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

Not Applicable

Terminated

• Conditions: Portal Hypertension; Vascular Diseases; Liver Diseases; Ascites Hepatic; Hydrothorax
• Interventions: Device: Scorpion Portal Vein Access Kit; Device: Cook Transjugular Liver Access Set; Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

• Registration Number: NCT05765253
• Lead Sponsor: Argon Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-13
• Study Start: 2023-07-13
• Primary Completion: 2023-10-16
• Study Completion: 2023-11-19
• Results First Submitted: 2024-10-09
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Results First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS with Cook Transjugular Liver Access Set	Transjugular Intrahepatic Portosystemic Shunt (TIPS)	Ring or Rosch-Uchida access set
TIPS with Scorpion Portal Vein Access Kit	Transjugular Intrahepatic Portosystemic Shunt (TIPS)	Scorpion or Scorpion X access set
TIPS with Scorpion Portal Vein Access Kit	Scorpion Portal Vein Access Kit	Scorpion or Scorpion X access set
TIPS with Cook Transjugular Liver Access Set	Cook Transjugular Liver Access Set	Ring or Rosch-Uchida access set

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

New York Presbyterian - Columbia University Medical Center; 🇺🇸 New York, New York, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States