Clinical Trial

Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)

Study acronym: CODEX1
Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-16.
Status change: Active, Not Recruiting → Recruiting 2026-04-20
Trial Details
NCT Number NCT06977295
Lead Sponsor Instituto de Investigación Biomédica de Salamanca
Conditions Coronary Artery Disease, Atherosclerosis, Myocardial Ischemia
Enrollment 1,000 participants
Start Date 2025-07-14
Primary Completion 2026-11-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-21