A Prospective, Observational, Non-randomized European, Multi-center Registry Collecting Real Life Information for the Utilization of Instantaneous Wave Free Ratio in Assessing Coronary Stenosis Relevance in the Multi-vessel Disease Patients Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Hemodynamic severity (Percentage of stenosis properly classified by iFR®)
研究概览
简要总结
The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization.
详细描述
The REAL Registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple European and Middle East countries, where product has received CE approval and is marketed. An average of 10 cases with a maximum of 50 patients will be enrolled per participating site.
No follow-up will be performed. The REAL Registry will only collect data during diagnostic angiogram or PCI procedure, when performed.
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
- •Over 18 year of age
- •Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- •Eligible for coronary angiography and PCI
- •Coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment.
排除标准
- •Inability to obtain a signed informed consent from potential patient.
- •Any contraindication for functional assessment as per the instructions per use and determined by the investigator.
结局指标
主要结局
Hemodynamic severity (Percentage of stenosis properly classified by iFR®)
时间窗: Day 1 (Post-Procedure)
Percentage of stenosis properly classified by iFR® in terms of hemodynamic severity compare to FFR in MVD patients. Hemodynamic severity will be established with an FFR value \<=0,80.
次要结局
- changes in iFR® and FFR(Day 1 (Post-Procedure))
- Changes to decision strategy of revascularization(Day 1 (Post-Procedure))