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Portal Hypertension Related to CirrhosisNCT06669806

Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension

A study testing TIPS Stent Graft in people with Portal Hypertension Related to Cirrhosis and Ascites Hepatic, run by C. R. Bard at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal hypertension with the TIPS Stent Graft will be conducted. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TIPS Stent Graft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
1 siteChina
Study dates
21 Nov 2024to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject who is 18 years old or above but 75 years old or below;
  • The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites;
  • The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;
  • The subject with platelet count≥ 20×10^9 /L;
  • Subjects or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the clinical trial.

Who cannot join

  • The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;
  • According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and affecting postoperative hemodynamics;
  • The subject who has received surgical or interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial;
  • The subject who needs to receive or have received splenectomy;
  • The subject who has received or plan to receive liver transplantation;
  • The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators;
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  • The subject with extrahepatic or hepatic malignancies;
  • The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome;
  • The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract;
  • The subject with polycystic liver disease;
  • The subject with cavernous transformation of the portal vein;
  • The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria);
  • The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients with cholestatic cirrhosis);
  • The subject with coagulation disorders (INR: \>2.5);
  • The subject with a systolic pressure lower than 80 mmHg;
  • The subject with severe tricuspid regurgitation or congestive heart failure;
  • The subject with myocardial infarction within the past 3 months;
  • The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome;
  • The subject with uncontrolled systemic infection or inflammation;
  • The subject with severe renal insufficiency (Scr level:\>199.5 μmol/L) or needing to receive dialysis;
  • The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment;
  • The subject with the history of epilepsy or mental illness or with cognitive impairment;
  • The subject with the expected survival time of less than 1 year;
  • The subject who is otherwise determined as ineligible for participation in this Study by investigators;
  • The subject who is participating in any other unfinished drug or medical device clinical trials.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huang contact

8617801014015

haojia.huang@bd.com

China1 site, 1 recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

    shengdan Nie, +86-0731-83929310, kybgcp@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multi-Center, Single-Arm Clinical Study to Evaluate the Effectiveness and Safety of LIVERTYTM TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension

This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal hypertension with the TIPS Stent Graft will be conducted. The primary evaluation endpoint of this Study is the stent patency at 6 months after treatment completion .

Being tested
TIPS Stent Graft
Keywords
Transjugular intrahepatic portosystemic shunt, TIPS stent, patency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIPS Stent GraftDevice

    a covered TIPS stent graft

Study groups in NCT06669806
Study groupRoleWhat they receive
TIPS Stent Graft deviceExperimentalafter creating and dilating the hepatic parenchymal tract, the device is planted to cover the intrahepatic shunt and hepatic vein. A second stent graft may be placed in overlapped fashion.
Receives: Device: TIPS Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stent patency rate after treatment completion*

    Measured: 6 months

Secondary outcomes (15)

  1. Technical success rate

    Measured: immediately after the intervention

  2. Hemodynamic success rate

    Measured: immediately after the intervention

  3. Incidence of subjects free from receiving TIPS shunt reoperation after treatment completion*

    Measured: 1 month, 3 months, 6 months and 12 months

  4. Stent patency rate after treatment completion*

    Measured: 1 month, 3 months and 12 months

  5. Incidence of subjects free from severe hepatic encephalopathy after treatment completion*

    Measured: 1 month, 3 months, 6 months and 12 months

  6. Incidence of subjects free from rebleeding after treatment completion*

    Measured: 1 month, 3 months, 6 months and 12 months

  7. The proportion of clinical improvement on ascites after treatment completion*

    Measured: 3 months, 6 months, and 12 months

  8. The proportion of clinical improvement on hepatic hydrothorax after treatment completion*

    Measured: 3 months, 6 months, and 12 months

  9. Liver transplant-free survival rate post-index procedure

    Measured: 6 months and 12 months

  10. Overall survival rate post-index procedure

    Measured: 1 month, 3 months, 6 months and 12 months

  11. Incidence of medical device-related and/or operation-related severe complications

    Measured: 1 month

  12. TEP related adverse events (AE) after treatment completion*

    Measured: 6 months and 12 months

  13. Adverse events (AE) after index procedure

    Measured: 6 months and 12 months

  14. Serious adverse events (SAE) after index procedure

    Measured: 6 months and 12 months

  15. Device deficiencies

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2024
  2. Study start21 Nov 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06669806
Sponsor's protocol ID
BDPI-22CHTIPS
Status last verified
Dec 2025
First submitted
18 Oct 2024
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TIPS Stent Graft in people with Portal Hypertension Related to Cirrhosis and Ascites Hepatic, run by C. R. Bard at 1 site 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 5 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huang (8617801014015, haojia.huang@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stent patency rate after treatment completion* (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06669806.

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 19 Dec 2025.

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