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NCT Number: NCT07676097

Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

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.

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Key information

Conditions

Non-obstructive Coronary Disease Acute or Chronic Coronary Artery Disease Angina Pectoris Cardiovascular Diseases Heart Diseases Microvascular Angina Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Palo Alto Veterans Administration Hospital, Palo Alto, California, United States

About this study

All patients will undergo clinically indicated invasive coronary angiography with physiological assessment according to standard of care.

Cohort 1: Patients with intermediate lesions (30-90% diameter stenosis) will undergo invasive FFR assessment. In patients with FFR >0.80 (non-flow limiting stenosis), subsequent assessment of the microcirculation with bolus and continuous thermodilution will be performed.

Cohort 2: Patients with non-obstructive (<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.

For patients in Cohort 1 with FFR ≤0.80 undergoing percutaneous coronary interventions (PCI), FFR measurements after PCI will be recommended. Use of intravascular imaging will be strongly encouraged to guide PCI procedures, in accordance with current practice guidelines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Cohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.

Microvascular assessment

Procedure

Cohort 2: Patients with non-obstructive (<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.

Primary outcomes

To establish the diagnostic performance of the AngioAI+ System

Time frame: June 2026 to December 2027
- 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Project Manager - Cardiovascular Research Foundation

CONTACT

[email protected]

Sr. VP Regulatory Affairs - AngioInsight

CONTACT

[email protected]

16122675004

Sponsors and collaborators

Lead sponsor

AngioInsight

Industry

Registry information

Official study title

Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW (SMARTFLOW) Study

Acronym: SMARTFLOW

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 30, 2026
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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