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Phases and Objectives

The Pilot Phase (Move Pilot Phase Up)

The pilot phase is aimed at establishing the feasibility of the project, the adherence to the protocol and the enrollment rate.

Objective of the Pilot Phase

The main objective of the pilot phase is to enroll 430 patients in 20/25 Core and Vanguard Centers, with a predicted enrolment rate of approximately 1 patient/center/week. This pilot phase will be carried out with limited external funding and using the research infrastructure of the participating centers. The results of the pilot phase will be used to apply for grants from healthcare agencies in the USA, Canada, and Europe asking for support to expand the network of participating centers and to complete the follow-up. A consent rate of >50% of eligible patients, an enrolment rate 80% of the predicted, a rate of compliance with the protocol >90% and a loss of follow-up of less than 1% will be considered as a demonstration of feasibility.

The patients enrolled in the pilot phase will be included in the main trial analysis. If substantive changes to the protocol are required based on the pilot, inclusion of these pilot patients may be reconsidered by the Steering Committee.

Trial Information

Principal Investigators: Mario Gaudino, M.D. & Stephen E. Fremes, M.D.
ClinicalTrials.gov Identifier: NCT03217006
Status: Active
Patient Accrual: Open to Accrual

MAIN TRIAL

Hypotheses

  1. The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent CABG, the use of 2 or more arterial grafts (Arterial Grafts) compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization.
  2. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of 2 or more arterial grafts (Arterial Grafts) compared with a single arterial graft (SAG) is associated with improved survival.

Objective

  1. The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more arterial grafts (AGs) compared to a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization.
  2. The secondary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more arterial grafts (AGs) compared with a single arterial graft (SAG) is associated with improved survival.

INCLUSION CRITERIA

  1. 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.
  2. Coronary artery disease will be defined as a stenosis ≥ 70% based on coronary angiography, a FFR value ≤ 0.80 or iFr value ≤0.89; a left main diameter stenosis ≥ 50%, left main IVUS MLA value ≤ 4.5 mm2, or equivalent OCT measurements will also be considered.

EXCLUSION CRITERIA

  1. Age >70 years
  2. Planned single graft
  3. Emergency operation
  4. Preoperative myocardial infarction within 48 hours
  5. Ejection Fraction (EF) < 35%
  6. Any concomitant cardiac or non-cardiac procedure
  7. Previous cardiac operation
  8. Planned hybrid revascularization
  9. Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years (not a separate bullet)
  10. Inability to use either the saphenous vein or both the right ITA and the RA as grafts
  11. Anticipated need for coronary thromboendarterectomy (PTE).

Special considerations regarding age and ejection fraction limits. These conservative limits were adopted to select a patient population, where the effect of the intervention could be maximized. In the case of a slow recruitment rate, these limits will be reviewed by the Steering Committee.

The ROMA Trial