Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- AngioInsight
- Study ID
- NCT07676097
- Status
- Not Yet Recruiting
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Conditions
- Acute or Chronic Coronary Artery Disease
- Non-obstructive Coronary Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment. — PROCEDURECohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.
- Microvascular assessment — PROCEDURECohort 2: Patients with non-obstructive (\<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.
Study Details
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.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 620 participants (estimated)
Arms
- Arm: Cohort 1Patients with intermediate coronary artery stenosis with clinically indicated invasive FFR assessment
- Arm: Cohort 2Symptomatic patients with non-obstructive coronary artery disease (NOCAD) with clinical indication for invasive coronary microvascular assessment
Primary Outcome Measure
To establish the diagnostic performance of the AngioAI+ System [ Time Frame: June 2026 to December 2027 ]
Central Contacts
- Sr. VP Regulatory Affairs - AngioInsight16122675004
- Project Manager - Cardiovascular Research Foundation
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Palo Alto Veterans Administration Hospital | Palo Alto | California | 94304 | William Fearon, MD (PRINCIPAL_INVESTIGATOR) |
| Stanford University | Palo Alto | California | 94304 | William Fearon, MD (PRINCIPAL_INVESTIGATOR) |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Hayder Hashim, MD (PRINCIPAL_INVESTIGATOR) |
| Minneapolis Heart | Minneapolis | Minnesota | 55407 | Yader Sandoval, MD (PRINCIPAL_INVESTIGATOR) |
| Valley Health System | Paramus | New Jersey | 07652 | Rajiv Tayal, MD (PRINCIPAL_INVESTIGATOR) |
| New York University | New York | New York | 10016 | Nathaniel Smilowitz, MD (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | New York | New York | 10075 | Michael C Kim, MD (PRINCIPAL_INVESTIGATOR) |
| Christ Hospital | Cincinnati | Ohio | 45219 | Tim Henry, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension Saint Thomas | Nashville | Tennessee | 37205 | Jimmy Kerrigan, MD (PRINCIPAL_INVESTIGATOR) |