Randomization of Single vs Multiple Arterial Grafts
Public ClinicalTrials.gov record NCT03217006. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03217006
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 4,300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 6, 2018
- Primary completion
- Dec 30, 2029
- Completion
- Dec 30, 2030
- Last update posted
- Aug 19, 2026
2018 – 2030
United States locations
- U.S. sites
- 11
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado | Boulder | Colorado | 80309 | Recruiting |
| Baystate Health | Springfield | Massachusetts | 01109 | Recruiting |
| Nebraska Heart Hospital | Lincoln | Nebraska | 68526 | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Recruiting |
| NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | Recruiting |
| Icahn School of Medicine, Mount Sinai | New York | New York | 10029 | Recruiting |
| Weil Cornell Medical College Department of Cardiothoracic Surgery | New York | New York | 10065 | Recruiting |
| Lenox Hill Hospital (Northwell) | New York | New York | 10075 | Recruiting |
| NewYork-Presbyterian Queens | New York | New York | 11355 | Recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44106 | Recruiting |
| Allegheny General Hospital (Cardiovascular Institute) | Pittsburgh | Pennsylvania | 15232 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03217006, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2026 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03217006 live on ClinicalTrials.gov.