Computed Tomography-derived Fractional Flow Reserve vs. Angiographic Quantitative Flow Ratio in Management of Patients With Coronary Artery Disease

N/ANot Yet RecruitingNCT07308496

China National Center for Cardiovascular Diseases1,402 enrolled

Overview

This is a multi-center, randomized controlled trial to compare the clinical outcomes between CT-derived fractional flow reserve (CT-FFR) guided strategy and angiography-derived quantitative flow ratio (QFR) guided strategy among patients with coronary artery disease (CAD). Participants who have at least one coronary stenosis of 70%-90% (vessel diameter ≥2.5 mm) detected by coronary CT angiography will be enrolled and are randomly assigned in a 1:1 ratio to CT-FFR guided group or QFR guided group. In CT-FFR group, the decisions of invasive angiography and revascularization will be guided by CT-FFR. In QFR group, the decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR. The primary endpoint is the 1-year incidence of major adverse cardiac events (MACEs), including death, myocardial infarction, and unplanned revascularization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,402

Conditions

Coronary Artery Disease

Interventions

Patients in this group will undergo CT-derived fractional flow reserve (CT-FFR) analysis. If the CT-FFR value is ≤0.80, patients will subsequently undergo invasive coronary angiography (ICA) and receive coronary revascularization. If the CT-FFR values of all vessels are \>0.80, patients will not undergo invasive angiography.

QFR guided strategyDIAGNOSTIC_TEST

Patients in this group will undergo invasive coronary angiography (ICA) according to routine clinical indications. During the procedure, quantitative flow ratio (QFR) analysis will be performed. If the QFR value is ≤0.80, coronary revascularization will be performed. If the QFR value is \>0.80, coronary revascularization will be forwent.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Patient-level inclusion criteria: 1. Adults aged ≥18 years. 2. Patients with stable angina, unstable angina, or post-myocardial infarction ≥72 hours. 3. Patients are able and willing to provide written informed consent. Lesion-level inclusion criteria: (1) Coronary CT angiography (CCTA) shows at least one coronary artery with 70%-90% diameter stenosis and vessel diameter ≥2.5 mm. Patient-level exclusion criteria: 1. Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). 2. Suspected acute myocardial infarction (ECG or biomarkers indicating acute phase). 3. Moderate to severe chronic kidney disease, defined as serum creatinine \>150 μmol/L or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². 4. Severe valvular heart disease, aortic disease, or large ventricular aneurysm requiring surgery. 5. Atrial fibrillation or other severe cardiac arrhythmias. 6. Refusal or inability to sign informed consent. Lesion-level exclusion criteria: 1. Poor-quality CCTA images that prevent CT-FFR analysis. 2. Severe coronary vessel tortuosity, overlapping segments, or other factors expected to cause poor-quality invasive angiography, hindering QFR measurement. 3. Combined with chronic total occlusion lesions. 4. The stenosis degree of the left main coronary artery was ≥50%.

Outcomes

Primary Outcomes

Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure

MACEs is defined as a composite of all-cause death, myocardial infarction, and unplanned revascularization.

Time frame: 12 Months Post-Procedural Follow-Up