Recruiting

MAG vs. SAG

Sponsor:

Weill Medical College of Cornell University

Code:

NCT03217006

Conditions

Coronary Artery Disease

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Single arterial graft

Multiple arterial grafting

Study Details

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.

Conditions

Coronary Artery Disease

Heart Diseases

Study ID

NCT03217006

Start date

Jan 7, 2018

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arterial Group

Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.

experimental: Multiple Arterial Group

Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.

Interventions

Single arterial graft

This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.

Multiple arterial grafting

This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.

Primary outcome measure

  • Composite Outcome [ Time Frame: > 72 hours after surgery and/or repeat revascularization ]

Central Contacts and Locations

Central contacts

Mario Gaudino, MD

212.746.1812mfg9004@med.cornell.edu

Marshagay Rodriques

(212) 746-5594mar4028@med.cornell.edu

Locations

University of Colorado

Recruiting

Boulder, Colorado, United States, 80309

Principal Investigator:

Jessica Rove

Baystate Health

Recruiting

Springfield, Massachusetts, United States, 01109

Contacts

Daniel Engelman

Daniel.Engelman@baystatehealth.org

Principal Investigator:

Daniel Engelman

Nebraska Heart Hospital

Recruiting

Lincoln, Nebraska, United States, 68526

Principal Investigator:

Thomas Kleisli

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator:

Aleem Siddique

NewYork-Presbyterian Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

Principal Investigator:

Sandhya Balaram, MD

Icahn School of Medicine, Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

John Puskas

John.Puskas@mountsinai.org

Principal Investigator:

John Puskas

Weil Cornell Medical College Department of Cardiothoracic Surgery

Recruiting

New York, New York, United States, 10065

Contacts

Mario FL Gaudino, MD

212-746-1815mfg9004@med.cornell.edu

Nathan T Palaparthi, MS

212-746-5194ntp2001@med.cornell.edu

Principal Investigator:

Mario FL Gaudino

Lenox Hill Hospital (Northwell)

Recruiting

New York, New York, United States, 10075

Contacts

Nirav Patel

nipatel@northwell.edu

Principal Investigator:

Nirav Patel

NewYork-Presbyterian Queens

Recruiting

New York, New York, United States, 11355

Principal Investigator:

Charles Mack, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Faisal Bakaeen

bakaeef@ccf.org

Principal Investigator:

Faisal Bakaeen

Allegheny General Hospital (Cardiovascular Institute)

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Scott Halbreiner

Scott.halbreiner@ahn.org

Principal Investigator:

Scott Halbreiner

Hamilton General Hospital

Recruiting

Hamilton, Canada

Contacts

Andre Lamy

lamya@mcmaster.ca

Principal Investigator:

Andre Lamy

London Health Sciences Ontario Canada

Recruiting

London, Canada

Contacts

Michael Chu

Michael.chu@lhsc.on.ca

Principal Investigator:

Michael Chu

University Hospital of Montreal (CHUM)

Recruiting

Montreal, Canada

Principal Investigator:

Nicolas Noiseux

University of Ottawa Heart Institute Canada

Recruiting

Ottawa, Canada

Contacts

Marc Ruel

mruel@ottawaheart.ca

Principal Investigator:

Marc Ruel

Royal Victoria Hospital (McGill)

Recruiting

Québec, Canada

Principal Investigator:

Kevin Lachapelle

Universite Laval Quebec (CRIUCPQ) Canada

Recruiting

Québec, Canada

Contacts

Pierre Voisine

pierre.voisine@chg.ulaval.ca

Principal Investigator:

Pierre Voisine

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Canada

Contacts

Stephen Fremes

Stephen.Fremes@sunnybrook.ca

Principal Investigator:

Stephen Fremes

Toronto General Hospital

Recruiting

Toronto, Canada

Principal Investigator:

Vivek Rao

St. Boniface General Hospital / WHRA

Recruiting

Winnipeg, Canada

Principal Investigator:

Rakesh Arora

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • coronary artery bypass surgery
  • multiple arterial graft
  • radial artery graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-20.