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

Completed

• Conditions: Coronary Artery Disease; Heart Diseases; Coronary Stenosis; Vascular Diseases; Ischemia; Arteriosclerosis; Cardiovascular Diseases
• Interventions: Other: AngioQFA

• Registration Number: NCT06039748
• Lead Sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-10
• Study First Submitted QC: 2023-09-10
• Study Start: 2023-09-13
• Study First Posted: 2023-09-15
• Primary Completion: 2024-01-14
• Study Completion: 2024-01-14
• Status Verified: 2024-04
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AngioQFA	AngioQFA	-

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.	1 hour	Positive FFR is defined as FFR≤0.80. Positive AngioQFA is defined as AngioQFA≤0.80.
Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.	1 hour	Positive IMR is defined as IMR≥25. Positive AngioIMR is defined as AngioIMR≥25.
Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.	1 hour	Negative FFR is defined as FFR\>0.80. Negative AngioQFA is defined as AngioQFA\>0.80.
Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.	1 hour	Negative IMR is defined as IMR\<25. Negative AngioIMR is defined as AngioIMR\<25.

Secondary Outcome Measures

Name	Time	Method
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	The Pearson correlation coefficient and consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis after PCI.
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	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.
Diagnostic performance of AngioQFA in comparison to FFR on a per-vessel basis.	1 hour	Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value.
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	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 performance of AngioIMR in comparison to IMR on a per-vessel basis.	1 hour	Diagnostic performance includes sensitivity, specificity, accuracy, positive predictive value and negative predictive value.
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	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 sensitivity and specificity of AngioQFA and QCA DS% versus wire-based FFR for demonstration of coronary ischemia.	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".
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	AUC and ROC 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	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 AngioIMR Versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-vessel basis and a per-patient basis.	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.
Diagnostic accuracy of AngioQFA versus wire-based FFR for demonstration of coronary ischemia after PCI.	1 hour	Postoperative FFR≤0.89 was defined as "positive", FFR\>0.89 is defined as "negative".

Trial Locations

Locations (5)

Jieyang People's Hospital; 🇨🇳 Jieyang, Guangdong, China

The Eighth Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Shenzhen, Guangdong, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Yan'an Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China