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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "During follow-up visits, the doctor will perform a physical exam, review medications, and perform a condition status assessment."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows adults with high blood pressure in the liver’s portal vein caused by liver scarring. It checks the safety and performance of the GORE VIATORR device (6–10 mm) for 2 years when used to create a TIPS, a new path for blood to flow through the liver. It also collects information about the GORE TIPS Set when used.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can receive the study device to create a new TIPS.
  • You have high blood pressure in the liver’s portal vein caused by cirrhosis (liver scarring).
  • You are at least 18 years old.
  • You can follow study rules and attend follow-up visits.
  • You or your legal representative have signed the study consent form.

Who can't join

  • You have a blood clot in the portal vein, even if it does not fully block blood flow.
  • You have had a liver transplant. Being on a transplant waiting list does not exclude you.
  • You are expected to live less than 6 months.
  • You have cancer or had cancer in the past, unless treatment to cure it was completed at least 5 years before joining. Non-melanoma skin cancer and cancer limited to the surface cells of the cervix are allowed.
  • Your liver does not work well enough, with a MELD score above 25 or a Child-Pugh score above 14. These scores measure how sick your liver is.
  • You are in another study testing a treatment or device, unless this study’s sponsor agrees in writing ahead of time.
  • You are pregnant when you sign the consent form.
  • You have another condition that the study doctor believes would keep you from taking part properly.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 sites (3)

GA

MN

OH