Assessment of the Performance of a New Suture Material (Optilene® Suture) for Coronary Artery Bypass Graft Surgery. An Observational Post CE-mark Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 245
- 试验地点
- 4
- 主要终点
- postoperative CABG adverse events in hospital
研究概览
简要总结
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.
详细描述
Coronary artery bypass graft (CABG) surgery is one of the most common elective surgical procedure. In total 40.000 CABG´s have been performed yearly in Germany in 2012 and 2013 which presents 60% of all cardiac surgical interventions. Coronary artery bypass grafting is performed for patients with coronary artery disease (CAD) to improve quality of life and to reduce cardiac-related mortality. CAD is the most leading cause of mortality in the Western world as well as in developing countries and it is the most common cause of heart failure. CABG was introduced in the 1960s. CABG operation has become the most studied intervention in the history of surgery. It is highly effective in the treatment of severe angina and it delays unfavorable events such as death, myocardial infarction and recurrence of angina in comparison to other treatment forms. There is a general agreement that already in the early postoperative period CABG surgery improves the disease in patients with symptomatic left main coronary artery stenosis or stenosis of the three main coronary vessels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing an elective primary coronary artery bypass graft surgery (CABG).
- •On pump or off pump CABG surgery
- •Age ≥25 years
- •Written informed consent
排除标准
- •Emergency surgery
- •Insulin dependent Diabetes Mellitus
- •Acute myocardial infarction with Creatinine Kinase-MB level > 10% of CK and /or ECG signs
- •Known immunodeficiency or immunosuppression
- •Other combined aortic valve intervention except cardiac valve or mitral valve surgery
- •Participation or planned participation in another cardiovascular study before study follow-up is completed.
- •Inability to give informed consent due to mental condition, mental retardation, or language barrier.
结局指标
主要结局
postoperative CABG adverse events in hospital
时间窗: day of discharge (average 7 to 10 days)
Incidence of individual postoperative CABG adverse events in hospital. Postoperative CABG adverse events are defined as the sum of the frequency of myocardial infarction, stroke, mortality, renal failure and gastrointestinal bleeding.
次要结局
- Incidence of myocardial infarction (MI)(until day of discharge (average 7 to 10 days), 30 days and 3 months postop)
- Incidence of renal failure(until day of discharge (average 7 to 10 days))
- Mortality(until day of discharge (average 7 to 10 days), 30 days and 3 months postop)
- Gastrointestinal bleeding(until day of discharge (average 7 to 10 days))
- Incidence of stroke(until day of discharge (average 7 to 10 days), 30 days and 3 months postop)
- Anastomosis revision rate due to rebleeding(until day of discharge (average 7 to 10 days))
- Other adverse events (wound infection, angina, reoperation)(until 3 months postop)