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临床试验/NCT01354119
NCT01354119终止4 期

Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
7
试验地点
2
主要终点
Aortic aneurysm and death

研究概览

简要总结

Background: Aortic stent-graft is useful to occlude intimal tear and prevent further dilatation of the false lumen in patients with aortic dissection. The long-term benefit of aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well demonstrated, especially in patients at high risk of aneurysmal change and death.

Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft insertion performed just after the acute phase into the descending thoracic aorta in patients with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Uncomplicated distal aortic dissection
  • Initial false lumen diameter >= 22 mm

排除标准

  • Old age (> 75 years old)
  • Other comorbidity or malignancy with life expectancy < 5 years
  • Complicated dissection requiring aortic surgery or intervention
  • Sudden death in acute phase
  • Marfan syndrome

结局指标

主要结局

Aortic aneurysm and death

时间窗: 4 years

次要结局

  • Events and complications(4 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong-Min Song

Associate professor

Asan Medical Center

研究点 (2)

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