Portal HypertensionAPASS2NCT06856655
Achieving Portal Access With Scorpion Post-Approval Study 2
An observational study of Portal Hypertension and Liver Diseases, run by Argon Medical Devices at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Portal Hypertension, Liver Diseases, Ascites Hepatic
- What is being tested?
- Scorpion Portal Vein Access Kit
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The procedure date window for the retrospective data was from 01-Feb-2022 to 05-Feb-2024.
Who may be able to join
- 1. Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein access
Who cannot join
- TIPS procedure was not initiated and/or no portion of the kit was introduced into the vasculature
- Inaccessible medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Scorpion Portal Vein Access Kit
- Keywords
- Transjugular Intrahepatic Portosystemic Shunt, TIPS, Portal Vein Access
- Medical subject headings
- Hypertension, Portal, Liver Diseases, Hydrothorax, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scorpion Portal Vein Access KitDevice
Procedure/Surgery: Transjugular Intrahepatic Portosystemic Shunt (TIPS)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Through 30 days post-TIPS procedure
Secondary outcomes (2)
Number of Participants with Procedural Success
Successful delivery of the shunt
Measured: TIPS Procedure
Device-Related Complications
Incidence of complications related to the device as judged by the Investigator
Measured: Through 30 days post-TIPS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Feb 2022
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argon Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856655
- Sponsor's protocol ID
- SCPVA02
- Acronym
- APASS2
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Data Collection Evaluating Portal Vein Access Sets For Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures
- ClinicalTrials.gov ID
- NCT06856655
- Acronym / sponsor ID
- APASS2 / SCPVA02
- Keywords
- Transjugular Intrahepatic Portosystemic Shunt, TIPS, Portal Vein Access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Argon Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The procedure date window for the retrospective data was from 01-Feb-2022 to 05-Feb-2024.
Key inclusion criteria (1 listed)
- 1. Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein access
Key exclusion criteria (2 listed)
- TIPS procedure was not initiated and/or no portion of the kit was introduced into the vasculature
- Inaccessible medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scorpion Portal Vein Access KitProcedure/Surgery: Transjugular Intrahepatic Portosystemic Shunt (TIPS) | Device | – |
Primary outcome
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
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.
2 secondary outcomes
Number of Participants with Procedural Success
Time frame: TIPS Procedure
Device-Related Complications
Time frame: Through 30 days post-TIPS procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Liver Diseases, run by Argon Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Technical Success (time frame: TIPS Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.