<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/NCT03782688</url>
  </required_header>
  <id_info>
    <org_study_id>CVBA-CRI_0001</org_study_id>
    <nct_id>NCT03782688</nct_id>
  </id_info>
  <brief_title>Precise Percutaneous Coronary Intervention Plan (P3) Study</brief_title>
  <acronym>P3</acronym>
  <official_title>Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With 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>Yes</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 PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated,&#xD;
      international and multicenter study of patients with an indication for PCI aiming at&#xD;
      assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow&#xD;
      reserve (FFR) as a reference.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying&#xD;
      the presence of significant coronary stenosis by means of coronary angiography and invasive&#xD;
      fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures:&#xD;
      Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence&#xD;
      tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation&#xD;
      drug-eluting stent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 18, 2021</completion_date>
  <primary_completion_date type="Actual">December 18, 2020</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.</measure>
    <time_frame>The primary endpoint will be assessed immediately after the procedure (PCI).</time_frame>
    <description>The agreement will be assessed by Bland Altman method</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Stable Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Single-arm cohort</arm_group_label>
    <description>Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FFRCT planner</intervention_name>
    <description>Non-invasive post-PCI fractional flow reserve prediction</description>
    <arm_group_label>Single-arm cohort</arm_group_label>
    <other_name>HeartFlow Planner</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Stable Coronary Artery Disease with Positive Fractional Flow Reserve and&#xD;
        indication for percutaneous myocardial revascularization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Coronary artery disease in a major epicardial vessel with an invasive fractional flow&#xD;
             reserve (FFR) ≤0.80&#xD;
&#xD;
          -  An indication to Percutaneous coronary intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Angiographic exclusion criteria&#xD;
&#xD;
          1. Severely calcified lesion/vessel&#xD;
&#xD;
          2. Bifurcation lesions.&#xD;
&#xD;
          3. Ostial lesions.&#xD;
&#xD;
          4. Left main disease.&#xD;
&#xD;
          5. Severe vessel tortuosity.&#xD;
&#xD;
        Clinical exclusion criteria&#xD;
&#xD;
          1. Chronic obstructive pulmonary disease&#xD;
&#xD;
          2. Contraindication to adenosine&#xD;
&#xD;
          3. NYHA class III or IV, or last known left ventricular ejection fraction &lt;30%&#xD;
&#xD;
          4. Uncontrolled or recurrent ventricular tachycardia&#xD;
&#xD;
          5. Atrial fibrillation, flutter or arrhythmia&#xD;
&#xD;
          6. History of recent stroke (≤90 days)&#xD;
&#xD;
          7. History of acute coronary syndrome (≤90 days)&#xD;
&#xD;
          8. Prior myocardial infarction&#xD;
&#xD;
          9. History of ischemic stroke (&gt;90 days) with modified RANKIN score ≥ 2&#xD;
&#xD;
         10. History of any hemorrhagic stroke&#xD;
&#xD;
         11. Previous revascularization (PCI or Coronary artery bypass grafting)&#xD;
&#xD;
         12. Active liver disease or hepatic dysfunction, defined as AST or ALT &gt; 3 times the ULN&#xD;
&#xD;
         13. Severe renal dysfunction, defined as an eGFR &lt;30 mL/min/1.73 m2&#xD;
&#xD;
         14. Body mass index&gt;35 kg/m2&#xD;
&#xD;
         15. Nitrate intolerance&#xD;
&#xD;
         16. Contra-indication to heart rate lowering drugs&#xD;
&#xD;
             Imaging-related&#xD;
&#xD;
         17. Insufficient coronary CT Angiography image quality.&#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>Oost-Vlaanderen</state>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</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 Cardiovascular Center OLV-Aalst</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>Undecided</sharing_ipd>
    <ipd_description>Undecided plan for data sharing</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/NCT03782688
org study id: CVBA-CRI_0001
nct id: NCT03782688
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated,
      international and multicenter study of patients with an indication for PCI aiming at
      assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow
      reserve (FFR) as a reference.
Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying
      the presence of significant coronary stenosis by means of coronary angiography and invasive
      fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures:
      Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence
      tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation
      drug-eluting stent.
observational model: Cohort
time perspective: Prospective
measure: Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.
time frame: The primary endpoint will be assessed immediately after the procedure (PCI).
description: The agreement will be assessed by Bland Altman method
arm group label: Single-arm cohort
description: Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80)
intervention type: Diagnostic Test
intervention name: FFRCT planner
description: Non-invasive post-PCI fractional flow reserve prediction
arm group label: Single-arm cohort
other name: HeartFlow Planner
study pop: 
sampling method: Non-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: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Onze Lieve Vrouw Hospital
investigator full name: Jeroen Sonck
investigator title: Co-Director Cardiovascular Center OLV-Aalst
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: Undecided
ipd description: Undecided plan for data sharing