
&#xD;
         22. Female who is pregnant or lactating or has a positive pregnancy test at time of&#xD;
             admission.&#xD;
&#xD;
         23. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol&#xD;
             (defined as regular or daily consumption of more than four alcoholic drinks per day).&#xD;
&#xD;
         24. Subject has a life expectancy of &lt;90 days.&#xD;
&#xD;
         25. Subject with a comorbid disease or condition that would confound the neurological and&#xD;
             functional evaluations or compromise survival or ability to complete follow-up&#xD;
             assessments.&#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>Tommy Andersson, M.D.; Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institute, Neuroradiology Clinic, Stockholm, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron; Unidad Ictus</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico of Barcelona; Section of Vascular Radiology &amp; Neuroradiology</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario (Valladolid); Dept. Neurology</name>
      <address>
        <city>Valladolid</city>
        <zip>47003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset i Solna</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>July 21, 2022</last_update_submitted>
  <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</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/NCT02994563
org study id: AmGR01
nct id: NCT02994563
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, single-arm, open label, Safety and Performance clinical investigation.
The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from
      intracranial vessels in patients experiencing ischemic stroke. Pre-CE mark clinical
      investigation. Population will be subjects with documented untreated, acute ischemic stroke
      with large vessel occlusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first).
time frame: 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first.
description: It will investigate whether the application of Amnis Thrombectomy device is a safe method, in acute stroke therapy, for obtaining recanalization of large vessels and with favorable patient outcome.
measure: All cause mortality (90 days).
time frame: 3 months post-procedure
description: Determine the number of participants with treatment-related adverse events.
measure: Arterial recanalization of the occluded target vessel in the immediate post-procedure angiogram.
time frame: Immediate post-procedure angiogram.
description: Arterial recanalization of the occluded target vessel as angiographically scored by a Thrombolysis in Cerebral Infarction (TICI) flow grade of 2b or greater in the immediate post-procedure angiogram.
measure: Proportion of patients with rapid neurological improvement as determined by a NIHSS ≤4.
time frame: First 24 hours after treatment
description: Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS or NIHSS ≤4) during the first 24 hours after treatment.
measure: Good functional clinical outcome as determine by a modified Rankin Scale score of 0-2.
time frame: First 24 hours after treatment.
description: Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS or NIHSS ≤4) during the first 24 hours after treatment.
arm group label: Open arm
arm group type: Experimental
description: Thrombectomy device to be used to retrieve clot and restore blood flow.
intervention type: Device
intervention name: Thrombectomy Device
description: The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke
arm group label: Open arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Tommy Andersson, M.D.; Ph.D.
role: Principal Investigator
affiliation: Karolinska Institute, Neuroradiology Clinic, Stockholm, Sweden
facility: 
facility: 
facility: 
facility: 
country: Spain
country: Sweden
responsible party type: Sponsor
mesh term: Ischemic Stroke
sharing ipd: No