<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/NCT04504695</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC20.0032</org_study_id>
    <nct_id>NCT04504695</nct_id>
  </id_info>
  <brief_title>Prediction of Patient-specific Outcomes After Interventional neuroRadiology Procedures</brief_title>
  <acronym>PREDICTNRI</acronym>
  <official_title>Prediction of Patient-specific Outcomes After Interventional Neuroradiology Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INTRADYS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Brest</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>
      Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the&#xD;
      brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of&#xD;
      irreversible brain damage, it is an absolute medical emergency.&#xD;
&#xD;
      An ischemic stroke (stroke) is the result of a lack of oxygen supply to a part of the brain.&#xD;
      It can be one of many causes of stroke as a result of a thrombosis (occlusion) of the&#xD;
      internal carotid artery or a cerebral embolism (migration of a clot or debris of fatty&#xD;
      deposits) from a carotid stenosis. In both cases part of the brain is less irrigated. There&#xD;
      will then be a neurological deficit (paralysis) more or less important corresponding to the&#xD;
      affected cerebral territory. The deficit may concern the whole hemicorps (hemiplegia) or a&#xD;
      part of the body (upper or lower limb) and sometimes is associated with facial paralysis&#xD;
      and/or language disorders.&#xD;
&#xD;
      A brain aneurysm occurs when the wall of an intracranial artery expands abnormally, creating&#xD;
      a pocket of blood. It is often caused by weakness in the vascular tissue, but it can also&#xD;
      occur later in life due to illness, head injury, oral contraceptives or certain lifestyle&#xD;
      habits (smoking, excessive alcohol consumption). Sudden increases in pressure due to stress&#xD;
      or strenuous exercise can serve as a trigger.&#xD;
&#xD;
      Interventional Neuroradiology (INR) is a medical specialty that manages stroke patients using&#xD;
      imaging to perform the medical procedure and thereby limit openings and their associated&#xD;
      risks. This specialty has a growing place in modern medicine.&#xD;
&#xD;
      In order to improve the quality of care, patient safety and functional outcomes, it is&#xD;
      necessary to keep patient information. A database storing patient data from the NRI&#xD;
      department will make it possible to track patients since their arrival at the Brest&#xD;
      University Hospital. Thanks to this structured database, clinical studies will be&#xD;
      facilitated, making it possible to advance knowledge of the pathology and its treatments.&#xD;
&#xD;
      From the bibliographical research, we can conclude as to the current state of the facts:&#xD;
      there is currently no method for predicting the functional results of the interventional&#xD;
      neuroradiologist's patient based on automated learning.&#xD;
&#xD;
      A strategy based on an innovation programme is therefore being implemented over several&#xD;
      years, the first stage of which is the retrospective data study which was approved by the&#xD;
      ethics committee on 12/09/2019 and the second stage is the prospective data study.&#xD;
&#xD;
      This innovation program requires the most complete and homogeneous data possible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 4, 2021</start_date>
  <completion_date type="Anticipated">January 4, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 4, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of predictive factors</measure>
    <time_frame>24 months</time_frame>
    <description>Number of predictive factors (pre- and intra-operative data) for the angiographic success of the procedure (intracranial aneurysm or thrombectomy).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical evolution</measure>
    <time_frame>24 months</time_frame>
    <description>Clinical evolution was followed by the relevant clinical signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological evolution</measure>
    <time_frame>24 months</time_frame>
    <description>Neurological evolution was followed by the neurologicsigns</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>Aneurysmal Disease</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Thrombectomy group</arm_group_label>
    <description>Major patients requiring management for endovascular thrombosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aneurysm group</arm_group_label>
    <description>Major patients requiring management for an intracranial aneurysm</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Major patient carrying either a small or large, ruptured or unruptured aneurysm or a&#xD;
        thrombectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Major patient carrying either a small or large, ruptured or unruptured aneurysm or a&#xD;
        thrombectomy, with in both cases, a treatment procedure carried out in the interventional&#xD;
        neuroradiology department of the Brest CHRU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years old&#xD;
&#xD;
          -  Incapacitated patients of full age (under guardianship or curatorship)&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Follow-up impossible&#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>Jean-Christophe GENTRIC, PUPH</last_name>
    <phone>209347479</phone>
    <phone_ext>+33</phone_ext>
    <email>jean-christophe.gentric@chu-brest.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Samuel GUIGO</last_name>
    <phone>298347532</phone>
    <phone_ext>+33</phone_ext>
    <email>samuel.guigo@chu-brest.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Christophe GENTRIC, PUPH</last_name>
      <phone>298347479</phone>
      <phone_ext>+33</phone_ext>
      <email>jean-christophe.gentric@chu-brest.fr</email>
    </contact>
    <contact_backup>
      <last_name>Samuel GUIGO</last_name>
      <phone>298347532</phone>
      <phone_ext>+33</phone_ext>
      <email>samuel.guigo@chu-brest.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>thrombectomy</keyword>
  <keyword>aneurysm</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available beginning five years and ending five years following the princeps publication</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
  </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/NCT04504695
org study id: 29BRC20.0032
nct id: NCT04504695
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the
      brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of
      irreversible brain damage, it is an absolute medical emergency.

