Achieving Portal Access With Scorpion Post-Approval Study (APASS)
Reason given: Low patient accrual
Key facts
- Where
- Atlanta, Chapel Hill, and New York, United StatesSee the 3 sites
Where in United States
- Emory UniversityAtlanta, United StatesNo longer taking part
- University of North Carolina at Chapel HillChapel Hill, United StatesNo longer taking part
- New York Presbyterian/Columbia University Medical CenterNew York, United StatesNo longer taking part
Trial details
- Who runs it
- Argon Medical Devices
- Trial code
- NCT05765253
- Record updated
- 11 December 2024
- Original description
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.Read full original descriptionShow less
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: ≥ 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: Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination; Known active malignancy; History of polycystic liver disease; Active bleeding from any source; Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt; Systemic infection/sepsis; Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome); MELD score ≥ 18 at time of screening; Active or uncontrolled hepatic encephalopathy; Biliary obstruction; Uncorrectable coagulopathy; Any diminutive or partially thrombosed right portal vein; Known sensitivity to contrast or serious contrast reaction such as anaphylaxis; Pregnant women or women who are planning to become pregnant.