Actively Recruiting
Randomization of Single vs Multiple Arterial Grafts
Led by Weill Medical College of Cornell University · Updated on 2026-04-21
4300
Participants Needed
59
Research Sites
625 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Randomization of Single vs Multiple Arterial Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Age over 70 years
- Single graft
- Emergency operation
- Evolving myocardial infarction within 48 hours of surgery
- Left ventricular ejection fraction of less than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 59 locations
1
University of Colorado
Boulder, Colorado, United States, 80309
Actively Recruiting
2
Baystate Health
Springfield, Massachusetts, United States, 01109
Actively Recruiting
3
Nebraska Heart Hospital
Lincoln, Nebraska, United States, 68526
Actively Recruiting
4
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
5
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Actively Recruiting
6
Icahn School of Medicine, Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
7
Weil Cornell Medical College Department of Cardiothoracic Surgery
New York, New York, United States, 10065
Actively Recruiting
8
Lenox Hill Hospital (Northwell)
New York, New York, United States, 10075
Actively Recruiting
9
NewYork-Presbyterian Queens
New York, New York, United States, 11355
Actively Recruiting
10
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44106
Actively Recruiting
11
Allegheny General Hospital (Cardiovascular Institute)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
Innsbruck (Medical University) Austria
Innsbruck, Austria
Actively Recruiting
13
Krankenhaus Nord Vienna North Hospital
Vienna, Austria
Actively Recruiting
14
MU Vienna Austria
Vienna, Austria
Actively Recruiting
15
Federal University of Sao Paulo
São Paulo, Brazil
Actively Recruiting
16
Hamilton General Hospital
Hamilton, Canada
Actively Recruiting
17
London Health Sciences Ontario Canada
London, Canada
Actively Recruiting
18
University Hospital of Montreal (CHUM)
Montreal, Canada
Actively Recruiting
19
University of Ottawa Heart Institute Canada
Ottawa, Canada
Actively Recruiting
20
Royal Victoria Hospital (McGill)
Québec, Canada
Actively Recruiting
21
Universite Laval Quebec (CRIUCPQ) Canada
Québec, Canada
Actively Recruiting
22
Sunnybrook Health Sciences Centre
Toronto, Canada
Actively Recruiting
23
Toronto General Hospital
Toronto, Canada
Actively Recruiting
24
St. Boniface General Hospital / WHRA
Winnipeg, Canada
Actively Recruiting
25
Fuwai Hospital
Beijing, China
Actively Recruiting
26
Jilin Heart Hospital
Changchun, China
Actively Recruiting
27
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
28
National Taiwan University Hospital
Taiwan, China
Actively Recruiting
29
Teda Hospital (TICH)
Tianjin, China
Actively Recruiting
30
University Hospital Dubrava
Zagreb, Croatia
Actively Recruiting
31
General University Hospital, Prague
Prague, Czechia
Actively Recruiting
32
Duisburg Heart Center
Duisburg, Germany
Actively Recruiting
33
Essen University
Duisburg, Germany
Actively Recruiting
34
Düsseldorf University
Düsseldorf, Germany
Actively Recruiting
35
University Hospital Erlangen
Erlangen, Germany
Actively Recruiting
36
Giessen Hospital
Giessen, Germany
Actively Recruiting
37
University Medical Center of Goettingen
Göttingen, Germany
Enrolling by Invitation
38
Jena University Hospital
Jena, Germany
Actively Recruiting
39
Heart Center (Herzzentrum)
Leipzig, Germany
Actively Recruiting
40
HDZ NRW Bad
Oeynhausen, Germany
Actively Recruiting
41
Robert-Bosch-Hospital
Stuttgart, Germany
Actively Recruiting
42
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Actively Recruiting
43
Anthea Hospital
Bari, Italy
Actively Recruiting
44
Fondazione Poliambulanza
Brescia, Italy
Actively Recruiting
45
Maria Cecilia Hospital GVM
Cotignola, Italy
Actively Recruiting
46
Universita' Cattolica del Sacro Cuore
Roma, Italy
Actively Recruiting
47
European Hospital
Rome, Italy
Actively Recruiting
48
Ospedale Le Molinette
Torino, Italy
Actively Recruiting
49
Saitama Medical University
Saitama, Japan
Actively Recruiting
50
MUMC Maastricht (University Medical Centre)
Maastricht, Netherlands
Actively Recruiting
51
Medical University of Silesia (Katowice)
Katowice, Poland
Actively Recruiting
52
Hospitalar de Lisboa Central
Capuchos, Portugal
Actively Recruiting
53
University Hospital (Praceta Mota Pinto)
Coimbra, Portugal
Actively Recruiting
54
Centro Hospitalar e Universitário São João
Porto, Portugal
Actively Recruiting
55
Dedinje Cardiovascular Institute
Belgrade, Serbia
Actively Recruiting
56
National University of Singapore
Singapore, Singapore
Actively Recruiting
57
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Sinchŏn-dong, South Korea
Actively Recruiting
58
Hospital Univeritario Del Vinalopo
Alicante, Spain
Actively Recruiting
59
Hospital Clinic de Barcelona (ICCV)
Barcelona, Spain
Actively Recruiting
Research Team
M
Mario Gaudino, MD
CONTACT
M
Marshagay Rodriques
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here