Viatorr CX Case-control Study for Complications of Portal Hypertension
VIATORR-CX
Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2016
CompletedFirst Submitted
Initial submission to the registry
March 3, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 24, 2019
April 1, 2019
2.5 years
March 3, 2017
April 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Readmissions
Number of readmissions will be documented using a structured CRF
12 months
Secondary Outcomes (3)
Hepatic encephalopathy (HE)
12 months
Liver injury
12 months
Response to TIPS
12 months
Study Arms (3)
Bare metal stent (BMS) TIPS
retrospective patients receiving BMS-TIPS for treatment of complications of portal hypertension.
Regular Viatorr (RV) TIPS
retrospective patients receiving RV-TIPS for treatment of complications of portal hypertension.
Viatorr Control Expansion (VCX)TIPS
prospective patients receiving VCX-TIPS for treatment of complications of portal hypertension.
Interventions
Transjugular Intrahepatic Portosystemic Shunt
Eligibility Criteria
Case-control study using the patients in our center receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents (all available data from our center). Thereby, we will choose 20 patients receiving 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. We will investigate a total 125 patients with the primary composite-endpoint HE/readmission, and secondary endpoints will be liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
You may qualify if:
- Patients suitable for TIPS
You may not qualify if:
- Contraindication for TIPS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory for Liver Fibrosis and Portal Hypertension
Bonn, 53127, Germany
Biospecimen
blood, stool, DNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonel Trebicka, MD, PhD
Laboratory for Liver Fibrosis and Portal Hypertension
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
March 3, 2017
First Posted
March 20, 2017
Study Start
May 23, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 24, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share