Impact of Interventional Revascularization on the Physiological Assessment of Bystander Coronary Lesions by FFR (ABC-FFR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- ΔFFR
研究概览
简要总结
The ABC-FFR trial examines the understudied hemodynamic interaction between parallel coronary stenoses, as the physiological impact of treating one lesion on the pressure indices of lesions in separate parallel branches is not yet fully understood. This prospective, multicenter study enrolls patients scheduled for percutaneous coronary intervention (PCI) of a designated index lesion who also present with a concurrent remote stenosis in a parallel coronary artery. It evaluates potential changes in fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) measurements within the remote lesion both before and after the index lesion is revascularized.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥ 18 years
- •Scheduled percutaneous coronary intervention for at least one coronary lesion (as indicated by evidence of myocardial ischemia on non-invasive stress imaging, an angiographic stenosis severity >90% diameter stenosis, or an hemodynamically significant intracoronary pressure measurement)
- •Additional stenosis of ≥ 30% diameter stenosis in a parallel coronary artery anatomically suitable for wire-based intracoronary pressure assessment
排除标准
- •ST-elevation myocardial infarction
- •Non-ST-elevation myocardial infarction with immediate invasive strategy recommended by current ESC guidelines (e.g. due to hemodynamic instability, cardiogenic shock, acute heart failure presumed secondary to ongoing myocardial ischemia, recurrent or ongoing chest pain refractory to medical treatment, or life-threatening arrhythmias or cardiac arrest after presentation)
- •Acute totally occluded coronary artery
- •Unsuitability for intracoronary measurement of FFR (e.g. due to contraindications for the administration of adenosine)
结局指标
主要结局
ΔFFR
时间窗: Baseline
Difference between fractional flow reserve measurements in the remote lesion after and before percutaneous coronary intervention of the index lesion
Change in Hemodynamic Classification by FFR
时间窗: Baseline
Change in hemodynamic classification of the remote lesion with fractional flow reserve after percutaneous coronary intervention of the index lesion
次要结局
- ΔNHPR(Baseline)
- Change in Hemodynamic Classification by NHPR(Baseline)
研究者
Johannes Michael Altstidl
Physician
Friedrich-Alexander-Universität Erlangen-Nürnberg