Acute or Chronic Coronary Artery Disease, Non-obstructive Coronary Disease
Conditions
Keywords
fractional flow reserve, coronary microvascular disease
Brief 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.
Detailed description
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.
Interventions
PROCEDUREPatients 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.
PROCEDUREMicrovascular assessment
Cohort 2: Patients with non-obstructive (\<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.
Sponsors
AngioInsight
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTSr. VP Regulatory Affairs - AngioInsight
CONTACTProject Manager - Cardiovascular Research Foundation
PRINCIPAL_INVESTIGATORCarlos Collet, MD, PhD
Cardiovascular Research Foundation; OLV Aalst
PRINCIPAL_INVESTIGATORTodd C Villines, MD
University of Virginia
Outcome results
None listed