RecruitingNCT06977295

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

CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study

Sponsor

Instituto de Investigación Biomédica de Salamanca

Enrollment

1,000 participants

Start Date

Jul 14, 2025

Study Type

OBSERVATIONAL

Conditions

Atherosclerosis Myocardial Ischemia Coronary Artery Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria1

\- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use

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Interventions

DEVICEDiagnostic 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.