U.S., March 12 -- ClinicalTrials.gov registry received information related to the study (NCT07464704) titled 'Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS' on Dec. 17, 2025.
Brief 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-...