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Coronary Artery DiseaseNCT06039748

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

An observational study of Coronary Artery Disease and Heart Diseases, run by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AngioQFA
How many people
330 participants
Where
5 sitesChina
Study dates
13 Sep 2023to 14 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310013

  • Jieyang People's Hospital

    Jieyang, Guangdong

  • Yan'an Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650051

  • The Eighth Affiliated Hospital of Sun Yat-Sen University

    Shenzhen, Guangdong, 518033

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430090

Other trials in China

About this study

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

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.

Being tested
AngioQFA
Medical subject headings
Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Coronary Stenosis, Vascular Diseases, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AngioQFAOther

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

Study groups in NCT06039748
Study groupRoleWhat they receive
AngioQFANot described
Receives: Other: AngioQFA

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 1 hour

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

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

    Measured: 1 hour

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

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

    Measured: 1 hour

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

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

    Measured: 1 hour

Secondary outcomes (11)

  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.

    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.

    Measured: 1 hour

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

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

    Measured: 1 hour

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

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

    Measured: 1 hour

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

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

    Measured: 1 hour

  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.

    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.

    Measured: 1 hour

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

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

    Measured: 1 hour

  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.

    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.

    Measured: 1 hour

  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.

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

    Measured: 1 hour

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

    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".

    Measured: 1 hour

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

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

    Measured: 1 hour

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

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

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start13 Sep 2023
  3. Primary completion14 Jan 2024
  4. Study completion14 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06039748
Sponsor's protocol ID
The FAIR Study
Status last verified
Apr 2024
First submitted
10 Sep 2023
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Heart Diseases, run by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis. (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06039748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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Clinical Trial NCT06039748 | AzTrials