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Compares two bypass surgery methods in women with coronary artery disease

Compares multiple versus single artery grafts in women having heart bypass surgery.

Key facts

Who runs it
Weill Medical College of Cornell University
Where
Leiden, Maastricht, and Rotterdam, NetherlandsSee the 3 sitesAlso in 25 other countries, 143 sites
Trial code
Registry title
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Status
Recruiting
People taking part
2,300 people, planned
Started
17 Apr 2023
Expected to end
Mar 2030
Type of study
Interventional, 2 groups
Treatments tested
  • Single arterial graft
  • Multiple arterial grafting
Record updated
1 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women having a first heart bypass operation for blocked heart arteries. It compares using one artery graft with using several.

Age
18 years or older
Sex
Women only
Disease stage
Significant disease of the left main coronary artery, or of the left anterior descending and circumflex coronary arteries, with or without right coronary artery disease. The operation is a bypass (CABG) only.
Earlier treatment
This must be the first heart surgery. People who had earlier heart surgery cannot join.

Main reasons for not taking part

  • Emergency operation
  • Heart attack within 72 hours of surgery
  • Left ventricular ejection fraction below 35%
  • Any other heart or non-heart procedure at the same time
  • Previous heart surgery

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Women patients ≥18 years old
  • Isolated coronary artery bypass grafting
  • Primary (first time) cardiac surgery procedure
  • Significant 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

Who cannot take part

  • Any concomitant cardiac or non-cardiac procedure
  • Previous cardiac surgery
  • Myocardial infarction within 72 hours of surgery
  • Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years
  • Left ventricular ejection fraction < 35%
  • Male gender
  • Single graft
  • Emergency operation
  • 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 in Netherlands

Also in 25 other countries, 143 sites

  • Leiden University Medical CenterLeiden, NetherlandsContact: Arend de Weger, MDTaking people
  • Maastricht University Medical CentreMaastricht, NetherlandsContact: Roberto Lorusso, MDTaking people
  • Erasmus Medical CenterRotterdam, NetherlandsContact: Sabrine Siregar, MDTaking people

About the trial

What the trial wants to find out

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG).

Read full original descriptionShow less

The specific aims of ROMA:Women are:

Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time.

Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events.

Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups.

Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated.

Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG.

Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG.

Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

The 2 groups in the trial

  • Single Arterial Graft (SAG) groupTreatment being tested

    Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.

    Treatment: Single arterial graft

  • Multiple Arterial Graft (MAG) groupTreatment being tested

    Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.

    Treatment: Multiple arterial grafting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
Plain-language title
Compares two bypass surgery methods in women with coronary artery diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 April 2026