Portal Hypertension
Conditions
Interventions
Test group:The covered stent will be used to treat Portal hypertension complications in the TIPS.
Sponsors
Hunan Provincial People 's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 80 years old 2) Diagnosed as the complications of portal hypertension 3) Willing to sign the informed consent form
Exclusion criteria
Exclusion criteria: 1) Patients Allergy to nickel titanium alloys 2) Pre-existing TIPS or surgical shunt 3) Isolated gastric variceal bleeding 4) Post-splenectomy 5) INR>1.8 or platelet50% of the portal veins/diffuse intravascular thrombosis in the superior mesenteric vein and splenic vein simultaneously 12) Intrahepatic tract connecting portal and hepatic veins cannot be created. 13) Mental disorders/History of Mental disorders/Inability to cooperate autonomously 14) Lactating, pregnant or planning pregnant women 15) Patients participating in other interventional clinical investigations 16) Not suitable for inclusion in the clinical investigation in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent Patency Rate at 12 Months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical Success Rate;Incidence of MAE within 3 Months;Postoperative Secondary Intervention Rate at 12 Months;Postoperative Incidence of Hepatic Encephalopathy at 12 Months;Incidence of AE;Incidence of SAE;Incidence of Device Defects;Product Performance Evaluation; | — |
Countries
China
Contacts
Public ContactXiang Hua
Hunan Provincial People 's Hospital
Outcome results
None listed