Status:
COMPLETED
SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery
Lead Sponsor:
Emory University
Collaborating Sponsors:
Medtronic
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at \> 5 years ...
Detailed Description
The Surgical Management of Arterial Revascularization Therapies (SMART) trial is a randomized, controlled, double blinded trial designed to compare completeness of revascularization, graft patency, cl...
Eligibility Criteria
Inclusion
- Referred for primary or re-operative elective coronary artery bypass graft (CABG) with coronary targets suitable for off-pump bypass graft and currently enrolled in Phase 1 of SMART Trial
Exclusion
- Emergent CABG
- Required pre-operative intra-aortic balloon pump (IABP)
- Cardiogenic shock
- Evolving acute myocardial infarction
- Coronary artery targets unsuitable for off-pump bypass surgery
- Inability or unwillingness to provide informed consent
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00209053
Start Date
January 1 2007
End Date
March 1 2009
Last Update
October 16 2013
Active Locations (1)
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1
Emory Healthcare/EmoryUniversity
Atlanta, Georgia, United States, 30308