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The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE.
This study is a prospective, multicenter, randomized controlled, non-inferiority clinical trial. It plans to enroll approximately 258 qualified participants from about 25 research centers nationwide. Participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group for the treatment of portal hypertension and its related complications. The primary endpoint of the study is the patency rate of the stents 12 months after the initial surgery. All participants will undergo clinical follow-ups at 1 month, 6 months, and 1 year post-stent implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group(A) | Experimental |
| |
| Group(B) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The intraparenchymal portal vein covered stent | Device | The intraparenchymal portal vein covered stent, produced by Shanghai Shenqi Medical Technology Co., Ltd., is used for a transjugular approach. It establishes an artificial shunt between the hepatic vein and the main branches of the portal vein within the liver. This helps in reducing portal venous pressure and alleviating or improving the symptoms of portal hypertension and its complications, such as variceal bleeding, gastropathy, refractory ascites, and/or hepatic hydrothorax. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Stent Patency Rate | In the absence of a secondary intervention, portal venography indicates a luminal narrowing of ā¤50% and a portal pressure gradient (PPG) of ā¤12mmHg or a reduction of ā„50% from the baseline value prior to the surgery. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Postoperative Technical Success Rate | Successful insertion and smooth withdrawal of the covered stent and delivery system, successful establishment of a shunt, accurate positioning of the stent, and postoperative angiography showing ā¤30% diameter narrowing. | Immediate postoperative |
| Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chaojun gu | Contact | +86-13636491192 | chaojun.gu@sqmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Medical University Nanfang Hospital | Guangzhou | Guangdong | China |
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| TIPS Covered Stent System GORE | Device | The GOREĀ® VIATORRĀ® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter. |
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| 1 Month, 6 Months, and 12 Months |
| Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively | 1 Month, 6 Months, and 12 Months |
| Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively | 1 Month, 6 Months, and 12 Months |
| All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively | 1 Month, 6 Months, and 12 Months |
| Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively | 1 Month, 6 Months, and 12 Months |
| Incidence of Portal Hypertension Rebleeding Confirmed by Endoscopy or Clinical Investigator at 1 Month, 6 Months, and 12 Months Postoperatively (For Original Bleeding Subjects Only) | 1 Month, 6 Months, and 12 Months |
| Incidence of Ultrasound-Confirmed Recurrence of Grade 2 or Higher Ascites due to Portal Hypertension at 1 Month, 6 Months, and 12 Months Postoperatively (For Subjects with Original Ascites Only) | 1 Month, 6 Months, and 12 Months |
| Incidence of Adverse Events/Serious Adverse Events | 12 Months |
| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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