NCT03226262已完成不适用
FFRangio Accuracy vs. Standard FFR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 9
- 主要终点
- Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
研究概览
简要总结
This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis.
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
- 是
入选标准
- •Male or female subjects, >18 years of age.
- •Patients with stable angina or unstable angina or NSTEMI, and in whom invasive FFR is being assessed in a non-culprit stenosis in at least one coronary artery.
- •Subject is undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
- •Provides written, informed consent (where required)
排除标准
- •Contraindication for FFR examination or administration of vasodilators.
- •Subject is presenting with acute infarct (STEMI) OR has documented prior STEMI on same side (right/left).
- •CTO in target vessel.
- •Prior CABG, heart transplant or valve surgery, or prior TAVI/TAVR.
- •Known LVEF ≤45%.
- •Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
- •TIMI Grade 2 or lower at baseline.
- •Target lesion involves Left Main (stenosis >50%).
- •PCI with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis.
- •Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
- •Target coronary vessel is supplied by major collaterals.
结局指标
主要结局
Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
时间窗: 1 hour
Sensitivity and specificity of the dichotomously scored FFRangio measured index per vessel as compared with invasively-derived FFR; Index ≤ 0.80 is scored "positive" while Index \> 0.8 is negative.
次要结局
- Continuously scored FFR (FFRangio and Invasive FFR).(1 hour)
- Procedure related Adverse and Serious Adverse Events(1 hour)
- Accuracy, Positive predictive value and negative predictive value per vessel and per lesion(1 hour)
- Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.(1 hour)
- Device Success(1 hour)
- Comprehensiveness of the FFRangio User Manual in providing adequate instructions(1 hour)
- Usability of FFRangio(1 hour)
- Device related Adverse and Serious Adverse Events(1 hour)
研究者
研究点 (9)
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