跳至主要内容
临床试验/NCT05636527
NCT05636527招募中不适用

A Non-Randomized, Prospective or Retrospective, Open-Label, Multi-Center, Observational Clinical Study With Two Arms to Further Evaluate Safety and Performance of the NEXUS® Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System

Endospan Ltd.18 个研究点 分布在 10 个国家目标入组 70 人开始时间: 2022年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Endospan Ltd.
入组人数
70
试验地点
18
主要终点
Mortality

研究概览

简要总结

The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting.

The main question[s] it aims to answer are:

  • Early mortality
  • Safety outcomes throughout the study
  • Device failure throughout the study
  • Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mortality

时间窗: 30 days

The primary outcome in this study is early mortality, defined as lesion related death or any death that occurs within 30-days post-procedure or within initial hospitalization following the index procedure (whichever occurs last), unless there is evidence of accidental or self-inflicted death

次要结局

  • Device failure(Procedure, 30 days, 12 months)
  • Major Adverse Event (MAE)(30 days and 12 months)
  • Mortality(12 months)

研究者

发起方
Endospan Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (18)

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