NCT00922454Unknown不适用
Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study
Center for Vascular Awareness, Albany, New York1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Acute technical success, successful exclusion of the aneurysm
研究概览
简要总结
The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center and St. Peter's Hospital in Albany, NY.
The investigators are comparing the two devices as part of the evolution of endovascular repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23, 2003, the Talent Abdominal Stent Graft System on April 15, 2008.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 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
- •subject with abdominal aortic aneurysm, with or without iliac involvement
- •iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
排除标准
- •less than 18 years of age
- •pregnant or lactating
- •have contraindications for use of contrast medium or anticoagulation drugs
- •are patients who have a condition that threatens to infect the graft
- •are patients with sensitivities or allergies to the device materials
研究组 & 干预措施
Talent Stent-Graft
Experimental
干预措施: Endovascular Repair of the abdominal aorta (Procedure)
Talent Stent-Graft
Experimental
干预措施: Talent Stent-Graft (Device)
Cook Zenith Stent-Graft
Experimental
干预措施: Endovascular Repair of the abdominal aorta (Procedure)
Cook Zenith Stent-Graft
Experimental
干预措施: Cook Zenith Stent-Graft (Device)
结局指标
主要结局
Acute technical success, successful exclusion of the aneurysm
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (1)
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