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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danyel C Carr, MS; Phone Number: 4697311421; Email: Danyel.Carr@argonmedical.com
• Study Contact Backup: Name: Brent McClean; Email: Brent.McClean@argonmedical.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian - Columbia University Medical Center
      • Contact: Ramona Jayasena; Email: rj2002@cumc.columbia.edu
      • Principal Investigator: Venkatesh Krishnasamy, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
      • Principal Investigator: Clayton Commander, MD
      • Contact: Desma Jones; Email: desma_jones@med.unc.edu
      • Sub-Investigator: Hyeon Yu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TIPS with Scorpion Portal Vein Access Kit; Scorpion or Scorpion X access set	Device: Scorpion Portal Vein Access Kit; Portal Vein Access with Scorpion or Scorpion X set; Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS); Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Active Comparator: TIPS with Cook Transjugular Liver Access Set; Ring or Rosch-Uchida access set	Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS); Transjugular Intrahepatic Portosystemic Shunt (TIPS); Device: Cook Transjugular Liver Access Set; Portal Vein Access with Ring or Rosch-Uchida set

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).	Index Procedure
Composite of Major Complications	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.	Through 30 days post-TIPS procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Creation of a shunt (stent bridging) between the portal and systemic veins.	Index Procedure
Number of Needle Passes	Count of needle throws between the hepatic and portal vein to create the parenchymal tract.	Index Procedure
Procedure Duration	Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.	Index Procedure
Fluoroscopy Time	Measured in minutes	Index Procedure
Device-Related Complications	Incidence of complications related to the device as judged by the Investigator	Through 30 days post-TIPS procedure
Portal Vein Access (PVA) time	Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram.	Index Procedure

Collaborators and Investigators

• Sponsor: Argon Medical Devices
• Collaborators: Avania
• Investigators: Principal Investigator: Venkatesh P. Krishnasamy, MD, New York Presbyterian - Columbia University Medical Center; Study Director: Danyel C Carr, MS, Argon Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): November 19, 2023

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: TIPS; Transjugular Intrahepatic Portosystemic Shunt; Portal Vein Access
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Respiratory Tract Diseases; Pleural Diseases; Liver Diseases; Vascular Diseases; Ascites; Hypertension, Portal; Hydrothorax
• Other Study ID Numbers: SCPVA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No