AzTrials
AzTrials

Portal HypertensionARCHNCT05711316

The BD Liverty™ TIPS Stent Graft Study

A study testing BD Liverty™ TIPS Stent Graft in people with Portal Hypertension and TIPS, run by C. R. Bard at 26 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The objective of the study is to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension from cirrhosis. This includes recurrent or refractory ascites, hepatic hydrothorax, and/or variceal bleeding (esophageal and/or gastric). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Portal Hypertension, TIPS
What is being tested?
BD Liverty™ TIPS Stent Graft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
26 sitesin 3 countries
Study dates
8 Aug 2023to 11 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • The subject must voluntarily sign and date the approved Informed Consent Form (ICF) prior to the conduct of any study-specific procedures including any procedure required to determine subject eligibility (apart from those conducted as part of the subject's routine clinical management).
  • The subject must be ≥18 years of age with a life expectancy of ≥12 months to allow for adequate completion of study procedures and collection of data.
  • The subject must be willing and able to comply with protocol requirements, including all study visits and procedures.
  • The subject must have a diagnosis of portal hypertension from cirrhosis with at least one of the following indications for de novo TIPS creation including:
  • Recurrent, or Refractory Ascites (defined as ascites that cannot be mobilized or recurs after large volume paracentesis despite dietary sodium restriction and diuretic therapy)
Show all 12Show fewer
  • Hepatic Hydrothorax
  • Esophageal Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Esophageal Variceal Bleeding, or Recurrent Esophageal Variceal Bleeding
  • Gastric Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Gastric Variceal Bleeding, or Recurrent Gastric Variceal Bleeding
  • The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤18 or Child-Pugh Score of ≤12.
  • The subject must have a platelet count of ≥50,000/microliter (with correction, if needed), as determined by the most recent pre-treatment laboratory tests performed within 7 days prior to treatment (Index Procedure).
  • Note: If multiple lab tests are performed within 7 days prior to the date of Index Procedure, the most recent results must demonstrate eligibility.

Who cannot join

  • Subjects are excluded from the study if any of the following criteria apply:
  • The subject is pregnant. Subjects of child-bearing potential must have a negative pregnancy test (urine or serum).
  • The subject has undergone prior transcatheter procedures for the treatment of complications from portal hypertension (e.g., TIPS, surgical shunt creation, peritoneovenous shunt, retrograde transvenous obliteration (-RTO)). Note: Subjects with variceal bleeding that have undergone -RTO at least 8 weeks prior to the planned Index Procedure may be enrolled.
  • The subject has undergone prior stent or stent graft placement in the hepatic vein, portal vein and/or inferior vena cava (IVC).
  • The subject is hemodynamically unstable with uncontrolled bleeding.
  • The subject has hepatic and/or portal vein thrombosis (PVT). Note: Subjects with partial non-flow-limiting, non-malignant PVT may be enrolled.
Show all 23Show fewer
  • The subject has undergone prior liver transplant or is a current transplant candidate that is likely to undergo liver transplant within 6 months of enrollment.
  • The subject has extrahepatic or hepatic malignancy or a history of previous hepatic malignancy, unless treated curatively ≥5 years prior to enrollment.
  • The subject has overt (West Haven Criteria Grade ≥2), controlled or uncontrolled hepatic encephalopathy.
  • The subject has any of the following medical conditions contraindicated to placement of TIPS:
  • Congestive Heart Failure or Pulmonary Edema
  • Severe Tricuspid Regurgitation
  • Elevated Right or Left Heart Pressures
  • Polycystic Liver Disease
  • Moderate or Severe Pulmonary Hypertension or Severe Hepatopulmonary Syndrome
  • Uncontrolled Systemic Infection or Sepsis
  • Unrelieved Biliary Obstruction
  • Acute Kidney Injury, Renal Failure, or Dialysis
  • Uncontrolled Blood Coagulation/Bleeding Disorder
  • The subject has a known allergy, intolerance, or condition (e.g., allergy to contrast media/narcotics/sedatives, bleeding diathesis, or severe peripheral arterial disease) that cannot be adequately pre-treated and would preclude angiography or selective catheterization.
  • The subject has a known allergy or hypersensitivity to any of the device materials including nickel-titanium (nitinol) or tantalum.
  • The subject is taking a medication or has another medical condition, which, in the opinion of the Investigator, would preclude safe treatment with the BD Liverty™ TIPS Stent Graft, may cause the subject to be non-compliant with the protocol, or may confound the data interpretation.
  • The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

Trial locations and contacts

26 sites in 3 countries.

