Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

NCT07676097 · tracked via the Priya Life Science USA tracker

Sponsor

AngioInsight

Phase

Observational

Started

2026-06

Last updated

2026-07-13

Condition(s) studied

Non-obstructive Coronary DiseaseAcute or Chronic Coronary Artery Disease

Investigational drug(s) / intervention(s)

Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment.Microvascular assessment

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

To establish the diagnostic performance of the AngioAI+ System — June 2026 to December 2027
1\. Per-vessel diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ FFR for identifying flow-limiting lesions, using measured FFR as the reference standard.
To establish the diagnostic performance of AngioAI+ System — June 2026 to December 2027
Description: 2. Diagnostic performance (i.e., sensitivity and specificity) of AngioAI+ for detecting CMD in patients with non-obstructive CAD using invasive coronary flow reserve (CFR) derived from continuous thermodilution as reference.

Trial sites (9)

Facility	City	Region
Palo Alto Veterans Administration Hospital	Palo Alto	California
Stanford University	Palo Alto	California
Washington Hospital Center	Washington D.C.	District of Columbia
Minneapolis Heart	Minneapolis	Minnesota
Valley Health System	Paramus	New Jersey
New York University	New York	New York
Northwell Health	New York	New York
Christ Hospital	Cincinnati	Ohio
Ascension Saint Thomas	Nashville	Tennessee

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07676097 on ClinicalTrials.gov ↗ ← All trials in the USA