Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS

Conditions

• High Grade Obstructive NSTE-ACS

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

The objective of this prospective, cross-sectional, multicenter pivotal trial study is to validate Infrasensor's clinical performance for the detection of high grade obstructive NSTE-ACS. High-grade obstructive NSTE-ACS is defined as an acute coronary syndrome in which severe obstructive coronary artery disease, including total coronary artery occlusion is present. Study Endpoints Primary Endpoint: Infrasensor performance (Lower bound of 95% CI for sensitivity, specificity) between device detection of high-grade obstructive NSTE-ACS and angiographic diagnosis of High-grade obstructive CAD defined as the aggregate of \>50% left main stenosis, or \>70% stenosis in 1 or more coronary arteries and/or emergent revascularization. Secondary Endpoint: Infrasensor performance (positive and negative predictive values, and overall accuracy).

Key Dates

First listed

Mar 11, 2026

Start date

Dec 30, 2025

Status verified

Mar 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

350 participants (estimated)

Arms

• Arm: symptomatic patients undergoing a hospital-based evaluation for ACS
  patients presenting to acute care settings, such as Emergency Departments (ED), with symptoms suggestive of an acute coronary syndrome (ACS)

Primary Outcome Measure

Diagnostic performance of the Infrasensor for detection of high-grade obstructive NSTE-ACS [ Time Frame: Baseline (ED presentation) through hospital discharge, up to 30 days ]

Locations (6)

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