Study to Evaluate the Safety and Effectiveness of LIVERTY TIPS Stent Graft for Treating Cirrhosis and Portal Hypertension Complications

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 devices 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 stents 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 treatments overall impact and safety.

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