Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone
研究概览
简要总结
This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.
详细描述
285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard
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
- •Age >18 years
- •Patients providing written informed consent
- •Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)
- •Has undergone >64 multidetector row CCTA within 60 days prior to ICA
- •No cardiac interventional therapy between the CCTA and ICA
排除标准
- •Prior coronary artery bypass graft (CABG) surgery
- •Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel
- •Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, , severe COPD or bronchodilator-dependent COPD
- •Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
- •Recent prior myocardial infarction within 40 days of ICA
- •Known complex congenital heart disease
- •Prior pacemaker or internal defibrillator lead implantation
- •Prosthetic heart valve
- •Significant arrhythmia or tachycardia
- •Impaired chronic renal function (serum creatinine >1.5 mg/dl
- •Patients with known anaphylactic allergy to iodinated contrast
- •Pregnancy or unknown pregnancy status
- •Body mass index >35
- •Patient requires an emergent procedure
- •Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
- •Any active, serious, life-threatening disease with a life expectancy of less than 2 months
- •Inability to comply with study procedures
研究组 & 干预措施
Single arm study
Patients will receive cCTA, ICA, FFR, and cFFR per protocol.
干预措施: FFR (Device)
结局指标
主要结局
Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone
时间窗: 1 day
Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis\* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values \>0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and \<50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.
次要结局
- Diagnostic Performance of CCTA Plus FFRCT at the Subject Level(1 day)