NCT00805831已完成不适用
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
HDH Medical Ltd2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events.
研究概览
简要总结
The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring device. This study was design in order to evaluate the safety and efficacy of using HDH device and method an innovative anastomotic device for sutureless aortic anastomosis in patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age above 18 (men and woman)
- •Patient suffers from infrarenal abdominal aortic or Aorto-iliac aneurysm
- •Aneurysm diameter is larger than 5cm/ its annual growth is more than 0.5cm/or iliac aneurysm size is larger than 2.5cm
- •The abdominal aneurysm neck is longer than 1.5 cm
- •Patient's physical condition allows performing general anesthesia
- •Patient is willing to sign the informed consent and follow the study protocol.
排除标准
- •Patient Age under 18 years
- •Patient's physical condition dose not allows to perform general anesthesia
- •Patient's with terminal disease and life expectancy of less than 3 months
- •Patient objects to the treatment or study protocol
- •Anesthesiologist or personal care physician object
- •Patient suffer from Supra/infrarenal AAA
- •The abdominal aneurysm neck is smaller than 1.5 cm
- •Aneurysm diameter is smaller than 5cm/ its annual growth is less than 0.5cm/
结局指标
主要结局
To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events.
时间窗: within 1 month
次要结局
- Time to complete the anastomosis(during the surgery)
研究者
研究点 (2)
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