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临床试验/NCT05072509
NCT05072509尚未招募不适用

Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
试验地点
1
主要终点
Lateral movement of the EVAR

研究概览

简要总结

The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Male or female > 18 years old
  • All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)

排除标准

  • Patient in emergency situation (ruptured abdominal aortic aneurysm)
  • Life expectancy supposed to be inferior to 1 year
  • Legal incapacity or limited capacity
  • Pregnant female
  • Patient unlikely to cooperate with the study
  • Patient without health insurance

结局指标

主要结局

Lateral movement of the EVAR

时间窗: through study completion, an average of 5 years

The lateral movement is defined by a movement of more than 5 mm.

Reintervention rate

时间窗: through study completion, an average of 5 years

For the the reintervention rate, all the intervention relative to a failure of the EVAR will be taken in account: as - Endoleak - Thrombosis - Conversion to open surgery - Infection - Secondary rupture

次要结局

  • EVAR's movements: other than lateral.(1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.)
  • Compliance(1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.)
  • Moving(1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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