跳至主要内容
临床试验/NCT06318780
NCT06318780招募中不适用

Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
69
试验地点
2
主要终点
Endoleak classification using the CT angiography

研究概览

简要总结

Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Patients 18 years of age and older,
  • Patients who have received EVAR ,
  • Detection of endoleak and/or with an aneurysmal sac enlargement greater than or equal to 5 mm over 6 months.

排除标准

  • Minor patients,
  • absence of endoleak and growth of the aneurysmal sac (greater than or equal to 5 mm over 6 months),
  • patient under guardianship, curators, safeguard of justice,
  • patient deprived of liberty,
  • pregnant woman
  • Patient who does not benefit from a social security scheme

结局指标

主要结局

Endoleak classification using the CT angiography

时间窗: 5 years

Endoleak classification using the CT angiography

Variation of Endoleak classification between CEUS ultrasound and the CT angiography

时间窗: 5 years

Variation of Endoleak classification between CEUS ultrasound and the CT angiography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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