VIATIPSAssessment of GORE® VIATORR® TIPS Endoprosthesis in Portal Hypertension Treatment
This observational study aims to assess the primary patency of the GORE® VIATORR® TIPS Endoprosthesis in treating portal hypertension over a period of 2 years, focusing on the absence of shunt occlusion or reintervention due to shunt dysfunction.
Data Collection
Collected from today forward - ProspectiveAscites+4
+ Digestive System Diseases
+ Fibrosis
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: June 1, 2026
Actual date on which the first participant was enrolled.The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) is a device designed to treat portal hypertension, a condition that can lead to complications like bleeding from enlarged veins (variceal bleeding) and fluid build-up in the abdomen that doesn't respond to treatment (recurrent ascites). This study aims to gather 'real world' data on its use in everyday medical practice. The study plans to enroll approximately 152 patients who meet all criteria and are receiving the device as part of their standard treatment. The goal is to understand how the device performs in typical medical settings and how it can improve care for those with portal hypertension. Participants in this study will have their first visit on the day of discharge or within 7 days after the procedure. They will then have follow-up visits at 1 month, 3 months, 6 months, 12 months, and 24 months. During these visits, the doctor will perform a physical exam, review medications, and assess the patient's condition. Imaging may be ordered by the doctor for safety follow-up purposes. Participants will also complete Quality of Life questionnaires at each follow-up visit to provide information on their well-being and daily life. The primary outcome of the study is to evaluate the device's patency, or freedom from shunt occlusion on imaging or from reintervention due to shunt dysfunction, over a period of 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.152 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation. 2. The subject has cirrhotic portal hypertension. 3. The subject is ≥18 years of age. 4. The subject is capable of complying with protocol requirements, including follow up. 5. The subject or legal representative signed the informed consent form (ICF). Exclusion Criteria: 1. The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis. 2. The subject has received a liver transplantation. Patients on the transplant list are still eligible. 3. The subject has a life expectancy of less than 6 months. 4. 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. 5. The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of \> 25 or Child Pugh Score of \> 14. 6. The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor. 7. The subject is pregnant at the time of informed consent signature. 8. The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives