Computed Tomography-derived Fractional Flow Reserve vs. Angiographic Quantitative Flow Ratio in Management of Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,402
- 主要终点
- Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient-level inclusion criteria:
- •Adults aged ≥18 years.
- •Patients with stable angina, unstable angina, or post-myocardial infarction ≥72 hours.
- •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
排除标准
- •Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- •Suspected acute myocardial infarction (ECG or biomarkers indicating acute phase).
- •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.
- •Severe valvular heart disease, aortic disease, or large ventricular aneurysm requiring surgery.
- •Atrial fibrillation or other severe cardiac arrhythmias.
- •Refusal or inability to sign informed consent.
- •Lesion-level exclusion criteria:
- •Poor-quality CCTA images that prevent CT-FFR analysis.
- •Severe coronary vessel tortuosity, overlapping segments, or other factors expected to cause poor-quality invasive angiography, hindering QFR measurement.
- •Combined with chronic total occlusion lesions.
- •The stenosis degree of the left main coronary artery was ≥50%.
研究组 & 干预措施
CT-FFR group
The decisions of invasive angiography and revascularization will be guided by CT-FFR.
干预措施: CT-FFR guided strategy (Diagnostic Test)
QFR group
The decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR.
干预措施: QFR guided strategy (Diagnostic Test)
结局指标
主要结局
Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure
时间窗: 12 Months Post-Procedural Follow-Up
MACEs is defined as a composite of all-cause death, myocardial infarction, and unplanned revascularization.
次要结局
- All-cause death(12 Months After Randomization)
- Myocardial infarction (MI)(12 Months After Randomization)
- Cardiac death(12 Months After Randomization)
- Revascularization rate(12 Months After Randomization)
- Repeat revascularization(12 Months After Randomization)
- Rate of optimal medical therapy(12 Months After Randomization)
- Rehospitalization(12 Months After Randomization)
- PCI rate(12 Months After Randomization)
- Rate of invasive coronary angiography avoidance(12 Months After Randomization)
- Total cost(12 Months After Randomization)
- Number of stents implanted or bypass grafts performed(12 Months After Randomization)
- CABG rate(12 Months After Randomization)