Coronary Artery DiseaseNCT04066062
Multicentre Registry of CCTA, IVUS and OCT
An observational study of Coronary Artery Disease, run by Cleerly, Inc. at 9 sites in Japan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,700 participants
- Where
- 9 sitesJapan
- Study dates
- 1 Oct 2019to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with single/multi vessel atherosclerotic coronary artery disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Ehime University
Ehime
Hiroshima University
Hiroshima
Yotsuba Circulation Clinic
Matsuyama
Okayama Red Cross Hospital
Okayama
Toho University Omori Medical Center
Tokyo, 143-8540
Edogawa Hospital
Tokyo
Juntendo University
Tokyo
Sakakibara Heart Institute
Tokyo
Tokai University
Tokyo
About this study
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
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.
Read the 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
- Keywords
- CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: June 2019- June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,700 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cleerly, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toho University - Omori Medical Center
- Responsible party
- Sponsor
- Investigators
- Rine Nakanishi, MD, Principal investigator, Toho University - Omori Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066062
- Sponsor's protocol ID
- Invictus Registry
- Status last verified
- Nov 2024
- First submitted
- 15 Aug 2019
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nakanishi R, Okubo R, Matsuo H, Sobue Y, Kaneko U, Sato H, Fujimoto S, Nozaki Y, Kajiya T, Miyoshi T, Ichikawa K, Abe M, Kitagawa T, Ikenaga H, Osawa K, Saji M, Iguchi N, Nakazawa G, Takahashi K, Ijichi T, Mikamo H, Kurata A, Moroi M, Iijima R, Bandeira D, Demuyakor A, Parise H, Malkasian S, Mintz GS, Lansky AJ, Earls JP, Chamie D. Artificial intelligence-based coronary computed tomography angiography quantification of atherosclerosis burden: comparison with intravascular ultrasound in the INVICTUS Registry. Eur Radiol. 2026 Jul;36(7):5364-5377. doi: 10.1007/s00330-026-12412-y. Epub 2026 Mar 5.
PubMed 41781729Nakanishi R, Okubo R, Sobue Y, Kaneko U, Sato H, Fujimoto S, Nozaki Y, Kajiya T, Miyoshi T, Ichikawa K, Abe M, Kitagawa T, Ikenaga H, Osawa K, Saji M, Iguchi N, Nakazawa G, Takahashi K, Ijich T, Mikamo H, Kurata A, Moroi M, Iijima R, Malkasian S, Crabtree T, Chamie D, Alexandra LJ, Min JK, Earls JP, Matsuo H. Rationale and design of the INVICTUS Registry: (Multicenter Registry of Invasive and Non-Invasive imaging modalities to compare Coronary Computed Tomography Angiography, Intravascular Ultrasound and Optical Coherence Tomography for the determination of Severity, Volume and Type of coronary atherosclerosiS). J Cardiovasc Comput Tomogr. 2023 Nov-Dec;17(6):401-406. doi: 10.1016/j.jcct.2023.08.011. Epub 2023 Sep 9.
PubMed 37679247
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04066062
- Acronym / sponsor ID
- Invictus Registry
- Conditions
- Coronary Artery Disease
- Keywords
- CAD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Cleerly, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Toho University - Omori Medical Center
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with single/multi vessel atherosclerotic coronary artery disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 41781729Nakanishi R, Okubo R, Matsuo H, Sobue Y, Kaneko U, Sato H, Fujimoto S, Nozaki Y, Kajiya T, Miyoshi T, Ichikawa K, Abe M, Kitagawa T, Ikenaga H, Osawa K, Saji M, Iguchi N, Nakazawa G, Takahashi K, Ijichi T, Mikamo H, Kurata A, Moroi M, Iijima R, Bandeira D, Demuyakor A, Parise H, Malkasian S, Mintz GS, Lansky AJ, Earls JP, Chamie D. Artificial intelligence-based coronary computed tomography angiography quantification of atherosclerosis burden: comparison with intravascular ultrasound in the INVICTUS Registry. Eur Radiol. 2026 Jul;36(7):5364-5377. doi: 10.1007/s00330-026-12412-y. Epub 2026 Mar 5.
- Derived from this study: PubMed 37679247Nakanishi R, Okubo R, Sobue Y, Kaneko U, Sato H, Fujimoto S, Nozaki Y, Kajiya T, Miyoshi T, Ichikawa K, Abe M, Kitagawa T, Ikenaga H, Osawa K, Saji M, Iguchi N, Nakazawa G, Takahashi K, Ijich T, Mikamo H, Kurata A, Moroi M, Iijima R, Malkasian S, Crabtree T, Chamie D, Alexandra LJ, Min JK, Earls JP, Matsuo H. Rationale and design of the INVICTUS Registry: (Multicenter Registry of Invasive and Non-Invasive imaging modalities to compare Coronary Computed Tomography Angiography, Intravascular Ultrasound and Optical Coherence Tomography for the determination of Severity, Volume and Type of coronary atherosclerosiS). J Cardiovasc Comput Tomogr. 2023 Nov-Dec;17(6):401-406. doi: 10.1016/j.jcct.2023.08.011. Epub 2023 Sep 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rine Nakanishi, MD principal investigator
Toho University - Omori Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Cleerly, Inc. at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the diagnostic performance of CCTA versus IVUS or OCT for the measurement of minimum lumen area. (time frame: June 2019- June 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04066062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.