Coronary Artery DiseasePhase 4NCT02894255
Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents
A Phase 4 study testing Coronary artery bypass grafting and Percutaneous coronary intervention in people with Coronary Artery Disease, run by Teikyo University.
Trial summary
This prospective multicenter registry evaluates the efficacy of hybrid coronary revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary artery bypass grafting and Percutaneous coronary intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with stable angina, unstable angina, or non-ST elevation myocardial infarction.
- Patients with multivessel coronary artery disease including significant stenotic lesion* in the right coronary artery and also including left main stem disease.
- Patients who will be referred for CABG.
- Patients with significant stenotic lesion in the right coronary artery amenable to PCI.
- Patients who can take DAPT medications.
- Patients who provided written informed consent. * Significant stenotic lesion means a condition where fractional flow reserve (FFR) is lower than 0.80 or visually confirmed stenosis is at least 75%.
Who cannot join
- • Patients with ST elevation myocardial infarction occurring within 24 hours before enrollment.
- Patients who previously underwent CABG.
- Patients who are at high risk of receiving CABG.
- Patients who need simultaneous surgery such as valve surgery other than CABG.
- Patients with a life expectancy of 1 year or shorter due to co-morbidities.
- Patients with a history of cerebral infarction within the last 6 months.
Show all 13Show fewer
- Patients with congestive cardiac failure of NYHA 3 or higher.
- Patients with unstable hemodynamics at enrollment.
- Patients with right coronary artery disease that is chronic total occlusion and difficult to treat with PCI (J-CTO score of ≥ 23).
- Patients receiving long-term dialysis.
- Patients who are allergic to antiplatelet agent.
- Patients who are critically allergic to contrast media.
- Patients who are allergic to any DES component.
About this study
This prospective multicenter registry evaluates the efficacy of hybrid coronary revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is to be performed in the left anterior descending artery and the left circumflex artery using only arterial grafts, whereas PCI is to be conducted for the treatment of significant stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This research plans to involve patients scheduled for coronary revascularization for multivessel coronary artery disease who consent to participate in the registry.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary artery bypass grafting, Percutaneous coronary intervention
- 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.
Coronary artery bypass graftingDevice
Percutaneous coronary interventionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PCI and CABG | Experimental | Not described Receives: Device: Coronary artery bypass grafting; Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teikyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Kozuma, Teikyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894255
- Sponsor's protocol ID
- 15-233
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
Publications
Sugimoto K, Takahashi K, Okune M, Ueno M, Fujita T, Doi H, Tobaru T, Takanashi S, Kinoshita Y, Okawa Y, Fuku Y, Komiya T, Tsujita K, Fukui T, Shimokawa T, Watanabe Y, Kozuma K, Sakaguchi G, Nakazawa G. Impact of quantitative flow ratio on graft function in patients undergoing coronary artery bypass grafting. Cardiovasc Interv Ther. 2023 Oct;38(4):406-413. doi: 10.1007/s12928-023-00929-8. Epub 2023 Apr 5.
PubMed 37017900
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents
- ClinicalTrials.gov ID
- NCT02894255
- Acronym / sponsor ID
- 15-233
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Teikyo UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- First posted
- 9 Sep 2016 (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 prospective multicenter registry evaluates the efficacy of hybrid coronary revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is to be performed in the left anterior descending artery and the left circumflex artery using only arterial grafts, whereas PCI is to be conducted for the treatment of significant stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This research plans to involve patients scheduled for coronary revascularization for multivessel coronary artery disease who consent to participate in the registry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI and CABG | Experimental | Device: Coronary artery bypass grafting, Procedure: Percutaneous coronary intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with stable angina, unstable angina, or non-ST elevation myocardial infarction.
Key exclusion criteria (13 listed)
- • Patients with ST elevation myocardial infarction occurring within 24 hours before enrollment.
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 |
|---|---|---|
| Coronary artery bypass grafting | Device | PCI and CABG |
| Percutaneous coronary intervention | Procedure or surgery | PCI and CABG |
Primary outcome
Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Derived from this study: PubMed 37017900Sugimoto K, Takahashi K, Okune M, Ueno M, Fujita T, Doi H, Tobaru T, Takanashi S, Kinoshita Y, Okawa Y, Fuku Y, Komiya T, Tsujita K, Fukui T, Shimokawa T, Watanabe Y, Kozuma K, Sakaguchi G, Nakazawa G. Impact of quantitative flow ratio on graft function in patients undergoing coronary artery bypass grafting. Cardiovasc Interv Ther. 2023 Oct;38(4):406-413. doi: 10.1007/s12928-023-00929-8. Epub 2023 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coronary artery bypass grafting and Percutaneous coronary intervention in people with Coronary Artery Disease, run by Teikyo University.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization) (time frame: 12 months). 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 NCT02894255, 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 9 Sep 2016.