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临床试验/NCT06856655
NCT06856655已完成不适用

A Retrospective Data Collection Evaluating Portal Vein Access Sets For Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures

Argon Medical Devices1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
Number of Participants With Technical Success

研究概览

简要总结

Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein access

排除标准

  • TIPS procedure was not initiated and/or no portion of the kit was introduced into the vasculature
  • Inaccessible medical records

结局指标

主要结局

Number of Participants With Technical Success

时间窗: TIPS Procedure

Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein and confirmed by portogram

Composite of Major Complications

时间窗: Through 30 days post-TIPS procedure

Major complications associated with the procedure or study device and defined as complications resulting in an unplanned increase in the level of care, prolonged hospitalization, permanent adverse sequelae, or death.

次要结局

  • Number of Participants with Procedural Success(TIPS Procedure)
  • Device-Related Complications(Through 30 days post-TIPS procedure)

研究者

发起方
Argon Medical Devices
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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