NCT01698671Unknown不适用
InterGard Synergy Post-Marketing Surveillance Study
Maquet Cardiovascular3 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Graft Patency and Complications
研究概览
简要总结
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.
详细描述
Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring an InterGard Synergy Vascular Graft
排除标准
- •Patients with contra-indications per InterGard Synergy Vascular Graft
- •Patients with current graft infection
- •Patients with a known allergy to collagen, triclosan or silver acetate
- •Patients who require urgent or emergent surgery
结局指标
主要结局
Graft Patency and Complications
时间窗: 6 months
* Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation. * Complications including the occurrence of graft infections will be assessed up to post implantation.
次要结局
- Mortality rate(6 months)
研究者
研究点 (3)
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