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Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039746
Enrollment
3650
Registered
2020-03-15
Start date
2020-04-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Coronary artery disease

Interventions

Saphenous vein graft as a 2nd graft conduit after internal thoracic artery. Arterial graft ( radial artery, gastroepiploic artery, or contralateral internal thoracic artery) as a 2nd graft conduit aft

Sponsors

Weill Cornell Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Age > 70 years Planned single graft Emergency operation Preoperative myocardial infarction within 48 hours Ejection Fraction (EF) < 35% Any concomitant cardiac or non-cardiac procedure Previous cardiac operation Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years. Inability to use either the saphenous vein or both the right ITA and the RA as grafts Anticipated need for coronary thrombo-endarterectomy. Planned hybrid revascularization

Design outcomes

Primary

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

Secondary

MeasureTime frame
The secondary outcome will be all cause mortality.

Countries

Japan,Asia(except Japan),North America,Europe

Contacts

Public ContactEiki Nagaoka

Tokyo Medical and Dental University Department of Cardiovascular Surgery

nagaoka.cvsg@tmd.ac.jp03-5803-5270

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026