<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/NCT03269734</url>
  </required_header>
  <id_info>
    <org_study_id>NI_RBC_2016_1</org_study_id>
    <nct_id>NCT03269734</nct_id>
  </id_info>
  <brief_title>Evaluation of the Accuracy of the Vessel Navigator Tool for Catheterization of Supra-aortic Vessels - ARCHIBALD</brief_title>
  <acronym>ARCHIBALD</acronym>
  <official_title>Evaluation of the Accuracy of the Vessel Navigator (Philips Healthcare) Tool for Catheterization of Aortic Arch and Supra-aortic Vessels - ARCHIBALD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray&#xD;
      imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms&#xD;
      or arteriovenous malformations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Catheterization of is performed for the diagnosis and treatment of cerebrovascular diseases.&#xD;
      It is performed under X-ray scopy in frontal incidence with possible variations of the&#xD;
      angulation of the arch to optimize the visualization of vessels 'origin (brachiocephalic&#xD;
      trunk, left and right common carotid arteries, subclavian arteries).&#xD;
&#xD;
      Before the beginning of catheterization, a conventional arterial roadmap with iodine&#xD;
      injection is usually performed. The Vessel Navigator (VN) developed by Philips allows the use&#xD;
      of pre-acquired angio-scan or angio-MRI image by superimposing it (X-ray Fusion) on X-ray&#xD;
      scopy to provide the arterial tracing (Fusion Roadmap).&#xD;
&#xD;
      An angio-MRI (Philips 3 Tesla MRI) imaging of the aortic arch will be first performed (as&#xD;
      part of preoperative assessment or systematic follow-up of aneurysms or arteriovenous&#xD;
      malformations). A first operator will perform the arteriography under the usual conditions&#xD;
      without using the VN. A second operator will have access to the fusion imaging and will&#xD;
      assess the accuracy of the coregistration. Snapshots will be taken by the second operator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging.</measure>
    <time_frame>baseline</time_frame>
    <description>Measurement will be performed 1 cm above each ostium. There will be 4 measurements per patient (4 vessels analyzed).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Vascular Diseases</condition>
  <condition>Cerebrovascular Diseases</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Aortic Aneurysm</condition>
  <condition>Arteriovenous Malformation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with preoperative assessment or systematic follow-up of aneurysms or arteriovenous&#xD;
        malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preoperative assessment or systematic follow-up of aneurysms or arteriovenous&#xD;
             malformations, arterial cervical or intracranial stenosis, head and neck vascular&#xD;
             tumors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contraindication to intravenous contrast.&#xD;
&#xD;
          -  Patients with catheterization of the supra-aortic vessels in an emergency settings&#xD;
             (Stroke, acute bleeding)&#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>Raphaël BLANC, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation ophtalmologique de Rothschild</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondation Opthalmologique A de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vascular Diseases</keyword>
  <keyword>Cerebrovascular Diseases</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Aortic aneurysm</keyword>
  <keyword>Arteriovenous malformations</keyword>
  <keyword>Catheterization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Arteriovenous Malformations</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03269734
org study id: NI_RBC_2016_1
nct id: NCT03269734
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray
      imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms
      or arteriovenous malformations.
Catheterization of is performed for the diagnosis and treatment of cerebrovascular diseases.
      It is performed under X-ray scopy in frontal incidence with possible variations of the
      angulation of the arch to optimize the visualization of vessels 'origin (brachiocephalic
      trunk, left and right common carotid arteries, subclavian arteries).

      Before the beginning of catheterization, a conventional arterial roadmap with iodine
      injection is usually performed. The Vessel Navigator (VN) developed by Philips allows the use
      of pre-acquired angio-scan or angio-MRI image by superimposing it (X-ray Fusion) on X-ray
      scopy to provide the arterial tracing (Fusion Roadmap).

      An angio-MRI (Philips 3 Tesla MRI) imaging of the aortic arch will be first performed (as
      part of preoperative assessment or systematic follow-up of aneurysms or arteriovenous
      malformations). A first operator will perform the arteriography under the usual conditions
      without using the VN. A second operator will have access to the fusion imaging and will
      assess the accuracy of the coregistration. Snapshots will be taken by the second operator.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging.
time frame: baseline
description: Measurement will be performed 1 cm above each ostium. There will be 4 measurements per patient (4 vessels analyzed).
measure: Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).
time frame: baseline
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raphaël BLANC, MD
role: Principal Investigator
affiliation: Fondation ophtalmologique de Rothschild
facility: 
country: France
responsible party type: Sponsor
mesh term: Cerebrovascular Disorders
mesh term: Cardiovascular Diseases
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Vascular Diseases
mesh term: Arteriovenous Malformations
mesh term: Congenital Abnormalities
sharing ipd: Undecided