<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/NCT03824600</url>
  </required_header>
  <id_info>
    <org_study_id>CRI-0002</org_study_id>
    <nct_id>NCT03824600</nct_id>
  </id_info>
  <brief_title>Physiological Patterns of Coronary Artery Disease</brief_title>
  <official_title>Physiological Patterns of Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Onze Lieve Vrouw Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Onze Lieve Vrouw Hospital</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>
      Registry of patients undergoing invasive fractional flow reserve measurement using a&#xD;
      motorized device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective registry of patients undergoing clinically indicated coronary angiography with&#xD;
      fractional flow reserve evaluation for vessels with intermediate coronary lesions defined as&#xD;
      visual diameter stenosis between 30% and 70%. A motorized fractional flow reservepullback&#xD;
      evaluation will be performed at the discretion of the operators. The objective of the present&#xD;
      study is to describe the physiological patterns of coronary artery disease using motorized&#xD;
      coronary pressure pullbacks during continuous hyperemia in patients with stable coronary&#xD;
      artery disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)</measure>
    <time_frame>Immediate post-procedure. No follow-up is schedule for this trial.</time_frame>
    <description>Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Classification of the physiological patterns of coronary artery disease using a quantitative metric</measure>
    <time_frame>Immediate post-procedure. No follow-up is schedule for this trial.</time_frame>
    <description>Based on the data obtained using the fractional flow reserve pullbacks and conventional coronary angiography a quantitative classification of the physiological pattern of coronary artery disease based on the functional contribution of the epicardial lesion (i.e. lesion-related pressure drop) with respect to the total vessel fractional flow reserve will be explored.</description>
  </other_outcome>
  <enrollment type="Actual">117</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fractional Flow Reserve Motorized Pullback</intervention_name>
    <description>A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing clinically indicated coronary angiography and fractional flow reserve&#xD;
        evaluation for intermediate coronary lesions defined as visual diameter stenosis between&#xD;
        30% and 70%&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable coronary artery disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute coronary syndromes&#xD;
&#xD;
          -  previous coronary artery bypass grafting&#xD;
&#xD;
          -  significant valvular disease&#xD;
&#xD;
          -  severe obstructive pulmonary disease or asthma bronchial&#xD;
&#xD;
          -  severe tortuosity or severe calcification&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Bernard De Bruyne, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>OLV-Aalst</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OLV Aalst</name>
      <address>
        <city>Aalst</city>
        <state>West Flanders</state>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Brussels</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Onze Lieve Vrouw Hospital</investigator_affiliation>
    <investigator_full_name>Jeroen Sonck</investigator_full_name>
    <investigator_title>Co-Director Catheterization Laboratory</investigator_title>
  </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>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/NCT03824600
org study id: CRI-0002
nct id: NCT03824600
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Registry of patients undergoing invasive fractional flow reserve measurement using a
      motorized device.
A prospective registry of patients undergoing clinically indicated coronary angiography with
      fractional flow reserve evaluation for vessels with intermediate coronary lesions defined as
      visual diameter stenosis between 30% and 70%. A motorized fractional flow reservepullback
      evaluation will be performed at the discretion of the operators. The objective of the present
      study is to describe the physiological patterns of coronary artery disease using motorized
      coronary pressure pullbacks during continuous hyperemia in patients with stable coronary
      artery disease.
observational model: Cohort
time perspective: Prospective
measure: Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)
time frame: Immediate post-procedure. No follow-up is schedule for this trial.
description: Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse).
measure: Classification of the physiological patterns of coronary artery disease using a quantitative metric
time frame: Immediate post-procedure. No follow-up is schedule for this trial.
description: Based on the data obtained using the fractional flow reserve pullbacks and conventional coronary angiography a quantitative classification of the physiological pattern of coronary artery disease based on the functional contribution of the epicardial lesion (i.e. lesion-related pressure drop) with respect to the total vessel fractional flow reserve will be explored.
intervention type: Diagnostic Test
intervention name: Fractional Flow Reserve Motorized Pullback
description: A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Bernard De Bruyne, MD, PhD
role: Study Chair
affiliation: OLV-Aalst
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Onze Lieve Vrouw Hospital
investigator full name: Jeroen Sonck
investigator title: Co-Director Catheterization Laboratory
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No