The BD Liverty™ TIPS Stent Graft Study

Running, not enrolling · Not applicable

Conditions studied: Portal Hypertension, TIPS

In brief

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).

Key facts

Study ID

NCT05711316

Run by

C. R. Bard

People needed

177

Starts

2023-08-08

Expected to finish

2027-01-11

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Stanford University — Palo Alto, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Trustees of Indiana University ("IU")/ Indiana University Health, Inc. — Indianapolis, Indiana, United States
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• The General Hospital Corporation d/b/a Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center, Inc. — Boston, Massachusetts, United States
• Washington University - Mallinckrodt Institute of Radiology — St Louis, Missouri, United States
• Rutgers, The State University of New Jersey — Newark, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• The Trustees of Columbia University in the City of New York — New York, New York, United States
• Charlotte Radiology — Charlotte, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States
• Medical College of Wisconsin / Froedtert Hospital — Milwaukee, Wisconsin, United States
• Centre Hospitalier Regional Universitaire de Tours — Chambray-lès-Tours, France
• CHU Dijon Bourgogne — Dijon, France
• Hospices Civils de Lyon — Lyon, France
• Charité-Universitätsmedizin Berlin — Berlin, Germany
• Universitätsklinikum Bonn — Bonn, Germany
• Universitatsklinikum Carl Gustav Carus Dresden — Dresden, Germany
• University Hospital Frankfurt — Frankfurt, Germany
• Medizinische Hochschule Hannover — Hanover, Germany

Full record on ClinicalTrials.gov

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