Achieving Portal Access With Scorpion Post-Approval Study 2

NCT06856655 | Completed FDA Device

• 1 other identifier: SCPVA02
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Transjugular Intrahepatic Portosystemic Shunt; TIPS; Portal Vein Access

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Technical Success

  Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein and confirmed by portogram

  TIPS 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 Outcomes (2)

• Number of Participants with Procedural Success

  TIPS Procedure

• Device-Related Complications

  Through 30 days post-TIPS procedure

Other Outcomes (5)

• Portal Vein Access (PVA) Time

  TIPS Procedure

• Procedure duration

  TIPS Procedure

• Fluoroscopy Time

  TIPS Procedure

Interventions

Scorpion Portal Vein Access Kit DEVICE

Procedure/Surgery: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The procedure date window for the retrospective data was from 01-Feb-2022 to 05-Feb-2024.

You may qualify if:

• \. Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein access

You may not qualify if:

• TIPS procedure was not initiated and/or no portion of the kit was introduced into the vasculature
• Inaccessible medical records

Sponsors & Collaborators

• Argon Medical Devices: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hypertension, Portal; Liver Diseases; Hydrothorax; Vascular Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pleural Diseases; Respiratory Tract Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 4, 2025
• Study Start: February 1, 2022
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)