Portal HypertensionNCT06117735
Clinical Study of PTFE Covered Stent for Treating Portal Hypertension
A study testing Transjugular Intrahepatic Portosystemic shunt in people with Portal Hypertension, run by Enlight Medical Technologies (Shanghai) Co., Ltd at 4 sites in China.
Trial summary
To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Transjugular Intrahepatic Portosystemic shunt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 4 sitesChina
- Study dates
- 30 Nov 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
Zhuting Fang, MD
- Recruiting
The first affiliated hospital of Guangzhou Medical University
Guangzhou, Guangzhou
Bin Xiong, MD
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Jinshan
Min Yuan, MD
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Duiping Feng, MD
Duiping Feng, MD
About this study
Official title: A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.
To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.
Read the detailed description
This trial is a prospective multi-center single-arm confirmatory study. A total 177 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo TIPS using the PTFE covered stent for the treatment of portal hypertension. Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days and 360 days postoperatively. Secondary endpoint measures include surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverce events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the PTFE covered stent produced by Enlight Medical Technologies (Shanghai) Co., Ltd..
- Conditions
- Portal Hypertension
- Being tested
- Transjugular Intrahepatic Portosystemic shunt
- Keywords
- transjugular intrahepatic portosystemic shunt
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| PTFE covered stent | Experimental | Use the experimental device, PTFE covered stent to treat protal hypertension. Receives: Device: Transjugular Intrahepatic Portosystemic shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Technical success rate
Successful implantation of a PTFE covered stent to create an intrahepatic portosystemic shunt and successful retrieval of the delivery system.
Measured: immediately after procedure
Procedure success rate
PPG (portosystemic pressure gradient) reduces more than 20% or PPG <=12mmHg
Measured: immediately after procedure
Treatment success rate
Treatment success is defined as the success of the procedure without major adverse event.
Measured: during the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Nov 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enlight Medical Technologies (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Xiong, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117735
- Sponsor's protocol ID
- YM-2023-002
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.
- ClinicalTrials.gov ID
- NCT06117735
- Acronym / sponsor ID
- YM-2023-002
- Conditions
- Portal Hypertension
- Keywords
- transjugular intrahepatic portosystemic shunt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Enlight Medical Technologies (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.
Detailed description
This trial is a prospective multi-center single-arm confirmatory study. A total 177 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo TIPS using the PTFE covered stent for the treatment of portal hypertension. Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days and 360 days postoperatively. Secondary endpoint measures include surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverce events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the PTFE covered stent produced by Enlight Medical Technologies (Shanghai) Co., Ltd..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTFE covered stent | Experimental | Device: Transjugular Intrahepatic Portosystemic shuntUse the experimental device, PTFE covered stent to treat protal hypertension. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transjugular Intrahepatic Portosystemic shuntThe 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. | Device | PTFE covered stent |
Primary outcome
Primary shunt patency rate
Time frame: 1 year
shunt dysfunction was defined as a TIPS stenosis >=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt.
3 secondary outcomes
Technical success rate
Time frame: immediately after procedure
Procedure success rate
Time frame: immediately after procedure
Treatment success rate
Time frame: during the perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Xiong principal investigator
The First Affiliated Hospital of Guangzhou Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transjugular Intrahepatic Portosystemic shunt in people with Portal Hypertension, run by Enlight Medical Technologies (Shanghai) Co., Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Echo Hu (08615221991087, echo_hu@enlight-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary shunt patency rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.