26 sites in 3 countries

United States17 sites

  • The General Hospital Corporation d/b/a Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center, Inc.

    Boston, Massachusetts, 02215

  • Charlotte Radiology

    Charlotte, North Carolina, 28203

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Trustees of Indiana University ("IU")/ Indiana University Health, Inc.

    Indianapolis, Indiana, 46202

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • Medical College of Wisconsin / Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • The Trustees of Columbia University in the City of New York

    New York, New York, 10032

  • Rutgers, The State University of New Jersey

    Newark, New Jersey, 07103

  • Stanford University

    Palo Alto, California, 94305

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19125

  • University of Utah

    Salt Lake City, Utah, 84112

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Washington University - Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63110

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

Germany6 sites

  • Charité-Universitätsmedizin Berlin

    Berlin, 13353

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • University Hospital Frankfurt

    Frankfurt, 60590

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Westfälische Wilhelms-Universität

    Münster, 48149

Other trials in Germany

France3 sites

  • Centre Hospitalier Regional Universitaire de Tours

    Chambray-lès-Tours, 37170

  • CHU Dijon Bourgogne

    Dijon, 21079

  • Hospices Civils de Lyon

    Lyon, 69002

Other trials in France

About this study

Official title: The BD Liverty™ TIPS Stent Graft Study - A Global, Prospective, Multi-Center, Single-Arm Clinical Study for the Treatment of Complications From Portal Hypertension

The objective of the study is to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension from cirrhosis. This includes recurrent or refractory ascites, hepatic hydrothorax, and/or variceal bleeding (esophageal and/or gastric).

Read the detailed description

This is a prospective, multi-center, single-arm study designed to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension. Safety and effectiveness measures for subjects receiving the BD Liverty™ TIPS Stent Graft will be compared to a Performance Goal (PG) derived from published literature.

Being tested
BD Liverty™ TIPS Stent Graft
Keywords
portal hypertension, ascites, hepatic hydrothorax, variceal bleeding, tips
Medical subject headings
Hypertension, Portal, Ascites

What participants receive

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

  • BD Liverty™ TIPS Stent GraftDevice

    Also called TIPS

    Treatment of portal hypertension complications with placement of the BD Liverty™ TIPS Stent Graft after creation of a Transjugular Intrahepatic Portosystemic Shunt.

Study groups in NCT05711316
Study groupRoleWhat they receive
SubjectsExperimentalSubjects that are treated with the BD Liverty™ TIPS Stent Graft
Receives: Device: BD Liverty™ TIPS Stent Graft

What is being measured

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

  1. Freedom from Major Complications through 30 days post-Index Procedure

    The primary safety endpoint is Freedom from Major Complications through 30 days post-Index Procedure.

    Major complications are defined as:

    The following Adverse Events (if determined to be related to the device and/or procedure and to meet the definition of a Serious Adverse Event (SAE)):

    • Accelerated Liver Failure
    • Biliary Peritonitis
    • Caval Occlusion
    • Death
    • Hemobilia
    • Hemoperitoneum
    • Hepatic Artery Injury
    • Hepatic Infarction
    • Radiation Skin Burn
    • Renal Failure
    • Severe Hepatic Encephalopathy
    • Vascular Perforation (resulting from stent graft malposition due to excessive extension of the stent graft into the inferior vena cava or the right atrium)

    The following Device Deficiencies, if having the potential to or if confirmed to have led to a Serious Adverse Event (SAE):

    • Stent Migration (within the portal or systemic venous circulations resulting from stent graft malposition)

    Measured: 30 days

  2. Freedom from Shunt Dysfunction through 6 months post-Treatment Completion

    The primary effectiveness endpoint is Freedom from Shunt Dysfunction through 6-months post-Treatment Completion. Shunt Dysfunction is defined as the proportion of subjects free from both a >50% reduction of the lumen of the stent (confirmed by direct shunt venography for subjects with suspected shunt dysfunction) and a PSG greater than the PSG achieved post-TIPS Index Procedure. Treatment Completion is defined as the latter to occur of (i) completion of the Index Procedure and (ii) if performed, the Tailored Expansion Procedure (TEP).

