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Study identifier: NCT06977295 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Coronary Artery Disease · Atherosclerosis · Myocardial Ischemia  ·  Sponsor: Instituto de Investigación Biomédica de Salamanca

PhaseN/A
Planned participants1000
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Candelas Pérez Del Villar Moro, PhD MD  ·  +34 923 29 11 00  ·  mcperezvi@saludcastillayleon.es

Always discuss trial participation with your own doctor first.

Locations (4)

Université Lyon 1Villeurbanne, FranceRecruiting
Amsterdam University Medical Center (AUMC)Amsterdam, NetherlandsRecruiting
Cardiologie Centra Nederland (CCM)Amsterdam, NetherlandsRecruiting
Institute of Biomedical Research of SalamancaSalamanca, Salamanca, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT06977295