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CABG Off or On Pump Revascularization Study (CORONARY) - a randomized multicenter study

Phase 4
Conditions
coronary artery sclerosis
10011082
10003184
Registration Number
NL-OMON31836
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
600
Inclusion Criteria

age 21 year or older
candidate for surgery
presence of one or more risk factors such as DM, peripheral vascular disease

Exclusion Criteria

Concommittant cardiac procedure
limited life expectancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary: In patients undergoing CABG surgery, does off-pump CABG surgery<br /><br>compared to on-pump CABG surgery reduce major clinical vascular events in the<br /><br>short term (30 days) and are the benefits maintained at long term (5 years).<br /><br>The primary outcome at 30 days is total mortality, stroke, MI and renal failure<br /><br>and at 5 years, the same outcomes plus repeat revascularization.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>.<br /><br>Secondary: In patients undergoing CABG surgery, does off-pump CABG surgery<br /><br>compared to on-pump CABG surgery reduce costs in the short term (30 days) and<br /><br>at long term (5 years) (cost-effectiveness analysis)?</p><br>
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