<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/NCT03815032</url>
  </required_header>
  <id_info>
    <org_study_id>18.238</org_study_id>
    <nct_id>NCT03815032</nct_id>
  </id_info>
  <brief_title>Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison</brief_title>
  <acronym>ACCURACY</acronym>
  <official_title>Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Opsens, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the ACCURACY study is to assess the differences, if any, in FFR measurements made&#xD;
      by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different&#xD;
      OptoWire DeuxTM guidewires (group 1). In addition, the investigators will compare (group 2)&#xD;
      the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR&#xD;
      measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical&#xD;
      practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, prospective, non-blinded clinical investigation enrolling&#xD;
      consecutive patients with coronary lesion candidate for FFR assessment. The study aim to&#xD;
      assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire&#xD;
      by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1,&#xD;
      n=30). In addition, The investigators will compare (group 2, n=15) the FFR measurements&#xD;
      obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a&#xD;
      VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice. The&#xD;
      clinical investigation will be conducted in the Centre Hospitalier de l'Université de&#xD;
      Montréal (CHUM). No clinical follow-up is requested after the end of the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>delta FFR</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drift recording</measure>
    <time_frame>Day 1</time_frame>
    <description>The rate of significant drift, defined as Pd/Pa &lt;0.97 or &gt;1.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta from guidewire to guidewire</measure>
    <time_frame>Day 1</time_frame>
    <description>Assess the magnitude of reading delta from guidewire to guidewire prior to equalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stents</measure>
    <time_frame>Day 1</time_frame>
    <description>The number of stents used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stents on FFR wire</measure>
    <time_frame>Day 1</time_frame>
    <description>The number of stents placed over an OptoWire DeuxTM guidewire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Workhorse guidewire</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of Workhorse guidewire used.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Stenosis</condition>
  <condition>Atherosclerosis</condition>
  <condition>Atherosclerosis, Coronary</condition>
  <condition>Angina, Stable</condition>
  <condition>Angina, Unstable</condition>
  <condition>NSTEMI - Non-ST Segment Elevation MI</condition>
  <arm_group>
    <arm_group_label>Optowire Deux FFR assessment (1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 45 consecutive patients will be recruited:&#xD;
group 1 (n=30): To assess the differences in FFR measurements (drift) made by the OptoWire Deux FFRTM guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optowire Deux FFR assessment (2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group 2 (n=15): To assess the differences in FFR measurements (drift) obtained from an OptoWire DeuxTM FFR guidewire and compare it to the FFR measurement by a VERRATATM guidewire</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Drift assessment of OptoWire Deux FFR wire (1)</intervention_name>
    <description>Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any.</description>
    <arm_group_label>Optowire Deux FFR assessment (1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Drift assessment of OptoWire Deux FFR wire (2)</intervention_name>
    <description>Simultaneous data of one Optowire Deux TM guide wires and one VERRATA-TM FFR wire (group 2) to assess a single coronary stenosis and detect any difference if any.</description>
    <arm_group_label>Optowire Deux FFR assessment (2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single de novo coronary lesion or in-stent restenosis lesion with an operator assessed&#xD;
             reference diameter ≥2.0 mm requiring FFR measurement based on the operator's clinical&#xD;
             judgment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ST-segment-elevation myocardial infarction (STEMI), culprit lesion of&#xD;
             non-ST-segment-elevation myocardial infarction (NSTEMI), New York Heart Association&#xD;
             class IV heart failure, suspected or visible thrombus, dissection or excessive&#xD;
             calcification or tortuosity in the target vessel, or a stenosis in a bypass graft will&#xD;
             be excluded.&#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>Samer Mansour, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X0C1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Pothineni NV, Shah NN, Rochlani Y, Nairooz R, Raina S, Leesar MA, Uretsky BF, Hakeem A. U.S. Trends in Inpatient Utilization of Fractional Flow Reserve and Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Feb 16;67(6):732-733. doi: 10.1016/j.jacc.2015.11.042. No abstract available.</citation>
    <PMID>26868697</PMID>
  </reference>
  <results_reference>
    <citation>Fearon WF. Percutaneous coronary intervention should be guided by fractional flow reserve measurement. Circulation. 2014 May 6;129(18):1860-70. doi: 10.1161/CIRCULATIONAHA.113.004300. No abstract available.</citation>
    <PMID>24799502</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</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>Myocardial Ischemia</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
  </condition_browse>
  <!-- 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/NCT03815032
org study id: 18.238
nct id: NCT03815032
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The goal of the ACCURACY study is to assess the differences, if any, in FFR measurements made
      by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different
      OptoWire DeuxTM guidewires (group 1). In addition, the investigators will compare (group 2)
      the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR
      measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical
      practice.
This is a single center, prospective, non-blinded clinical investigation enrolling
      consecutive patients with coronary lesion candidate for FFR assessment. The study aim to
      assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire
      by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1,
      n=30). In addition, The investigators will compare (group 2, n=15) the FFR measurements
      obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a
      VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice. The
      clinical investigation will be conducted in the Centre Hospitalier de l'Université de
      Montréal (CHUM). No clinical follow-up is requested after the end of the procedure.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: delta FFR
time frame: Day 1
description: To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention
measure: Drift recording
time frame: Day 1
description: The rate of significant drift, defined as Pd/Pa <0.97 or >1.03
measure: Delta from guidewire to guidewire
time frame: Day 1
description: Assess the magnitude of reading delta from guidewire to guidewire prior to equalization.
measure: Stents
time frame: Day 1
description: The number of stents used.
measure: Stents on FFR wire
time frame: Day 1
description: The number of stents placed over an OptoWire DeuxTM guidewire.
measure: Workhorse guidewire
time frame: Day 1
description: Number of Workhorse guidewire used.
arm group label: Optowire Deux FFR assessment (1)
arm group type: Experimental
description: A total of 45 consecutive patients will be recruited:
group 1 (n=30): To assess the differences in FFR measurements (drift) made by the OptoWire Deux FFRTM guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires
arm group label: Optowire Deux FFR assessment (2)
arm group type: Experimental
description: group 2 (n=15): To assess the differences in FFR measurements (drift) obtained from an OptoWire DeuxTM FFR guidewire and compare it to the FFR measurement by a VERRATATM guidewire
intervention type: Device
intervention name: Drift assessment of OptoWire Deux FFR wire (1)
description: Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any.
arm group label: Optowire Deux FFR assessment (1)
intervention type: Device
intervention name: Drift assessment of OptoWire Deux FFR wire (2)
description: Simultaneous data of one Optowire Deux TM guide wires and one VERRATA-TM FFR wire (group 2) to assess a single coronary stenosis and detect any difference if any.
arm group label: Optowire Deux FFR assessment (2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samer Mansour, MD
role: Principal Investigator
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
facility: 
country: Canada
citation: Pothineni NV, Shah NN, Rochlani Y, Nairooz R, Raina S, Leesar MA, Uretsky BF, Hakeem A. U.S. Trends in Inpatient Utilization of Fractional Flow Reserve and Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Feb 16;67(6):732-733. doi: 10.1016/j.jacc.2015.11.042. No abstract available.
PMID: 26868697
citation: Fearon WF. Percutaneous coronary intervention should be guided by fractional flow reserve measurement. Circulation. 2014 May 6;129(18):1860-70. doi: 10.1161/CIRCULATIONAHA.113.004300. No abstract available.
PMID: 24799502
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Atherosclerosis
mesh term: Angina Pectoris
mesh term: Coronary Stenosis
mesh term: Angina, Unstable
mesh term: Angina, Stable