NCT04066062

Multicentre Registry of CCTA, IVUS and OCT

Registry of Coronary Computed Tomography Angiography Intravenous Ultrasound and Optical Coherence Tomography to Compare Invasive/Non-invasive Imaging Modalities for Determination of Severity Volume and Type of Coronary Atherosclerosis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,700 (estimated)
• Sponsor: Cleerly, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The Invictus Registry will compare the diagnostic performance of coronary computed tomography angiography (CCTA) versus intravascular imaging by intravenous ultrasound (IVUS) or optical coherence tomography (OCT) for the measurement of minimum lumen area, the identification of stenosis severity, burden, morphology and vulnerability of coronary atherosclerosis.

Detailed description

Clinical Significance: Coronary computed tomographic angiography (CCTA) is a robust non-invasive modality to evaluate the presence, extent and severity of Coronary Artery Disease (CAD). For a plaque assessment, previous studies demonstrated that CCTA provides a high correlation with intravascular imaging by intravenous ultrasound (IVUS) in assessing coronary plaque characteristics stenosis severity and volume. High risk (vulnerable) plaque characteristics (positive remodeling, low attenuation plaque, spotty calcifications) are recognized to be more prone to rupture with increased rates of short-term cardiovascular disease events. Although several studies similarly demonstrated the good concordance between CCTA and IVUS or optical coherence tomography (OCT) in assessing high risk plaque features, patient numbers in these prior studies were limited to fully understand the effect of CCTA for the assessment of coronary atherosclerotic plaque features. The Research is a multi-center, registry enrolling patients with single/multi vessel atherosclerotic coronary artery disease. The study will be conducted in up to 15 Medical Centers in Japan. In each patient, a CCTA, IVUS), and/ or OCT will be performed, to provide a total of 1,300 vessels from 1,000 patients. Thus, the full cohort (Prospective plus Retrospective patients) will provide a total of 2,000 vessels as basis for a diagnostic performance comparison between CCTA and IVUS or OCT. Accrual is expected to take 24 months.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2019-08-26
• Last updated: 2024-11-26

Locations

9 sites across 1 country: Japan