Comparing One Versus Several Artery Grafts in Bypass Heart Surgery
Tests using one artery graft or several in bypass surgery for coronary artery disease.
Plain-language title generated from the registry record
Registry title: Randomization of Single vs Multiple Arterial Grafts
Key facts
- Where
- Maastricht, NetherlandsSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT03217006, who can take part
Where in Netherlands
- MUMC Maastricht (University Medical Centre)Maastricht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Weill Medical College of Cornell University
- Trial code
- NCT03217006
- Record updated
- 20 August 2026
- Original description
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.Read full original descriptionShow less
Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
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 randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.
Inclusion: 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: Any concomitant cardiac or non-cardiac procedure; Previous cardiac surgery; Evolving myocardial infarction within 48 hours of 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; Left ventricular ejection fraction of < 35%; Age > 70 years; Single graft; Emergency operation; 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.