NCT01328197已完成1 期
A Phase I Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Bolton Medical12 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- major morbidity and mortality
研究概览
简要总结
The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.
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
- •Subjects with diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
- •Subjects with an infrarenal AAA that is >/= 4.5 cm in diameter for males, or >/= 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months
- •Subjects who consent to participate
- •Subjects who agree to comply with the follow-up schedule
排除标准
- •Subjects with dissections, ruptured aneurysms, or symptomatic aneurysms
- •Subjects with prior AAA repair
- •Subjects with medical conditions that would complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
- •Subjects who are pregnant or lactating
- •Subjects participating in other investigational studies
- •Subjects with less than 2 years life expectancy
研究组 & 干预措施
Treovance
Experimental
干预措施: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System (Device)
结局指标
主要结局
major morbidity and mortality
时间窗: 1, 6, 12 months
次要结局
- Device performance(implant, 1, 6, and 12 months)
研究者
研究点 (12)
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