Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Readmissions
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients suitable for TIPS
Exclusion Criteria
- •Contraindication for TIPS
Outcomes
Primary Outcomes
Readmissions
Time Frame: 12 months
Number of readmissions will be documented using a structured CRF
Secondary Outcomes
- Hepatic encephalopathy (HE)(12 months)
- Liver injury(12 months)
- Response to TIPS(12 months)
Investigators
Jonel Trebicka
Prof. Dr.
University Hospital, Bonn