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

NCT07464704 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2026-03-27

No results posted yet for this study

Summary

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).

Conditions

  • High Grade Obstructive NSTE-ACS

Sponsors & Collaborators

  • Remote Cardiac Enablement

    lead INDUSTRY

Principal Investigators

  • Sanjeev Bhavnani, MD · Remote Cardiac Enablement

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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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 NCT07464704 on ClinicalTrials.gov