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.
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.
Study Type
OBSERVATIONAL
Enrollment
40
Transjugular Intrahepatic Portosystemic Shunt
Laboratory for Liver Fibrosis and Portal Hypertension
Bonn, Germany
Readmissions
Number of readmissions will be documented using a structured CRF
Time frame: 12 months
Hepatic encephalopathy (HE)
Number of Episodes of overt HE (West Haven Criteria \> Grad I)
Time frame: 12 months
Liver injury
Increase in liver function tests
Time frame: 12 months
Response to TIPS
grade of ascites after TIPS
Time frame: 12 months
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