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NCT06039748Completed

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

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

Source: ClinicalTrials.gov · Last updated 16 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
330 (actual)
First submitted
10 Sept 2023
Start date
13 Sept 2023
Primary completion date
14 Jan 2024
Lead sponsor
Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
NCT number
NCT06039748

What you commit to

  • Study type: Observational
  • Participants enrolled: 330
  • From 13 Sept 2023 to the primary completion date, 14 Jan 2024
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Lab values

  • 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.

Other

  • Patients meeting any of the following criteria will be excluded:

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sir Run Run Shaw Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Jieyang People's Hospital
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JieyangChinaUnknown status
Yan'an Affiliated Hospital of Kunming Medical University
Coordinator of this site? Confirm its status
KunmingChinaUnknown status
The Eighth Affiliated Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
ShenzhenChinaUnknown status
Renmin Hospital of Wuhan University
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.