A Prospective, Multicenter Study to Evaluate the Performance and Safety of CometTM Pressure Guidewire in the Measurement of FFR in Chinese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Fractional Flow Reserve (FFR)
研究概览
简要总结
A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements
详细描述
The COMET China study is a prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements. Patient with stable angina or any form of non-ST elevation acute coronary syndrome, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient must be at least 18 years old and less than or equal to 75 years of age
- •Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure
- •Patient with stable angina or any form of non-ST elevation acute coronary syndrome and is clinically indicated of intra-coronary diagnostic angiography and FFR assessment
- •Angiographic Inclusion Criteria:
- •Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography
排除标准
- •Patients unable to provide informed consent
- •Patients in pregnant state
- •Known renal insufficiency or failure (serum creatinine level of > 2.5 mg/dL, or on dialysis)
- •Allergy to the contrast
- •Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia
- •Spastic bronchial asthma
- •ST elevation coronary syndrome
- •Hemodynamic instability
- •Contraindication to nitroglycerin or ATP
- •Current participation in another investigational drug or device clinical study that may affect the FFR measurements
- •Angiographic Exclusion Criteria:
- •CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction
结局指标
主要结局
Fractional Flow Reserve (FFR)
时间窗: during procedure, 1 hour
All eligible subjects will receive FFR measurements simultaneously by both CometTM Pressure Guidewire and Pressure wires Certus®. Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR lower than 0.75-0.80 is generally considered to be associated with myocardial ischemia (MI). Agreement between the method of measurement will be confirmed if both conditions are met: The mean paired difference is within +/- 0.005
次要结局
未报告次要终点