NCT03083925

Viatorr CX Case-control Study for Complications of Portal Hypertension

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Liver Cirrhoses
• Portal Hypertension

Interventions

Type	Name	Description
DEVICE	TIPS	Transjugular Intrahepatic Portosystemic Shunt

Timeline

• Start date: 2016-05-23
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-03-20
• Last updated: 2019-04-24

Locations

1 site across 1 country: Germany