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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02894255
• Other study ID #: 15-233
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: September 5, 2016
• Last updated: September 8, 2016
• Start date: September 2016

Study information

• Verified date: September 2016
• Source: Teikyo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary artery bypass grafting

Procedure:
• Percutaneous coronary intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teikyo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)		12 months	Yes