NCT00604552终止不适用
AneuRx Post Market Surveillance Registry
Medtronic Cardiovascular8 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2003年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 349
- 试验地点
- 8
- 主要终点
- Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
研究概览
简要总结
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair.
The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients implanted with an AneuRx Stent Graft per Instructions for Use
- •Patients must provide written informed consent and agree to be accessible for follow-up at the study center.
排除标准
- 未提供
结局指标
主要结局
Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
时间窗: 5 year
Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion
次要结局
- Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events(5 years)
研究者
研究点 (8)
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