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

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ClinicalTrials.gov Identifier: NCT03083925
Recruitment Status : Completed
First Posted : March 20, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jonel Trebicka, University Hospital, Bonn

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.

Condition or disease Intervention/treatment
Liver Cirrhoses Portal Hypertension Device: TIPS

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension
Actual Study Start Date : May 23, 2016
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bare metal stent (BMS) TIPS
retrospective patients receiving BMS-TIPS for treatment of complications of portal hypertension.
Device: TIPS
Transjugular Intrahepatic Portosystemic Shunt

Regular Viatorr (RV) TIPS
retrospective patients receiving RV-TIPS for treatment of complications of portal hypertension.
Device: TIPS
Transjugular Intrahepatic Portosystemic Shunt

Viatorr Control Expansion (VCX)TIPS
prospective patients receiving VCX-TIPS for treatment of complications of portal hypertension.
Device: TIPS
Transjugular Intrahepatic Portosystemic Shunt




Primary Outcome Measures :
  1. Readmissions [ Time Frame: 12 months ]
    Number of readmissions will be documented using a structured CRF


Secondary Outcome Measures :
  1. Hepatic encephalopathy (HE) [ Time Frame: 12 months ]
    Number of Episodes of overt HE (West Haven Criteria > Grad I)

  2. Liver injury [ Time Frame: 12 months ]
    Increase in liver function tests

  3. Response to TIPS [ Time Frame: 12 months ]
    grade of ascites after TIPS


Biospecimen Retention:   Samples With DNA
blood, stool, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patients suitable for TIPS

Exclusion Criteria:

  • Contraindication for TIPS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083925


Locations
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Germany
Laboratory for Liver Fibrosis and Portal Hypertension
Bonn, Germany, 53127
Sponsors and Collaborators
University Hospital, Bonn
Investigators
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Principal Investigator: Jonel Trebicka, MD, PhD Laboratory for Liver Fibrosis and Portal Hypertension
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Responsible Party: Jonel Trebicka, Prof. Dr., University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT03083925    
Other Study ID Numbers: TIPS-CX
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hypertension
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases