<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/NCT03005028</url>
  </required_header>
  <id_info>
    <org_study_id>FFRAngio 1.0</org_study_id>
    <nct_id>NCT03005028</nct_id>
  </id_info>
  <brief_title>Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study</brief_title>
  <official_title>Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CathWorks Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CathWorks Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the present study we aim at validating the computation of FFRangio values from the&#xD;
      angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a&#xD;
      completely blinded manner. Investigation of a wide range of users in various conditions may&#xD;
      strengthen the reliability of the FFRAngio measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">March 15, 2016</completion_date>
  <primary_completion_date type="Actual">March 15, 2016</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>Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI</measure>
    <time_frame>1 hour</time_frame>
    <description>Immediately following the invasive FFR procedure.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">184</enrollment>
  <condition>CAD - Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study will enroll male and female subjects above the age of 18, with stable angina who&#xD;
        were referred to coronary angiography and have an FFR measurement in at least one coronary&#xD;
        artery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female above 18 years old age which undergo FFR as part of their standard&#xD;
             care&#xD;
&#xD;
          -  TIMI Grade Flow is equal to 3&#xD;
&#xD;
          -  LVEF larger than 45%.&#xD;
&#xD;
          -  Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindicated for FFR examination or adenosine administration&#xD;
&#xD;
          -  STEMI&#xD;
&#xD;
          -  CTO&#xD;
&#xD;
          -  TIMI Grade Flow below 3&#xD;
&#xD;
          -  Arteries supplying akinetic or severe hypokinetic territories&#xD;
&#xD;
          -  Prior CABG on the study vessel&#xD;
&#xD;
          -  Left Main stenosis, In-stent restenosis and Collaterals&#xD;
&#xD;
          -  Diffused atherosclerosis diseases and tandem lesions&#xD;
&#xD;
          -  Aorto-ostial lesion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tiqva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2018</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>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03005028
org study id: FFRAngio 1.0
nct id: NCT03005028
lead sponsor: 
has dmc: No
In the present study we aim at validating the computation of FFRangio values from the
      angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a
      completely blinded manner. Investigation of a wide range of users in various conditions may
      strengthen the reliability of the FFRAngio measurements.
observational model: Cohort
time perspective: Retrospective
measure: Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI
time frame: 1 hour
description: Immediately following the invasive FFR procedure.
arm group label: Control
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Coronary Disease
sharing ipd: No