Testing an AI tool that estimates heart artery blood flow during angiography
Checks an AI software tool's accuracy for estimating narrowed heart artery blood flow in adults.
Plain-language title generated from the registry record
Registry title: Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Key facts
- Where
- Cincinnati, Minneapolis, Nashville, New York, Palo Alto, Paramus, and Washington D.C., United StatesSee the 10 sites
Where in United States
- Christ HospitalCincinnati, United StatesNo longer taking part
- Minneapolis HeartMinneapolis, United StatesNo longer taking part
- Ascension Saint ThomasNashville, United StatesNo longer taking part
- Columbia University Medical Center/ NewYork Presbyterian HospitalNew York, United StatesNo longer taking part
- New York UniversityNew York, United StatesNo longer taking part
- Northwell HealthNew York, United StatesNo longer taking part
- Palo Alto Veterans Administration HospitalPalo Alto, United StatesNo longer taking part
- Stanford UniversityPalo Alto, United StatesNo longer taking part
- Valley Health SystemParamus, United StatesNo longer taking part
- Washington Hospital CenterWashington D.C., United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AngioInsight
- Trial code
- NCT07676097
- Record updated
- 2 November 2026
- Original description
The aim of this study is to establish the diagnostic performance of the AngioAI+ System (AngioInsight, Inc, USA) for estimating:Read full original descriptionShow less
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW (SMARTFLOW) Study
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.
Inclusion: Patients with acute or chronic coronary syndromes referred for invasive coronary angiography with clinically indicated coronary physiologic assessment. In patients with acute coronary syndromes, the physiological evaluation will be restricted to non-culprit vessels; Patients with intermediate CAD (30-90% visual stenosis) with clinically indicated FFR assessment; Patients with NOCAD (<30% visual stenosis) with clinically indicated microvascular assessment.
Exclusion: Prior myocardial infarction in the target vessel; Previous coronary artery bypass grafting surgery (CABG); Previous heart valve surgery; Previous heart transplantation; Target vessel receiving collaterals; Moderate-to-severe valvular disease; Less than thrombolysis in myocardial infarction (TIMI) 3 flow in the target vessel; Left ventricular ejection fraction (EF) ≤45%; Patients presenting with ST-elevation; Stent implantation in the target vessel within the last 12 months; Hemodynamic instability or cardiogenic shock; Angiographic Exclusion Criteria; Left main stenosis≥50%; Chronic total occlusion in the target vessel; CTO in a non-target vessel; Inadequate coronary angiographic images; Ostial lesions; Severe tortuosity.