Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06669806

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

Led by C. R. Bard · Updated on 2025-12-19

166

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Diagnosed with portal hypertension caused by liver cirrhosis with history of gastrointestinal variceal bleeding, hepatic hydrothorax, or refractory/recurrent ascites
  • Adequate liver function with MELD Score ≤13 or Child-Pugh Score ≤18
  • Platelet count ≥ 20 × 10^9 /L
  • Ability to understand the trial, voluntarily agree to participate, sign informed consent, and complete follow-up
Not Eligible

You will not qualify if you...

  • Pregnant, lactating, or planning pregnancy during the trial
  • Main portal vein thrombosis with >50% lumen blockage affecting blood flow
  • Previous surgical or interventional treatments for portal hypertension complications (except -RTO at least 8 weeks prior)
  • Need for or prior splenectomy
  • Received or planned liver transplantation
  • Unable to establish shunt channel between hepatic and portal veins
  • Presence of extrahepatic or hepatic cancers
  • Budd-Chiari syndrome or hepatic sinusoidal obstruction syndrome
  • Congenital cystic dilatation of bile duct or biliary tract obstruction
  • Polycystic liver disease
  • Cavernous transformation of the portal vein
  • Severe or refractory hepatic encephalopathy (Grade 2 or above)
  • Total bilirubin level above 51.3 µmol/L (except cholestatic cirrhosis)
  • Coagulation disorders (INR > 2.5)
  • Systolic blood pressure below 80 mmHg
  • Severe tricuspid regurgitation or congestive heart failure
  • Myocardial infarction within past 3 months
  • Moderate to severe pulmonary arterial hypertension or severe hepatopulmonary syndrome
  • Uncontrolled systemic infection or inflammation
  • Severe renal insufficiency or need for dialysis
  • Allergy to contrast media or TIPS device materials
  • History of epilepsy, mental illness, or cognitive impairment
  • Expected survival less than 1 year
  • Otherwise deemed ineligible by investigators
  • Participation in other ongoing drug or device trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hunan Provincial People's Hospital

Changsha, Hunan, China, 410005

Actively Recruiting

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Research Team

H

Huang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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