Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.
研究概览
简要总结
Prospective intervention study to assess the accuracy of the predicted QFR-derived virtual angioplasty compared to hyperaemic and non-hyperaemic pressure-wire derived indexes after PCI, as well as with QFR post-PCI.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis with PCI indication.
排除标准
- •Severe stenosis of the left main coronary artery.
- •Patients admitted with ST-elevation myocardial infarction.
- •Culprit lesions in Non-ST-Elevation Acute Coronary Syndromes (NSTEACS) patients.
- •Unability to identify the culprit lesion in NSTE-ACS patients.
研究组 & 干预措施
QFR Intervention
Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis between 50 and 90% and PCI indication with paired assessment of QFR, dFR, RFR and FFR, before and after PCI once informed consent is provided.
干预措施: Quantitative Flow Ratio (QFR) measurement (Diagnostic Test)
结局指标
主要结局
Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.
时间窗: 1 hour
次要结局
- Specificity(1 hour)
- Summary of the receiver-operator characteristics curve (sROC)(1 hour)
- Negative predictive value(1 hour)
- Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.(1 hour)
- Negative likelihood ratio(1 hour)
- Sensitivity(1 hour)
- Positive likelihood ratio(1 hour)
- Positive predictive value(1 hour)
研究者
Carlos Baladron, PhD
Research Coordinator, Cardiology
Hospital Clínico Universitario de Valladolid