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Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
Sponsor: Instituto de Investigación Biomédica de Salamanca
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.
Official title: CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2024-09-23
Completion Date
2025-12-31
Last Updated
2025-05-18
Healthy Volunteers
No
Interventions
Diagnostic Software Application for CAD Assessment
A novel on-premises diagnostic software integrating automated coronary stenosis detection, CT-derived fractional flow reserve (CT-FFR), and plaque quantification for evaluation of coronary artery disease (CAD) using coronary computed tomography angiography (CCTA) datasets.
Locations (4)
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