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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
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.
The GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter.
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Postoperative Stent Patency Rate
In the absence of a secondary intervention, portal venography indicates a luminal narrowing of ≤50% and a portal pressure gradient (PPG) of ≤12mmHg or a reduction of ≥50% from the baseline value prior to the surgery.
Time frame: 12 months
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 ≤30% diameter narrowing.
Time frame: Immediate postoperative
Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 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)
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Time frame: 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)
Time frame: 1 Month, 6 Months, and 12 Months
Incidence of Adverse Events/Serious Adverse Events
Time frame: 12 Months