The BD Liverty™ TIPS Stent Graft Study

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).

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:

1. 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).

2. 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.

3. The subject must be willing and able to comply with protocol requirements, including all study visits and procedures.

4. 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:

   1. Recurrent, or Refractory Ascites (defined as ascites that cannot be mobilized or recurs after large volume paracentesis despite dietary sodium restriction and diuretic therapy)
   2. Hepatic Hydrothorax
   3. Esophageal Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Esophageal Variceal Bleeding, or Recurrent Esophageal Variceal Bleeding
   4. Gastric Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Gastric Variceal Bleeding, or Recurrent Gastric Variceal Bleeding

5. 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.

6. 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:

1. The subject is pregnant. Subjects of child-bearing potential must have a negative pregnancy test (urine or serum).

2. 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.

3. The subject has undergone prior stent or stent graft placement in the hepatic vein, portal vein and/or inferior vena cava (IVC).

4. The subject is hemodynamically unstable with uncontrolled bleeding.

5. The subject has hepatic and/or portal vein thrombosis (PVT). Note: Subjects with partial non-flow-limiting, non-malignant PVT may be enrolled.

6. 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.

7. The subject has extrahepatic or hepatic malignancy or a history of previous hepatic malignancy, unless treated curatively ≥5 years prior to enrollment.

8. The subject has overt (West Haven Criteria Grade ≥2), controlled or uncontrolled hepatic encephalopathy.

9. The subject has any of the following medical conditions contraindicated to placement of TIPS:

   1. Congestive Heart Failure or Pulmonary Edema
   2. Severe Tricuspid Regurgitation
   3. Elevated Right or Left Heart Pressures
   4. Polycystic Liver Disease
   5. Moderate or Severe Pulmonary Hypertension or Severe Hepatopulmonary Syndrome
   6. Uncontrolled Systemic Infection or Sepsis
   7. Unrelieved Biliary Obstruction
   8. Acute Kidney Injury, Renal Failure, or Dialysis
   9. Uncontrolled Blood Coagulation/Bleeding Disorder

10. 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.

11. The subject has a known allergy or hypersensitivity to any of the device materials including nickel-titanium (nitinol) or tantalum.

12. 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.

13. 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.