The objective of this prospective, cross-sectional, multicenter pivotal trial study is to validate Infrasensor's clinical performance for the detection of high grade obstructive NSTE-ACS. High-grade obstructive NSTE-ACS is defined as an acute coronary syndrome in which severe obstructive coronary artery disease, including total coronary artery occlusion is present.
Study Endpoints Primary Endpoint: Infrasensor performance (Lower bound of 95% CI for sensitivity, specificity) between device detection of high-grade obstructive NSTE-ACS and angiographic diagnosis of High-grade obstructive CAD defined as the aggregate of >50% left main stenosis, or >70% stenosis in 1 or more coronary arteries and/or emergent revascularization.
Secondary Endpoint: Infrasensor performance (positive and negative predictive values, and overall accuracy).
Infrasensor for Early Identification of High-grade Obstructive Non-ST-segment Elevation Acute Coronary Syndrome in Patients With Suspected Acute Coronary Syndrome