MedHub AutocathFFR United States Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medhub Ltd.
- 入组人数
- 277
- 试验地点
- 4
- 主要终点
- Per-Vessel Sensitivity of AutocathFFR vs. Invasive FFR
研究概览
简要总结
This observational study evaluated how well the AutocathFFR software measures fractional flow reserve (FFR) from coronary angiogram images. AutocathFFR runs on standard two-dimensional (2D) angiograms taken during cardiac catheterization. Researchers compared its results to invasive FFR, the gold standard.
The main questions were:
- What is the sensitivity of AutocathFFR per vessel compared to invasive FFR?
- What is the specificity of AutocathFFR per vessel compared to invasive FFR?
A vessel is scored "positive" when FFR ≤ 0.80 and "negative" when FFR > 0.80. Researchers retrospectively analyzed consecutive angiograms from 4 sites in the United States. 278 patients (300 vessels) were analyzed with the AutocathFFR software, and 277 patients (297 vessels) completed AutocathFFR analysis. Participants were adults with stable angina, unstable angina, or non-ST-elevation myocardial infarction (NSTEMI) who underwent invasive coronary angiography and invasive FFR.
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
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 22 years
- •Subjects with stable angina pectoris, unstable angina pectoris, or NSTEMI and in whom invasive FFR was performed to assess a non-culprit stenosis in at least one coronary artery
- •Subject underwent a clinically indicated Invasive Coronary Angiogram (ICA)
- •Subject underwent invasive FFR with intravenous (IV) or intracoronary adenosine, or adenosine triphosphate (ATP), as hyperemic stimulus
排除标准
- •Angiogram not obtained on a United States Food and Drug Administration (FDA)-cleared C-arm angiography system
- •Invasive FFR not obtained on an FDA-cleared FFR catheter tip pressure transducer (also known as a pressure wire)
- •Vessel size less than 2 mm
- •Subject presents with an ST-elevation myocardial infarction (STEMI)
- •Chronic total occlusion (CTO) in target vessel
- •Prior coronary artery bypass graft (CABG) surgery, heart transplant or valve surgery, prior transcatheter aortic valve implantation/replacement (TAVI/TAVR), or severe left-sided valvular disease
- •Known left ventricular ejection fraction (LVEF) ≤ 30%
- •Arteries supplying akinetic or severe hypokinetic territories on target lesion, if already known based on prior imaging
- •Thrombolysis in Myocardial Infarction (TIMI) flow grade equal to or lower than 2 at baseline
- •Target lesion involves Left Main (stenosis >50%)
- •Percutaneous coronary intervention (PCI) with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis
- •Target coronary vessel provides collaterals to a chronically occluded vessel
- •Coronary angiography was not performed per standard of care at a cine frame rate of at least 7 frames per second
- •Presence of aortic damping
- •Distortion of the waveform
- •Less than two different angiographic views for each lesion of interest in the Left Circumflex Artery (LCX), Left Anterior Descending Artery (LAD), or Right Coronary Artery (RCA)
- •Lesion is not clearly visible
研究组 & 干预措施
AutocathFFR Validation Cohort
Adult subjects with stable angina, unstable angina or NSTEMI who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured to assess the hemodynamic significance of suspected coronary lesions.
干预措施: MedHub AutocathFFR (Device)
结局指标
主要结局
Per-Vessel Sensitivity of AutocathFFR vs. Invasive FFR
时间窗: Day 1 (the day of the index invasive coronary angiography procedure)
Sensitivity of the dichotomously scored AutocathFFR per vessel compared to the gold standard, invasive FFR measurements, where an FFR ≤ 0.80 is scored "positive" and an FFR \> 0.80 is considered "negative". Performance goal: lower bound of one-sided 97.5% confidence interval must exceed 80%.
Per-Vessel Specificity of AutocathFFR vs. Invasive FFR
时间窗: Day 1 (the day of the index invasive coronary angiography procedure)
Specificity of the dichotomously scored AutocathFFR per vessel compared to the gold standard, invasive FFR measurements, where an FFR ≤ 0.80 is scored "positive" and an FFR \> 0.80 is considered "negative". Performance goal: lower bound of one-sided 97.5% confidence interval must exceed 80%.
次要结局
- Per-Patient Sensitivity and Specificity(Day 1 (the day of the index invasive coronary angiography procedure))
- Sensitivity, Specificity, PPV, and NPV Including "No FFR" Output(Day 1 (the day of the index invasive coronary angiography procedure))
- Device Success Rate(Through study completion, up to 8 months)
- Device-Related Malfunctions(Through study completion, up to 8 months)