Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease

Silesian Centre for Heart Diseases2 sites in 1 country200 target enrollmentNovember 2009

ConditionsHeart Disease Myocardial Ischaemia Coronary Disease Coronary Artery Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Heart Disease
Sponsor: Silesian Centre for Heart Diseases
Enrollment: 200
Locations: 2
Primary Endpoint: Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to assess the safety and efficacy of hybrid revascularization in comparison with coronary artery bypass grafting among patients with multivessel coronary artery disease.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

October 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Silesian Centre for Heart Diseases

Responsible Party

Principal Investigator

Marian Zembala

MD, PhD, Head of the Cardiosurgery and Transplantology Department

Silesian Centre for Heart Diseases

Eligibility Criteria

Inclusion Criteria

•Age 18 or more
•Angiographically confirmed multivessel CAD with involved LAD and critical (\>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG
•Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia
•Patient is willing to comply with all follow-up visits
•Patient signed an Informed Consent

Exclusion Criteria

•Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment
•Prior surgery with the opening of pericardium or pleura
•Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects
•Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation
•One or more chronic total occlusions in major coronary territories
•Left main stenosis (at least 50% diameter stenosis)
•Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization
•Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
•Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition
•Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.

Outcomes

Primary Outcomes

Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding.

Time Frame: 1 year

Secondary Outcomes

Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2(1 year)
Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments(1 year)
Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.(1 year)