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
- •General Inclusion Criteria:
- •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
研究组 & 干预措施
Pressure Guidewire test subject
Stable patients with suspected or known CAD, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.
干预措施: Pressure Guidewire (Device)
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