Achieving Portal Access With Scorpion Post-Approval Study (APASS)
Portal Hypertension, Liver Diseases, Ascites Hepatic
About this trial
This is an interventional treatment trial for Portal Hypertension focused on measuring Transjugular Intrahepatic Portosystemic Shunt, TIPS, Portal Vein Access
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age at the time of the TIPS procedure TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization Willing and able to comply with the study procedures and follow up schedule Exclusion Criteria: Known active malignancy MELD score ≥ 18 at time of screening History of polycystic liver disease Active bleeding from any source Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination Active or uncontrolled hepatic encephalopathy Systemic infection/sepsis Biliary obstruction Uncorrectable coagulopathy Any diminutive or partially thrombosed right portal vein Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome) Known sensitivity to contrast or serious contrast reaction such as anaphylaxis Pregnant women or women who are planning to become pregnant
Sites / Locations
- Emory University
- New York Presbyterian - Columbia University Medical Center
- University of North Carolina at Chapel HillRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
TIPS with Scorpion Portal Vein Access Kit
TIPS with Cook Transjugular Liver Access Set
Scorpion or Scorpion X access set
Ring or Rosch-Uchida access set