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

NCT02226900•InCor Heart Institute

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

InCor -Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Key Dates

Start Date

August 1, 2014

Primary Completion Date

December 1, 2018

Last Updated

November 29, 2018

Enrollment

ESTIMATED participants

Conditions

Multivessel Coronary Artery Disease

Interventions

Hybrid Revascularization

PROCEDURE

Conventional Coronary Artery Bypass Surgery

PROCEDURE

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

NCT01311323

Multivessel Coronary Artery DiseaseAcute Coronary Syndrome

View study

RECRUITING

STICH3C Cardiac Magnetic Resonance Observational Study

NCT07133984

Ischemic Left Ventricle Systolic DysfunctionMultivessel Coronary Artery Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

STICH3C Cardiac Magnetic Resonance Observational Study

Functional Testing Underlying Coronary Revascularisation

Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery

In-hospital Versus After-discharge Complete Revascularization

Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI