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To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.
This trial is a prospective multi-center single-arm confirmatory study. A total 177 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo TIPS using the PTFE covered stent for the treatment of portal hypertension. Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days and 360 days postoperatively. Secondary endpoint measures include surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverce events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the PTFE covered stent produced by Enlight Medical Technologies (Shanghai) Co., Ltd..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTFE covered stent | Experimental | Use the experimental device, PTFE covered stent to treat protal hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transjugular Intrahepatic Portosystemic shunt | Device | The experimental device is a class III implanted shunt device, which will be used to create a shunt between intrahepatic and portosystemic to reduce portal hypertension. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary shunt patency rate | shunt dysfunction was defined as a TIPS stenosis >=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Successful implantation of a PTFE covered stent to create an intrahepatic portosystemic shunt and successful retrieval of the delivery system. | immediately after procedure |
| Procedure success rate |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary patency rate | Second patency was defined as graft stenosis or occlusion with patency restored and maintained by TIPS revision. | 1 year |
| all cause mortalidy | through study completion, an average of 1 year |
Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for this study:
Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Echo Hu | Contact | 08615221991087 | echo_hu@enlight-medical.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Xiong | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Recruiting | Fuzhou | Fujian | China |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
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PPG (portosystemic pressure gradient) reduces more than 20% or PPG <=12mmHg
| immediately after procedure |
| Treatment success rate | Treatment success is defined as the success of the procedure without major adverse event. | during the perioperative period |
| Device-related adverse events | through study completion, an average of 1 year |
| Serious adver events | through study completion, an average of 1 year |
| The first affiliated hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangzhou | China |
|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Jinshan | China |
|
| First Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | China |
|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |