NCT06977295Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 9 May 2025
- Start date
- 14 Jul 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Diseases
- Coronary artery disease
- NCT number
- NCT06977295
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 14 Jul 2025 to the primary completion date, 30 Nov 2026
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Biomedical Research of Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Université Lyon 1 Coordinator of this site? Confirm its status | Villeurbanne | France | Recruiting |
| Amsterdam University Medical Center (AUMC) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Cardiologie Centra Nederland (CCM) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.