Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device
研究概览
简要总结
Patients with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System). Both articles are used within the same participant and the FFR values are statistically compared with each other.
详细描述
The objective of the 'Pressure guidewire system multi-center, prospective, single-subject design clinical trial' is to evaluate the effectiveness and safety of Zurich Medical's pressure guidewire system (including guidewire with high-fidelity sensors and a unique paired portable display unit), which is used to measure the coronary artery blood fractional flow reserve (FFR) to diagnose coronary artery disease, and to direct a catheter through a blood vessel. This clinical trial uses a multi-center, prospective, single-subject design trial method, using St. Jude Medical's pressure guidewire and Analyzer Express as a control device. The subjects who met the criteria for this study will be registered with the central registration system after enrollment. Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System). Both articles are used within the same participant and the FFR values are statistically compared with each other. The subject's FFR of coronary artery stenosis will first be measured using investigational device and recorded, and then measured using control device and recorded. The safety follow-up period is 48 hours.
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
- •Age 18 to 75 years old, gender-unrestricted, non-pregnant female;
- •Understand and be willing to sign an informed consent form;
- •Diagnosed with coronary heart disease;
- •Intrusive ICA and FFR measurement are needed;
- •Visual coronary angiography showed at least one moderate stenosis lesion (diameter stenosis of 30% - 70%) on the coronary artery with diameter ≥ 2.5mm
排除标准
- •Patient who do not understand or are unwilling to sign an informed consent form;
- •Has a history of myocardial infarction;
- •Patient with other serious diseases are not suitable for clinical trials, such as a complex congenital heart disease history, severe heart failure(NYHA cardiac function level IV), long QT syndrome, severe hypertension, Severe asthma, severe chronic obstructive pulmonary disease, liver and kidney dysfunction and other serious infections and critical illnesses;
- •Coronary intervention surgery contraindications;
- •Patient with ATP contraindications (ATP contraindications: sinus syndrome, sinus insufficiency and the elderly with cautious use or no use);
- •The clinical manifestations of patients show acute instability, including acute chest pain (sudden appearance), cardiogenic shock, unstable blood pressure (systolic pressure less than 90mmHg), severe congestive heart failure or acute pulmonary edema;
- •The angiography shown or suspect of thrombosis;
- •The angiography shown or suspect of dissection;
- •Left main coronary artery disease, target blood vessels with severe curvature or calcification lesions, total occlusion;
- •There are any other factors that the investigator considers unsuitable for inclusion or completion of this study.
结局指标
主要结局
Number of Participants With Diagnostic Consistency When Comparing FFR Measurement Between Control Device and Investigational Device
时间窗: Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.
Diagnostic consistency rate: When the measurement of control device is positive (FFRPW ≤ 0.80) or negative (FFRPW \> 0.80), investigational device is also positive (FFRWS ≤ 0.80) or negative (FFRWS \> 0.80). Each subject will be considered a research unit (for patients with multiple lesions, the method of converting the results of multiple lesions into patient level is defined in the statistical analysis plan), and the coronary artery FFRPW measured by control device will be taken as reference. Measurements are taken on patients with both the trial device and control device, sequentially during the same visit.
次要结局
- The Sensitivity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)
- The Specificity of the Trial Device Compared to the Control Device in Diagnosing Coronary Heart Disease(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)
- Positive Predictive Value (PPV) of the Trial Device for Diagnosing Coronary Heart Disease(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)
- Negative Predictive Value (NPV) of the Trial Device for Diagnosing Coronary Heart Disease(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)
- Receiver Operating Characteristic (ROC) Curve of the Trial Device in Diagnosing Coronary Heart Disease(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)
- Passing-Bablok Regression Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)
- Bland-Altman Bias Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)
- Pearson Linear Correlation Analysis Results for the Trial Device in Diagnosing Coronary Heart Disease(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)
- Device Success Rate Analysis Results for Subjects(Acute - all measurements are taken and assessed during each procedure. Each participant completes their procedure in one visit, with each procedure taking up to 30 minutes.)