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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03083925
Other study ID # TIPS-CX
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 23, 2016
Est. completion date December 1, 2018

Study information

Verified date April 2019
Source University Hospital, Bonn
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 1, 2018
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients suitable for TIPS

Exclusion Criteria:

- Contraindication for TIPS

Study Design


Intervention

Device:
TIPS
Transjugular Intrahepatic Portosystemic Shunt

Locations

Country Name City State
Germany Laboratory for Liver Fibrosis and Portal Hypertension Bonn

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmissions Number of readmissions will be documented using a structured CRF 12 months
Secondary Hepatic encephalopathy (HE) Number of Episodes of overt HE (West Haven Criteria > Grad I) 12 months
Secondary Liver injury Increase in liver function tests 12 months
Secondary Response to TIPS grade of ascites after TIPS 12 months
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