Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicentre Registry of CCTA, IVUS and OCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066062
Recruitment Status : Not yet recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Toho University – Omori Medical Center
Information provided by (Responsible Party):
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.

Condition or disease
Coronary Artery Disease

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1700 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Retrospective
A total of 700 vessel from 700 patients clinically indicated CCTA and IVUS or OCT performed within 3 months.
Prospective
A total of 1,000 subjects will be enrolled in this Registry. This number of subject is expected to provide a maximum of 1,300 vessels. All CCTA and IVUS/OCT will be performed within 3 months



Primary Outcome Measures :
  1. To compare the diagnostic performance of CCTA versus IVUS or OCT for the measurement of minimum lumen area. [ Time Frame: 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with single/multi vessel atherosclerotic coronary artery disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066062


Contacts
Layout table for location contacts
Contact: Alejandra Guerchicoff, PhD 6463624255 alejandra.guerchicoff@cleerlymed.com
Contact: James Min, MD 6463624255 james.min@cleerlymed.com

Sponsors and Collaborators
Cleerly, Inc.
Toho University – Omori Medical Center

Layout table for additonal information
Responsible Party: Cleerly, Inc.
ClinicalTrials.gov Identifier: NCT04066062     History of Changes
Other Study ID Numbers: Invictus Registry
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cleerly, Inc.:
CAD
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases