NCT02511834已完成不适用
VEST III PMS Clinical Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 15
- 主要终点
- Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones.
研究概览
简要总结
Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for on-pump CABG on clinical grounds
- •Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds
- •Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed
- •Ability to give their informed written consent
- •Ability and willingness to comply with study follow up requirements
- •Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years
排除标准
- •Concomitant non-CABG cardiac procedure
- •Prior cardiac surgery
- •Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- •Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta)
- •Calcification at the intended anastomotic sites, as assessed upon opening of the chest, before randomization
- •Severe vein varicosity
- •Prior debilitating stroke less than 1 year before surgery
- •Severe renal dysfunction (Cr>2.0 mg/dL or >177 μmol/L)
- •Women of child bearing age
- •Concomitant life-threatening disease likely to limit life expectancy to less than 5 years
- •Indication for Warfarin up to time of surgery
- •Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled.
- •inability to take aspirin
- •Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
- •Inability to comply with required follow-ups including angiographic and/or CT imaging methods.
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
结局指标
主要结局
Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones.
时间窗: 2 years
Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones.
次要结局
- MACCE(2 years)
- Vein graft failure(2 years)
- Early vein graft failure(6 months)
- Intimal hyperplasia area(2 years)
研究者
研究点 (15)
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