This study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. Eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (CT-FFR guided group) or the control group (QFR guided group).
Age ≥18 years
with stable chest pain who underwent CCTA and have at least 1 lesion with a percent diameter stenosis (DS%) between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment.These patients plan to undergo further non-invasive or invasive diagnosis and treatment.
Able to undergo invasive coronary angiography (ICA)
Capable of complying with the study procedures and fully understand the informed consent form approved by the ethics committee, and provide voluntary consent.
Patients with acute coronary syndrome requiring urgent revascularization.
Patients with unstable angina, including those with first-onset chest pain within 48 hours, CCS III or higher first-onset angina, those whose angina has worsened to CCS III or IV within a short period of time, or those with rest angina lasting more than 20 minutes.
Patients with iodine contrast agent allergy.
Pregnant or lactating women.
Parallel
CT-FFR
DeviceCT -FFR(coronary computed tomography angiography drived fractional flow reserve derived) uses routine coronary computed tomography angiography (CTA) images and applies a specific algorithm to extract both anatomical and physiological information of the coronary arteries. By combining these two pieces of information, a fluid dynamics model of the coronary arteries can be established, allowing the calculation of FFR at any location of the coronary arteries.
QFR
DeviceQuantitative flow ratio (QFR) is a new method for evaluating the functional significance of coronary artery stenosis based on angiography. It can be used for real-time detection of hemodynamic abnormalities in the coronary arteries in the catheterization lab. Unlike traditional methods that require the use of pressure wires and vasodilators such as adenosine, the QFR examination process only requires routine coronary angiography. By reconstructing the three-dimensional structure of the blood vessels and analyzing the hemodynamics, the QFR can evaluate the fractional flow reserve (FFR) without the need for pressure wires and vasodilators.
1-year MACE
Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death 2. myocardial infarction (MI) 3. Repeat myocardial revascularization 4. non-lethal stroke
MACE
Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death 2. myocardial infarction (MI) 3. Repeat myocardial revascularization 4. non-lethal stroke
All cause death
All cause death defined as: Cardiovascular death, non-cardiovascular death, death of unknown cause
Non-fatal myocardial infarction (MI)
myocardial infarction (MI) defined as: Spontaneous myocardial infarction , perioperative myocardial infarction
repeat myocardial
Repeat myocardial defined as:Planned revascularization,Unplanned revascularization
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