Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension

NCT06669806 | Recruiting

• 1 other identifier: BDPI-22CHTIPS
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Portal Hypertension Related to Cirrhosis; Ascites Hepatic; Variceal Bleeding

Keywords

Transjugular intrahepatic portosystemic shunt; TIPS stent; patency

Outcome Measures

Primary Outcomes (1)

• Stent patency rate after treatment completion*

  6 months

Secondary Outcomes (15)

• 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*

  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

Study Arms (1)

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.

Device: TIPS Stent Graft

Interventions

TIPS Stent Graft DEVICE

a covered TIPS stent graft

TIPS Stent Graft device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject who is 18 years old or above but 75 years old or below;
• The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites;
• The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;
• The subject with platelet count≥ 20×10\^9 /L;
• Subjects or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the clinical trial.

You may not qualify if:

• The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;
• According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and affecting postoperative hemodynamics;
• The subject who has received surgical or interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial;
• The subject who needs to receive or have received splenectomy;
• The subject who has received or plan to receive liver transplantation;
• The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators;
• The subject with extrahepatic or hepatic malignancies;
• The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome;
• The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract;
• The subject with polycystic liver disease;
• The subject with cavernous transformation of the portal vein;
• The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria);
• The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients with cholestatic cirrhosis);
• The subject with coagulation disorders (INR: \>2.5);
• The subject with a systolic pressure lower than 80 mmHg;

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Hunan Provincial People's Hospital

Changsha, Hunan, 410005, China

RECRUITING

Central Study Contacts

Huang

CONTACT

8617801014015; haojia.huang@bd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: November 1, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)