跳至主要内容
临床试验/NCT04299984
NCT04299984招募中不适用

Italian Multicenter Prospective Database for Open Conversions and SemiConversions After Endovascular Aneurysm Repair

Azienda Ospedaliero-Universitaria di Parma1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年1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
500
试验地点
1
主要终点
Early Mortality

研究概览

简要总结

Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC).

LOC is defined as a total or partial endograft explantation >30 days after the initial EVAR.

SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation.

The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.

研究设计

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

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

  • open or laparoscopic surgery for EVAR complications, with or without endograft explantation

排除标准

  • endovascular reinterventions
  • extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft surgery

结局指标

主要结局

Early Mortality

时间窗: 30 days

30-day mortality after surgery

In-hospital Mortality

时间窗: 90 days

Mortality during in-hospital stay

Long-term survival

时间窗: 4 years

Long-term survival rate

次要结局

  • Related complications(4 years)
  • Early Morbidity(30 days)

研究者

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

Paolo Perini

MD, PhD

Azienda Ospedaliero-Universitaria di Parma

研究点 (1)

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