Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease

InCor Heart Institute1 site in 1 country60 target enrollmentAugust 2014

ConditionsMultivessel Coronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Multivessel Coronary Artery Disease
Sponsor: InCor Heart Institute
Enrollment: 60
Locations: 1
Primary Endpoint: Feasibility of Revascularization Procedure Proposed by the Heart Team
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

December 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

InCor Heart Institute

Responsible Party

Principal Investigator

Pedro A. Lemos

Pedro A. Lemos, Professor of Medicine, InCor Heart Institute

InCor Heart Institute

Eligibility Criteria

Inclusion Criteria

•Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis \> 70% by visual analysis in all three territories, requiring myocardial revascularization OR triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
•Total SYNTAX score \> 22
•LCx and RCA territories estimated to be equivalently revascularized by either PCI or CABG, with at least one major non-LAD vessel to be treated
•Clinical and anatomic eligibility for both PCI and CABG as agreed to by both interventional and surgical consensus
•Interventionalist determines PCI appropriateness and eligibility
•Surgeon determines surgical appropriateness and eligibility
•Silent ischemia, stable angina, unstable angina or recent MI
•If recent MI, cardiac biomarkers must have returned to normal prior to randomization
•Ability to sign informed consent and comply with all study procedures

Exclusion Criteria

•Prior PCI or CABG at any time prior to randomization
•Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
•Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
•Patients requiring additional surgery (cardiac or non cardiac) within one year
•The presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by PCI, but rather should be managed with CABG or medical therapy - reasons will be documented)
•The presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by CABG, but rather should be managed with PCI. or medical therapy - reasons will be documented)
•Non cardiac co-morbidities with life expectancy less than 1 year
•Other investigational drug or device studies that have not reached their primary endpoint.

Outcomes

Primary Outcomes

Feasibility of Revascularization Procedure Proposed by the Heart Team

Time Frame: 30 days

The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days.