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

Launched by ARGON MEDICAL DEVICES · Mar 1, 2023

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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