The BD Liverty™ TIPS Stent Graft Study

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.

Inclusion criteria

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.

Exclusion criteria

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.