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Randomization of Single vs Multiple Arterial Grafts

RecruitingNAAges 18 Years - 70 YearsAllWeill Medical College of Cornell University
NCT03217006 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery. Exclusion Criteria: * Age \> 70 years * Single graft * Emergency operation * Evolving myocardial infarction within 48 hours of surgery * Left ventricular ejection fraction of \< 35% * Any concomitant cardiac or non-cardiac procedure * Previous cardiac surgery * Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduce life expectancy to less than 5 years. * Inability to use the saphenous vein or to use both radial and right internal thoracic arteries * Anticipated need for coronary thrombo-endarterectomy * Planned hybrid revascularization
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What it tests

  • Single arterial graft
  • Multiple arterial grafting
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Where

59 sites
University of Colorado
Boulder, United States
Baystate Health
Springfield, United States
Nebraska Heart Hospital
Lincoln, United States
University of Nebraska Medical Center
Omaha, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, United States
Icahn School of Medicine, Mount Sinai
New York, United States
Weil Cornell Medical College Department of Cardiothoracic Surgery
New York, United States
Lenox Hill Hospital (Northwell)
New York, United States

…and 51 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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