<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/NCT04406090</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0322</org_study_id>
    <nct_id>NCT04406090</nct_id>
  </id_info>
  <brief_title>Endovascular Thrombectomy in COVID-19 Infected Patients</brief_title>
  <acronym>ET-COVID-19</acronym>
  <official_title>Endovascular Thrombectomy in COVID-19 Infected Patients: Intrahospital and Peri-operative Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS).&#xD;
      Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19&#xD;
      infected patients harboring large vessel occlusion is largely unknown.&#xD;
&#xD;
      This multicentric study aims to investigate morbidity, mortality and neurological outcomes&#xD;
      after MT performed in patients with COVID-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the identification of the first case of Severe Acute Respiratory Syndrome (SARS) CoV-2&#xD;
      infection in December 2019 in Wuhan, China, the global number of confirmed COVID-19 cases is&#xD;
      roughly 5 000 000, with 216 involved countries. Increasing evidence shows that SARS-CoV-2 may&#xD;
      be associated with neurological manifestations, with up to 36% of patients showing&#xD;
      neurological symptoms related to the neurovirulence of the SARS-CoV-2.&#xD;
&#xD;
      It has been reported that roughly 5% of COVID-19 infected patients may present acute ischemic&#xD;
      stroke (AIS), and these patients may have an unfavorable clinical evolution due to the&#xD;
      systemic involvement of the infective disease. In addition, these patients are quite young:&#xD;
      the mean age of COVID-19 patients having AIS is lower (56 years), compared to general&#xD;
      population of AIS patients (mean age=73 years). Moreover, most of these patients require an&#xD;
      intensive care units (ICU) management. Stroke mechanisms may be multiple and can include&#xD;
      hypercoagulability from critical illness, cardioembolism from virus-related cardiac injury,&#xD;
      and severe inflammation. Indeed, the dysfunction of endothelial cells induced by infection&#xD;
      may promote an increased thrombin generation and fibrinolysis; moreover, the hypoxia found in&#xD;
      severe COVID-19 patients can be a trigger for thrombosis, increasing blood viscosity, and&#xD;
      inducing hypoxia-inducible transcription factors.&#xD;
&#xD;
      Outcomes related to the treatment of COVID-19 patients harboring large vessel occlusion and&#xD;
      requiring MT is substantially unknown, but it is likely that the combined morbidity and&#xD;
      mortality rate of the two pathologies is high. Accordingly, patient's selection,&#xD;
      treatment-management, and results should be urgently elucidated.&#xD;
&#xD;
      Involving 4 different countries (France, Italy, Spain, and US), this multicentric cohort&#xD;
      study aims to analyze the largest possible number of COVID-19 infected patients treated with&#xD;
      MT for AIS, with the intention to provide treatment-results and neurological outcomes,&#xD;
      elucidating the best patient-selection and treatment-management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intrahospital mortality</measure>
    <time_frame>1day</time_frame>
    <description>Intrahospital mortality after MT for COVID-19 infected patients harboring large vessel occlusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>short-term morbidity</measure>
    <time_frame>1 day</time_frame>
    <description>short-term morbidity after MT for COVID-19 infected patients harboring large vessel occlusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Angiographic success</measure>
    <time_frame>1 day</time_frame>
    <description>Angiographic success after MT for COVID-19 infected patients harboring large vessel occlusion</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Covid 19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mechanical Trombectomy</intervention_name>
    <description>Stent retriever for treatment of cerebral arterial occlusions</description>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      NC&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients &gt;18 years infected with the SARR-CoV-2, presenting an acute ischemic stroke,&#xD;
        and eligible to be treated with mechanical thrombectomy (based on the current guide-lines)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Patients &gt;18 years infected with the SARR-CoV-2 with acute ischemic stroke, and eligible&#xD;
        for mechanical thrombectomy (based on the current guide-lines)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Patients &lt;18 years ; no eligibility to mechanical thrombectomy ; absence of diagnosis of&#xD;
        COVID-19&#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>Federico Cagnazzo, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute ischemic stroke related to large vessel occlusion</keyword>
  <keyword>Mechanical Trombectomy</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04406090
org study id: RECHMPL20_0322
nct id: NCT04406090
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS).
      Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19
      infected patients harboring large vessel occlusion is largely unknown.

      This multicentric study aims to investigate morbidity, mortality and neurological outcomes
      after MT performed in patients with COVID-19 infection.
Since the identification of the first case of Severe Acute Respiratory Syndrome (SARS) CoV-2
      infection in December 2019 in Wuhan, China, the global number of confirmed COVID-19 cases is
      roughly 5 000 000, with 216 involved countries. Increasing evidence shows that SARS-CoV-2 may
      be associated with neurological manifestations, with up to 36% of patients showing
      neurological symptoms related to the neurovirulence of the SARS-CoV-2.

      It has been reported that roughly 5% of COVID-19 infected patients may present acute ischemic
      stroke (AIS), and these patients may have an unfavorable clinical evolution due to the
      systemic involvement of the infective disease. In addition, these patients are quite young:
      the mean age of COVID-19 patients having AIS is lower (56 years), compared to general
      population of AIS patients (mean age=73 years). Moreover, most of these patients require an
      intensive care units (ICU) management. Stroke mechanisms may be multiple and can include
      hypercoagulability from critical illness, cardioembolism from virus-related cardiac injury,
      and severe inflammation. Indeed, the dysfunction of endothelial cells induced by infection
      may promote an increased thrombin generation and fibrinolysis; moreover, the hypoxia found in
      severe COVID-19 patients can be a trigger for thrombosis, increasing blood viscosity, and
      inducing hypoxia-inducible transcription factors.

      Outcomes related to the treatment of COVID-19 patients harboring large vessel occlusion and
      requiring MT is substantially unknown, but it is likely that the combined morbidity and
      mortality rate of the two pathologies is high. Accordingly, patient's selection,
      treatment-management, and results should be urgently elucidated.

      Involving 4 different countries (France, Italy, Spain, and US), this multicentric cohort
      study aims to analyze the largest possible number of COVID-19 infected patients treated with
      MT for AIS, with the intention to provide treatment-results and neurological outcomes,
      elucidating the best patient-selection and treatment-management.
observational model: Cohort
time perspective: Retrospective
measure: Intrahospital mortality
time frame: 1day
description: Intrahospital mortality after MT for COVID-19 infected patients harboring large vessel occlusion
measure: short-term morbidity
time frame: 1 day
description: short-term morbidity after MT for COVID-19 infected patients harboring large vessel occlusion
measure: Angiographic success
time frame: 1 day
description: Angiographic success after MT for COVID-19 infected patients harboring large vessel occlusion
intervention type: Other
intervention name: Mechanical Trombectomy
description: Stent retriever for treatment of cerebral arterial occlusions
NC
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Federico Cagnazzo, MD PhD
role: Principal Investigator
affiliation: UH Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Ischemic Stroke
sharing ipd: Undecided
ipd description: NC