Actively Recruiting
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
Led by C. R. Bard · Updated on 2025-12-19
166
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the LIVERTYTM TIPS Stent Graft device to treat patients with cirrhosis and complications of portal hypertension, including variceal bleeding, hepatic hydrothorax, and refractory ascites. This prospective, multi-center, single-arm study follows patients for 12 months to assess the device's performance, focusing primarily on how well the stent remains open six months after treatment. The study aims to provide important information about the effectiveness and safety of this treatment option for liver-related complications. During the study, the TIPS Stent Graft device is placed by creating and dilating a channel through the liver tissue to connect the portal vein and hepatic vein. The device covers the intrahepatic shunt and hepatic vein, and if needed, a second stent graft may be placed overlapping the first. The intervention is a one-time procedure with follow-up assessments at multiple time points over a year to monitor the device and patient condition. Participants will be monitored through regular evaluations over 12 months, including checks immediately after the procedure and at 1, 3, 6, and 12 months post-treatment. Researchers will assess the stent's openness, technical and hemodynamic success, and track complications such as reoperation, hepatic encephalopathy, rebleeding, and adverse events related to the device or procedure. Survival rates and clinical improvements in ascites and hepatic hydrothorax will also be measured to understand the treatment's overall impact and safety.
CONDITIONS
Brief Title
Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with portal hypertension caused by liver cirrhosis with history of gastrointestinal variceal bleeding, hepatic hydrothorax, or refractory/recurrent ascites
- Adequate liver function with MELD score of 13 or less or Child-Pugh score of 18 or less
- Platelet count of at least 20 x 10^9/L
- Ability to understand the trial, voluntarily consent, and complete follow-up
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy during the trial
- Main portal vein thrombosis with over 50% blockage affecting blood flow
- Previous surgical or interventional treatments for portal hypertension complications, except RTO done at least 8 weeks before consent
- Need for or history of splenectomy
- Past or planned liver transplantation
- Unable to establish shunt channel between hepatic and portal veins
- Presence of liver or extrahepatic cancers
- Budd-Chiari syndrome or hepatic sinusoidal obstruction syndrome
- Congenital or obstructive biliary tract diseases like Caroli disease
- Polycystic liver disease
- Cavernous transformation of the portal vein
- Severe or refractory hepatic encephalopathy (Grade 2 or above)
- Total bilirubin level higher than 51.3 µmol/L (except cholestatic cirrhosis)
- Coagulation disorders with INR greater than 2.5
- Systolic blood pressure below 80 mmHg
- Severe tricuspid regurgitation or congestive heart failure
- Recent myocardial infarction within 3 months
- Moderate to severe pulmonary arterial hypertension or severe hepatopulmonary syndrome
- Uncontrolled infection or inflammation
- Severe kidney failure or dialysis
- Allergy to contrast media or device materials
- History of epilepsy, mental illness, or cognitive impairment
- Expected survival less than 1 year
- Other investigator-determined ineligibility
- Participation in other ongoing drug or device trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants receive the TIPS Stent Graft device after creating and dilating the hepatic parenchymal tract to cover the intrahepatic shunt and hepatic vein. A second stent graft may be placed if needed.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for stent patency, clinical improvement, and adverse events following the procedure.
Visits at 1 month, 3 months, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
Actively Recruiting
Research Team
H
Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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