NCT03217006 Randomization of Single vs Multiple Arterial Grafts
| NCT ID | NCT03217006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,300 participants |
| Start Date | 2018-01-07 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,300 participants in total. It began in 2018-01-07 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Mario Gaudino, MD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT03217006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03217006 currently recruiting?
Yes, NCT03217006 is actively recruiting participants. Contact the research team at mfg9004@med.cornell.edu for enrollment information.
Where is the NCT03217006 trial being conducted?
This trial is being conducted at Boulder, United States, Springfield, United States, Lincoln, United States, Omaha, United States and 11 additional locations.
Who is sponsoring the NCT03217006 clinical trial?
NCT03217006 is sponsored by Weill Medical College of Cornell University. The principal investigator is Mario Gaudino, MD at Weill Medical College of Cornell University. The trial plans to enroll 4,300 participants.