Multicentre Registry of CCTA, IVUS and OCT

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04066062
• Other study ID #: Invictus Registry
• Status: Active, not recruiting
• Start date: October 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Cleerly, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1700
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Japan	Ehime University	Ehime
Japan	Hiroshima University	Hiroshima
Japan	Yotsuba Circulation Clinic	Matsuyama
Japan	Okayama Red Cross Hospital	Okayama
Japan	Edogawa Hospital	Tokyo
Japan	Juntendo University	Tokyo
Japan	Sakakibara Heart Institute	Tokyo
Japan	Toho University Omori Medical Center	Tokyo
Japan	Tokai University	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Cleerly, Inc.	Toho University - Omori Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the diagnostic performance of CCTA versus IVUS or OCT for the measurement of minimum lumen area.	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	June 2019- June 2021