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NOT YET RECRUITING
NCT07676097

Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

Sponsor: AngioInsight

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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