Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07464704
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-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).
Study:
NCT07464704
Study Brief:
Protocol Section:
NCT07464704