Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Starting soon
Conditions studied: Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT07676097
- Run by
- AngioInsight
- People needed
- 620
- Starts
- 2026-06-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients presenting with ST-elevation
- Prior myocardial infarction in the target vessel
- Stent implantation in the target vessel within the last 12 months
- Previous coronary artery bypass grafting surgery (CABG)
- Previous heart valve surgery
- Previous heart transplantation
- Moderate-to-severe valvular disease
- Left ventricular ejection fraction (EF) ≤45%
- 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
- Less than thrombolysis in myocardial infarction (TIMI) 3 flow in the target vessel
- Target vessel receiving collaterals
- Inadequate coronary angiographic images
- Ostial lesions
- Severe tortuosity
Where it is running
- 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
Full record on ClinicalTrials.gov
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