Actively Recruiting
A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension
Led by Enlight Medical Technologies (Shanghai) Co., Ltd · Updated on 2024-03-12
177
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a PTFE covered stent used in Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures for treating portal hypertension. This prospective, multi-center, single-arm study plans to enroll 177 subjects with cirrhotic portal hypertension who meet specific criteria and agree to participate voluntarily. Participants will receive the experimental PTFE covered stent device, designed to create a shunt between intrahepatic and portosystemic veins to reduce portal hypertension. Follow-up assessments will take place at discharge, and again at 30, 90, 180, and 360 days after the procedure. The study will measure technical, procedural, and treatment success rates alongside monitoring device-related safety and complications. During the study, participants will undergo regular evaluations including clinical assessments and data collection related to the stent's function and patient health. The primary outcome is the one-year shunt patency rate, with secondary measures including surgical success, mortality rates, and adverse event monitoring. The total participation period spans approximately one year, with close safety follow-up to assess the device's performance.
CONDITIONS
Brief Title
Clinical Study of PTFE Covered Stent for Treating Portal Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- Diagnosis of cirrhotic portal hypertension requiring TIPS procedure
- Willingness to follow study protocol and data collection
- Ability to understand study purpose
- Voluntary participation with signed informed consent by participant or legal guardian
You will not qualify if you...
- Chronic heart or lung disease
- Active or suspected systemic, hepatobiliary, or ascitic fluid infection
- Severe liver failure (bilirubin >51.3 µmol/L, Child-Pugh >13, or MELD >18)
- Hepatic encephalopathy
- Coagulation disorders
- Portal vein thrombosis
- Allergy to device components
- Presence of extrahepatic malignancy
- Pregnant, breastfeeding, or planning pregnancy during study
- Participation in another interventional clinical trial
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo the Transjugular Intrahepatic Portosystemic Shunt procedure using the PTFE covered stent to treat portal hypertension.
1 visit (in-person)
Duration - Up to 360 days after surgery
Participants are monitored at discharge and through multiple postoperative visits to assess safety and efficacy of the stent.
Visits at discharge, 30 days, 90 days, 180 days, and 360 days postoperatively
Trial Site Locations
Total: 4 locations
1
Fujian Provincial Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
The first affiliated hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
Actively Recruiting
3
Shanghai Public Health Clinical Center
Shanghai, Jinshan, China
Actively Recruiting
4
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
E
Echo Hu
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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