Tests a TIPS stent graft for liver scarring and portal hypertension complications
Tests a stent placed in the liver for cirrhosis with bleeding or fluid buildup.
Plain-language title generated from the registry record
Registry title: Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension
Key facts
- Where
- Changsha, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with portal hypertension caused by liver cirrhosis, who have had variceal bleeding, fluid around the lung, or ascites (fluid in the belly) that keeps coming back or does not respond to treatment.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Portal hypertension caused by liver cirrhosis, with a history of bleeding from varices in the digestive tract, fluid around the lung (hepatic hydrothorax), or refractory or recurrent ascites. Liver function must be adequate: MELD score of 13 or lower, or Child-Pugh score of 18 or lower. Platelet count of 20×10^9 /L or higher.
- Earlier treatment
- People who have had TIPS, surgical shunt or other surgical or interventional treatment for portal hypertension complications cannot join. Exception: retrograde transvenous obliteration (RTO) for variceal bleeding at least 8 weeks before signing consent is allowed. People who have had or need a splenectomy or a liver transplant cannot join.
Main reasons for not taking part
- Pregnant or breastfeeding, or planning pregnancy during the trial
- Liver or other cancer
- Severe or refractory hepatic encephalopathy (Grade 2 or above)
- Severe kidney problems or needing dialysis
- Expected survival of less than 1 year
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06669806, who can take part
Where in China
- Hunan Provincial People's HospitalChangsha, ChinaContact: shengdan NieTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- C. R. Bard
- Trial code
- NCT06669806
- Record updated
- 19 December 2025
- Original description
This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal hypertension with the TIPS Stent Graft will be conducted. The primary evaluation endpoint of this Study is the stent patency at 6 months after treatment completion .Read full original descriptionShow less
A Prospective, Multi-Center, Single-Arm Clinical Study to Evaluate the Effectiveness and Safety of LIVERTYTM TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension
This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal hypertension with the TIPS Stent Graft will be conducted. The primary evaluation endpoint of this Study is the stent patency at 6 months after treatment completion .
Inclusion: The subject who is 18 years old or above but 75 years old or below; The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites; The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18; The subject with platelet count≥ 20×10\^9 /L; Subjects or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the clinical trial.
Exclusion: The subject who has received surgical or interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial; The subject who needs to receive or have received splenectomy; The subject who has received or plan to receive liver transplantation; The subject who is participating in any other unfinished drug or medical device clinical trials; According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and affecting postoperative hemodynamics; The subject with extrahepatic or hepatic malignancies; The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome; The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract; The subject with polycystic liver disease; The subject with severe tricuspid regurgitation or congestive heart failure; The subject with myocardial infarction within the past 3 months; The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome; The subject with uncontrolled systemic infection or inflammation; The subject with severe renal insufficiency (Scr level:\>199.5 μmol/L) or needing to receive dialysis; The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment; The subject with the history of epilepsy or mental illness or with cognitive impairment; The subject with coagulation disorders (INR: \>2.5); The subject who is pregnant or lactating or plan to get pregnant during the clinical trial; The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators; The subject with cavernous transformation of the portal vein; The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria); The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients with cholestatic cirrhosis); The subject with a systolic pressure lower than 80 mmHg; The subject with the expected survival time of less than 1 year; The subject who is otherwise determined as ineligible for participation in this Study by investigators.