VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Proportion of Subjects achieving primary patency through 2 years
研究概览
简要总结
This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting.
Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.
详细描述
The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) was developed and approved for the treatment of portal hypertension and its complications such as bleeding from enlarged or swollen veins (variceal bleeding) and abnormal build-up of fluid in the abdomen that does not respond to therapy (ascites which recurs despite conventional treatment).
Subjects will receive the Registry Device as part of standard treatment for their condition. This means within this Registry, the information collected reflects the use of the Registry Device in typical, everyday medical practice by physicians, often referred to as "real world" data.
Patient total sample size will target a total approximately 152 patients treated with GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm).
Subjects who meet all criteria may be enrolled in the Registry.
The first visit after the procedure will be performed at the day of discharge or within 7 days after the procedure, whatever comes first. Subjects will have follow-up visits at 1 month, 3 months, 6 months, 12 months, and 24 months after their procedure so their health and the performance of the Registry Device can be monitored.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation.
- •The subject has cirrhotic portal hypertension.
- •The subject is ≥18 years of age.
- •The subject is capable of complying with protocol requirements, including follow up.
- •The subject or legal representative signed the informed consent form (ICF).
排除标准
- •The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.
- •The subject has received a liver transplantation. Patients on the transplant list are still eligible.
- •The subject has a life expectancy of less than 6 months.
- •The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and/or carcinoma in situ of the cervix remain eligible.
- •The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of > 25 or Child Pugh Score of >
- •The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.
- •The subject is pregnant at the time of informed consent signature.
- •The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.
研究组 & 干预措施
Subjects treated for portal hypertension with the Registry device
The study population consists of patients treated with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for portal hypertension and its complications including but not limited to variceal bleeding and/or ascites.
干预措施: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) (Device)
结局指标
主要结局
Proportion of Subjects achieving primary patency through 2 years
时间窗: Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months.
Freedom from shunt occlusion on imaging or from reintervention due to shunt dysfunction (occlusion or thrombosis on imaging or significant stenosis confirmed by venography).
次要结局
- Proportion of Subject procedures that are a technical success(Day 0)
- Reduction in portosystemic gradient (PSG)(Day 0)
- Proportion of Subjects with variceal rebleeding through 2 years(Variceal rebleeding will be analyzed at 1, 3, 6, 12 and 24 months.)
- Rate of large volume paracentesis (LVP) through 2 years per subject-month(LVP frequency will be analyzed at 1, 3, 6, 12, and 24 months.)
- Change in Quality of Life from baseline(Baseline and 1, 3, 6, 12, and 24 months)