Achieving Portal Access With Scorpion Post-Approval Study (APASS)

A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures

Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.

Inclusion Criteria:

1. ≥ 18 years of age at the time of the TIPS procedure
2. TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax
3. Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization
4. Willing and able to comply with the study procedures and follow up schedule

Exclusion Criteria:

1. Known active malignancy
2. MELD score ≥ 18 at time of screening
3. History of polycystic liver disease
4. Active bleeding from any source
5. Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt
6. Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination
7. Active or uncontrolled hepatic encephalopathy
8. Systemic infection/sepsis
9. Biliary obstruction
10. Uncorrectable coagulopathy
11. Any diminutive or partially thrombosed right portal vein
12. Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome)
13. Known sensitivity to contrast or serious contrast reaction such as anaphylaxis
14. Pregnant women or women who are planning to become pregnant