<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/NCT04479020</url>
  </required_header>
  <id_info>
    <org_study_id>REVISAR Revision 4.0</org_study_id>
    <nct_id>NCT04479020</nct_id>
  </id_info>
  <brief_title>REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®</brief_title>
  <official_title>REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acandis GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acandis GmbH</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>
      The purpose of the REVISAR PMCF is to collect data in clinical practice of the APERIO® and&#xD;
      APERIO® Hybrid(17) Thrombectomy Device, which are intended to restore blood flow in the&#xD;
      neurovasculature by removing thrombus in patients experiencing ischemic stroke.&#xD;
      Recanalization status will be assessed at the end of the procedure using the modified TICI&#xD;
      (Thrombolysis in cerebral infarction) score.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Type: prospective, multicenter, single-arm, open-label, national&#xD;
&#xD;
      Participants: 11 participating centers in Germany&#xD;
&#xD;
      PI: Dr. Franziska Dorn, University Hospital Bonn, Germany&#xD;
&#xD;
      Estimated Enrolment: A minimum of 130 patients treated with the APERIO® or APERIO® Hybrid(17)&#xD;
      Thrombectomy Device due to thrombotic occlusions in a distal vessel of the anterior and&#xD;
      posterior circulation (postbifurcal MCA, ACA, PCA)&#xD;
&#xD;
      Follow up: 3 months&#xD;
&#xD;
      Estimated Final Assessment: End of 2022&#xD;
&#xD;
      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® and APERIO® Hybrid(17) Thrombectomy Device in a distal vessel of&#xD;
      the anterior and posterior circulation (postbifurcal MCA, ACA, PCA). Aperio® and Aperio®&#xD;
      Hybrid(17) Thrombectomy Device will be used within its approved indication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Primary efficacy endpoint</measure>
    <time_frame>Immediatley after interventional procedure</time_frame>
    <description>Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary safety endpoint</measure>
    <time_frame>48 hours</time_frame>
    <description>• Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (&lt;48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary safety endpoint</measure>
    <time_frame>90 days</time_frame>
    <description>Rates of device and procedure related (serious) adverse events ((S)AEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety endpoint</measure>
    <time_frame>90 days</time_frame>
    <description>Mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Good neurological outcome</measure>
    <time_frame>90 days</time_frame>
    <description>mRS (modified Ranking Scale)= 0-2&#xD;
0 No Symptoms&#xD;
No significant disability, despite symptoms, able to perform all usual duties and activities&#xD;
Slight disability; unable to perform all previous activities but able to look after own affairs without assistance&#xD;
Moderate disability; requires some help, but able to walk without assistance&#xD;
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance&#xD;
Severe disability bedridden incontinent and requires constant nursing care and attention&#xD;
Patient died</description>
  </secondary_outcome>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Acute Stroke</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mechanical Thrombectomy</intervention_name>
    <description>Mechanical thrombectomy requiring the use an APERIO® or APERIO® Hybrid(17) Thrombectomy device due to an thrombotic occlusion in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with an APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to a&#xD;
        thrombotic occlusion in distal vessel of the anterior and posterior circulation&#xD;
        (postbifurcal MCA, ACA, PCA).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to&#xD;
             occlusion in distal vessel of the anterior and posterior circulation (postbifurcal&#xD;
             MCA, ACA, PCA) according to IFU&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre stroke mRS ≥ 3&#xD;
&#xD;
          -  Any contraindication according to IFU&#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>Franziska Dorn, Prof. Dr. med.</last_name>
    <phone>+49 (0) 228-287-16505</phone>
    <email>Franziska.Dorn@ukbonn.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Schlosspark Klinik Charlottenburg</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annette Förschler, Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franziska Dorn, Prof. Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernd Turowski, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Fulda gAG</name>
      <address>
        <city>Fulda</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kallenberg Kai, PD. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen</name>
      <address>
        <city>Göttingen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marielle Ernst, PD Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wolfgang Reith, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Köln</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christoph Kabbasch, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Magdeburg A. ö. R.</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Behme, PD. Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Johannes Wesling Klinikum Minden</name>
      <address>
        <city>Minden</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Borggrefe Jan, Prof. Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München</name>
      <address>
        <city>München</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Liebig, Prof.Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>radprax Neurozentrum Solingen</name>
      <address>
        <city>Solingen</city>
        <zip>42697</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hannes Nordmeyer, Dr. med.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 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>
  </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/NCT04479020
org study id: REVISAR Revision 4.0
nct id: NCT04479020
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the REVISAR PMCF is to collect data in clinical practice of the APERIO® and
      APERIO® Hybrid(17) Thrombectomy Device, which are intended to restore blood flow in the
      neurovasculature by removing thrombus in patients experiencing ischemic stroke.
      Recanalization status will be assessed at the end of the procedure using the modified TICI
      (Thrombolysis in cerebral infarction) score.
Study Type: prospective, multicenter, single-arm, open-label, national

      Participants: 11 participating centers in Germany

      PI: Dr. Franziska Dorn, University Hospital Bonn, Germany

      Estimated Enrolment: A minimum of 130 patients treated with the APERIO® or APERIO® Hybrid(17)
      Thrombectomy Device due to thrombotic occlusions in a distal vessel of the anterior and
      posterior circulation (postbifurcal MCA, ACA, PCA)

      Follow up: 3 months

      Estimated Final Assessment: End of 2022

      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® and APERIO® Hybrid(17) Thrombectomy Device in a distal vessel of
      the anterior and posterior circulation (postbifurcal MCA, ACA, PCA). Aperio® and Aperio®
      Hybrid(17) Thrombectomy Device will be used within its approved indication.
observational model: Cohort
time perspective: Prospective
measure: Primary efficacy endpoint
time frame: Immediatley after interventional procedure
description: Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion
measure: Primary safety endpoint
time frame: 48 hours
description: • Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (<48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours.
measure: Primary safety endpoint
time frame: 90 days
description: Rates of device and procedure related (serious) adverse events ((S)AEs)
measure: Primary Safety endpoint
time frame: 90 days
description: Mortality
measure: Good neurological outcome
time frame: 90 days
description: mRS (modified Ranking Scale)= 0-2
0 No Symptoms
No significant disability, despite symptoms, able to perform all usual duties and activities
Slight disability; unable to perform all previous activities but able to look after own affairs without assistance
Moderate disability; requires some help, but able to walk without assistance
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
Severe disability bedridden incontinent and requires constant nursing care and attention
Patient died
intervention type: Device
intervention name: Mechanical Thrombectomy
description: Mechanical thrombectomy requiring the use an APERIO® or APERIO® Hybrid(17) Thrombectomy device due to an thrombotic occlusion in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Franziska Dorn, Prof. Dr. med.
phone: +49 (0) 228-287-16505
email: Franziska.Dorn@ukbonn.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Stroke