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 .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
a covered TIPS stent graft
Hunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGStent patency rate after treatment completion*
Time frame: 6 months
Technical success rate
Time frame: immediately after the intervention
Hemodynamic success rate
Time frame: immediately after the intervention
Incidence of subjects free from receiving TIPS shunt reoperation after treatment completion*
Time frame: 1 month, 3 months, 6 months and 12 months
Stent patency rate after treatment completion*
Time frame: 1 month, 3 months and 12 months
Incidence of subjects free from severe hepatic encephalopathy after treatment completion*
Time frame: 1 month, 3 months, 6 months and 12 months
Incidence of subjects free from rebleeding after treatment completion*
Time frame: 1 month, 3 months, 6 months and 12 months
The proportion of clinical improvement on ascites after treatment completion*
Time frame: 3 months, 6 months, and 12 months
The proportion of clinical improvement on hepatic hydrothorax after treatment completion*
Time frame: 3 months, 6 months, and 12 months
Liver transplant-free survival rate post-index procedure
Time frame: 6 months and 12 months
Overall survival rate post-index procedure
Time frame: 1 month, 3 months, 6 months and 12 months
Incidence of medical device-related and/or operation-related severe complications
Time frame: 1 month
TEP related adverse events (AE) after treatment completion*
Time frame: 6 months and 12 months
Adverse events (AE) after index procedure
Time frame: 6 months and 12 months
Serious adverse events (SAE) after index procedure
Time frame: 6 months and 12 months
Device deficiencies
Time frame: through study completion, an average of 1 year
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