単一動脈グラフトと複数動脈グラフトのランダム化

基本情報

NCT ID

NCT03217006

ステータス

実施中（募集終了）

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

4,300

治験依頼者名

Weill Medical College of Cornell University

概要

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)