Coronary Artery DiseasePhase 3NCT01873222
OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
A Phase 3 study testing OFDI-guided PCI & IVUS and IVUS-guided PCI & OFDI in people with Coronary Artery Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- OFDI-guided PCI & IVUS and IVUS-guided PCI & OFDI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2013to Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients participating in the OPINION Trial
- Patients who has provided written informed consent
Who cannot join
- Ineligible patients according to the investigator's judgment
- Inability or unwillingness to perform required follow up procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.
Read the detailed description
Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.
This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how OFDI or IVUS imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.
We will enroll the first 100 patients who have enrolled in the main-study of OPINION trial.(UMIN000010580). We will assess lesions by the other device in addition to the assigned device in the main study at the time of post-PCI.
We will then assess lesions by OFDI at a 8-month follo-up.
- Conditions
- Coronary Artery Disease
- Being tested
- OFDI-guided PCI & IVUS, IVUS-guided PCI & OFDI
- Keywords
- Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Frequency Domain Imaging, Intravascular Ultrasound
- 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.
OFDI-guided PCI & IVUSDevice
Also called OFDI, LUNAWAVE, Biolimus A9-eluting stent (Nobori stent)
- Assessment by IVUS at post-PCI
- Assessment by OFDI at a 8-month follow-up
IVUS-guided PCI & OFDIDevice
Also called VISIWAVE, ViewIT, Biolimus A9-eluting stent (Nobori stent)
- Assessment by OFDI at post-PCI
- Assessment by OFDI at a 8-month follow-up
| Study group | Role | What they receive |
|---|---|---|
| OFDI-guided PCI & IVUS | Experimental | * Assessment by IVUS at post-PCI
* Assessment by OFDI at a 8-month follow-up Receives: Device: OFDI-guided PCI & IVUS |
| IVUS-guided PCI & OFDI | Active comparator | * Assessment by OFDI at post-PCI
* Assessment by OFDI at a 8-month follow-up Receives: Device: IVUS-guided PCI & OFDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum stent area by OFDI
The investigators will assess "Minimum stent area" by OFDI at post-PCI.
Measured: at just after the PCI
Frequency of malapposed struts
The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
Measured: at just after the PCI
Dissection
The investigators will assess "Dissection" by OFDI at post-PCI.
Measured: at just after the PCI
Minimum stent area by IVUS
The investigators will assess "Minimum stent area" by IVUS at post-PCI.
Measured: at just after the PCI
Frequency of uncovered struts
The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.
Measured: 8 months after PCI
Minimum lumen area
The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.
Measured: 8-month follow-up after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Wakayama Medical University
- Responsible party
- Sponsor
- Investigators
- Takashi Akasaka, MD, PhD, Principal investigator, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873222
- Sponsor's protocol ID
- TRICVD1311
- Other IDs
- UMIN000010581
- Status last verified
- Jul 2016
- First submitted
- 27 May 2013
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Otake H, Kubo T, Takahashi H, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Kozuma K, Ioji T, Kaneda H, Akasaka T; OPINION Investigators. Optical Frequency Domain Imaging Versus Intravascular Ultrasound in Percutaneous Coronary Intervention (OPINION Trial): Results From the OPINION Imaging Study. JACC Cardiovasc Imaging. 2018 Jan;11(1):111-123. doi: 10.1016/j.jcmg.2017.06.021. Epub 2017 Oct 5.
PubMed 28917678
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
- ClinicalTrials.gov ID
- NCT01873222
- Acronym / sponsor ID
- TRICVD1311
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Frequency Domain Imaging, Intravascular Ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Wakayama Medical University
- Study start
- Jun 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Jun 2013 (estimated)
- 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.
This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.
Detailed description
Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.
This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how OFDI or IVUS imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.
We will enroll the first 100 patients who have enrolled in the main-study of OPINION trial.(UMIN000010580). We will assess lesions by the other device in addition to the assigned device in the main study at the time of post-PCI.
We will then assess lesions by OFDI at a 8-month follo-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFDI-guided PCI & IVUS | Experimental | Device: OFDI-guided PCI & IVUS* Assessment by IVUS at post-PCI * Assessment by OFDI at a 8-month follow-up |
| IVUS-guided PCI & OFDI | Active comparator | Device: IVUS-guided PCI & OFDI* Assessment by OFDI at post-PCI * Assessment by OFDI at a 8-month follow-up |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients participating in the OPINION Trial
- Patients who has provided written informed consent
Key exclusion criteria (2 listed)
- Ineligible patients according to the investigator's judgment
- Inability or unwillingness to perform required follow up procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFDI-guided PCI & IVUSAlso: OFDI, LUNAWAVE, Biolimus A9-eluting stent (Nobori stent)* Assessment by IVUS at post-PCI * Assessment by OFDI at a 8-month follow-up | Device | OFDI-guided PCI & IVUS |
| IVUS-guided PCI & OFDIAlso: VISIWAVE, ViewIT, Biolimus A9-eluting stent (Nobori stent)* Assessment by OFDI at post-PCI * Assessment by OFDI at a 8-month follow-up | Device | IVUS-guided PCI & OFDI |
Primary outcome
Minimum stent area by OFDI
Time frame: at just after the PCI
The investigators will assess "Minimum stent area" by OFDI at post-PCI.
Frequency of malapposed struts
Time frame: at just after the PCI
The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
Dissection
Time frame: at just after the PCI
The investigators will assess "Dissection" by OFDI at post-PCI.
Minimum stent area by IVUS
Time frame: at just after the PCI
The investigators will assess "Minimum stent area" by IVUS at post-PCI.
Frequency of uncovered struts
Time frame: 8 months after PCI
The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.
Minimum lumen area
Time frame: 8-month follow-up after PCI
The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Derived from this study: PubMed 28917678Otake H, Kubo T, Takahashi H, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Kozuma K, Ioji T, Kaneda H, Akasaka T; OPINION Investigators. Optical Frequency Domain Imaging Versus Intravascular Ultrasound in Percutaneous Coronary Intervention (OPINION Trial): Results From the OPINION Imaging Study. JACC Cardiovasc Imaging. 2018 Jan;11(1):111-123. doi: 10.1016/j.jcmg.2017.06.021. Epub 2017 Oct 5.
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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.
Takashi Akasaka, MD, PhD principal investigator
Wakayama Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OFDI-guided PCI & IVUS and IVUS-guided PCI & OFDI in people with Coronary Artery Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Minimum stent area by OFDI (time frame: at just after the PCI). The study lists 6 primary outcomes in all. 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 NCT01873222, which also lists 1 linked publication.
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 14 Jul 2016.