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Clinical Trials in France / NCT06977295
Recruiting Observational

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

NCT06977295 · tracked via the Priya Life Science France tracker
Sponsor
Instituto de Investigación Biomédica de Salamanca
Phase
Observational
Started
2025-07-14
Last updated
2026-04-21

Condition(s) studied

Coronary Artery DiseaseAtherosclerosisMyocardial Ischemia

Investigational drug(s) / intervention(s)

Diagnostic Software Application for CAD Assessment

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Diagnostic accuracy of CAD-RADS classification using the diagnostic software — At study completion (expected March 2025)
    Accuracy of the CAD-RADS category assigned by the software compared to expert adjudication using invasive coronary angiography (ICA) and/or other non-invasive imaging.
  • Reproducibility of CAD-RADS classification using the diagnostic software — At study completion (expected March 2025)
    Assessment of inter-reader and intra-reader reproducibility in CAD-RADS classification using the software, evaluated via kappa statistics and intraclass correlation coefficients (ICC), stratified by reader experience.

Trial sites (4)

FacilityCityRegionStatus
Université Lyon 1 Villeurbanne France Recruiting
Amsterdam University Medical Center (AUMC) Amsterdam Netherlands Recruiting
Cardiologie Centra Nederland (CCM) Amsterdam Netherlands Recruiting
Institute of Biomedical Research of Salamanca Salamanca Salamanca Recruiting

Other trials for the same condition

Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions Recruiting
Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT Recruiting
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events Active, not recruiting
Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations (PHYCO) Active, not recruiting
INSIGHTFUL-FFR Clinical Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06977295 on ClinicalTrials.gov ↗ ← All trials in France