Clinical Trial

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

Suspended
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Why the trial stopped
Study enrollment and interventions are temporarily paused due to lack of operational funding. This is not an IRB suspension.
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).
Protocol Amendment History 2 changes
critical Recruitment suspended 2026-07-02
notable Trial sites expanded: 2 -> 6 locations 2026-03-27
Trial Details
NCT Number NCT07464704
Lead Sponsor Remote Cardiac Enablement
Conditions High Grade Obstructive NSTE-ACS
Enrollment 350 participants
Start Date 2025-12-30
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-01