Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement: A Multi-center Prospective Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 4
- 主要终点
- FFR Measurements
研究概览
简要总结
TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. This study will compare the differences, if any, between the coronary fractional flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.
详细描述
Many studies have reported that FFR-guided coronary revascularization leads to improved long-term clinical outcomes and reduced costs compared with angiography-guided coronary revascularization alone. Current guidelines emphasize the measurement of FFR as the standard of reference when determining the functional significance of coronary artery stenosis in stable patients when evidence of ischemia is not available (class IA indication). But FFR is still underutilized in clinical practice. One of the reasons may be the difficulty in manipulating the Pressure Wire.
TruePhysioTM Microcatheter is a novel device for evaluating the functional significance of coronary stenosis, which may simplify FFR measurements by allowing the use of standard guidewires best suited to negotiating the patients' anatomy. This study is a prospective, open label, multi-center study with the purpose of comparing the differences, if any, between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. The secondary purpose is to analyze the correlation between FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. A total of 239 patients will be recruited at 4 centers in China.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old
- •Subjects with coronary artery disease
- •Able to understand and provide signed consent
- •Angiographic Inclusion Criteria:
- •Subject has an intermediate stenosis in a native coronary vessel
- •The target stenosis has a reference diameter ≥2.50 mm by visual assessment.
排除标准
- •General Exclusion Criteria:
- •Acute ST-elevation or non-ST-elevation myocardial infarction
- •Severe heart failure (NYHA≥IV)
- •Left ventricular ejection fraction <30%
- •Allergy to adenosine triphosphate (ATP)
- •Contraindications for percutaneous coronary intervention (PCI)
- •Angiographic Exclusion Criteria:
- •Target vessel has angiographically visible or suspected thrombus
- •Angiographic evidence of a dissection
- •Excessive tortuosity or calcification stenosis, left main stenosis, serial stenosis
结局指标
主要结局
FFR Measurements
时间窗: Duration of FFR measurement
Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis.
次要结局
- Pearson analysis(Duration of FFR measurement)
- Intercept of Passing-Bablok fit(Duration of FFR measurement)
- Slope of Passing-Bablok fit(Duration of FFR measurement)
- PW FFR measurements with TruePhysioTM Microcatheter across and not across lesion(Duration of FFR Procedure)
- Rate of clinically significant drift(Duration of FFR measurement)
- Diagnostic FFR concurrence of functionally significant stenosis(Duration of FFR measurement)
- Device success rate(Duration of FFR measurement)
- Rate of device-related adverse effects(Duration of FFR Procedure)
- Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis(Duration of FFR measurement)
- Mean drift(Duration of FFR measurement)