VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)

W.L. Gore & Associates

Status: Begins enrollment in 3 months

Conditions: Variceal Bleeding; Portal Hypertension Related to Cirrhosis; Ascites

Treatments: Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)

Study type: Observational

Funder types: Industry

Identifiers

NCT07390344

VTR 25-07

Details and patient eligibility

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.

Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.

Full description

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.

During follow-up visits, the doctor will perform a physical exam, review medications, and perform a condition status assessment. Imaging will not be collected as part of the Registry but may be ordered by the doctor for safety follow-up purposes as imaging is often collected as part of standard medical care.

Subjects will be asked to complete Quality of Life questionnaires at each follow-up visit to collect information on their well-being and daily life.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

152 participants in 1 patient group

Subjects treated for portal hypertension with the Registry device

Description:

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.

Treatment:

Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)