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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hunan Provincial People's Hospital
RECRUITING
Changsha
Contact Information
Primary
Huang
haojia.huang@bd.com
8617801014015
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 166
Treatments
Experimental: TIPS Stent Graft device
after creating and dilating the hepatic parenchymal tract, the device is planted to cover the intrahepatic shunt and hepatic vein. A second stent graft may be placed in overlapped fashion.
Sponsors
Leads: C. R. Bard

This content was sourced from clinicaltrials.gov

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