Multicentre Registry of CCTA, IVUS and OCT

Active, not recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT04066062
• Lead Sponsor: Cleerly, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-26
• Study Start: 2019-10-01
• Primary Completion: 2022-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

• Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
• Age 18 years or older
• Known or suspected Coronary Artery Disease and subsequently indicated for coronary artery angiography

Exclusion Criteria

• Individuals unable to provide informed consent
• Acute ST elevation myocardial infarction
• Pregnant woman
• Angiographically visible thrombus at the site of the lesion interrogated by IVUS or OCT
• Patients with lesions required balloon angioplasty before OCT and/or IVUS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the diagnostic performance of CCTA versus IVUS or OCT for the measurement of minimum lumen area.	June 2019- June 2021	Patients will undergo invasive coronary angiography with IVUS/OCT for the measurement of minimum lumen area, the identification of stenosis severity, burden, morphology and vulnerability of coronary atherosclerosis.; The co-registration of IVUS/OCT images with CCTA segmented images will be implemented in the following three stages by locating the corresponding anatomical landmarks/fiduciary points (coronary ostia, side-branches, calcified plaques, and/or overlapping veins) and matching the corresponding coronary segments in all the imaging modalities

Trial Locations

Locations (9)

Yotsuba Circulation Clinic; 🇯🇵 Matsuyama, Japan

Ehime University; 🇯🇵 Ehime, Japan

Hiroshima University; 🇯🇵 Hiroshima, Japan

Okayama Red Cross Hospital; 🇯🇵 Okayama, Japan

Juntendo University; 🇯🇵 Tokyo, Japan

Toho University Omori Medical Center; 🇯🇵 Tokyo, Japan

Edogawa Hospital; 🇯🇵 Tokyo, Japan

Sakakibara Heart Institute; 🇯🇵 Tokyo, Japan

Tokai University; 🇯🇵 Tokyo, Japan