Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04066062
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-20
First Post:
2019-08-15
Brief Title:
Multicentre Registry of CCTA IVUS and OCT
Sponsor:
Cleerly Inc
Organization:
Cleerly Inc
Study Overview
Official Title:
Registry of Coronary Computed Tomography Angiography Intravenous Ultrasound and Optical Coherence Tomography to Compare InvasiveNon-invasive Imaging Modalities for Determination of Severity Volume and Type of Coronary Atherosclerosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 singlemulti 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 1300 vessels from 1000 patients Thus the full cohort Prospective plus Retrospective patients will provide a total of 2000 vessels as basis for a diagnostic performance comparison between CCTA and IVUS or OCT Accrual is expected to take 24 months
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 singlemulti 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 1300 vessels from 1000 patients Thus the full cohort Prospective plus Retrospective patients will provide a total of 2000 vessels as basis for a diagnostic performance comparison between CCTA and IVUS or OCT Accrual is expected to take 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None