An observational study in Coronary Artery Disease, sponsored by CoreAalst BV. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by CoreAalst BV · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 250 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →CoreAalst BV is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Coronary Artery Disease with an epicardial stenosis of more than 50% of visual assessment.
1. Epicardial stenosis more than 50% by visual assessment.
Exclusion Criteria:
assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.
To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to quantify total atheroma volume (TAV) with IVUS (Intravascular Ultrasound) as reference.
Time frame: day 0 (day of the procedure)
Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.
To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to determine minimal stent area with IVUS (Intravascular Ultrasound) as reference.
Time frame: day 0 (day of the procedure)
Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.
To determine the diagnostic performance (mean difference) of FFRCT (Fractional Flow Reserve derived from CT) in stented segments with invasive FFR (Fractional Flow Reserve ) as reference.
Time frame: day 0 (day of the procedure)
Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT.
To describe the impact of coronary microvascular dysfunction assessed by IMR (Index of Microcirculatory Resistance) and absolute coronary resistance on the accuracy of FFRCT (Fractional Flow Reserve derived from CT).
Time frame: day 0 (day of the procedure
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CoreAalst BV