Active — Not RecruitingNot Applicable

VIATORR Device Registry

Austria, France, Germany196 participantsStarted 2023-02-21

Plain-language summary

The primary objective is to confirm the clinical performance and safety of the GORE® VIATORR® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis with Controlled Expansion throughout the device functional lifetime of 3 years in real world setting. The secondary objective is to collect information on quality of life after treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion. Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for TIPS creation
✓. Patient is ≥18 years of age
✓. Capable of complying with protocol requirements, including follow-up
✓. Signed informed consent by patient

Exclusion criteria

✕. Unable or not willing to sign informed consent
✕. Patient is enrolled in an investigational study
✕. Patient has been previously enrolled in this registry
✕. Pregnant or breastfeeding female at time of informed consent signature
✕. Any other condition which in the judgement of the investigator would preclude adequate registry participation

What they're measuring

Shunt primary patency through 3 years

Timeframe: Through 3 years

Trial details

NCT IDNCT05661331

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-03-31

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