NCT00668681撤回不适用
Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures
Lombard Medical13 个研究点 分布在 1 个国家开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 13
研究概览
简要总结
This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >21 years of age
- •Undergoing endovascular stent grafting for AAA repair
- •Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak.
排除标准
- •Religious, cultural or other objection to the receipt of blood, or blood products.
- •Unwilling to comply with follow-up schedule
- •Unwillingness, or inability to provide informed consent to both trila and procedure
- •Ruptured Aneurysm
- •Area where staple is to be placed has significant loose thrombus associated with it
- •Acute or chronic aortic dissection or mycotoc aneurysm
- •Allergy to device materials
- •Allergy to or intolerance to use of contrast media or cannot be exposed to suitable remedial treatment such as steroids and/or diphenhydramine.
- •Clinically and morbidly obese such that imaging would be severely adversely affected.
- •Uncorrectable bleeding abnormality
- •Inflammatory aneurysm
- •Connective tissue disease (e.g., Marfans syndrome, Ehlers Danlos syndrome)
- •Patients with PTFE grafts
- •Patients with investigational grafts (i.e., those grafts that are not FDA approved)
研究者
研究点 (13)
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