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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIPS Stent Graft device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIPS Stent Graft | Device | a covered TIPS stent graft |
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| Measure | Description | Time Frame |
|---|---|---|
| Stent patency rate after treatment completion* | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | immediately after the intervention | |
| Hemodynamic success rate | immediately after the intervention | |
| Incidence of subjects free from receiving TIPS shunt reoperation after treatment completion* |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang | Contact | 8617801014015 | haojia.huang@bd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | 410005 | China |
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| 1 month, 3 months, 6 months and 12 months |
| Stent patency rate after treatment completion* | 1 month, 3 months and 12 months |
| Incidence of subjects free from severe hepatic encephalopathy after treatment completion* | 1 month, 3 months, 6 months and 12 months |
| Incidence of subjects free from rebleeding after treatment completion* | 1 month, 3 months, 6 months and 12 months |
| The proportion of clinical improvement on ascites after treatment completion* | 3 months, 6 months, and 12 months |
| The proportion of clinical improvement on hepatic hydrothorax after treatment completion* | 3 months, 6 months, and 12 months |
| Liver transplant-free survival rate post-index procedure | 6 months and 12 months |
| Overall survival rate post-index procedure | 1 month, 3 months, 6 months and 12 months |
| Incidence of medical device-related and/or operation-related severe complications | 1 month |
| TEP related adverse events (AE) after treatment completion* | 6 months and 12 months |
| Adverse events (AE) after index procedure | 6 months and 12 months |
| Serious adverse events (SAE) after index procedure | 6 months and 12 months |
| Device deficiencies | through study completion, an average of 1 year |