NCT06205810 · ClinicalTrials.gov record · last posted 2026-01-20
The COMPLETE Study
Study acronym: COMPLETE
StatusRecruiting
PhaseNot specified
Started2023-10-24
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from the ClinicalTrials.gov record
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.
Amendment record
2 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 2 times since 2024-01-03; most recent amendment 2026-01-16. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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| NCT Number |
NCT06205810 |
| Lead Sponsor |
CoreAalst BV
Collaborators: HeartFlow, Inc. |
| Conditions |
Coronary Artery Disease |
| Enrollment |
250 participants |
| Start Date |
2023-10-24 |
| Primary Completion |
2030-10-15 (estimated) |
| Study Completion |
2031-10-15 (estimated) |
| Updated on ClinicalTrials.gov |
2026-01-20 |