Randomization of Single vs Multiple Arterial Grafts (ROMA)

April 20, 2026 updated by: Weill Medical College of Cornell University

Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the 1980's, it was recognized that long-term survival was enhanced in patients undergoing coronary surgery when the left anterior descending (LAD) was grafted with a left internal thoracic artery (ITA) rather than a saphenous vein (1). This difference was predicated, at least in part, due to greater and more durable patency of the left ITA compared to an increased early occlusion rate and later progressive atherosclerosis of saphenous vein grafts (SVG) (2).

For more than 20 years it has generally been accepted that patients who receive multiple arterial grafts (AGs) at the time of coronary artery bypass surgery (CABG) have increased postoperative survival compared to those who receive only one AG, especially over the long term (3-5). The current United States and European Guidelines encourage the use of AGs in patients with a long life expectancy (6, 7). Last year, a position paper from the Society of Thoracic Surgeons strongly recommended a wider use of AGs (8).

The putative mechanism underlying the AG hypothesis is greater patency. In line with the original findings of improved LAD graft patency with ITA vs. SVG, data from randomized control trials (RCTs) as well as observational studies and a network meta-analysis (9) have demonstrated that the patency of the RA, as well as the right ITA, exceed that of a SVG, providing mechanistic basis to support the AG hypothesis.

ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The trial is powered to detect a 20% relative reduction in the primary outcome with 90% power at 5% alpha.

The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of a two or more AGs 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 aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more AGs compared to a single arterial graft is associated with improved survival.

Study Type

Interventional

Enrollment (Estimated)

