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

• Scorpion Portal Vein Access Kit (Device): Portal Vein Access with Scorpion or Scorpion X set
• Cook Transjugular Liver Access Set (Device): Portal Vein Access with Ring or Rosch-Uchida set
• Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure): Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Primary outcomes

• Number of Participants With Procedural Success [TIPS Procedure (Day 0), up to 93 minutes]: Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).
• Composite of Major Complications [Through 30 days post-TIPS procedure]: Major complications associated with the procedure or study device and defined as complications resulting in an unplanned increase in the level of care, prolonged hospitalization, permanent adverse sequelae, or death.

Secondary outcomes

• Portal Vein Access (PVA) Time [TIPS Procedure (Day 0), up to 52 minutes]: Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram.
• Number of Participants With Technical Success [TIPS Procedure (Day 0), up to 93 minutes]: Creation of a shunt (stent bridging) between the portal and systemic veins.
• Number of Needle Passes [TIPS Procedure (Day 0), up to 93 minutes]: Count of needle throws between the hepatic and portal vein to create the parenchymal tract.
• Procedure Duration [TIPS Procedure (Day 0), up to 93 minutes]: Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.
• Fluoroscopy Time [TIPS Procedure (Day 0), up to 31.5 minutes]: Measured in minutes
• Device-Related Complications [Through 30 days post-TIPS procedure]: Incidence of complications related to the device as judged by the Investigator

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Number of Participants With Procedural Success (Primary), Number, Participants: TIPS With Scorpion Portal Vein Access Kit 2; TIPS With Cook Transjugular Liver Access Set 1
• Composite of Major Complications (Primary), Number, Events: TIPS With Scorpion Portal Vein Access Kit 0; TIPS With Cook Transjugular Liver Access Set 1
• Portal Vein Access (PVA) Time (Secondary), Number, minutes: TIPS With Scorpion Portal Vein Access Kit ; TIPS With Cook Transjugular Liver Access Set 52
• Number of Participants With Technical Success (Secondary), Number, Participants: TIPS With Scorpion Portal Vein Access Kit 2; TIPS With Cook Transjugular Liver Access Set 1
• Number of Needle Passes (Secondary), Number, Number of Needle Passes: TIPS With Scorpion Portal Vein Access Kit ; TIPS With Cook Transjugular Liver Access Set 3
• Procedure Duration (Secondary), Number, Minutes: TIPS With Scorpion Portal Vein Access Kit ; TIPS With Cook Transjugular Liver Access Set 93
• Fluoroscopy Time (Secondary), Number, Minutes: TIPS With Scorpion Portal Vein Access Kit ; TIPS With Cook Transjugular Liver Access Set 31.5
• Device-Related Complications (Secondary), Number, Number of AEs: TIPS With Scorpion Portal Vein Access Kit ; TIPS With Cook Transjugular Liver Access Set 2

Adverse events

Time frame: Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.

Serious adverse events by term

Other adverse events by term

Limitations and caveats: The study was terminated early due to insufficient enrollment. Three (3) subjects were enrolled before the early termination leading to limited analyses.

• Study Protocol and Statistical Analysis Plan (PDF, 2023-05-10)

• Venkatesh P. Krishnasamy, MD, Principal investigator, New York Presbyterian - Columbia University Medical Center
• Danyel C Carr, MS, Study director, Argon Medical Devices