NCT07390344 · W.L.Gore & Associates
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
(VIATIPS)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
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). The Registry Device is a small tube (stent) that creates a pathway for blood flow. It consists of a metal frame (nitinol), covered with a thin, flexible material called expandable polytetrafluoroethylene (ePTFE).
Primary outcome measures
Proportion of Subjects achieving primary patency through 2 years
Time frame: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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 \> 14.
- 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.
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 18, 2026 · Source of record for eligibility and locations