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

Официальное название

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

Обзор

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 .

Вмешательства

• Устройство TIPS Stent Graft
  a covered TIPS stent graft

Первичные конечные точки

• Stent patency rate after treatment completion* [Срок оценки: 6 months]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Hunan Provincial People's Hospital — Чанша

Идентификаторы

NCT: NCT06669806 · BDPI-22CHTIPS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