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Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02894255
Enrollment
100
Registered
2016-09-09
Start date
2016-09-30
Completion date
Unknown
Last updated
2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICECoronary artery bypass grafting
PROCEDUREPercutaneous coronary intervention

Sponsors

Teikyo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026