Percutaneous Coronary Intervention (PCI) Clinical Trials

Clinical trials related to Percutaneous Coronary Intervention (PCI) Procedure

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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Université Lyon 1
RECRUITING
Villeurbanne
Netherlands
Amsterdam University Medical Center (AUMC)
RECRUITING
Amsterdam
Cardiologie Centra Nederland (CCM)
RECRUITING
Amsterdam
Spain
Institute of Biomedical Research of Salamanca
RECRUITING
Salamanca
Contact Information
Primary
Candelas Pérez Del Villar Moro, PhD MD
mcperezvi@saludcastillayleon.es
+34 923 29 11 00
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 1000
Treatments
Cohort_1
Patients who underwent coronary computed tomography angiography (CCTA) between 2019 and 2024 for the assessment or diagnosis of coronary artery disease (CAD), with available comparator diagnostic data such as invasive coronary angiography (ICA) and/or other non-invasive imaging. No interventions are performed as part of this study
Sponsors
Leads: Instituto de Investigación Biomédica de Salamanca

This content was sourced from clinicaltrials.gov