Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study (NCT07676097) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
United States620 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To establish the diagnostic performance of the AngioAI+ System
Timeframe: June 2026 to December 2027
2
To establish the diagnostic performance of AngioAI+ System