Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study

N/ANot Yet RecruitingNCT07676097

AngioInsight620 enrolled

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.

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

620

Conditions

Non-obstructive Coronary Disease Acute or Chronic Coronary Artery Disease

Interventions

Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment.PROCEDURE

Cohort 1. Patients with intermediate coronary artery stenosis (30-90% diameter stenosis) with clinically indicated FFR assessment.

Microvascular assessmentPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Palo Alto Veterans Administration Hospital

Palo Alto, California, United States

Stanford University

Palo Alto, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Minneapolis Heart

Minneapolis, Minnesota, United States

Valley Health System

Paramus, New Jersey, United States

New York University

New York, New York, United States

Northwell Health

New York, New York, United States

Christ Hospital

Cincinnati, Ohio, United States

Ascension Saint Thomas

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

To establish the diagnostic performance of the AngioAI+ System

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.

Time frame: June 2026 to December 2027

To establish the diagnostic performance of AngioAI+ System

Description: 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.