Viatorr CX Case-control Study for Complications of Portal Hypertension

Portal Hypertension Clinical Trial

— VIATORR-CX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083925
• Other study ID #: TIPS-CX
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Cirrhoses
• Liver Cirrhosis
• Portal Hypertension

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