Using a special stent to treat portal hypertension

A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.

This study is testing a new type of stent to see if it can safely help people with portal hypertension feel better after a special procedure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 177 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd (industry)
• Locations: 4 sites (Fuzhou, Fujian and 3 other locations)
• Trial ID: NCT06117735 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to validate the safety and efficacy of a PTFE covered stent in performing Transjugular Intrahepatic Portosystemic Shunt (TIPS) for patients with portal hypertension. A total of 177 subjects will be enrolled across multiple centers nationwide, and those who meet the eligibility criteria will undergo the procedure. Follow-up assessments will be conducted at various intervals postoperatively to evaluate surgical success, mortality rates, and adverse events. The study seeks to provide comprehensive data on the effectiveness of this new stent design in treating this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-85 with cirrhotic portal hypertension.

Not a fit: Patients with severe hepatic failure, active infections, or other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from portal hypertension.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific use of a PTFE covered stent is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for this study:

* Age 18-85 years;
* Cirrhotic portal hypertension required for TIPS;
* Willingness to comply with the protocol requirements and ata collection procedures, ability to understand the purpose of the trial, voluntary participation, and signing of informed consent by the subject or legal guardian.

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for this study:

* Concomitant chronic heart or lung disease;
* Presence or suspicion of active systemic, hepatobiliary or ascitic fluid infection;
* Severe hepatic failure (with bilirubin levels of \>51.3μmol/L or Child-Pugh \>13 or MELD \>18);
* Hepatic encephalopathy;
* Coagulation disorders;
* Portal vein thrombosis;
* Allergies to device components;
* Extrahepatic malignancy;
* Pregnant or brestfeeding women or those planning pregnancy during the trial peroid;
* Intending or currently participating in another interventional clinical trial;
* Other conditions deemed inappropriate for participation in this study by the investigator.

Where this trial is running

Fuzhou, Fujian and 3 other locations

• Fujian Provincial Hospital — Fuzhou, Fujian, China (RECRUITING)
• The first affiliated hospital of Guangzhou Medical University — Guangzhou, Guangzhou, China (RECRUITING)
• Shanghai Public Health Clinical Center — Shanghai, Jinshan, China (RECRUITING)
• First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (RECRUITING)

Study contacts

• Principal investigator: Bin Xiong — The First Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Echo Hu

Conditions: Portal Hypertension, transjugular intrahepatic portosystemic shunt