Portal HypertensionNCT05765253

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

A study testing Scorpion Portal Vein Access Kit, Cook Transjugular Liver Access Set and Transjugular Intrahepatic Portosystemic Shunt (TIPS) in people with Portal Hypertension and Liver Diseases, run by Argon Medical Devices at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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?: Ages 18 years and older
Conditions the study is for: Portal Hypertension, Liver Diseases, Ascites Hepatic
What is being tested?: Scorpion Portal Vein Access Kit, Cook Transjugular Liver Access Set and Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 3 sitesUnited States
Study dates: 13 Jul 2023to 19 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years of age at the time of the TIPS procedure
TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax
Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization
Willing and able to comply with the study procedures and follow up schedule

Who cannot join

Known active malignancy
MELD score ≥ 18 at time of screening
History of polycystic liver disease
Active bleeding from any source
Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt
Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination

Show all 14Show fewer

Active or uncontrolled hepatic encephalopathy
Systemic infection/sepsis
Biliary obstruction
Uncorrectable coagulopathy
Any diminutive or partially thrombosed right portal vein
Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome)
Known sensitivity to contrast or serious contrast reaction such as anaphylaxis
Pregnant women or women who are planning to become pregnant

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Emory University
Atlanta, Georgia, 30322
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
New York Presbyterian - Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures

Conditions: Portal Hypertension, Liver Diseases, Ascites Hepatic, Hydrothorax, Vascular Diseases
Being tested: Scorpion Portal Vein Access Kit, Cook Transjugular Liver Access Set, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
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
Portal Vein Access with Scorpion or Scorpion X set
Cook Transjugular Liver Access SetDevice
Portal Vein Access with Ring or Rosch-Uchida set
Transjugular Intrahepatic Portosystemic Shunt (TIPS)Procedure or surgery
Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Study groups in NCT05765253
Study group	Role	What they receive
TIPS with Scorpion Portal Vein Access Kit	Active comparator	Scorpion or Scorpion X access set Receives: Device: Scorpion Portal Vein Access Kit; Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)
TIPS with Cook Transjugular Liver Access Set	Active comparator	Ring or Rosch-Uchida access set Receives: Device: Cook Transjugular Liver Access Set; Procedure: 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 Procedural Success
Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).
Measured: TIPS Procedure (Day 0), up to 93 minutes
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 (6)

Portal Vein Access (PVA) Time
Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram.
Measured: TIPS Procedure (Day 0), up to 52 minutes
Number of Participants With Technical Success
Creation of a shunt (stent bridging) between the portal and systemic veins.
Measured: TIPS Procedure (Day 0), up to 93 minutes
Number of Needle Passes
Count of needle throws between the hepatic and portal vein to create the parenchymal tract.
Measured: TIPS Procedure (Day 0), up to 93 minutes
Procedure Duration
Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.
Measured: TIPS Procedure (Day 0), up to 93 minutes
Fluoroscopy Time
Measured in minutes
Measured: TIPS Procedure (Day 0), up to 31.5 minutes
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.

13 Jul 202319 Nov 2023

First posted13 Mar 2023
Study start13 Jul 2023
Primary completion16 Oct 2023
Study completion19 Nov 2023

Why it stopped: Low patient accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05765253
Sponsor's protocol ID: SCPVA01
Status last verified: Nov 2024
First submitted: 1 Mar 2023
Last updated: 11 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
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RecruitingPhase 4
Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
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RecruitingObservational study
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Not yet recruitingObservational study
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Portal Hypertension, Chronic Liver Disease
Not yet recruiting
"Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis
Cirrhosis

All Portal Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures
ClinicalTrials.gov ID: NCT05765253
Acronym / sponsor ID: SCPVA01
Conditions: Portal Hypertension, Liver Diseases, Ascites Hepatic, Hydrothorax, Vascular Diseases
Keywords: Transjugular Intrahepatic Portosystemic Shunt, TIPS, Portal Vein Access
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low patient accrual
Enrolment: 3 participants (actual)
Lead sponsor: Argon Medical DevicesIndustry (pharma, biotech, devices)
Collaborators: Avania
Study start: 13 Jul 2023 (actual)
Primary completion: 16 Oct 2023 (actual)
Study completion: 19 Nov 2023 (actual)
First posted: 13 Mar 2023 (actual)
Results: Posted 11 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TIPS with Scorpion Portal Vein Access Kit	Active comparator	Device: Scorpion Portal Vein Access Kit, Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)Scorpion or Scorpion X access set
TIPS with Cook Transjugular Liver Access Set	Active comparator	Device: Cook Transjugular Liver Access Set, Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)Ring or Rosch-Uchida access set

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

≥ 18 years of age at the time of the TIPS procedure
TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax
Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization
Willing and able to comply with the study procedures and follow up schedule

Key exclusion criteria (14 listed)

Known active malignancy
MELD score ≥ 18 at time of screening
History of polycystic liver disease
Active bleeding from any source
Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt

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 KitPortal Vein Access with Scorpion or Scorpion X set	Device	TIPS with Scorpion Portal Vein Access Kit
Cook Transjugular Liver Access SetPortal Vein Access with Ring or Rosch-Uchida set	Device	TIPS with Cook Transjugular Liver Access Set
Transjugular Intrahepatic Portosystemic Shunt (TIPS)Transjugular Intrahepatic Portosystemic Shunt (TIPS)	Procedure or surgery	TIPS with Cook Transjugular Liver Access Set, TIPS with Scorpion Portal Vein Access Kit

Primary outcome

Number of Participants With Procedural Success
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).
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.

6 secondary outcomes

Portal Vein Access (PVA) Time
Time frame: TIPS Procedure (Day 0), up to 52 minutes
Number of Participants With Technical Success
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Number of Needle Passes
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Procedure Duration
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Fluoroscopy Time
Time frame: TIPS Procedure (Day 0), up to 31.5 minutes
Device-Related Complications
Time frame: Through 30 days post-TIPS procedure

Results and safety

Results posted to the registry on 11 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TIPS With Scorpion Portal Vein Access Kit	2	2
TIPS With Cook Transjugular Liver Access Set	1	1

Primary outcome: Number of Participants With Procedural Success

Time frame: TIPS Procedure (Day 0), up to 93 minutes. Number. Unit: Participants

Measure	TIPS With Scorpion Portal Vein Access Kit n = 2	TIPS With Cook Transjugular Liver Access Set n = 1
Yes	2	1
No	0	0

Population analysed: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set

Primary outcome: Composite of Major Complications

Time frame: Through 30 days post-TIPS procedure. Number. Unit: Events

Measure	TIPS With Scorpion Portal Vein Access Kit n = 2	TIPS With Cook Transjugular Liver Access Set n = 1
Value	0	1

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TIPS With Scorpion Portal Vein Access Kit	1 of 2 (50%)	2 of 2 (100%)	0 of 2
TIPS With Cook Transjugular Liver Access Set	1 of 1 (100%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): The study was terminated early due to insufficient enrollment. Three (3) subjects were enrolled before the early termination leading to limited analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Portal Hypertension

RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
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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.

Venkatesh P. Krishnasamy, MD principal investigator

New York Presbyterian - Columbia University Medical Center

Danyel C Carr, MS study director

Argon Medical Devices

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Procedural Success (time frame: TIPS Procedure (Day 0), up to 93 minutes). 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?

On the ClinicalTrials.gov record for NCT05765253.

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 11 Dec 2024.