Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications

Официальное название

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Study Evaluating the Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents for the Treatment of Portal Hypertension and Its Complications

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Postoperative Stent Patency Rate [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Immediate Postoperative Technical Success Rate [Срок оценки: Immediate postoperative]
• Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively [Срок оценки: 1 Month, 6 Months, and 12 Months]
• Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively [Срок оценки: 1 Month, 6 Months, and 12 Months]
• Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively [Срок оценки: 1 Month, 6 Months, and 12 Months]
• All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively [Срок оценки: 1 Month, 6 Months, and 12 Months]
• Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively [Срок оценки: 1 Month, 6 Months, and 12 Months]
• 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) [Срок оценки: 1 Month, 6 Months, and 12 Months]
• 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) [Срок оценки: 1 Month, 6 Months, and 12 Months]
• Incidence of Adverse Events/Serious Adverse Events [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Southern Medical University Nanfang Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06320912 · TIPS01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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