Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Technical Success (Graft Patency) in a MICS Approach
研究概览
简要总结
This clinical study has been developed to evaluate the clinical outcomes in patients undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a minimally invasive coronary bypass procedure that is done on a beating heart via a smaller chest incision, thus avoiding the invasiveness of the standard procedure.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> or equal to 18 and < or equal to 80 years of age
- •Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first time, single or multivessel coronary artery bypass grafting (on pump or off pump)
- •Left ventricle ejection fraction >30%
- •Willing and able to provide written informed consent and comply with study requirements
排除标准
- •Severe cerebrovascular disease within 90 days of surgery including history of prior stroke.
- •Previous cardiac surgery procedures such as CABG revisions, surgical ablations or valve replacements
- •Congestive heart failure with a New York Heart Association (NYHA) Class IV
- •History of renal insufficiency (i.e. prior serum creatinine of >2mg/dl) and/or requiring dialysis
- •Uncontrolled diabetes (i.e. >2 serum glucose concentrations of >350 mg/dl)
- •Severe uncontrolled systemic hypertension (i.e. systolic pressure >160 mmHg)
- •Peripheral/systemic active infection excluding the patient from cardiac surgery
- •Life expectancy of less than 1 year due to other illness such as cancer or pulmonary, hepatic or renal disease
- •Participation in another investigational protocol that may confound the results of this study
- •Female of child bearing potential and lactating or intends to become pregnant during the study
- •Severe distal disease and small posterior lateral targets
结局指标
主要结局
Technical Success (Graft Patency) in a MICS Approach
时间窗: At time of procedure (day 1)
For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.
Patency of the Index Graft at 6 Months
时间窗: 6 months post-procedure
For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results. The FitzGibbon Scoring system is as follows: A:Excellent graft with unimpaired runoff (\< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to \<50% of the grafted coronary artery. O:Occluded (100% stenosed)
Procedural Success in a MICS Approach
时间窗: At time of procedure (day 1)
A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.
Composite Major Adverse Event Rate (Early)
时间窗: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)
During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include: * Major hemorrhage/bleeding requiring surgical intervention * Aortic complications * Graft vessel revision (GVR) * Transient ischemic attacks (TIA) * Cerebrovascular accidents (CVA)/stroke * Myocardial infarction (MI) * Death
次要结局
- Composite Major Adverse Event Rate (Late)(After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation)