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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06320912
Other study ID # TIPS01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 5, 2024
Est. completion date November 1, 2026

Study information

Verified date January 2024
Source Shanghai Shenqi Medical Technology Co., Ltd
Contact chaojun gu
Phone +86-13636491192
Email chaojun.gu@sqmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 258
Est. completion date November 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Age 18-75 years (inclusive); male or non-pregnant female. - Diagnosed with cirrhosis and associated complications of portal hypertension (such as esophageal and gastric variceal bleeding, refractory ascites), and meeting the consensus recommendations for TIPS indications (see Appendix 5). - Participants must understand the purpose of the trial, voluntarily participate, sign an informed consent form, and be willing to complete the follow-up according to the project requirements. Exclusion Criteria: - Severe right heart failure, congestive heart failure (LVEF < 40%), or severe valvular heart dysfunction. - Uncontrolled systemic infection or inflammation. - Persistent moderate to severe pulmonary hypertension after treatment (tricuspid regurgitant peak velocity > 3.4 m/s or pulmonary artery systolic pressure > 50 mmHg). - Patients in hepatic encephalopathy coma or comatose phase (West Haven Criteria Stage III, IV). - Severe liver dysfunction, Child-Pugh score > 13, or MELD score > 18. - Serum creatinine (Scr) > 178 umol/L or on dialysis. - Stage IIIa or higher liver malignancy. - Budd-Chiari syndrome, hepatic veno-occlusive disease, or obstructive cholestasis. - Polycystic liver disease. - Unrectifiable coagulopathy (INR > 5 or PLT count < 20 x 10^9/L). - Main portal vein thrombosis occupying > 50% of the lumen area or cavernous transformation of the portal vein. - Previous TIPS procedure or planned liver transplantation within a year. - Allergy to contrast agents or nickel-titanium alloys. - Life expectancy less than 1 year. - Participation in other drug or medical device clinical trials within three months before screening. - Other conditions deemed by the researcher as unsuitable for participation in this clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
The intraparenchymal portal vein covered stent
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.
TIPS Covered Stent System GORE
The GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter.

Locations

Country Name City State
China Southern Medical University Nanfang Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Shenqi Medical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
Secondary 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. Immediate postoperative
Secondary Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively 1 Month, 6 Months, and 12 Months
Secondary Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively 1 Month, 6 Months, and 12 Months
Secondary Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively 1 Month, 6 Months, and 12 Months
Secondary All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively 1 Month, 6 Months, and 12 Months
Secondary Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively 1 Month, 6 Months, and 12 Months
Secondary 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
Secondary 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
Secondary Incidence of Adverse Events/Serious Adverse Events 12 Months
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