Coronary Artery DiseasePhase 3OPINIONNCT01873027
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON
A Phase 3 study testing OFDI and IVUS in people with Coronary Artery Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance. 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 and IVUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 829 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 with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines
- Patients aged between 20 and 85 years old
- Patients who has provided written informed consent
Who cannot join
- Patients with Acute Myocardial Infarction (AMI) within 3 months
- Patients with cardiogenic shock
- Patients with chronic heart failure
- Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL)
- Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.
- Patients planned use of bare metal stent
Show all 15Show fewer
- Patients with 3-vessel diseases
- Planned surgery within 1 year
- Patient on dialysis
- Target lesion such as:
- Left main coronary artery
- Aorto-Ostial lesion location within 3mm of the aorta junction
- Chronic total occlusion
- Small vessel (reference vessel diameter <2.5mm)
- Coronary artery bypass graft
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)
The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.
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.
The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.
We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm.
Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.
- Conditions
- Coronary Artery Disease
- Being tested
- OFDI, IVUS
- 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.
OFDIDevice
Also called LUNAWAVE, Fastview, Biolimus a9-eluting stent (Nobori stent)
- OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI
- Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI
IVUSDevice
Also called VISIWAVE, ViewIT, Biolimus A9-eluting stent (Nobori stent)
- IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI
- Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI
| Study group | Role | What they receive |
|---|---|---|
| OFDI-guided PCI | Experimental | * OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI
* Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI. Receives: Device: OFDI |
| IVUS-guided PCI | Active comparator | * IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI
* Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI. Receives: Device: IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)
Measured: 12 months after PCI
Secondary outcomes (9)
Cardiac death
Measured: 12 months after PCI
Myocardial Infarction (MI)
Measured: 12 months after PCI
Clinically-driven Target lesion revascularization (TLR)
Measured: 12 months after PCI
MACE (composite of cardiac death, MI, TLR)
Measured: 12 months after PCI
Target Vessel Revascularization (TVR)
Measured: 12 months after PCI
Stroke
Measured: 12 months after PCI
Stent thrombosis
Measured: 12 months after PCI
Binary restenosis
Measured: 12 months after PCI
Renal dysfunction
Measured: 8 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 829 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
- NCT01873027
- Sponsor's protocol ID
- TRICVD1225
- Other IDs
- UMIN000010580
- Acronym
- OPINION
- Status last verified
- Jul 2016
- First submitted
- 26 May 2013
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.
PubMed 29121226
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)
- ClinicalTrials.gov ID
- NCT01873027
- Acronym / sponsor ID
- OPINION / TRICVD1225
- 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
- 829 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
- 7 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.
The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.
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.
The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.
We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm.
Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFDI-guided PCI | Experimental | Device: OFDI* OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI * Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI. |
| IVUS-guided PCI | Active comparator | Device: IVUS* IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI * Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines
- Patients aged between 20 and 85 years old
- Patients who has provided written informed consent
Key exclusion criteria (15 listed)
- Patients with Acute Myocardial Infarction (AMI) within 3 months
- Patients with cardiogenic shock
- Patients with chronic heart failure
- Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL)
- Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.
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 |
|---|---|---|
| OFDIAlso: LUNAWAVE, Fastview, Biolimus a9-eluting stent (Nobori stent)* OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI * Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI | Device | OFDI-guided PCI |
| IVUSAlso: VISIWAVE, ViewIT, Biolimus A9-eluting stent (Nobori stent)* IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI * Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI | Device | IVUS-guided PCI |
Primary outcome
Target Vessel Failure (TVF)
Time frame: 12 months after PCI
The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)
9 secondary outcomes
Cardiac death
Time frame: 12 months after PCI
Myocardial Infarction (MI)
Time frame: 12 months after PCI
Clinically-driven Target lesion revascularization (TLR)
Time frame: 12 months after PCI
MACE (composite of cardiac death, MI, TLR)
Time frame: 12 months after PCI
Target Vessel Revascularization (TVR)
Time frame: 12 months after PCI
Stroke
Time frame: 12 months after PCI
Stent thrombosis
Time frame: 12 months after PCI
Binary restenosis
Time frame: 12 months after PCI
Renal dysfunction
Time frame: 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 29121226Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.
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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 and IVUS 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 3 inclusion and 15 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?
Target Vessel Failure (TVF) (time frame: 12 months after PCI). 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 NCT01873027, 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.