Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW (SMARTFLOW) Study
AngioInsight
Summary
The aim of this study is to establish the diagnostic performance of the AngioAI+ System (AngioInsight, Inc, USA) for estimating: 1. Fractional flow reserve (FFR) and 2. Detection of coronary microvascular disease (CMD) SMARTFLOW is a prospective, single-arm, observational multicenter study of patients with suspected coronary artery disease (CAD) undergoing clinically indicated invasive coronary angiography with physiological assessment. The study is designed to prospectively enroll patient cohorts and collect data according to their reference procedures (e.g. FFR, CFR measures). A core lab will evaluate performance of the AngioAI+ software retrospectively using the collected SMARTFLOW study data. As such, the investigational AngioAI+ device will not inform clinical decisions amid the study procedure.
Description
All patients will undergo clinically indicated invasive coronary angiography with physiological assessment according to standard of care. Cohort 1: Patients with intermediate lesions (30-90% diameter stenosis) will undergo invasive FFR assessment. In patients with FFR \>0.80 (non-flow limiting stenosis), subsequent assessment of the microcirculation with bolus and continuous thermodilution will be performed. Cohort 2: Patients with non-obstructive (\<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution. For patients in Cohort 1 with…