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Not yet recruiting NCT07676097

Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

— Observational Non-obstructive Coronary Disease Acute or Chronic Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment., Microvascular assessment.
Who it may be relevant to
Registry conditions: Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • To establish the diagnostic performance of the AngioAI+ System [Time frame: June 2026 to December 2027]
  • To establish the diagnostic performance of AngioAI+ System [Time frame: June 2026 to December 2027]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 9 centers
  • Palo Alto Veterans Administration Hospital — Palo Alto
  • Stanford University — Palo Alto
  • Washington Hospital Center — Washington D.C.
  • Minneapolis Heart — Minneapolis
  • Valley Health System — Paramus
  • New York University — New York
  • Northwell Health — New York
  • Christ Hospital — Cincinnati
  • … and 1 more center

Identifiers

NCT: NCT07676097 · CSP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