Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- FFR measurement using a guide catheter with and without side holes
研究概览
简要总结
The investigators propose a single center prospective study that will assess two different strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be measured with a non-side hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) to determine, whether measurements obtained with an engaged side-hole guide catheter are more accurate as compared with those obtained with the engaged non-side hole catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Undergoing a clinically indicated coronary catheterization
- •Need FFR of a coronary artery lesion
- •Agree to participate and able to provide informed consent
排除标准
- •Significant difficulty advancing the pressure measuring guidewire into the coronary artery
- •Severe chronic obstructive pulmonary disease
- •Severe ostial disease (>70% diameter stenosis within 5 mm from the coronary artery ostium)
结局指标
主要结局
FFR measurement using a guide catheter with and without side holes
时间窗: Less than 1 hour during the coronary angiography
次要结局
未报告次要终点
研究者
Emmanouil Brilakis
Emmanouil S Brilakis, MD, PhD
North Texas Veterans Healthcare System