4300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria
        • Recruiting
        • Innsbruck (Medical University) Austria
        • Contact:
        • Principal Investigator:
          • Elfriede Ruttmann-Ulmer
      • Vienna, Austria
        • Recruiting
        • Krankenhaus Nord Vienna North Hospital
        • Contact:
        • Principal Investigator:
          • Berhard Winkler
      • Vienna, Austria
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Federal University of São Paulo
        • Contact:
          • Fabio Biscegli Jatene
        • Principal Investigator:
          • Fabio Biscegli Jatene
  • Canada
      • Hamilton, Canada
        • Recruiting
        • Hamilton General Hospital
        • Contact:
        • Principal Investigator:
          • Andre Lamy
      • London, Canada
        • Recruiting
        • London Health Sciences Ontario Canada
        • Contact:
        • Principal Investigator:
          • Michael Chu
      • Montreal, Canada
        • Recruiting
        • University Hospital of Montreal (CHUM)
        • Contact:
          • Nicolas Noiseux
        • Principal Investigator:
          • Nicolas Noiseux
      • Ottawa, Canada
        • Recruiting
        • University of Ottawa Heart Institute Canada
        • Contact:
        • Principal Investigator:
          • Marc Ruel
      • Québec, Canada
        • Recruiting
        • Royal Victoria Hospital (McGill)
        • Contact:
          • Kevin Lachapelle,
        • Principal Investigator:
          • Kevin Lachapelle
      • Québec, Canada
        • Recruiting
        • Universite Laval Quebec (CRIUCPQ) Canada
        • Contact:
        • Principal Investigator:
          • Pierre Voisine
      • Toronto, Canada
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Stephen Fremes
      • Toronto, Canada
        • Recruiting
        • Toronto General Hospital
        • Contact:
          • Vivek Rao
        • Principal Investigator:
          • Vivek Rao
      • Winnipeg, Canada
        • Recruiting
        • St. Boniface General Hospital / WHRA
        • Contact:
          • Rakesh Arora
        • Principal Investigator:
          • Rakesh Arora
  • China
      • Beijing, China
        • Recruiting
        • Fuwai Hospital
        • Contact:
        • Principal Investigator:
          • Zhe Zheng
      • Changchun, China
        • Recruiting
        • Jilin Heart Hospital
        • Contact:
        • Principal Investigator:
          • Massimo Lemma
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Qiang Zhao
      • Taiwan, China
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Yih-Sharng Chen
      • Tianjin, China
        • Recruiting
        • Teda Hospital (TICH)
        • Contact:
        • Principal Investigator:
          • Guo-Wei He
  • Croatia
      • Zagreb, Croatia
        • Recruiting
        • University Hospital Dubrava
        • Contact:
        • Principal Investigator:
          • Igor Rudez
  • Czechia
      • Prague, Czechia
        • Recruiting
        • General University Hospital, Prague
        • Contact:
          • Tomas Prskavec
        • Principal Investigator:
          • Tomas Prskavec
  • Germany
      • Duisburg, Germany
        • Recruiting
        • Duisburg Heart Center
        • Contact:
        • Principal Investigator:
          • Jochen Börgermann
      • Duisburg, Germany
        • Recruiting
        • Essen University
        • Contact:
        • Principal Investigator:
          • Matthias Klaus Thielmann
      • Düsseldorf, Germany
        • Recruiting
        • Düsseldorf University
        • Contact:
          • Alexander Assmann
        • Principal Investigator:
          • Alexander Assmann
      • Erlangen, Germany
        • Recruiting
        • University Hospital Erlangen
        • Contact:
        • Principal Investigator:
          • Ehab Nooh
      • Giessen, Germany
      • Göttingen, Germany
        • Enrolling by invitation
        • University Medical Center of Goettingen
      • Jena, Germany
        • Recruiting
        • Jena University Hospital
        • Contact:
          • Torsten Doenst
        • Principal Investigator:
          • Torsten Doenst
      • Leipzig, Germany
        • Recruiting
        • Heart Center (Herzzentrum)
        • Contact:
          • Michael Borger
        • Principal Investigator:
          • Michael Borger
      • Oeynhausen, Germany
        • Recruiting
        • HDZ NRW Bad
        • Contact:
        • Principal Investigator:
          • Kavous Haikim- Meibodi
      • Stuttgart, Germany
        • Recruiting
        • Robert-Bosch-Hospital
        • Contact:
        • Principal Investigator:
          • Marc Alber
      • Trier, Germany
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
        • Contact:
          • Terrence John Donovan
        • Principal Investigator:
          • Terrence John Donovan
  • Italy
      • Bari, Italy
        • Recruiting
        • Anthea Hospital
        • Contact:
        • Principal Investigator:
          • Giuseppe Speziale
      • Brescia, Italy
      • Cotignola, Italy
        • Recruiting
        • Maria Cecilia Hospital GVM
        • Contact:
          • Alberto Albertini
        • Principal Investigator:
          • Alberto Albertini
      • Roma, Italy
        • Recruiting
        • Universita' Cattolica del Sacro Cuore
        • Contact:
        • Principal Investigator:
          • Massimo Massetti
      • Rome, Italy
        • Recruiting
        • European Hospital
        • Contact:
        • Principal Investigator:
          • Ruggero De Paulis
      • Torino, Italy
        • Recruiting
        • Ospedale Le Molinette
        • Contact:
        • Principal Investigator:
          • Mauro Rinaldi
  • Japan
      • Saitama, Japan
        • Recruiting
        • Saitama Medical University
        • Contact:
        • Principal Investigator:
          • Hiroyuki Nakajima
  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • MUMC Maastricht (University Medical Centre)
        • Contact:
        • Principal Investigator:
          • Roberto Lorusso
  • Poland
      • Katowice, Poland
        • Recruiting
        • Medical University of Silesia (Katowice)
        • Contact:
          • Mark Deja
        • Principal Investigator:
          • Mark Deja
  • Portugal
      • Capuchos, Portugal
        • Recruiting
        • Hospitalar de Lisboa Central
        • Contact:
          • Miguel Sousa Uva
        • Principal Investigator:
          • Miguel Sousa Uva
      • Coimbra, Portugal
        • Recruiting
        • University Hospital (Praceta Mota Pinto)
        • Contact:
        • Principal Investigator:
          • Manuel Antunes
      • Porto, Portugal
        • Recruiting
        • Centro Hospitalar e Universitário Sao João
        • Contact:
          • Adelino Leite-Moreira
        • Principal Investigator:
          • Adelino Leite-Moreira
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Dedinje Cardiovascular Institute
        • Contact:
        • Principal Investigator:
          • Milan Milojevic
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University of Singapore
        • Contact:
        • Principal Investigator:
          • Theodoros Kofidis
  • South Korea
      • Sinchŏn-dong, South Korea
        • Recruiting
        • Severance Cardiovascular Hospital, Yonsei University College of Medicine
        • Contact:
        • Principal Investigator:
          • Kyung-Jong Yoo
  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital Univeritario Del Vinalopo
        • Contact:
          • Jose Albors Martin
        • Principal Investigator:
          • Jose Albors Martin
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic de Barcelona (ICCV)
        • Contact:
          • Jorge Alcocer
        • Principal Investigator:
          • Jorge Alcocer
  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • Recruiting
        • University of Colorado
        • Contact:
          • Jessica Rove
        • Principal Investigator:
          • Jessica Rove
    • Massachusetts
      • Springfield, Massachusetts, United States, 01109
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Nebraska Heart Hospital
        • Contact:
          • Thomas Kleisli
        • Principal Investigator:
          • Thomas Kleisli
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Aleem Siddique
        • Principal Investigator:
          • Aleem Siddique
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • NewYork-Presbyterian Brooklyn Methodist Hospital
        • Contact:
          • Sandhya Balaram, MD
        • Principal Investigator:
          • Sandhya Balaram, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine, Mount Sinai
        • Contact:
        • Principal Investigator:
          • John Puskas
      • New York, New York, United States, 10065
        • Recruiting
        • Weil Cornell Medical College Department of Cardiothoracic Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario FL Gaudino
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital (Northwell)
        • Contact:
        • Principal Investigator:
          • Nirav Patel
      • New York, New York, United States, 11355
        • Recruiting
        • NewYork-Presbyterian Queens
        • Contact:
          • Charles Mack, MD
        • Principal Investigator:
          • Charles Mack, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Faisal Bakaeen
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Allegheny General Hospital (Cardiovascular Institute)
        • Contact:
        • Principal Investigator:
          • Scott Halbreiner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Outcome
Time Frame: > 72 hours after surgery and/or repeat revascularization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days post-operatively
Death from any cause at 30-days
30 days post-operatively
Major postoperative complications
Time Frame: In-hospital stay, up to 30 days post-operatively
Revision for bleeding, perioperative myocardial infarction, any stroke, need for dialysis, need for tracheostomy, and surgical site infection.
In-hospital stay, up to 30 days post-operatively
Sternal wound complication
Time Frame: 6 months post-operatively
Wound drainage, skin separation, unstable sternum, and sternal dehiscence, infection
6 months post-operatively
Composite Outcome of Death from any cause
Time Frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
A composite of death from any cause, post discharge myocardial infarction,stroke, and/or repeat revascularization
Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
Stroke
Time Frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
Post discharge myocardial infarction and repeat revascularization considered as individual events
Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
Cause-specific death (cardiac vs non-cardiac)
Time Frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
Death as either cardiac or non-cardiac in etiology
Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
Hospital readmissions
Time Frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
Hospital readmissions with specific causes
Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Mario Gaudino, MD, Weill Medical College of Cornell University
  • Principal Investigator: Stephen Fremes, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2018

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1703018094
  • 1R01HL152021-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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