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RECRUITING
NCT06205810

The COMPLETE Study

Sponsor: CoreAalst BV

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2023-10-24

Completion Date

2031-10-15

Last Updated

2026-01-20

Healthy Volunteers

No

Locations (1)

OLV Hospital Aalst

Aalst, Oost-Vlaanderen, Belgium