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Single versus multiple arterial grafts for coronary bypass

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

Not applicable Interventional Weill Medical College of Cornell University · NCT03217006

This trial will test whether using two or more arterial grafts instead of a single arterial graft during planned coronary artery bypass surgery for people with coronary artery disease leads to fewer deaths, strokes, heart attacks, or repeat procedures.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment4300 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorWeill Medical College of Cornell University Academic / other
Locations59 sites (Boulder, Colorado and 58 other locations)
Trial IDNCT03217006 on ClinicalTrials.gov

What this trial studies

ROMA is a prospective, unblinded, randomized multicenter trial enrolling at least 4,300 patients undergoing primary, non-emergency isolated CABG across international centers. Participants are randomized 1:1 to receive either a single arterial graft (SAG) or multiple arterial grafts (MAG), with permuted block randomization stratified by center and type of second arterial graft. The primary endpoint is a composite of death from any cause, any stroke, post-discharge myocardial infarction, and repeat revascularization, and the trial is event-driven. Key exclusions include age over 70, left ventricular ejection fraction below 35%, emergency or repeat operations, severe end-organ dysfunction, active cancer, or lack of suitable conduit vessels.

Who should consider this trial

Good fit: Ideal candidates are adults under 70 having planned primary isolated CABG for coronary artery disease who have adequate heart function and suitable vessels for arterial grafting.

Not a fit: Patients over 70, with very low ejection fraction, emergency or repeat surgeries, severe comorbidities limiting life expectancy, or unsuitable conduit vessels are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, using multiple arterial grafts could reduce long-term rates of death, stroke, heart attack, and the need for repeat coronary procedures after bypass surgery.

How similar studies have performed: Smaller randomized trials and many observational studies have demonstrated better arterial graft patency and suggest long-term survival benefits, but large definitive randomized comparisons of single versus multiple arterial grafts remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Boulder, Colorado and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseHeart Diseasescoronary artery bypass surgerymultiple arterial graftradial artery graft
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.