Pressure Microcatheter for Physiological Measurements - A Prospective, Multicenter, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 487
- 试验地点
- 11
- 主要终点
- The accuracy of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia
研究概览
简要总结
TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and its safety and efficacy on the measurement of hyperemic index have been validated in the previous SUPREME study (NCT03541577). This study will further evaluate the safety and efficacy of the physiological indices measured by the TruePhysio pressure microcatheter, including resting and hyperemic indices, with respect to the physiological indices measured by the Pressure Wire.
详细描述
This study will evaluate the safety and efficacy of the constant-resistance ratio (cRR) measured by the TruePhysio pressure microcatheter, in both binary and hybrid strategy, with respect to its own fractional flow reserve (FFR) and the FFR or resting full-cycle ratio (RFR) by the Pressure Wire. And the safety and efficacy of the FFR measured by the TruePhysio pressure microcatheter in patients with a border range of diameter stenosis also be validated with respect to the FFR by the Pressure Wire.
The diagnostic accuracy of cRR by the TruePhysio pressure microcatheter system is evaluated, using FFR measured by both systems as reference;
Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire is evaluated, using FFR measured by Pressure Wire as the reference;
The diagnostic accuracy of the hybrid cRR-FFR scheme by the TruePhysio pressure microcatheter is evaluated, using its own FFR as reference;
The diagnostic accuracy of the hybrid RFR-FFR scheme by the Pressure Wire system is evaluated, using its own FFR as reference.
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
- •At least 18 years old;
- •Having at least one 30-90% coronary artery stenosis by visual estimation under angiogram;
- •Clinically indicated to physiological assessment.
排除标准
- •Unable to comprehend, or unwilling to sign the informed consent form;
- •Contraindicated to the procedures of invasive coronary angiography or percutaneous coronary intervention;
- •Clinically diagnosed with severe coronary artery vasospasm;
- •Other operator-discerned facts that will make enrollment or the procedure impossible to complete.
结局指标
主要结局
The accuracy of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia
时间窗: Immediate upon completion of the procedure for the last enrolled patient
Using FFR measured by TruePhysio pressure microcatheter as the reference. The optimal binary cutoff for cRR is determined by using Youden's index.
次要结局
- When the RFR value is out of the gray zone of the hybrid RFR-FFR scheme, the RFR-FFR hybrid scheme's accuracy in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Pearson correlation between the cRR and FFR measured by TruePhysio pressure microcatheter(Immediate upon completion of the procedure for the last enrolled patient)
- Mean bias between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire as assessed by Bland-Altman analysis(Immediate upon completion of the procedure for the last enrolled patient)
- The AUC of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- The AUC of RFR measured by the Pressure Wire in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- The proportion of the subcohort, whose cRR value is in the gray zone of the hybrid cRR-FFR scheme, to the entire cohort(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Passing-Bablok regression analysis between RFR and FFR measured by Pressure Wire(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Pearson's correlation between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire(Immediate upon completion of the procedure for the last enrolled patient)
- The area under the Receiver Operating Characteristic (ROC) curve (AUC) of cRR measured by the TruePhysio pressure microcatheter in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- The sensitivity, specificity, positive and negative predictive values of cRR measured by TruePhysio pressure microcatheter in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- The overall accuracy, sensitivity, specificity, positive predictive value and negative predictive value of RFR in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- The overall accuracy, sensitivity, specificity, positive and negative predictive values of the hybrid cRR-FFR scheme, concluded by TruePhysio pressure microcatheter, in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- The overall accuracy, sensitivity, specificity, positive and negative predictive values of the hybrid RFR-FFR scheme, concluded by Pressure Wire, in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- The proportion of the subcohort, whose RFR value is in the gray zone of the hybrid RFR-FFR scheme, to the entire cohort(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Passing-Bablok regression analysis between the cRR and FFR measured by TruePhysio pressure microcatheter(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Pearson correlation between the RFR and FFR measured by Pressure Wire(Immediate upon completion of the procedure for the last enrolled patient)
- When the cRR value is out of the gray zone of the hybrid cRR-FFR scheme, the cRR-FFR hybrid scheme's accuracy in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- The overall accuracy, sensitivity, specificity, positive and negative predictive values of cRR in diagnosing myocardial ischemia(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Bland-Altman analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Passing-Bablok regression analysis between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire(Immediate upon completion of the procedure for the last enrolled patient)
- Rate of significant drift(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Passing-Bablok regression analysis between cRR measured by the TruePhysio pressure microcatheter, and RFR measured by the Pressure Wire(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Pearson correlation between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire(Immediate upon completion of the procedure for the last enrolled patient)
- Results of Bland-Altman analysis between the FFR values measured by TruePhysio pressure microcatheter and Pressure Wire among the patients with atrial fibrillation or in severe stenosis or with small vessels(Immediate upon completion of the procedure for the last enrolled patient)
- Rate of device success(Immediate upon completion of the procedure for the last enrolled patient)