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

NCT ID: NCT02894255

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI and CABG

Group Type: EXPERIMENTAL

Coronary artery bypass grafting

Intervention Type: DEVICE

Percutaneous coronary intervention

Intervention Type: PROCEDURE

Interventions

Coronary artery bypass grafting

Intervention Type: DEVICE

Percutaneous coronary intervention

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teikyo University

OTHER

Sponsor Role: lead

Responsible Party

Ken Kozuma

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 37017900 (View on PubMed)

Other Identifiers

15-233

Identifier Type: -

Identifier Source: org_study_id