Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Readmissions
研究概览
简要总结
To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12 months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4 months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE, readmission, liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
详细描述
Case-control study using the patients in the University Clinic Bonn receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents.
Of these patients, 20 patients will receive Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year.
The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS.
A total of 125 patients with the primary composite-endpoint HE/readmission will be investigated Secondary endpoints are liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Patients suitable for TIPS
排除标准
- •Contraindication for TIPS
结局指标
主要结局
Readmissions
时间窗: 12 months
Number of readmissions will be documented using a structured CRF
次要结局
- Hepatic encephalopathy (HE)(12 months)
- Liver injury(12 months)
- Response to TIPS(12 months)
研究者
Jonel Trebicka
Prof. Dr.
University Hospital, Bonn