Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Endothelial integrity of the radial artery using histological examination.
研究概览
简要总结
Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is performed in the standard fashion according to the institutional routine. The patients are randomized preoperatively to one of the devices. The proximal end of the radial artery will be preserved and deep-frozen for histological assessment. Endothelial integrity will be investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all adult patients undergoing CABG using the radial artery
- •capability to give informed consent
排除标准
- •no specific exclusion criteria
结局指标
主要结局
Endothelial integrity of the radial artery using histological examination.
时间窗: Through study completion, an average of 1 year.
次要结局
- Hemostasis in the arm indicated by bleeding from radial artery side branches or veins in the arm.(Intraoperatively and directly after vessel harvesting the arm is controlled using the endoscope and bleeding can be detected during this control. End of surgery is end of this outcome parameter.)
- Accuracy of vessel sealing, if side branches of the radial artery are bleeding after blood insufflation, additional clips have to placed at the side branch.(The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.)
- Harvesting time(The harvesting time will be measured during the vessel harvesting surgery.)