RecruitingNot ApplicableNCT06669806

Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension

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


Sponsor

C. R. Bard

Enrollment

166 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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 .


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a stent graft device used in a procedure called TIPS (transjugular intrahepatic portosystemic shunt), which creates a channel inside the liver to relieve dangerous pressure buildup caused by cirrhosis (severe liver scarring). It is for people with complications like internal bleeding from enlarged veins or fluid buildup in the abdomen. **You may be eligible if...** - You are 18–75 years old - You have cirrhosis with portal hypertension and have experienced GI variceal bleeding, chest fluid, or persistent abdominal fluid buildup - Your liver function score (MELD ≤ 13 or Child-Pugh ≤ 18) suggests adequate liver reserve - Your platelet count is at least 20 × 10⁹/L **You may NOT be eligible if...** - You are pregnant or plan to become pregnant - You have had a prior TIPS or surgical shunt procedure - Your portal vein is more than 50% blocked by clot - You are on a liver transplant list or have had liver cancer - You have severe brain confusion (hepatic encephalopathy grade 2+) or very poor liver function - You have heart, bile duct, or blood clotting disorders that would make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETIPS Stent Graft

a covered TIPS stent graft


Locations(1)

Hunan Provincial People's Hospital

Changsha, Hunan, China

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NCT06669806


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