Randomization of Single vs Multiple Arterial Grafts

NCT03217006 | Recruiting DMC

• 2 other identifiers: 17030180941R01HL152021-01
• Study Type: interventional
• Target: 4,300
• Locations: 17 countries
• Sites: 59

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite Outcome

  A composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.

  > 72 hours after surgery and/or repeat revascularization

Secondary Outcomes (7)

• 30-day mortality

  30 days post-operatively

• Major postoperative complications

  In-hospital stay, up to 30 days post-operatively

• Sternal wound complication

  6 months post-operatively

• Composite Outcome of Death from any cause

  Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.

• Stroke

  Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.

Study Arms (2)

Single Arterial Group

EXPERIMENTAL

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.

Procedure: Single arterial graft

Multiple Arterial Group

EXPERIMENTAL

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.

Procedure: Multiple arterial grafting

Interventions

Single arterial graft PROCEDURE

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.

Single Arterial Group

Multiple arterial grafting PROCEDURE

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.

Multiple Arterial Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (59)

University of Colorado

Boulder, Colorado, 80309, United States

RECRUITING

Baystate Health

Springfield, Massachusetts, 01109, United States

RECRUITING

Nebraska Heart Hospital

Lincoln, Nebraska, 68526, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

RECRUITING

Icahn School of Medicine, Mount Sinai

New York, New York, 10029, United States

RECRUITING

Weil Cornell Medical College Department of Cardiothoracic Surgery

New York, New York, 10065, United States

RECRUITING

Lenox Hill Hospital (Northwell)

New York, New York, 10075, United States

RECRUITING

NewYork-Presbyterian Queens

New York, New York, 11355, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

RECRUITING

Allegheny General Hospital (Cardiovascular Institute)

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Innsbruck (Medical University) Austria

Innsbruck, Austria

RECRUITING

Krankenhaus Nord Vienna North Hospital

Vienna, Austria

RECRUITING

MU Vienna Austria

Vienna, Austria

RECRUITING

Federal University of Sao Paulo

São Paulo, Brazil

RECRUITING

Hamilton General Hospital

Hamilton, Canada

RECRUITING

London Health Sciences Ontario Canada

London, Canada

RECRUITING

University Hospital of Montreal (CHUM)

Montreal, Canada

RECRUITING

University of Ottawa Heart Institute Canada

Ottawa, Canada

RECRUITING

Royal Victoria Hospital (McGill)

Québec, Canada

RECRUITING

Universite Laval Quebec (CRIUCPQ) Canada

Québec, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Canada

RECRUITING

Toronto General Hospital

Toronto, Canada

RECRUITING

St. Boniface General Hospital / WHRA

Winnipeg, Canada

RECRUITING

Fuwai Hospital

Beijing, China

RECRUITING

Jilin Heart Hospital

Changchun, China

RECRUITING

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

National Taiwan University Hospital

Taiwan, China

RECRUITING

Teda Hospital (TICH)

Tianjin, China

RECRUITING

University Hospital Dubrava

Zagreb, Croatia

RECRUITING

General University Hospital, Prague

Prague, Czechia

RECRUITING

Duisburg Heart Center

Duisburg, Germany

RECRUITING

Essen University

Duisburg, Germany

RECRUITING

Düsseldorf University

Düsseldorf, Germany

RECRUITING

University Hospital Erlangen

Erlangen, Germany

RECRUITING

Giessen Hospital

Giessen, Germany

RECRUITING

University Medical Center of Goettingen

Göttingen, Germany

ENROLLING BY INVITATION

Jena University Hospital

Jena, Germany

RECRUITING

Heart Center (Herzzentrum)

Leipzig, Germany

RECRUITING

HDZ NRW Bad

Oeynhausen, Germany

RECRUITING

Robert-Bosch-Hospital

Stuttgart, Germany

RECRUITING

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

RECRUITING

Anthea Hospital

Bari, Italy

RECRUITING

Fondazione Poliambulanza

Brescia, Italy

RECRUITING

Maria Cecilia Hospital GVM

Cotignola, Italy

RECRUITING

Universita' Cattolica del Sacro Cuore

Roma, Italy

RECRUITING

European Hospital

Rome, Italy

RECRUITING

Ospedale Le Molinette

Torino, Italy

RECRUITING

Saitama Medical University

Saitama, Japan

RECRUITING

MUMC Maastricht (University Medical Centre)

Maastricht, Netherlands

RECRUITING

Medical University of Silesia (Katowice)

Katowice, Poland

RECRUITING

Hospitalar de Lisboa Central

Capuchos, Portugal

RECRUITING

University Hospital (Praceta Mota Pinto)

Coimbra, Portugal

RECRUITING

Centro Hospitalar e Universitário São João

Porto, Portugal

RECRUITING

Dedinje Cardiovascular Institute

Belgrade, Serbia

RECRUITING

National University of Singapore

Singapore, Singapore

RECRUITING

Severance Cardiovascular Hospital, Yonsei University College of Medicine

Sinchŏn-dong, South Korea

RECRUITING

Hospital Univeritario Del Vinalopo

Alicante, Spain

RECRUITING

Hospital Clinic de Barcelona (ICCV)

Barcelona, Spain

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mario Gaudino, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Stephen Fremes, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Gaudino, MD

CONTACT

212.746.1812; mfg9004@med.cornell.edu

Marshagay Rodriques

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The endpoint assessors will be blinded to treatment allocation (PROBE).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients undergoing coronary artery bypass surgery will be in one of two groups. One group will receive a single arterial graft and the second group will receive two or more arterial grafts.

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 13, 2017
• Study Start: January 7, 2018
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

NL (1); CN (5); CA (9); DE (11); JP (1); AU (3); BR (1); US (11); KR (1); PL (1); ES (2); SG (1); CR (1); SE (1); CZ (1); PT (3); IT (6)