Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial.

Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial. - ROMA - WOMAN trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54591

Enrollment

250

Registered

2018-01-25

Start date

2018-10-10

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

In all patients, one internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for al

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: primary isolated CABG patients with disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery. Coronary artery disease will be defined as a stenosis >= 70% based on coronary angiography, a FFR value = 50%, left main IVUS MLA value

Exclusion criteria

Exclusion criteria: • Age 70 years • Planned single graft • Emergency operation • Preoperative myocardial infarction within 48 hours • Ejection Fraction (EF)

Design outcomes

Primary

Measure	Time frame
The primary outcome will be a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.	—

Secondary

Measure	Time frame
The secondary outcome will be all cause mortality. Additional secondary outcomes will be: • 30-day mortality • Major postoperative complications (revision for bleeding, perioperative myocardial infarction, any stroke, need for dialysis, need for tracheostomy, and surgical site complications) • Sternal wound complications • A composite of death from any cause, post discharge myocardial infarction, and/or repeat revascularization • A composite of death from any cause, any stroke, any myocardial infarction, and/or repeat revascularization • Stroke, post discharge myocardial infarction and repeat revascularization considered as individual events • Cause-specific death (cardiac vs non-cardiac) • Hospital readmissions with specific causes. Each item of the composite outcomes will also be analyzed individually.	—

Measure

Time frame

The secondary outcome will be all cause mortality. Additional secondary outcomes will be: • 30-day mortality • Major postoperative complications (revision for bleeding, perioperative myocardial infarction, any stroke, need for dialysis, need for tracheostomy, and surgical site complications) • Sternal wound complications • A composite of death from any cause, post discharge myocardial infarction, and/or repeat revascularization • A composite of death from any cause, any stroke, any myocardial infarction, and/or repeat revascularization • Stroke, post discharge myocardial infarction and repeat revascularization considered as individual events • Cause-specific death (cardiac vs non-cardiac) • Hospital readmissions with specific causes. Each item of the composite outcomes will also be analyzed individually.

—

Countries

Netherlands, United States

Contacts

Public ContactJLR Romeo

Maastricht Universitair Medisch Centrum +

roberto.lorussobs@gmail.com0433872133

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026