NCT00590759已完成不适用
A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms
W.L.Gore & Associates25 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2005年8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
- 150
- 试验地点
- 25
- 主要终点
- Aneurysm Related Death
研究概览
简要总结
The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms
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
- •Descending thoracic aortic aneurysm deemed to warrant surgical repair:
- •Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta
- •Saccular aneurysm
- •Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
- •Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
- •<60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment
- •Life expectancy > 2 years
- •Surgical Candidate
- •ASA Class I, II, III, or IV
- •NYHA Class I, II, III or no heart disease
- •Male or infertile female
- •Minimum 21 years of age
- •Able to comply with protocol requirements
- •Signed Informed Consent Form
排除标准
- •4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
- •Significant thrombus at the proximal or distal implantation zones
- •Mycotic aneurysm
- •Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)
- •Acute or chronic aortic dissection
- •Planned occlusion of the left carotid or celiac arteries
- •"Planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days
- •Myocardial infarction or cerebral vascular accident within 6 weeks
- •Severe respiratory insufficiency sufficient that precludes open thoracotomy
- •Renal insufficiency (Creatinine > 2.0 mg/dL) with or without dialysis
- •Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
- •Participation in another investigational device or drug study within 1 year
- •Documented history of drug abuse within 6 months
结局指标
主要结局
Aneurysm Related Death
时间窗: 5 years
Freedom from aneurysm related mortality for TAG 05-02 subjects
次要结局
- A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.(5 years)
研究者
研究点 (25)
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