Achieving Portal Access With Scorpion Post-Approval Study 2 (APASS2)

February 28, 2025 updated by: Argon Medical Devices

A Retrospective Data Collection Evaluating Portal Vein Access Sets For 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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Major Complications
Time Frame: 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.
Through 30 days post-TIPS procedure
Number of Participants With Technical Success
Time Frame: TIPS Procedure
Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein and confirmed by portogram
TIPS Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-Related Complications
Time Frame: Through 30 days post-TIPS procedure
Incidence of complications related to the device as judged by the Investigator
Through 30 days post-TIPS procedure
Number of Participants with Procedural Success
Time Frame: TIPS Procedure
Successful delivery of the shunt
TIPS Procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Portal Vein Access (PVA) Time
Time Frame: TIPS Procedure
Time (in minutes) from hepatic vein access to portal vein access
TIPS Procedure
Procedure duration
Time Frame: TIPS Procedure
Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from subject
TIPS Procedure
Fluoroscopy Time
Time Frame: TIPS Procedure
Measured in minutes
TIPS Procedure
Change in MELD score
Time Frame: up to 30 days post-TIPs procedure
Change in score from Baseline Characteristics to Follow Up Data
up to 30 days post-TIPs procedure
Change in Child-Pugh score
Time Frame: up to 30 days post-TIPs procedure
Change in score from Baseline Characteristics to Follow Up Data
up to 30 days post-TIPs procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Argon Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

March 28, 2024

Study Completion (Actual)

March 28, 2024

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCPVA02

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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