VIATORR TIPS 6–10 mm: Real-world use in cirrhosis with portal hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational registry that collects data from adults treated with the VIATORR TIPS device to manage portal hypertension complications. Participants receive standard care with the registry device and are followed for up to 24 months to monitor safety and device performance. Study visits occur at discharge or within 7 days, then at 1, 3, 6, 12, and 24 months, focusing on health status and any device-related issues. Imaging is not mandated by the registry but may be used for safety when ordered by clinicians. The study aims to provide real-world evidence to complement existing trial data and enhance understanding of device performance in routine practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Azienda Ospedaliero Universitaria Careggi
  Florence, Italy Recruiting

Study contacts

• Study coordinator: The VIATIPS clinical study team
• Email: viatips@wlgore.com
• Phone: 800-437-8181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using TIPS Stent Graft to treat complications of cirrhosis and portal hypertension

  This study is testing if a special stent can help people with liver cirrhosis and high blood pressure in the liver feel better and avoid serious complications over a year.

  Recruiting C. R. Bard · Changsha, Hunan · NCT06669806

• Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis

  This study tests how well endovascular procedures for portal hypertension–related GI bleeding work in adults with cirrhosis, and what factors predict outcomes.

  Recruiting University Medical Center Ho Chi Minh City (UMC) · Ho Chi Minh City · NCT07918378

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  Recruiting University of Oxford · Chittagong, Chattogram Division · NCT07602920

• Apixaban plus carvedilol to prevent portal-hypertension complications in cirrhosis

  This will test whether adding apixaban to carvedilol can help prevent variceal bleeding, portal vein thrombosis, and other portal-hypertension complications in adults with Child-Pugh B cirrhosis.

  Recruiting Phase 4 Asian Institute Of Medical Sciences · Hyderābād, Sindh · NCT07521332

• Factors that affect reopening of blocked portal veins in people with cirrhosis and gastroesophageal varices

  This project looks at past records and follow-up to see which factors are linked with reopening (recanalization) of blocked portal veins in people who have cirrhosis and endoscopy-confirmed gastroesophageal varices.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07473375

• Intraperitoneal SK-NK cell infusion for advanced ovarian cancer with massive ascites

  This will try giving highly activated donor NK cells directly into the abdomen once weekly for four weeks to see if it helps people with advanced ovarian cancer who have large-volume malignant ascites and no standard treatment options.

  Recruiting Phase 1/2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07435701

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.