NCT01710878已完成不适用
Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position
Maquet Cardiovascular8 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2008年2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
- 60
- 试验地点
- 8
- 主要终点
- Primary Graft Patency
研究概览
简要总结
Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.
详细描述
The purpose of this multi center, single arm study is to demonstrate the safety and performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the treatment of aneurismal and occlusive diseases of the abdominal aorta.
The primary endpoint is the assessment of primary and secondary graft patency. The secondary endpoints were the assessment of adverse events and the assessment of triclosan and silver contents in the serum over the time.
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
- •Patient aged 18-85 years
- •Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft
排除标准
- •Patient treated as an emergency
- •Patient included in another investigation
- •Patient pregnant or lactating or woman of childbearing potential
- •Patient with a known allergy to the material device used (collagen, triclosan, silver)
- •Patient with previous aorto-iliac bypass or replacement
结局指标
主要结局
Primary Graft Patency
时间窗: Up to 36 months
Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
次要结局
- Secondary endpoint - assessment of AEs(Up to 36 months)
研究者
研究点 (8)
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