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Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Sponsor: 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.
Official title: Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW (SMARTFLOW) Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
620
Start Date
2026-06
Completion Date
2027-12
Last Updated
2026-07-13
Healthy Volunteers
No
Interventions
Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment.
Cohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.
Microvascular assessment
Cohort 2: Patients with non-obstructive (\<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.
Locations (9)
Palo Alto Veterans Administration Hospital
Palo Alto, California, United States
Stanford University
Palo Alto, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Minneapolis Heart
Minneapolis, Minnesota, United States
Valley Health System
Paramus, New Jersey, United States
New York University
New York, New York, United States
Northwell Health
New York, New York, United States
Christ Hospital
Cincinnati, Ohio, United States
Ascension Saint Thomas
Nashville, Tennessee, United States