Clinical trialNCT07676097Not, yet, recruitingObservational

Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

SponsorAngioInsightEnrollment620Acute or Chronic Coronary Artery DiseaseNon-obstructive Coronary Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Carlos Collet, MD, PhD
Cardiovascular Research Foundation; OLV Aalst
Principal Investigator
clinicaltrials.gov ↗
Todd C Villines, MD
University of Virginia
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Palo Alto Veterans Administration Hospital
Palo Alto, California, United States
William Fearon, MD
Stanford University
Palo Alto, California, United States
William Fearon, MD
Washington Hospital Center
Washington D.C., District of Columbia, United States
Hayder Hashim, MD
Minneapolis Heart
Minneapolis, Minnesota, United States
Yader Sandoval, MD
Valley Health System
Paramus, New Jersey, United States
Rajiv Tayal, MD
New York University
New York, New York, United States
Nathaniel Smilowitz, MD
Northwell Health
New York, New York, United States
Michael C Kim, MD
Christ Hospital
Cincinnati, Ohio, United States
Tim Henry, MD
Ascension Saint Thomas
Nashville, Tennessee, United States
Jimmy Kerrigan, MD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2026
Primary completion: 31 Dec 2027
Completion: 31 Dec 2027
Last update posted: 13 Jul 2026
Registered enrollment: 620
Registry id: NCT07676097

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.