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Summary

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 Multiple Arterial Graft 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.

Investigators

Name
Institution
Location
Mario F. L. Gaudino MD, Principal Investigator Department of Cardiothoracic Surgery, Weill Cornell Medicine New York, NY, USA
Stephen Fremes MD, Principal Investigator Sunnybrook Health Science, University of Toronto Toronto, ON, Canada
John H. Alexander MD Duke Clinical Research Institute, Duke Health Durham, NC, USA
Faisal G. Bakaeen MD Cleveland Clinic Foundation Cleveland, OH, USA
Karla Ballman MD Department of Biostatistics and Epidemiology, Weill Cornell Medicine New York, NY, USA
Fabio Barili MD Department of Cardiovascular Surgery, S. Croce e Carle Hospital Cuneo, Italy
Antonio Maria Calafiore MD Fondazione Giovanni Paolo II Campobasso, Italy
Steven Goldman MD Department of Medicine, University of Arizona Tucson, AZ, USA
Peter Kappetein MD Thoraxcenter, Erasmus MC Rotterdam, Netherlands
Roberto Lorusso MD Maastricht University Medical Centre Maastricht, Netherlands
Darren Mylotte MD Galway University Hospitals Galway, Ireland
Domenico Pagano MD University Hospital Birmingham Birmingham, UK
Marc Ruel MD University of Ottawa Heart Institute Ottawa, ON, Canada
Thomas Schwann MD The University of Toledo Toledo, OH, USA
Hisayoshi Suma MD Suma Heart Clinic Tokyo, Japan
David P. Taggart MD University of Oxford Oxford, UK
Robert F. Tranbaugh MD Department of Cardiothoracic Surgery, Weill Cornell Medicine New York, NY, USA

The ROMA Trial