    Measured: 6 months

Secondary outcomes (11)

  1. Technical Success

    Technical Success, defined as the successful creation of a BD Liverty™ TIPS Stent Graft lined shunt between the hepatic vein and a branch of the portal vein, as assessed by the Investigator during the Index Procedure.

    Measured: Index Procedure

  2. Hemodynamic Success

    Hemodynamic Success, defined as the successful post-TIPS reduction of the portosystemic gradient (PSG) to an Investigator-determined target of ≤12 mmHg or by ≥50% from the baseline PSG, as assessed by the Investigator during the Index Procedure.

    Measured: Index Procedure

  3. Clinical Success for subjects with Recurrent or Refractory Ascites

    Clinical Success for subjects with recurrent or refractory ascites through 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from large volume paracentesis (LVP) of >5L occurring >6 weeks post-Treatment Completion.

    Measured: 3, 6, 12, 18, and 24 months post-Treatment Completion

  4. Clinical Success for subjects with Hepatic Hydrothorax

    Clinical Success for subjects with hepatic hydrothorax through 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from thoracentesis of >1L occurring >6 weeks post-Treatment Completion.

    Measured: 3, 6, 12, 18, and 24 months post-Treatment Completion

  5. Clinical Success for subjects with Esophagogastric Variceal Re-Bleeding

    Clinical Success for subjects with esophagogastric variceal bleeding through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from endoscopically-confirmed esophagogastric variceal re-bleeding.

    Measured: 3, 6, 12, 18, and 24 months post-Treatment Completion

  6. Freedom from Shunt Re-Intervention

    Freedom from Shunt Re-Intervention through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion.

    Measured: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion

  7. Freedom from Hepatic Encephalopathy of Grade ≥3 per West Haven Criteria

    Freedom from Hepatic Encephalopathy of Grade ≥3 per West Haven Criteria through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion.

    Measured: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion

  8. Liver Transplant-Free Survival

    Liver Transplant-Free Survival post-Index Procedure, defined as the proportion of subjects with freedom from death from any cause and from liver transplantation.

    Measured: Through 24 months

  9. Overall Survival

    Overall Survival post-Index Procedure, defined as the proportion of subjects with freedom from death from any cause.

    Measured: Through 24 months

  10. Health-Related Quality of Life (HRQoL) Questionnaire

    Health-Related Quality of Life (HRQoL) at Screening and at 1, 3, 6, 12, 18, and 24 months post-Treatment Completion, as measured by PROMIS-29 Profile v2.1.

    Measured: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion

  11. Freedom from Shunt Dysfunction

    Freedom from Shunt Dysfunction through 1, 3, 12, 18, and 24 months post-Treatment Completion. Shunt Dysfunction is defined as the proportion of subjects free from both a >50% reduction of the lumen of the stent (confirmed by direct shunt venography for subjects with suspected shunt dysfunction) and a PSG greater than the PSG achieved post-TIPS Index Procedure.

    Measured: 1, 3, 12, 18, and 24 months post-Treatment Completion

Timeline

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

  1. First posted3 Feb 2023
  2. Study start8 Aug 2023
  3. Primary completion23 Jun 2025
  4. Study completion11 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
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05711316
Sponsor's protocol ID
BDPI-20-004
Acronym
ARCH
Status last verified
Jun 2026
First submitted
19 Jan 2023
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing BD Liverty™ TIPS Stent Graft in people with Portal Hypertension and TIPS, run by C. R. Bard at 26 sites in 3 countries.

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 12 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Germany, France. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from Major Complications through 30 days post-Index Procedure (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT05711316.

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 27 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in