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Clinical Trials/NL-OMON54591
NL-OMON54591
Recruiting
Not Applicable

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

Weill Cornell Medicine0 sites250 target enrollmentTBD
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ConditionsCoronary artery disease10003216

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary artery disease
Sponsor
Weill Cornell Medicine
Enrollment
250
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •primary isolated CABG patients with disease of the left main coronary artery or
  • •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 \<\= 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

  • •Age \<18, and men \> 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 • Preoperative brain

Outcomes

Primary Outcomes

Not specified

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