An observational study in Coronary Artery Disease, Heart Diseases and Cardiovascular Diseases, sponsored by Shenzhen Raysight Intelligent Medical Technology Co., Ltd.. Completed at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. · Observational
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 330 is close to the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Shenzhen Raysight Intelligent Medical Technology Co., Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: AngioQFA
FFR measured by pressure wire, AngioQFA computed by coronary angiographic images
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.
Time frame: 1 hour
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.
Time frame: 1 hour
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.
Time frame: 1 hour
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.
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.
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 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.
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.
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
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.
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.
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 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.
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.
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
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.
Time frame: 1 hour
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".
Time frame: 1 hour
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".
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.
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
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Shenzhen Raysight Intelligent Medical Technology Co., Ltd.