NCT06117735

Brief Summary

To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Nov 2023Jun 2026

First Submitted

Initial submission to the registry

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

October 31, 2023

Last Update Submit

March 7, 2024

Conditions

Portal Hypertension

Keywords

transjugular intrahepatic portosystemic shunt

Outcome Measures

Primary Outcomes (1)

  • Primary shunt patency rate

    shunt dysfunction was defined as a TIPS stenosis \>=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt.

    1 year

Secondary Outcomes (3)

  • Technical success rate

    immediately after procedure

  • Procedure success rate

    immediately after procedure

  • Treatment success rate

    during the perioperative period

Other Outcomes (4)

  • Secondary patency rate

    1 year

  • all cause mortalidy

    through study completion, an average of 1 year

  • Device-related adverse events

    through study completion, an average of 1 year

  • +1 more other outcomes

Study Arms (1)

PTFE covered stent

EXPERIMENTAL

Use the experimental device, PTFE covered stent to treat protal hypertension.

Device: Transjugular Intrahepatic Portosystemic shunt

Interventions

Transjugular Intrahepatic Portosystemic shuntDEVICE

The experimental device is a class III implanted shunt device, which will be used to create a shunt between intrahepatic and portosystemic to reduce portal hypertension.

PTFE covered stent

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • Bin Xiong

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Echo Hu

CONTACT

08615221991087echo_hu@enlight-medical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

November 30, 2023

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

CN(4)