Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial.

Recruiting

Conditions: Coronary artery disease
10003216

Registration Number: NL-OMON54591

Lead Sponsor: Weill Cornell Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

primary isolated CABG patients with disease of the left main coronary artery or
of the
left anterior descending and the circumflex coronary system with or without
disease of the right
coronary artery. Coronary artery disease will be defined as a stenosis >= 70%
based on coronary
angiography, a FFR value <= 0.80 or iFr value <=0.89; a left main diameter
stenosis >= 50%, left main IVUS
MLA value <= 4.5 mm2, or equivalent OCT measurements will also be considered.

Exclusion Criteria

• Age <18, and men > 70 years • Planned single graft • Emergency operation •
Preoperative myocardial infarction within 48 hours • Ejection Fraction (EF) <
35% • Any concomitant cardiac or non-cardiac procedure • Previous cardiac
operation • Preoperative severe end-organ dysfunction (dialysis, liver failure,
respiratory failure), cancer or any co-morbidity that reduces life expectancy
to less than 5 years. • Inability to use either the saphenous vein or both the
right ITA and the RA as grafts • Anticipated need for coronary
thrombo-endarterectomy. • Planned hybrid revascularization • Preoperative brain
damage

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be a composite of death from any cause, any stroke,<br /><br>post discharge myocardial infarction and/or repeat revascularization. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome will be all cause mortality.<br /><br>Additional secondary outcomes will be:<br /><br>• 30-day mortality<br /><br>• Major postoperative complications (revision for bleeding, perioperative<br /><br>myocardial infarction, any stroke, need for dialysis, need for tracheostomy,<br /><br>and surgical site complications)<br /><br>• Sternal wound complications<br /><br>• A composite of death from any cause, post discharge myocardial infarction,<br /><br>and/or repeat revascularization<br /><br>• A composite of death from any cause, any stroke, any myocardial infarction,<br /><br>and/or repeat revascularization<br /><br>• Stroke, post discharge myocardial infarction and repeat revascularization<br /><br>considered as individual events<br /><br>• Cause-specific death (cardiac vs non-cardiac)<br /><br>• Hospital readmissions with specific causes.<br /><br>Each item of the composite outcomes will also be analyzed individually.</p><br>