A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
⁃ 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.
Locations
Other Locations
China
Fujian Provincial Hospital
RECRUITING
Fuzhou
The first affiliated hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Shanghai Public Health Clinical Center
RECRUITING
Shanghai
First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Contact Information
Primary
Echo Hu
echo_hu@enlight-medical.com
08615221991087
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 177
Treatments
Experimental: PTFE covered stent
Use the experimental device, PTFE covered stent to treat protal hypertension.
Related Therapeutic Areas
Sponsors
Leads: Enlight Medical Technologies (Shanghai) Co., Ltd