      An ischemic stroke (stroke) is the result of a lack of oxygen supply to a part of the brain.
      It can be one of many causes of stroke as a result of a thrombosis (occlusion) of the
      internal carotid artery or a cerebral embolism (migration of a clot or debris of fatty
      deposits) from a carotid stenosis. In both cases part of the brain is less irrigated. There
      will then be a neurological deficit (paralysis) more or less important corresponding to the
      affected cerebral territory. The deficit may concern the whole hemicorps (hemiplegia) or a
      part of the body (upper or lower limb) and sometimes is associated with facial paralysis
      and/or language disorders.

      A brain aneurysm occurs when the wall of an intracranial artery expands abnormally, creating
      a pocket of blood. It is often caused by weakness in the vascular tissue, but it can also
      occur later in life due to illness, head injury, oral contraceptives or certain lifestyle
      habits (smoking, excessive alcohol consumption). Sudden increases in pressure due to stress
      or strenuous exercise can serve as a trigger.

      Interventional Neuroradiology (INR) is a medical specialty that manages stroke patients using
      imaging to perform the medical procedure and thereby limit openings and their associated
      risks. This specialty has a growing place in modern medicine.

      In order to improve the quality of care, patient safety and functional outcomes, it is
      necessary to keep patient information. A database storing patient data from the NRI
      department will make it possible to track patients since their arrival at the Brest
      University Hospital. Thanks to this structured database, clinical studies will be
      facilitated, making it possible to advance knowledge of the pathology and its treatments.

      From the bibliographical research, we can conclude as to the current state of the facts:
      there is currently no method for predicting the functional results of the interventional
      neuroradiologist's patient based on automated learning.

      A strategy based on an innovation programme is therefore being implemented over several
      years, the first stage of which is the retrospective data study which was approved by the
      ethics committee on 12/09/2019 and the second stage is the prospective data study.

      This innovation program requires the most complete and homogeneous data possible.
observational model: Cohort
time perspective: Prospective
measure: Identification of predictive factors
time frame: 24 months
description: Number of predictive factors (pre- and intra-operative data) for the angiographic success of the procedure (intracranial aneurysm or thrombectomy).
measure: Clinical evolution
time frame: 24 months
description: Clinical evolution was followed by the relevant clinical signs
measure: Neurological evolution
time frame: 24 months
description: Neurological evolution was followed by the neurologicsigns
arm group label: Thrombectomy group
description: Major patients requiring management for endovascular thrombosis
arm group label: Aneurysm group
description: Major patients requiring management for an intracranial aneurysm
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Christophe GENTRIC, PUPH
phone: 209347479
phone ext: +33
email: jean-christophe.gentric@chu-brest.fr
last name: Samuel GUIGO
phone: 298347532
phone ext: +33
email: samuel.guigo@chu-brest.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
sharing ipd: Yes
ipd description: All collected data that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: Data will be available beginning five years and ending five years following the princeps publication
ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.