MedTrace Logo

Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

NCT07676097 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 620

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • Non-obstructive Coronary Disease
  • Acute or Chronic Coronary Artery Disease

Interventions

PROCEDURE

Patients 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.

PROCEDURE

Microvascular assessment

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

Sponsors & Collaborators

  • AngioInsight

    lead INDUSTRY

Principal Investigators

  • Carlos Collet, MD, PhD · Cardiovascular Research Foundation; OLV Aalst

  • Todd C Villines, MD · University of Virginia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676097 on ClinicalTrials.gov