ROMA is a prospective event-driven un-blinded randomized multicenter clinical trial. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). All patients will receive a single internal thoracic artery (ITA) to the left anterior descending coronary artery (LAD). In the MAG group, the major vessel to the lateral wall will be grafted with a radial or a second ITA. The primary outcome will be a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all cause mortality. The sample size is estimated at 4300 patients.
Principal Investigator/s: Mario Gaudino, M.D. and Stephem E. Fremes, M.D.
Contact: Renee Aviv, RN 212-746-5194
ClinicalTrials.gov Identifier: NCT03217006
Patient Accrual: Open to Accrual