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OpenTrials
Completed

NCT Number: NCT06856655

Achieving Portal Access With Scorpion Post-Approval Study 2

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.

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Key information

Conditions

Portal Hypertension Ascites Hepatic Cardiovascular Diseases Digestive System Diseases Hydrothorax Hypertension, Portal Liver Diseases Pleural Diseases Respiratory Tract Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Scorpion Portal Vein Access Kit

Device

Procedure/Surgery: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Number of Participants with Procedural Success

    Time frame: TIPS Procedure

    Successful delivery of the shunt

  2. Device-Related Complications

    Time frame: Through 30 days post-TIPS procedure

    Incidence of complications related to the device as judged by the Investigator

Other outcomes

  1. Portal Vein Access (PVA) Time

    Time frame: TIPS Procedure

    Time (in minutes) from hepatic vein access to portal vein access

  2. Procedure duration

    Time frame: TIPS Procedure

    Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from subject

  3. Fluoroscopy Time

    Time frame: TIPS Procedure

    Measured in minutes

  4. Change in MELD score

    Time frame: up to 30 days post-TIPs procedure

    Change in score from Baseline Characteristics to Follow Up Data

  5. Change in Child-Pugh score

    Time frame: up to 30 days post-TIPs procedure

    Change in score from Baseline Characteristics to Follow Up Data

Sponsors and collaborators

Lead sponsor

Argon Medical Devices

Industry

Registry information

Official study title

A Retrospective Data Collection Evaluating Portal Vein Access Sets For Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures

Acronym: APASS2

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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