Viatorr CX Case-control Study for Complications of Portal Hypertension

NCT ID: NCT03083925

Last Updated: 2019-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-23

Study Completion Date

2018-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhoses Portal Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bare metal stent (BMS) TIPS

retrospective patients receiving BMS-TIPS for treatment of complications of portal hypertension.

TIPS

Intervention Type DEVICE

Transjugular Intrahepatic Portosystemic Shunt

Regular Viatorr (RV) TIPS

retrospective patients receiving RV-TIPS for treatment of complications of portal hypertension.

TIPS

Intervention Type DEVICE

Transjugular Intrahepatic Portosystemic Shunt

Viatorr Control Expansion (VCX)TIPS

prospective patients receiving VCX-TIPS for treatment of complications of portal hypertension.

TIPS

Intervention Type DEVICE

Transjugular Intrahepatic Portosystemic Shunt

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TIPS

Transjugular Intrahepatic Portosystemic Shunt

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients suitable for TIPS

Exclusion Criteria

* Contraindication for TIPS
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jonel Trebicka

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonel Trebicka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Laboratory for Liver Fibrosis and Portal Hypertension

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Laboratory for Liver Fibrosis and Portal Hypertension

Bonn, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TIPS-CX

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
NCT05409976 ACTIVE_NOT_RECRUITING NA