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

June 24, 2026 updated by: AngioInsight

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

620

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Project Manager - Cardiovascular Research Foundation
  • Email: jungarten@crf.org

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
        • Principal Investigator:
          • William Fearon, MD
        • Contact:
      • Palo Alto, California, United States, 94304
        • Palo Alto Veterans Administration Hospital
        • Principal Investigator:
          • William Fearon, MD
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Washington Hospital Center
        • Principal Investigator:
          • Hayder Hashim, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart
        • Contact:
        • Principal Investigator:
          • Yader Sandoval, MD
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • Valley Health System
        • Contact:
        • Principal Investigator:
          • Rajiv Tayal, MD
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10075
        • Northwell Health
        • Contact:
        • Principal Investigator:
          • Michael C Kim, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Ascension Saint Thomas
        • Principal Investigator:
          • Jimmy Kerrigan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute or chronic coronary artery disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Patients with intermediate coronary artery stenosis with clinically indicated invasive FFR assessment
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.
Cohort 2
Symptomatic patients with non-obstructive coronary artery disease (NOCAD) with clinical indication for invasive coronary microvascular assessment
Procedure: Microvascular assessment
Cohort 2: Patients with non-obstructive (<30% stenosis) disease will undergo assessment of the microcirculation with bolus and continuous thermodilution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To establish the diagnostic performance of the AngioAI+ System
Time Frame: 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.
  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.
June 2026 to December 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AngioInsight

Investigators

  • Principal Investigator: Carlos Collet, MD, PhD, Cardiovascular Research Foundation; OLV Aalst
  • Principal Investigator: Todd C Villines, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Decision regarding IPD sharing will be made in the future.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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