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临床试验/NCT06358248
NCT06358248招募中不适用

Standardized Physician-modified Fenestrated Endograft Registry

University Hospital Padova1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月1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
50
试验地点
1
主要终点
Technical success

研究概览

简要总结

Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia (Medtronic, Minneapolis, MN-USA).

详细描述

INTRODUCTION

Abdominal aortic aneurysms (AAA) without an adequate proximal neck length for safe sealing and fixation with a standard EVAR may benefit from complex endovascular repair. The most common are short neck AAA, juxta/para-renal AAA, and type IV thoracoabdominal aneurysm (TAAA), where incorporation of renal and visceral vessels is required to obtain an adequate proximal sealing. Several endovascular options are available, with the most effective being represented by incorporation of target vessels by custom-made or off-the-shelf fenestrated/branched endografts.

Custom-made devices have shown excellent early and long-term outcomes, but due to manufacturing time (up to three months), they can be used only for elective cases. In urgent cases, readily available off-the-shelf devices can be used, but their anatomical feasibility is not exhaustive, and may require long segment of aortic coverage above the celiac trunk. Parallel aortic grafts with chimneys or periscopes have been proposed as a timely alternative; however, gutter endoleaks and lack of proximal sealing are serious concerns for these techniques, especially for those cases where more than two target vessels need to be incorporated.

In patients presenting with large aneurysm, symptomatic, or requiring urgent repair, the use of physician-modified endograft (PMEG) represents a valid option. It allows for a rapid customization of a standard abdominal or thoracic device with the creation of fenestrations, scallops or branches, based on patient aneurysm anatomical extent and target vessel position.

However, these techniques demand high level of skills and experience; a recent review showed also that in the literature there is an extreme variability on indication to treatment, type of aneurysm and extension, type of graft, and method of modification, thus limiting the possibility to adequately analyze outcomes or drive comparison between different techniques.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Technical success

时间窗: Intra-operative

Number of participants who underwent a successful deployment of the endograft and stenting of the 4 visceral vessels

Freedom from target vessel instability

时间窗: 5 years

Number of participants who experience any occlusion, endoleak, aneurysm rupture, stent restenosis needing a re-intervention

Freedom from endograft instability

时间窗: 5 years

Number of participants who show absence of endoleak, aneurysm rupture, endograft migration

次要结局

  • Early (30-days) Major Adverse Event (MAE)(5 years)
  • Aneurysm sac dynamics(5 years)

研究者

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

Michele Piazza

Principal Investigator

University Hospital Padova

研究点 (1)

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