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

Recruitingn/aAges 18 Years - anyAllInstituto de Investigación Biomédica de Salamanca
NCT06977295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older * Underwent coronary computed tomography angiography (CCTA) for the diagnosis or assessment of coronary artery disease (CAD) between 2019 and 2024 * Availability of comparator diagnostic data within 1 month before or after the CCTA, such as: Invasive coronary angiography (ICA), Stress MRI, Alternative CCTA analysis software, Documented clinical events Exclusion Criteria: \- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
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What it tests

  • Diagnostic Software Application for CAD Assessment
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Where

4 sites
Université Lyon 1
Villeurbanne, France
Amsterdam University Medical Center (AUMC)
Amsterdam, Netherlands
Cardiologie Centra Nederland (CCM)
Amsterdam, Netherlands
Institute of Biomedical Research of Salamanca
Salamanca, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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