Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Coronary patency of index graft at the sixth post-operative month
研究概览
简要总结
This evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterio descending coronary artery during myocardial revascularization in patients with coronary artery disease requiring surgical intervention. The study is designed to assess the ability to compare the patency of grafts created using an automated device versus hand-sewn grafts of the same vessels in the same patient population.
详细描述
Evaluation of automated distal anastomotic device as a surrogate for hand-sewn grafts for completion of arterial conduit anastomosis between the Left Internal Mammary Artery and Left Anterior Descending Artery among patients with coronary artery disease requiring surgical revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 85 years (inclusive)
- •Diagnostically confirmed coronary disease
- •Ejection fraction > 30%
- •Tolerate contrast media
- •Acceptable LIMA (conduit) and LAD (target)for grafting
- •Life expectancy > 1 year
排除标准
- •Refusal to give informed consent
- •Unable to meet study travel and general health requirements
- •Pregnancy
- •Previous cardiac surgery
- •NYHA Class IV
- •Preoperative need for IABP
- •Acute or chronic dialysis (creatinine > 200mmolor 2.3 mg/dL) within 30 days of surgery
- •Acute or suspected systemic infection
- •Need for ongoing immunosuppressive therapy
- •Recent history (<2 weeks) of CVA
- •Aspirin allergy
结局指标
主要结局
Coronary patency of index graft at the sixth post-operative month
时间窗: 6 months post-op
次要结局
- Establish preliminary safety profile(6 months post-op)