Liver CirrhosesVIATORR-CXNCT03083925
Viatorr CX Case-control Study for Complications of Portal Hypertension
An observational study of Liver Cirrhoses and Portal Hypertension, run by University Hospital, Bonn at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhoses, Portal Hypertension
- What is being tested?
- TIPS
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 23 May 2016to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients suitable for TIPS
Who cannot join
- Contraindication for TIPS
Trial locations and contacts
1 site in 1 country.
Germany1 site
Laboratory for Liver Fibrosis and Portal Hypertension
Bonn, 53127
About this study
Official title: Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension
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.
Read the 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.
- Conditions
- Liver Cirrhoses, Portal Hypertension
- Being tested
- TIPS
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPSDevice
Transjugular Intrahepatic Portosystemic Shunt
| Study group | Role | What they receive |
|---|---|---|
| Bare metal stent (BMS) TIPS | retrospective patients receiving BMS-TIPS for treatment of complications of portal hypertension. Receives: Device: TIPS | |
| Regular Viatorr (RV) TIPS | retrospective patients receiving RV-TIPS for treatment of complications of portal hypertension. Receives: Device: TIPS | |
| Viatorr Control Expansion (VCX)TIPS | prospective patients receiving VCX-TIPS for treatment of complications of portal hypertension. Receives: Device: TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmissions
Number of readmissions will be documented using a structured CRF
Measured: 12 months
Secondary outcomes (3)
Hepatic encephalopathy (HE)
Number of Episodes of overt HE (West Haven Criteria > Grad I)
Measured: 12 months
Liver injury
Increase in liver function tests
Measured: 12 months
Response to TIPS
grade of ascites after TIPS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start23 May 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonel Trebicka, University Hospital, Bonn
- Investigators
- Jonel Trebicka, MD, PhD, Principal investigator, Laboratory for Liver Fibrosis and Portal Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083925
- Sponsor's protocol ID
- TIPS-CX
- Acronym
- VIATORR-CX
- Status last verified
- Apr 2019
- First submitted
- 3 Mar 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension
- ClinicalTrials.gov ID
- NCT03083925
- Acronym / sponsor ID
- VIATORR-CX / TIPS-CX
- Conditions
- Liver Cirrhoses, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 23 May 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bare metal stent (BMS) TIPS | – | Device: TIPSretrospective patients receiving BMS-TIPS for treatment of complications of portal hypertension. |
| Regular Viatorr (RV) TIPS | – | Device: TIPSretrospective patients receiving RV-TIPS for treatment of complications of portal hypertension. |
| Viatorr Control Expansion (VCX)TIPS | – | Device: TIPSprospective patients receiving VCX-TIPS for treatment of complications of portal hypertension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients suitable for TIPS
Key exclusion criteria (1 listed)
- Contraindication for TIPS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIPSTransjugular Intrahepatic Portosystemic Shunt | Device | Bare metal stent (BMS) TIPS, Regular Viatorr (RV) TIPS, Viatorr Control Expansion (VCX)TIPS |
Primary outcome
Readmissions
Time frame: 12 months
Number of readmissions will be documented using a structured CRF
3 secondary outcomes
Hepatic encephalopathy (HE)
Time frame: 12 months
Liver injury
Time frame: 12 months
Response to TIPS
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonel Trebicka, MD, PhD principal investigator
Laboratory for Liver Fibrosis and Portal Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhoses and Portal Hypertension, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmissions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.