xml: <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/NCT06039748</url>
    </required_header>
    <id_info>
      <org_study_id>The FAIR Study</org_study_id>
      <nct_id>NCT06039748</nct_id>
    </id_info>
    <brief_title>Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study</brief_title>
    <official_title>Diagnostic Performance of Angiography-Derived Quantitative Functional Assessment Compared to Pressure-Derived Fractional Flow Reserve and Index of Microcirculatory Resistance: The FAIR Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shenzhen Raysight Intelligent Medical Technology Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Renmin Hospital of Wuhan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Yan'an Affiliated Hospital of Kunming Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sir Run Run Shaw Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Eighth Affiliated Hospital of Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jieyang People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shenzhen Raysight Intelligent Medical Technology Co., Ltd.</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 angiography-derived FFR assessment (AngioQFA) is a novel technique for physiological&#xD;
        lesion assessment based on 3-dimensional (3D) quantitative coronary angiography (QCA) and&#xD;
        virtual hyperemic flow derived from contrast frame count without drug-induced hyperemia. The&#xD;
        goal of this prospective, multicenter trial is to compare the diagnostic performance of&#xD;
        AngioQFA with invasive FFR as the reference standard. The secondary purpose is to compare the&#xD;
        diagnostic accuracies of the computational fluid dynamics (CFD)-based index of&#xD;
        microcirculatory resistance (IMR) using wire-based IMR as the reference standard.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>Positive FFR is defined as FFR≤0.80. Positive AngioQFA is defined as AngioQFA≤0.80.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>Positive IMR is defined as IMR≥25. Positive AngioIMR is defined as AngioIMR≥25.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>Negative FFR is defined as FFR&gt;0.80. Negative AngioQFA is defined as AngioQFA&gt;0.80.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>Negative IMR is defined as IMR&lt;25. Negative AngioIMR is defined as AngioIMR&lt;25.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diagnostic accuracy, positive predictive value and negative predictive value of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>Diagnostic accuracy, positive predictive value and negative predictive value of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic performance of AngioQFA in comparison to FFR on a per-vessel basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic accuracy, positive predictive value and negative predictive value of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>Diagnostic accuracy, positive predictive value and negative predictive value of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic performance of AngioIMR in comparison to IMR on a per-vessel basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC and ROC of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>AUC and ROC of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.</measure>
      <time_frame>1 hour</time_frame>
      <description>The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic sensitivity and specificity of AngioQFA and QCA DS% versus wire-based FFR for demonstration of coronary ischemia.</measure>
      <time_frame>1 hour</time_frame>
      <description>FFR≤0.80 is defined as &quot;positive&quot;, FFR&gt;0.80 is defined as &quot;negative&quot;; DS%≥50% is defined as &quot;positive&quot;, DS%&lt;50% is defined as &quot;negative&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic accuracy of AngioQFA versus wire-based FFR for demonstration of coronary ischemia after PCI.</measure>
      <time_frame>1 hour</time_frame>
      <description>Postoperative FFR≤0.89 was defined as &quot;positive&quot;, FFR&gt;0.89 is defined as &quot;negative&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI.</measure>
      <time_frame>1 hour</time_frame>
      <description>The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">330</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Heart Diseases</condition>
    <condition>Cardiovascular Diseases</condition>
    <condition>Arteriosclerosis</condition>
    <condition>Coronary Stenosis</condition>
    <condition>Vascular Diseases</condition>
    <condition>Ischemia</condition>
    <arm_group>
      <arm_group_label>AngioQFA</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>AngioQFA</intervention_name>
      <description>FFR measured by pressure wire, AngioQFA computed by coronary angiographic images</description>
      <arm_group_label>AngioQFA</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with coronary artery disease admitted for coronary angiography due to high risk of&#xD;
          significant coronary stenosis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            -  General Inclusion Criteria:&#xD;
  &#xD;
                 1. Age ≥18 years.&#xD;
  &#xD;
                 2. Coronary angiography is required for patients with suspected or confirmed&#xD;
                    coronary artery disease.&#xD;
  &#xD;
                 3. The subject has been informed of the nature of the study, agrees to its&#xD;
                    provisions and has provided written informed consent.&#xD;
  &#xD;
            -  Angiographic Inclusion Criteria:&#xD;
  &#xD;
                 1. Diameter stenosis of 30%-90% by visual estimate&#xD;
  &#xD;
                 2. Reference vessel size ≥2 mm in stenotic segment by visual estimate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients meeting any of the following criteria will be excluded:&#xD;
  &#xD;
            -  General Exclusion Criteria:&#xD;
  &#xD;
                 1. Subject has undergone CABG of the target vessel.&#xD;
  &#xD;
                 2. Evidence of an acute myocardial infarction within one week prior to the intended&#xD;
                    procedure.&#xD;
  &#xD;
                 3. Severe heart failure (NYHA≥III)&#xD;
  &#xD;
                 4. Patients with other serious conditions not eligible for clinical trials, such as&#xD;
                    severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic&#xD;
                    obstructive pulmonary disease.&#xD;
  &#xD;
                 5. Serum creatinine level of &gt;150µmol / L.&#xD;
  &#xD;
                 6. Subject has known allergy to iodinated contrast agents, adenosine, or ATP.&#xD;
  &#xD;
                 7. Pregnant or breastfeeding.&#xD;
  &#xD;
                 8. Repeated enrollment.&#xD;
  &#xD;
                 9. Any other factors that the researchers consider not suitable for diagnostic&#xD;
                    intervention or FFR and IMR detection, such as the target vessel has collateral&#xD;
