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

Official title

A Prospective, Multi-Center, Single-Arm Clinical Study to Evaluate the Effectiveness and Safety of LIVERTYTM TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension

Overview

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 .

Interventions

• Device TIPS Stent Graft
  a covered TIPS stent graft

Primary outcome measures

• Stent patency rate after treatment completion* [Time frame: 6 months]

Secondary outcome measures (12)

• Technical success rate [Time frame: immediately after the intervention]
• Hemodynamic success rate [Time frame: immediately after the intervention]
• Incidence of subjects free from receiving TIPS shunt reoperation after treatment completion* [Time frame: 1 month, 3 months, 6 months and 12 months]
• Stent patency rate after treatment completion* [Time frame: 1 month, 3 months and 12 months]
• Incidence of subjects free from severe hepatic encephalopathy after treatment completion* [Time frame: 1 month, 3 months, 6 months and 12 months]
• Incidence of subjects free from rebleeding after treatment completion* [Time frame: 1 month, 3 months, 6 months and 12 months]
• The proportion of clinical improvement on ascites after treatment completion* [Time frame: 3 months, 6 months, and 12 months]
• The proportion of clinical improvement on hepatic hydrothorax after treatment completion* [Time frame: 3 months, 6 months, and 12 months]
• Liver transplant-free survival rate post-index procedure [Time frame: 6 months and 12 months]
• Overall survival rate post-index procedure [Time frame: 1 month, 3 months, 6 months and 12 months]
• Incidence of medical device-related and/or operation-related severe complications [Time frame: 1 month]
• TEP related adverse events (AE) after treatment completion* [Time frame: 6 months and 12 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• The subject with severe tricuspid regurgitation or congestive heart failure;
• The subject with myocardial infarction within the past 3 months;
• The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome;
• The subject with uncontrolled systemic infection or inflammation;
• The subject with severe renal insufficiency (Scr level:\>199.5 μmol/L) or needing to receive dialysis;
• The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment;
• The subject with the history of epilepsy or mental illness or with cognitive impairment;
• The subject with the expected survival time of less than 1 year;
• The subject who is otherwise determined as ineligible for participation in this Study by investigators;
• The subject who is participating in any other unfinished drug or medical device clinical trials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Hunan Provincial People's Hospital — Changsha

Identifiers

NCT: NCT06669806 · BDPI-22CHTIPS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