<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/NCT03770520</url>
  </required_header>
  <id_info>
    <org_study_id>Z171100001017059</org_study_id>
    <nct_id>NCT03770520</nct_id>
  </id_info>
  <brief_title>Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting</brief_title>
  <official_title>The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Municipal Science &amp; Technology Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Anzhen 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>
      Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery&#xD;
      disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but&#xD;
      many trials of PCI have shown that visually stenosis in CAG may not have functional&#xD;
      significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR)&#xD;
      can be adopted in CABG and achieve a better graft patency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CABG is the major treatment of three vessels or left main disease. CAG is the main basis on&#xD;
      choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due&#xD;
      to competitive flow, these vessels may not be significantly stenosis in functional assessment&#xD;
      such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for&#xD;
      evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no&#xD;
      need for pressure wire or ATP when performing QFR. This study plan to investigate the&#xD;
      clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups:&#xD;
      QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of&#xD;
      QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to&#xD;
      evaluate the 1 year graft patency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>QFR will be masked to care providers and participants, and open to investigators, the allocation will be based on QFR.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of graft patency</measure>
    <time_frame>12 months</time_frame>
    <description>graft patency will be evaluated by CTA, 2 doctors will be invited to read the CT and draw their own conclusion without knowing the other result</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular event(MACE)</measure>
    <time_frame>12 months</time_frame>
    <description>The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of angina relief</measure>
    <time_frame>12 months</time_frame>
    <description>whether angina is relieved will be evaluated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">208</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>QFR-guided</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be performed a CABG surgery based on CAG and QFR, whether graft the moderate stenosis vessels will be based on the result of QFR.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angio-guided</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>QFR-guided CABG</intervention_name>
    <description>CABG surgery based on CAG and QFR</description>
    <arm_group_label>QFR-guided</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Angio-guided CABG</intervention_name>
    <description>CABG surgery based on heart team discussion of CAG</description>
    <arm_group_label>Angio-guided</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with evidence of angina pectoris&#xD;
&#xD;
          -  left main or three vessels disease, have the indication for CABG after discussion of&#xD;
             the heart team&#xD;
&#xD;
          -  at least one main vessels stenosis on 40%-70%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  former cardiac surgery patients&#xD;
&#xD;
          -  need to perform other cardiac or major surgery( i.e. valve surgery, carotid&#xD;
             endarterectomy&#xD;
&#xD;
          -  emergent CABG&#xD;
&#xD;
          -  acute myocardial infarction time less than 7 days&#xD;
&#xD;
          -  life expectancy less than 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ran Dong, MD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Anzhen Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Zhao, MD</last_name>
    <phone>13810050821</phone>
    <email>allen_hya731@sohu.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Zhao, MD</last_name>
      <phone>86-10-64456411</phone>
      <email>allen_hya731@sohu.com</email>
    </contact>
    <investigator>
      <last_name>Ran Dong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yang Zhao, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 9, 2018</last_update_submitted>
  <last_update_submitted_qc>December 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Anzhen Hospital</investigator_affiliation>
    <investigator_full_name>Dong Ran</investigator_full_name>
    <investigator_title>Direcotr,chief of ward No.11, Department of cardiac surgery</investigator_title>
  </responsible_party>
  <keyword>Quantitative Flow Ratio</keyword>
  <keyword>Coronary Artery Bypass Grafting</keyword>
  <keyword>Graft patency</keyword>
  <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>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03770520
org study id: Z171100001017059
nct id: NCT03770520
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery
      disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but
      many trials of PCI have shown that visually stenosis in CAG may not have functional
      significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR)
      can be adopted in CABG and achieve a better graft patency.
CABG is the major treatment of three vessels or left main disease. CAG is the main basis on
      choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due
      to competitive flow, these vessels may not be significantly stenosis in functional assessment
      such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for
      evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no
      need for pressure wire or ATP when performing QFR. This study plan to investigate the
      clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups:
      QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of
      QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to
      evaluate the 1 year graft patency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: QFR will be masked to care providers and participants, and open to investigators, the allocation will be based on QFR.
measure: The rate of graft patency
time frame: 12 months
description: graft patency will be evaluated by CTA, 2 doctors will be invited to read the CT and draw their own conclusion without knowing the other result
measure: Major adverse cardiovascular event(MACE)
time frame: 12 months
description: The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization
measure: The rate of angina relief
time frame: 12 months
description: whether angina is relieved will be evaluated
arm group label: QFR-guided
arm group type: Experimental
description: This group will be performed a CABG surgery based on CAG and QFR, whether graft the moderate stenosis vessels will be based on the result of QFR.
arm group label: Angio-guided
arm group type: Active Comparator
description: This group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team.
intervention type: Procedure
intervention name: QFR-guided CABG
description: CABG surgery based on CAG and QFR
arm group label: QFR-guided
intervention type: Procedure
intervention name: Angio-guided CABG
description: CABG surgery based on heart team discussion of CAG
arm group label: Angio-guided
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ran Dong, MD
role: Study Director
affiliation: Beijing Anzhen Hospital
last name: Yang Zhao, MD
phone: 13810050821
email: allen_hya731@sohu.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Anzhen Hospital
investigator full name: Dong Ran
investigator title: Direcotr,chief of ward No.11, Department of cardiac surgery
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Heart Diseases
sharing ipd: Undecided