                    circulation, coronary spasm, the target vessel plaque rupture resulting in&#xD;
                    myocardial infarction, or other reasons deemed unsuitable for inclusion.&#xD;
  &#xD;
            -  Angiographic Exclusion Criteria:&#xD;
  &#xD;
                 1. Myocardial bridge or coronary artery fistula on the study lesions.&#xD;
  &#xD;
                 2. The target lesion ≥50% diameter stenosis in the left main coronary artery or&#xD;
                    ostial lesions less than 3 mm to the RCA.&#xD;
  &#xD;
                 3. Low-quality angiography with poor contrast agent filling or inability to detect&#xD;
                    vascular boundaries due to various reasons, vascular overlap or severe distortion&#xD;
                    of the target vessel to fully expose the lesion location is not expected to be&#xD;
                    calculated.&#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>Hong Jiang</last_name>
      <role>Study Director</role>
      <affiliation>Renmin Hospital of Wuhan University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qiang Xue</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yan'an Affiliated Hospital of Kunming Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Guosheng Fu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sir Run Run Shaw Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jianwen Liang</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Eighth Affiliated Hospital of Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qiang Wu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Jieyang People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lihui Li</last_name>
      <phone>13636480344</phone>
      <email>lihui.li@raysightmed.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Cardiovascular Diseases</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Vascular Diseases</mesh_term>
      <mesh_term>Arteriosclerosis</mesh_term>
      <mesh_term>Coronary Stenosis</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039748
  org study id: The FAIR Study
  nct id: NCT06039748
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Coronary angiography-derived FFR assessment (AngioQFA) is a novel technique for physiological
        lesion assessment based on 3-dimensional (3D) quantitative coronary angiography (QCA) and
        virtual hyperemic flow derived from contrast frame count without drug-induced hyperemia. The
        goal of this prospective, multicenter trial is to compare the diagnostic performance of
        AngioQFA with invasive FFR as the reference standard. The secondary purpose is to compare the
        diagnostic accuracies of the computational fluid dynamics (CFD)-based index of
        microcirculatory resistance (IMR) using wire-based IMR as the reference standard.
  observational model: Cohort
  time perspective: Prospective
  measure: Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.
  time frame: 1 hour
  description: Positive FFR is defined as FFR≤0.80. Positive AngioQFA is defined as AngioQFA≤0.80.
  measure: Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.
  time frame: 1 hour
  description: Positive IMR is defined as IMR≥25. Positive AngioIMR is defined as AngioIMR≥25.
  measure: Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.
  time frame: 1 hour
  description: Negative FFR is defined as FFR>0.80. Negative AngioQFA is defined as AngioQFA>0.80.
  measure: Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.
  time frame: 1 hour
  description: Negative IMR is defined as IMR<25. Negative AngioIMR is defined as AngioIMR<25.
  measure: Diagnostic accuracy, positive predictive value and negative predictive value of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.
  time frame: 1 hour
  description: Diagnostic accuracy, positive predictive value and negative predictive value of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.
  measure: Diagnostic performance of AngioQFA in comparison to FFR on a per-vessel basis.
  time frame: 1 hour
  description: Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value.
  measure: AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.
  time frame: 1 hour
  description: AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.
  measure: The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.
  time frame: 1 hour
  description: The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.
  measure: Diagnostic accuracy, positive predictive value and negative predictive value of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.
  time frame: 1 hour
  description: Diagnostic accuracy, positive predictive value and negative predictive value of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.
  measure: Diagnostic performance of AngioIMR in comparison to IMR on a per-vessel basis.
  time frame: 1 hour
  description: Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value.
  measure: AUC and ROC of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.
  time frame: 1 hour
  description: AUC and ROC of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.
  measure: The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.
  time frame: 1 hour
  description: The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.
  measure: Diagnostic sensitivity and specificity of AngioQFA and QCA DS% versus wire-based FFR for demonstration of coronary ischemia.
  time frame: 1 hour
  description: FFR≤0.80 is defined as "positive", FFR>0.80 is defined as "negative"; DS%≥50% is defined as "positive", DS%<50% is defined as "negative".
  measure: Diagnostic accuracy of AngioQFA versus wire-based FFR for demonstration of coronary ischemia after PCI.
  time frame: 1 hour
  description: Postoperative FFR≤0.89 was defined as "positive", FFR>0.89 is defined as "negative".
  measure: The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI.
  time frame: 1 hour
  description: The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI.
  arm group label: AngioQFA
  intervention type: Other
  intervention name: AngioQFA
  description: FFR measured by pressure wire, AngioQFA computed by coronary angiographic images
  arm group label: AngioQFA
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hong Jiang
  role: Study Director
  affiliation: Renmin Hospital of Wuhan University
  last name: Qiang Xue
  role: Principal Investigator
  affiliation: Yan'an Affiliated Hospital of Kunming Medical University
  last name: Guosheng Fu
  role: Principal Investigator
  affiliation: Sir Run Run Shaw Hospital
  last name: Jianwen Liang
  role: Principal Investigator
  affiliation: The Eighth Affiliated Hospital of Sun Yat-sen University
  last name: Qiang Wu
  role: Principal Investigator
  affiliation: Jieyang People's Hospital
  last name: Lihui Li
  phone: 13636480344
  email: lihui.li@raysightmed.com
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  mesh term: Coronary Artery Disease
  mesh term: Heart Diseases
  mesh term: Vascular Diseases
  mesh term: Arteriosclerosis
  mesh term: Coronary Stenosis
  mesh term: Ischemia