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TerminatedNCT05765253Updated Dec 11, 2024Results posted

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

An interventional study of Scorpion Portal Vein Access Kit and Cook Transjugular Liver Access Set in Portal Hypertension, Liver Diseases and Ascites Hepatic, sponsored by Argon Medical Devices. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by Argon Medical Devices · Not applicable, Interventional, and Treatment

Why this study was terminated
Low patient accrual
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Transjugular Intrahepatic Portosystemic Shunt
  • TIPS
  • Portal Vein Access
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.

This study's enrollment of 3 is below the median of 50 across 1,322 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Argon Medical Devices is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Active comparator
    TIPS with Scorpion Portal Vein Access Kit

    Scorpion or Scorpion X access set

    Device: Scorpion Portal Vein Access Kit · Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

  • Active comparator
    TIPS with Cook Transjugular Liver Access Set

    Ring or Rosch-Uchida access set

    Device: Cook Transjugular Liver Access Set · Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Interventions

  • DeviceScorpion Portal Vein Access Kit

    Portal Vein Access with Scorpion or Scorpion X set

  • DeviceCook Transjugular Liver Access Set

    Portal Vein Access with Ring or Rosch-Uchida set

  • ProcedureTransjugular Intrahepatic Portosystemic Shunt (TIPS)

    Transjugular Intrahepatic Portosystemic Shunt (TIPS)

06

What researchers measure

Primary outcomes

  1. Number of Participants With Procedural Success

    Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).

    Time frame: TIPS Procedure (Day 0), up to 93 minutes

  2. 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.

    Time frame: Through 30 days post-TIPS procedure

Secondary outcomes

  1. Portal Vein Access (PVA) Time

    Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram.

    Time frame: TIPS Procedure (Day 0), up to 52 minutes

  2. Number of Participants With Technical Success

    Creation of a shunt (stent bridging) between the portal and systemic veins.

    Time frame: TIPS Procedure (Day 0), up to 93 minutes

  3. Number of Needle Passes

    Count of needle throws between the hepatic and portal vein to create the parenchymal tract.

    Time frame: TIPS Procedure (Day 0), up to 93 minutes

  4. Procedure Duration

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

    Time frame: TIPS Procedure (Day 0), up to 93 minutes

  5. Fluoroscopy Time

    Measured in minutes

    Time frame: TIPS Procedure (Day 0), up to 31.5 minutes

  6. Device-Related Complications

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

    Time frame: Through 30 days post-TIPS procedure

07

Results

Posted Dec 11, 2024
Limitations and caveats
The study was terminated early due to insufficient enrollment. Three (3) subjects were enrolled before the early termination leading to limited analyses.

Participant flow

Participant flow — Overall Study
MilestoneTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Started21
Completed21
Not completed00

Outcome measures

PrimaryNumber of Participants With Procedural Success

Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).

Time frame:
TIPS Procedure (Day 0), up to 93 minutes
Reported as:
Number · Participants
Number of Participants With Procedural Success
ParticipantsTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Yes21
No00
PrimaryComposite 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.

Time frame:
Through 30 days post-TIPS procedure
Reported as:
Number · Events
Composite of Major Complications
EventsTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Composite of Major Complications01
SecondaryPortal Vein Access (PVA) Time

Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram.

Time frame:
TIPS Procedure (Day 0), up to 52 minutes
Reported as:
Number · minutes
Portal Vein Access (PVA) Time
minutesTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Subject ID 02-001—52
Subject ID 02-0027—
Subject ID 02-0038—
SecondaryNumber of Participants With Technical Success

Creation of a shunt (stent bridging) between the portal and systemic veins.

Time frame:
TIPS Procedure (Day 0), up to 93 minutes
Reported as:
Number · Participants
Number of Participants With Technical Success
ParticipantsTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Yes21
No00
SecondaryNumber of Needle Passes

Count of needle throws between the hepatic and portal vein to create the parenchymal tract.

Time frame:
TIPS Procedure (Day 0), up to 93 minutes
Reported as:
Number · Number of Needle Passes
Number of Needle Passes
Number of Needle PassesTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Subject ID 02-001—3
Subject ID 02-0021—
Subject ID 02-0031—
SecondaryProcedure Duration

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

Time frame:
TIPS Procedure (Day 0), up to 93 minutes
Reported as:
Number · Minutes
Procedure Duration
MinutesTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Subject ID 02-001—93
Subject ID 02-00235—
Subject ID 02-00349—
SecondaryFluoroscopy Time

Measured in minutes

Time frame:
TIPS Procedure (Day 0), up to 31.5 minutes
Reported as:
Number · Minutes
Fluoroscopy Time
MinutesTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Subject ID 02-001—31.5
Subject ID 02-00218.2—
Subject ID 02-00316.7—
SecondaryDevice-Related Complications

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

Time frame:
Through 30 days post-TIPS procedure
Reported as:
Number · Number of AEs
Device-Related Complications
Number of AEsTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Subject ID 02-001—2
Subject ID 02-0022—
Subject ID 02-0034—

Adverse events

Collected over Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TIPS With Scorpion Portal Vein Access Kit0/2 (0%)1/2 (50%)2/2 (100%)
TIPS With Cook Transjugular Liver Access Set0/1 (0%)1/1 (100%)1/1 (100%)
Most frequent serious events
Most frequent serious events
EventTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
Hepatic encephalopathyNervous system disorders0/21/1
Abdominal painGastrointestinal disorders1/20/1
Oedema peripheralGeneral disorders1/20/1
DyspneaRespiratory, thoracic and mediastinal disorders1/20/1
Most frequent other events
Most frequent other events
EventTIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access Set
VomitingGastrointestinal disorders0/21/1
Dyspnea exertionalRespiratory, thoracic and mediastinal disorders1/20/1
Abdominal distensionGastrointestinal disorders1/20/1
Decreased activityGeneral disorders1/20/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)TIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access SetTotal
<=18 years000
Between 18 and 65 years101
>=65 years112
Sex: Female, Male
Sex: Female, Male(Participants)TIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access SetTotal
Female112
Male101
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access SetTotal
Hispanic or Latino101
Not Hispanic or Latino011
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TIPS With Scorpion Portal Vein Access KitTIPS With Cook Transjugular Liver Access SetTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White112
More than one race000
Unknown or Not Reported101
08

Study locations

3 sites
  • Emory University
    Atlanta, Georgia 30322, United States
  • New York Presbyterian - Columbia University Medical Center
    New York, New York 10032, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 10, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05765253
Lead sponsor
Argon Medical Devices
Collaborators
Avania
Responsible party
Sponsor
First posted
Mar 13, 2023
Start date
Jul 13, 2023
Primary completion
Oct 16, 2023
Completion
Nov 19, 2023
Results posted
Dec 11, 2024
Last update
Dec 11, 2024

Study contacts

Venkatesh P. Krishnasamy, MD
principal investigator · New York Presbyterian - Columbia University Medical Center
Danyel C Carr, MS
study director · Argon Medical Devices

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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