<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/NCT03791320</url>
  </required_header>
  <id_info>
    <org_study_id>FASTII Study: June 26, 2018</org_study_id>
    <nct_id>NCT03791320</nct_id>
  </id_info>
  <brief_title>Fast Assessment of STenosis Severity- FASTII Study</brief_title>
  <acronym>FASTII</acronym>
  <official_title>Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tokyo Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Cardiologico Monzino</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Carl Gustav Carus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</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 Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective&#xD;
      observational multicenter study designed to evaluate the diagnostic accuracy of offline&#xD;
      3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands)&#xD;
      in identifying hemodynamically significant coronary artery disease with pressure wire-based&#xD;
      FFR (≤0.80) as the reference standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Multicenter FAST study is a prospective observational multicenter international study in&#xD;
      which offline computation of vFFR is compared to conventional invasive, wire based FFR&#xD;
      measurements. Pressure wire based FFR will be performed in patients with at least one&#xD;
      intermediate coronary lesion at the discretion of the operator (typically defined as a&#xD;
      coronary artery lesion with a diameter stenosis of 30-70% by visual assessment). A total of 3&#xD;
      two-dimensional angiography images, will be recorded and exported to the CAAS workstation 8.0&#xD;
      (Pie Medical Imaging, Maastricht, the Netherlands): two orthogonal views to create a 3D&#xD;
      reconstruction of the coronary arteries and one view to ascertain the position of the FFR&#xD;
      pressure wire. vFFR will be calculated automatically, by using the invasively measured aortic&#xD;
      root pressure. vFFR measurements will be performed online by the different centers. In&#xD;
      addition, all angiographic imaging data will be sent to an independent core laboratory&#xD;
      (Cardialysis, Rotterdam, The Netherlands) for offline analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Diagnostic accuracy of vFFR to identify FFR (≤0.8 or &gt;0.8) calculated by corelab</measure>
    <time_frame>1 year</time_frame>
    <description>The diagnostic accuracy of offline vFFR assessed by a blinded independent core laboratory to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or &gt;0.8) as the reference standard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of vFFR to identify FFR (≤0.8 or &gt;0.8) calculated by site/operator</measure>
    <time_frame>1 year</time_frame>
    <description>The diagnostic accuracy of operator or cathlab technician calculated online vFFR to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or &gt;0.8) as the reference standard.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interobserver variability</measure>
    <time_frame>1 year</time_frame>
    <description>3D-QCA based FFR (vFFR) will be calculated twice: by the operator/technician of different centers AND by an independent corelab (Cardoalysis). Correlation and agreement between these two measurements will be assessed in order to investigate the Inter-observer variability.</description>
  </secondary_outcome>
  <enrollment type="Actual">330</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Vessel Fractional Flow Reserve</intervention_name>
    <description>FFR measurement based on coronary angiography</description>
    <other_name>3D-QCA based FFR</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients ≥ 18 years presenting with stable or unstable angina or non-ST elevation acute&#xD;
        coronary syndrome.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients ≥ 18 years&#xD;
&#xD;
          -  indication procedure: stable, unstable angina or non-ST elevation acute coronary&#xD;
             syndrome&#xD;
&#xD;
          -  Diagnostic coronary angiography or PCI with an indication to perform re-PCI FFR&#xD;
             assessment of at least one coronary artery lesion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ST-elevation myocardial infarction (STEMI)&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Severe hemodynamic instability&#xD;
&#xD;
          -  Adenosine intolerance&#xD;
&#xD;
          -  Lesions containing thrombus, left main lesions, grafts, arteries with collaterals&#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>Joost Daemen, MD;PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiologico Monzino</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 23, 2020</last_update_submitted>
  <last_update_submitted_qc>December 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Joost Daemen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fractional Flow Reserve</keyword>
  <keyword>Coronary Physiology</keyword>
  <keyword>3D-QCA</keyword>
  <keyword>Percutaneous coronary intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data are needed for the final analysis which will be done by Erasmus MC.</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/NCT03791320
org study id: FASTII Study: June 26, 2018
nct id: NCT03791320
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective
      observational multicenter study designed to evaluate the diagnostic accuracy of offline
      3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands)
      in identifying hemodynamically significant coronary artery disease with pressure wire-based
      FFR (≤0.80) as the reference standard.
The Multicenter FAST study is a prospective observational multicenter international study in
      which offline computation of vFFR is compared to conventional invasive, wire based FFR
      measurements. Pressure wire based FFR will be performed in patients with at least one
      intermediate coronary lesion at the discretion of the operator (typically defined as a
      coronary artery lesion with a diameter stenosis of 30-70% by visual assessment). A total of 3
      two-dimensional angiography images, will be recorded and exported to the CAAS workstation 8.0
      (Pie Medical Imaging, Maastricht, the Netherlands): two orthogonal views to create a 3D
      reconstruction of the coronary arteries and one view to ascertain the position of the FFR
      pressure wire. vFFR will be calculated automatically, by using the invasively measured aortic
      root pressure. vFFR measurements will be performed online by the different centers. In
      addition, all angiographic imaging data will be sent to an independent core laboratory
      (Cardialysis, Rotterdam, The Netherlands) for offline analysis.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by corelab
time frame: 1 year
description: The diagnostic accuracy of offline vFFR assessed by a blinded independent core laboratory to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or >0.8) as the reference standard.
measure: Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by site/operator
time frame: 1 year
description: The diagnostic accuracy of operator or cathlab technician calculated online vFFR to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or >0.8) as the reference standard.
measure: Interobserver variability
time frame: 1 year
description: 3D-QCA based FFR (vFFR) will be calculated twice: by the operator/technician of different centers AND by an independent corelab (Cardoalysis). Correlation and agreement between these two measurements will be assessed in order to investigate the Inter-observer variability.
intervention type: Diagnostic Test
intervention name: Vessel Fractional Flow Reserve
description: FFR measurement based on coronary angiography
other name: 3D-QCA based FFR
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joost Daemen, MD;PhD.
role: Principal Investigator
affiliation: Erasmus Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Italy
country: Japan
country: Netherlands
country: United States
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Joost Daemen
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
sharing ipd: No
ipd description: Individual participant data are needed for the final analysis which will be done by Erasmus MC.