Prospective Validation of the Angio-based Fractional Flow Reserve (Quantitative Flow Ratio, QFR) System to Discriminate Patients at Risk of Adverse Events After Stent Implantation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 602
- 试验地点
- 5
- 主要终点
- Device-oriented cardiac events
研究概览
简要总结
The investigators will collect prospectively baseline, procedural and follow-up data of all patients receiving successful percutaneous coronary intervention (PCI) and stent implantation. Angio-based flow fractional reserve (quantitative flow ratio, QFR, Medis medical imaging systems Leiden, The Netherlands) will be estimated in all patients. Especially, the investigators at the end of the procedure (this is defined according operator's judgement) will record 2 orthogonal angiograms (as suggested by QFR instructions) at 15 frames/second and the same 2 orthogonal angiograms at 30 frames/second. An independent corelab (blinded to procedural data and clinical outcome) will estimate QFR value (one with the angiograms at 15 frames and one with those at 30 frames
详细描述
Fractional flow reserve (FFR) allows to evaluate the functional significance of coronary artery lesions, through the ratio of the mean coronary artery pressure after the stenosis to the mean aortic pressure during maximum hyperaemia. The actual widely accepted cutoff value is 0.80. Below this value, an intermediate coronary lesion is considered significant and its treatment with percutaneous coronary intervention (PCI) is justified.
The measurement FFR after stent implantation has a strong predictive value with respect to death, myocardial infarction, or need for repeat revascularization of the target vessel within 6 months. The higher the FFR, the lower the event rate. FFR cut-off of 0.90 might be a useful indicator in daily practice for optimal physiologic stent implantation. Nevertheless, the use of the FFR in the post stenting , is relatively low, because of costs of the pressure wire and the adverse effects related to the use of adenosine.
A new method (QFR by Medis medical imaging) for evaluation of the functional significance of coronary stenosis is based on computer calculation of the FFR value. This calculation is performed by analysing the coronary angiogram and thus reduces or potentially eliminates the need for measuring FFR by pressure wires. The QFR method combines a 3D reconstructions of the target vessel based on two angiographic projections and the contrast flow velocity to compute the "FFR value". To perform QFR the investigators will acquire two angiographic projections with angle >25 degree that allow the 3D reconstruction of the vessel (see values below).
Projections for left main (LM) and proximal left anterior descending (LAD) or proximal left circumflex (LCX): right anterior oblique (RAO) 20, Caudal 45 and anterior-posterior (AP), Caudal 10
Projections for LAD/diagonal: AP, Cranial 45 and RAO 35, Cranial 20
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •successfull percutaneous coronary intervention and stent implantation
排除标准
- •inability to provide consent
- •inability to guarantee at least 1-year follow-up
- •thrombolysis in myocardial infarction (TIMI) flow <3
- •life expectancy <1 year
- •previous coronary artery bypass graft
- •atrial fibrillation
- •ongoing ventricular arrhythmias
- •significant and persistent tachycardia (heart rate >100 bpm)
结局指标
主要结局
Device-oriented cardiac events
时间窗: 1-year
cumulative occurrence of cardiac death, target vessel myocardial infarction, target lesion revascularization
次要结局
- stent thrombosis(1-year)
- cardiac death(1-year)
- any myocardial infarction(1-year)
- target vessel revascularization(1-year)
- all-cause mortality(1-year)
- hospital admission for all causes(1-year)
研究者
Gianluca Campo
Associate Professor, Interventional Cardiologist
University Hospital of Ferrara