NCT06205810

The COMPLETE Study

Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: CoreAalst BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion \>50% stenosis on CCTA, patients eligible for the study will be invited to participate. The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference. Patients will be divided into 2 sub-groups: Cohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography. Cohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography. In both cohorts, patients should have undergone coronary CT angiography as part of the standard of care. Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2023-10-24
• Primary completion: 2030-10-15
• Completion: 2031-10-15
• First posted: 2024-01-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: Belgium