A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 177
- 试验地点
- 4
- 主要终点
- Primary shunt patency rate
研究概览
简要总结
To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.
详细描述
This trial is a prospective multi-center single-arm confirmatory study. A total 177 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo TIPS using the PTFE covered stent for the treatment of portal hypertension. Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days and 360 days postoperatively. Secondary endpoint measures include surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverce events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the PTFE covered stent produced by Enlight Medical Technologies (Shanghai) Co., Ltd..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be eligible for this study:
- •Age 18-85 years;
- •Cirrhotic portal hypertension required for TIPS;
- •Willingness to comply with the protocol requirements and ata collection procedures, ability to understand the purpose of the trial, voluntary participation, and signing of informed consent by the subject or legal guardian.
排除标准
- •Subjects meeting any of the following criteria are not eligible for this study:
- •Concomitant chronic heart or lung disease;
- •Presence or suspicion of active systemic, hepatobiliary or ascitic fluid infection;
- •Severe hepatic failure (with bilirubin levels of >51.3μmol/L or Child-Pugh >13 or MELD >18);
- •Hepatic encephalopathy;
- •Coagulation disorders;
- •Portal vein thrombosis;
- •Allergies to device components;
- •Extrahepatic malignancy;
- •Pregnant or brestfeeding women or those planning pregnancy during the trial peroid;
- •Intending or currently participating in another interventional clinical trial;
- •Other conditions deemed inappropriate for participation in this study by the investigator.
结局指标
主要结局
Primary shunt patency rate
时间窗: 1 year
shunt dysfunction was defined as a TIPS stenosis \>=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt.
次要结局
- Technical success rate(immediately after procedure)
- Procedure success rate(immediately after procedure)
- Treatment success rate(during the perioperative period)