NCT00608829已完成2 期
Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta
W.L.Gore & Associates2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2007年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair
- •Fusiform (≥50 mm), or
- •Saccular (no diameter criteria)
- •All proximal and/or all distal landing zone inner diameters between 37-42 mm
- •Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications
- •Proximal and distal landing zone length greater than 2.0 cm
- •Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
- •Life expectancy > 2 years
- •Subject is open surgical candidate defined as:
- •Able to tolerate thoracotomy
- •American Society of Anesthesiologists class I-IV (class V excluded)
- •New York Heart Association class I-III or not applicable (class IV excluded)
- •Male or infertile female
- •Age greater than 21 years
- •Able to comply with study protocol requirements, including follow-up
排除标准
- •Mycotic aneurysm
- •Hemodynamically unstable aneurysm rupture
- •Aortic dissection
- •Planned occlusion of left carotid or celiac arteries
- •Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
- •Myocardial infarction or stroke within 6 weeks of treatment
- •Pre-treatment creatinine > 2.0 mg/dL
- •Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- •Participation in another drug or device study within 1 year of treatment
- •History of drug abuse within 6 months of treatment
结局指标
主要结局
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
时间窗: one year
Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (\>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).
次要结局
未报告次要终点
研究者
研究点 (2)
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