Viatorr CX Case-control Study for Complications of Portal Hypertension (VIATORR-CX)

University Hospital Bonn (UKB)

Status: Completed

Conditions: Liver Cirrhoses; Portal Hypertension

Treatments: Device: TIPS

Study type: Observational

Funder types: Other

Identifiers

NCT03083925

TIPS-CX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suitable for TIPS

Exclusion criteria

• Contraindication for TIPS

Trial design

40 participants in 3 patient groups

Bare metal stent (BMS) TIPS

Description:

retrospective patients receiving BMS-TIPS for treatment of complications of portal hypertension.

Treatment:

Device: TIPS

Regular Viatorr (RV) TIPS

Description:

retrospective patients receiving RV-TIPS for treatment of complications of portal hypertension.

Treatment:

Device: TIPS

Viatorr Control Expansion (VCX)TIPS

Description:

prospective patients receiving VCX-TIPS for treatment of complications of portal hypertension.

Treatment:

Device: TIPS