The CODEX-1 study is a multicenter retrospective observational study designed to assess the diagnostic performance of a novel software application for coronary artery disease (CAD) evaluation. The application integrates automated stenosis detection, CT-derived fractional flow reserve (CT-FFR), and plaque quantification, all performed on-site. A total of 1,000 patients who previously underwent coronary computed tomography angiography (CCTA) and diagnostic invasive coronary angiography (ICA) and/or other non-invasive imaging will be included. The study compares the diagnostic outputs of the software to current clinical practice and expert adjudication, focusing on CAD-RADS categorization, prediction of the need for percutaneous coronary intervention (PCI), and reduction in unnecessary ICA procedures.
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Diagnostic accuracy of CAD-RADS classification using the diagnostic software
Timeframe: At study completion (expected March 2025)
Reproducibility of CAD-RADS classification using the diagnostic software
Timeframe: At study completion (expected March 2025)
Candelas Pérez Del Villar Moro, PhD MD