NCT03005028已完成不适用
Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI
研究概览
简要总结
In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male and female above 18 years old age which undergo FFR as part of their standard care
- •TIMI Grade Flow is equal to 3
- •LVEF larger than 45%.
- •Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.
排除标准
- •Contraindicated for FFR examination or adenosine administration
- •TIMI Grade Flow below 3
- •Arteries supplying akinetic or severe hypokinetic territories
- •Prior CABG on the study vessel
- •Left Main stenosis, In-stent restenosis and Collaterals
- •Diffused atherosclerosis diseases and tandem lesions
- •Aorto-ostial lesion
结局指标
主要结局
Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI
时间窗: 1 hour
Immediately following the invasive FFR procedure.
次要结局
未报告次要终点
研究者
研究点 (1)
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