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Completed

NCT Number: NCT06039748

Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jieyang People's Hospital, Jieyang, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • General Inclusion Criteria:
  • Age ≥18 years.
  • Coronary angiography is required for patients with suspected or confirmed coronary artery disease.
  • The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  • Angiographic Inclusion Criteria:
  • Diameter stenosis of 30%-90% by visual estimate
  • Reference vessel size ≥2 mm in stenotic segment by visual estimate

Exclusion criteria

Patients meeting any of the following criteria will be excluded:

  • General Exclusion Criteria:
  • Subject has undergone CABG of the target vessel.
  • Evidence of an acute myocardial infarction within one week prior to the intended procedure.
  • Severe heart failure (NYHA≥III)
  • Patients with other serious conditions not eligible for clinical trials, such as severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic obstructive pulmonary disease.
  • Serum creatinine level of >150µmol / L.
  • Subject has known allergy to iodinated contrast agents, adenosine, or ATP.
  • Pregnant or breastfeeding.
  • Repeated enrollment.
  • Any other factors that the researchers consider not suitable for diagnostic intervention or FFR and IMR detection, such as the target vessel has collateral circulation, coronary spasm, the target vessel plaque rupture resulting in myocardial infarction, or other reasons deemed unsuitable for inclusion.
  • Angiographic Exclusion Criteria:
  • Myocardial bridge or coronary artery fistula on the study lesions.
  • The target lesion ≥50% diameter stenosis in the left main coronary artery or ostial lesions less than 3 mm to the RCA.
  • Low-quality angiography with poor contrast agent filling or inability to detect vascular boundaries due to various reasons, vascular overlap or severe distortion of the target vessel to fully expose the lesion location is not expected to be calculated.

Treatment and study plan

AngioQFA

Other

FFR measured by pressure wire, AngioQFA computed by coronary angiographic images

Primary outcomes

  1. Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.

    Time frame: 1 hour

    Positive FFR is defined as FFR≤0.80. Positive AngioQFA is defined as AngioQFA≤0.80.

  2. Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.

    Time frame: 1 hour

    Positive IMR is defined as IMR≥25. Positive AngioIMR is defined as AngioIMR≥25.

  3. Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.

    Time frame: 1 hour

    Negative FFR is defined as FFR>0.80. Negative AngioQFA is defined as AngioQFA>0.80.

  4. Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.

    Time frame: 1 hour

    Negative IMR is defined as IMR<25. Negative AngioIMR is defined as AngioIMR<25.

Secondary outcomes

  1. 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

    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.

  2. Diagnostic performance of AngioQFA in comparison to FFR on a per-vessel basis.

    Time frame: 1 hour

    Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value.

  3. 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

    AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.

  4. 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

    The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.

  5. 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

    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.

  6. Diagnostic performance of AngioIMR in comparison to IMR on a per-vessel basis.

    Time frame: 1 hour

    Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value.

  7. 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

    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.

  8. 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

    The consistency of AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.

  9. Diagnostic sensitivity and specificity of AngioQFA and QCA DS% versus wire-based FFR for demonstration of coronary ischemia.

    Time frame: 1 hour

    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".

  10. Diagnostic accuracy of AngioQFA versus wire-based FFR for demonstration of coronary ischemia after PCI.

    Time frame: 1 hour

    Postoperative FFR≤0.89 was defined as "positive", FFR>0.89 is defined as "negative".

  11. 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

    The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI.

Sponsors and collaborators

Lead sponsor

Shenzhen Raysight Intelligent Medical Technology Co., Ltd.

Industry

Collaborators

  • Eighth Affiliated Hospital, Sun Yat-sen University
  • Jieyang People's Hospital
  • Renmin Hospital of Wuhan University
  • Sir Run Run Shaw Hospital
  • Yan'an Affiliated Hospital of Kunming Medical University

Registry information

Official study title

Diagnostic Performance of Angiography-Derived Quantitative Functional Assessment Compared to Pressure-Derived Fractional Flow Reserve and Index of Microcirculatory Resistance: The FAIR Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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