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Completed

NCT Number: NCT03083925

Viatorr CX Case-control Study for Complications of Portal Hypertension

To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12 months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4 months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE, readmission, liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.

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Key information

Conditions

Liver Cirrhoses Digestive System Diseases Hypertension, Portal Liver Diseases Portal Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratory for Liver Fibrosis and Portal Hypertension

Bonn, 53127, Germany

About this study

Case-control study using the patients in the University Clinic Bonn receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents.

Of these patients, 20 patients will receive Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year.

The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS.

A total of 125 patients with the primary composite-endpoint HE/readmission will be investigated Secondary endpoints are liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suitable for TIPS

Exclusion criteria

  • Contraindication for TIPS

Treatment and study plan

TIPS

Device

Transjugular Intrahepatic Portosystemic Shunt

Primary outcomes

  1. Readmissions

    Time frame: 12 months

    Number of readmissions will be documented using a structured CRF

Secondary outcomes

  1. Hepatic encephalopathy (HE)

    Time frame: 12 months

    Number of Episodes of overt HE (West Haven Criteria > Grad I)

  2. Liver injury

    Time frame: 12 months

    Increase in liver function tests

  3. Response to TIPS

    Time frame: 12 months

    grade of ascites after TIPS

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension

Acronym: VIATORR-CX

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2017
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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