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SMARTFLOW Study: Assessing the AngioAI+ System for Coronary Artery Disease

This study, called SMARTFLOW, is looking at a new system called AngioAI+ to see how well it can measure blood flow in your heart arteries. This system aims to help doctors understand if you have blockages (Fractional Flow Reserve or FFR) or problems with your small blood vessels (coronary microvascular disease). You might be able to join if you have acute or chronic coronary syndromes (heart conditions) and are already scheduled for a heart catheterization (invasive coronary angiography) where doctors look at your heart arteries. The study is observational, meaning researchers will collect information during your standard care. They plan to enroll 620 participants. The study aims to see how accurate the AngioAI+ System is by June 2026 to December 2027.

Study design
This is an observational study, meaning researchers will collect data during your standard medical care. It is a single-arm study, involving 620 participants.
What's involved
You will undergo a clinically indicated invasive coronary angiography with physiological assessment. Depending on your condition, this may include FFR assessment and microvascular assessment with thermodilution.
Compensation
Not stated in the trial record.
Follow-up
The diagnostic performance of the AngioAI+ System will be measured from June 2026 to December 2027.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07676097

Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

Not Yet Recruiting
Not specifiedAges 18+Observational
AngioInsight
~620 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment.Microvascular assessment

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To establish the diagnostic performance of the AngioAI+ System
Measured over June 2026 to December 2027
+1 more outcome measured

Conditions

Non-obstructive Coronary Disease
Acute or Chronic Coronary Artery Disease

Explore related trials

Acute Coronary SyndromeChronic Coronary SyndromeCoronary Artery DiseaseNonocclusive coronary artery atherosclerosis

NCT07676097

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascension Saint Thomas

    Nashville, Tennesseestudy coordinator listed

  • Christ Hospital

    Cincinnati, Ohiostudy coordinator listed

  • Minneapolis Heart

    Minneapolis, Minnesotastudy coordinator listed

  • New York University

    New York, New Yorkstudy coordinator listed

  • Northwell Health

    New York, New Yorkstudy coordinator listed

  • Palo Alto Veterans Administration Hospital

    Palo Alto, Californiastudy coordinator listed

  • Stanford University

    Palo Alto, Californiastudy coordinator listed

  • Valley Health System

    Paramus, New Jerseystudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Carlos Collet, MD, PhD · PRINCIPAL_INVESTIGATOR · Cardiovascular Research Foundation; OLV Aalst
  • Todd C Villines, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Sr. VP Regulatory Affairs - AngioInsight
[email protected]
16122675004
Email the study team

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Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • To establish the diagnostic performance of the AngioAI+ SystemJune 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+ SystemJune 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.