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

Argon Medical Devices

Status: Terminated

Conditions: Portal Hypertension; Vascular Diseases; Hydrothorax; Ascites Hepatic; Liver Diseases

Treatments: Device: Cook Transjugular Liver Access Set; Device: Scorpion Portal Vein Access Kit; Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05765253

SCPVA01

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

TIPS with Scorpion Portal Vein Access Kit

Active Comparator group

Description:

Scorpion or Scorpion X access set

Treatment:

Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Device: Scorpion Portal Vein Access Kit

TIPS with Cook Transjugular Liver Access Set

Active Comparator group

Description:

Ring or Rosch-Uchida access set

Treatment:

Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Device: Cook Transjugular Liver Access Set