<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/NCT04457479</url>
  </required_header>
  <id_info>
    <org_study_id>HYBRID</org_study_id>
    <nct_id>NCT04457479</nct_id>
  </id_info>
  <brief_title>APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke</brief_title>
  <official_title>APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acandis GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acandis GmbH</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical&#xD;
      Follow-up study to collect comprehensive information on technical and clinical success and&#xD;
      safety of the use of APERIO® Hybrid(17/21) Thrombectomy Device in clinical practice. APERIO®&#xD;
      Hybrid(17/21) Thrombectomy Device will be used within its approved indication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      German APERIO® Hybrid Post- Market Clinical Follow-up Study&#xD;
&#xD;
      APERIO® Hybrid PMCF Study- Thrombectomy device for flow restoration in vessels of patients&#xD;
      experiencing acute ischemic stroke&#xD;
&#xD;
      Study Type: prospective, multicenter, single-armed, open-label&#xD;
&#xD;
      Participants: 8 participating centers in Germany&#xD;
&#xD;
      PI: Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany&#xD;
&#xD;
      Estimated Enrolment: 190 patients treated with APERIO® HYBRID(17/21) Thrombectomy Device as a&#xD;
      result of an acute stroke&#xD;
&#xD;
      Follow up: 3 months&#xD;
&#xD;
      Estimated Final Assessment: Mid to End of 2023&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 16, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Technical success</measure>
    <time_frame>until 24 hours after intervention</time_frame>
    <description>mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Good clinical outcome at 90 days</measure>
    <time_frame>90 days after intervention</time_frame>
    <description>Modified Rankin Scale (mRS) &lt; 3 (mRS 1= no symptoms/ good outcome; mRS 6= Patient died/ worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periprocural symptomatic intracranial hemorrhage (sICH):</measure>
    <time_frame>until 24 hours after intervention</time_frame>
    <description>ICH in postinterventional (&lt;24 hours) CT associated with worsening of NIHSS by ≥ 4 points within 24 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular events until hospital discharge:</measure>
    <time_frame>between 24 hours after intervention and discharge from hospital</time_frame>
    <description>Intracranial haemorrhage (symptomatic / asymptomatic)&#xD;
Death&#xD;
TIA in the region of the target vessel&#xD;
Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel&#xD;
Disabling ischemic stroke (MRS 3-6) in the region of the target vessel&#xD;
TIA outside the region of the target vessel&#xD;
Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel&#xD;
Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular events at 90 days</measure>
    <time_frame>at 90 days</time_frame>
    <description>Intracranial haemorrhage (symptomatic / asymptomatic)&#xD;
Death&#xD;
TIA&#xD;
Non-disabling ischemic stroke (MRS 0-2)&#xD;
Disabling ischemic stroke (MRS 3-6)</description>
  </secondary_outcome>
  <enrollment type="Actual">190</enrollment>
  <condition>Acute Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with acute large vessel occlusion (stroke) treated with the APERIO®&#xD;
        Hybrid(17/21) Thrombectomy Device.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All patients treated with APERIO® HYBRID and/or APERIO® Hybrid(17/21) Thrombectomy Device&#xD;
        as a result of an acute stroke.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient age &lt; 18 years&#xD;
&#xD;
          -  Pre stroke mRS ≥ 3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus Oldenburg</name>
      <address>
        <city>Oldenburg</city>
        <zip>26122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 10, 2019</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 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>
  </condition_browse>
  <!-- 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/NCT04457479
org study id: HYBRID
nct id: NCT04457479
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical
      Follow-up study to collect comprehensive information on technical and clinical success and
      safety of the use of APERIO® Hybrid(17/21) Thrombectomy Device in clinical practice. APERIO®
      Hybrid(17/21) Thrombectomy Device will be used within its approved indication.
German APERIO® Hybrid Post- Market Clinical Follow-up Study

      APERIO® Hybrid PMCF Study- Thrombectomy device for flow restoration in vessels of patients
      experiencing acute ischemic stroke

      Study Type: prospective, multicenter, single-armed, open-label

      Participants: 8 participating centers in Germany

      PI: Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany

      Estimated Enrolment: 190 patients treated with APERIO® HYBRID(17/21) Thrombectomy Device as a
      result of an acute stroke

      Follow up: 3 months

      Estimated Final Assessment: Mid to End of 2023
observational model: Cohort
time perspective: Prospective
measure: Technical success
time frame: until 24 hours after intervention
description: mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)
measure: Good clinical outcome at 90 days
time frame: 90 days after intervention
description: Modified Rankin Scale (mRS) < 3 (mRS 1= no symptoms/ good outcome; mRS 6= Patient died/ worse outcome)
measure: Periprocural symptomatic intracranial hemorrhage (sICH):
time frame: until 24 hours after intervention
description: ICH in postinterventional (<24 hours) CT associated with worsening of NIHSS by ≥ 4 points within 24 hours
measure: Cerebrovascular events until hospital discharge:
time frame: between 24 hours after intervention and discharge from hospital
description: Intracranial haemorrhage (symptomatic / asymptomatic)
Death
TIA in the region of the target vessel
Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel
Disabling ischemic stroke (MRS 3-6) in the region of the target vessel
TIA outside the region of the target vessel
Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel
Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel
measure: Cerebrovascular events at 90 days
time frame: at 90 days
description: Intracranial haemorrhage (symptomatic / asymptomatic)
Death
TIA
Non-disabling ischemic stroke (MRS 0-2)
Disabling ischemic stroke (MRS 3-6)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke