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临床试验/NCT04062734
NCT04062734已完成不适用

Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Primary Patency

研究概览

简要总结

In situ fenestration (ISF) could represent an alternative in the treatment of aorto-iliac disease when usual techniques are not available. The aim of this study was to present the results of ISF in aorto-iliac disease. Data will retrospectively be analyzed. Inclusion criteria will be: a surgical abdominal aortic aneurysm (AAA) with an unsuitable anatomy for a standard endograft, aorto-iliac occlusion with narrow distal aorta (<14mm). Technically, after placement of the endograft, a transjugular intrahepatic access set was used to perform ISF. The hole was secondary enlarged using a cutting or non-compliant balloon. Finally, a kissing stent was performed to the aorto- uni-iliac into a bifurcated endograft.

详细描述

ISF are mainly described at the level of the aortic arch. Different means are reported to perforate the graft: the mechanical (needles, transjugular intra hepatic access needles or guidewires) or physical (laser and radiofrequency catheters).

ISF could be an alternative in the endovascular treatment of aorto iliac disease including both occlusive and aneurysmal pathologies. In this cases, when a narrow distal aorta is present conventional technique as CERAB, bifurcated endograft are challenging. In situ fenestrations allows conversion of an aorto-uni-iliac endograft into a bifurcated endograft, thereby avoiding crossover femorofemoral bypass and its complications.

The aim of the study was to report the results of ISF technique at the level of the abdominal aorta.

Inclusion criteria will be: a surgical abdominal aortic aneurysm (AAA) with an unsuitable anatomy for a standard endograft, aorto-iliac occlusion with narrow distal aorta (<14mm).

All patients had a preoperative CT scan to assess the anatomy of the abdominal aorta.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Underwent in situ fenestration treatment between 2014 and 2019

排除标准

  • Patient aged < 40 years or > 90 years
  • Under guardianship

结局指标

主要结局

Primary Patency

时间窗: at 1 month

Evaluate primary patency at 1 month after in situ fenestration by doppler ultrasound.

次要结局

  • Technical success(at baseline)
  • Secondary Patency(at 6 and 12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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