Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg
研究概览
简要总结
The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.
详细描述
Cook Medical has reported thrombus formation with or without occlusion of the Zenith Alpha Spiral-Z®. The purpose of this study is to measure the extent of thrombus formation and occlusion of these stent graft limbs in patients with aortic aneurysms treated at St. Olavs Hospital in 2017, 2018 and 2019. Information is collected from the Norwegian registry for vascular surgery (NORKAR), electronic patient journal and the picture archiving and communication system (PACS). The total number of included patients is estimated to be approximately 100.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients that have received endovascular treatment with the Zenith Alpha Spiral-Z® for an aortic aneurysm
- •The endovascular procedure was performed at St Olavs Hospital from January 2017 until December 2019
排除标准
- 未提供
结局指标
主要结局
Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg
时间窗: 12-36 months
Any amputation in the affected limb / same side as thrombosed stent graft leg
Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg
时间窗: 12-36 months
Any endovascular or surgical procedure to treat thrombosis or occlusion
Percentage of patients who died post-surgery
时间窗: 12-36 months
Death of any cause during the observation time
次要结局
未报告次要终点