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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06039748
Other study ID # The FAIR Study
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 11, 2023
Est. completion date October 30, 2024

Study information

Verified date September 2023
Source Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Contact Lihui Li
Phone 13636480344
Email lihui.li@raysightmed.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 330
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - General Inclusion Criteria: 1. Age =18 years. 2. Coronary angiography is required for patients with suspected or confirmed coronary artery disease. 3. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. - Angiographic Inclusion Criteria: 1. Diameter stenosis of 30%-90% by visual estimate 2. 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: 1. Subject has undergone CABG of the target vessel. 2. Evidence of an acute myocardial infarction within one week prior to the intended procedure. 3. Severe heart failure (NYHA=III) 4. Patients with other serious conditions not eligible for clinical trials, such as severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic obstructive pulmonary disease. 5. Serum creatinine level of >150µmol / L. 6. Subject has known allergy to iodinated contrast agents, adenosine, or ATP. 7. Pregnant or breastfeeding. 8. Repeated enrollment. 9. 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: 1. Myocardial bridge or coronary artery fistula on the study lesions. 2. The target lesion =50% diameter stenosis in the left main coronary artery or ostial lesions less than 3 mm to the RCA. 3. 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.

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
Shenzhen Raysight Intelligent Medical Technology Co., Ltd. Jieyang People's Hospital, Renmin Hospital of Wuhan University, Sir Run Run Shaw Hospital, The Eighth Affiliated Hospital of Sun Yat-sen University, Yan'an Affiliated Hospital of Kunming Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 hour
Primary 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. 1 hour
Primary 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. 1 hour
Primary 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. 1 hour
Secondary 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. 1 hour
Secondary 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. 1 hour
Secondary 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. 1 hour
Secondary 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. 1 hour
Secondary 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. 1 hour
Secondary 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. 1 hour
Secondary 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. 1 hour
Secondary 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. 1 hour
Secondary 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". 1 hour
Secondary 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". 1 hour
Secondary 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. 1 hour
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