Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Coronary artery bypass grafting
Percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
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%.
Exclusion Criteria:
• 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PCI and CABG
Arm Description
Outcomes
Primary Outcome Measures
Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02894255
Brief Title
Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Teikyo University
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCI and CABG
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Coronary artery bypass grafting
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%.
Exclusion Criteria:
• 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.
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.
12. IPD Sharing Statement
Learn more about this trial
Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents
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