NCT00824109Unknown4 期
Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Graft patency at three years
研究概览
简要总结
The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is 18 - 85 years of age
- •Is presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and is eligible for a revascularization with a bifurcated graft
- •Is affiliated with a social welfare organization system
- •Is willing to participate in the clinical evaluation after signature of the informed consent
- •Is able to attend all follow up visits and diagnostics and laboratory exams required by the present protocol
排除标准
- •Is treated as an emergency
- •Is included in another investigation
- •Is pregnant or lactating, or a woman of childbearing potential unwillint to use an effective form of contraception for the duration of the trial
- •Has a known allergy to the material device used
- •Has previous aorto-iliac bypass or replacement
结局指标
主要结局
Graft patency at three years
时间窗: three years
次要结局
未报告次要终点
研究者
研究点 (1)
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