About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
STEMI.
Hemodynamic instability.
Rapid atrial fibrillation, flutter or arrhythmia (HR > 80 bpm).
Insufficient CCTA image quality.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
CoreAalst BV
Lead sponsor
HeartFlow, Inc.
Collaborator