NCT03455244已完成不适用
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 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, single-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 in Multi-Vessel Disease.
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
- •>18 years of age.
- •Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses ≥ 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses.
- •Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
- •Written, informed consent.
排除标准
- •Contraindication for FFR examination or administration of vasodilators.
- •Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year.
- •CTO in a target vessel.
- •Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation.
- •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 lesions involve Left Main (stenosis ≥50%.)
- •In-stent restenosis in a target vessel.
- •Heavily diffused atherosclerosis diseases defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
- •Target coronary vessels are supplied by major collaterals.
- •Lesion is in ectatic segment which includes dilatation in diameter at least 1.5 times that of the adjacent normal coronary artery.
- •Coronary angiograms not acquired per instructions as defined in the Study Protocol.
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
- Accuracy, Positive predictive value and negative predictive value per vessel and per lesion(1 hour)
- Continuously scored FFR (FFRangio and Invasive FFR).(1 hour)
研究者
研究点 (1)
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