A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures
Phase: NA
Conditions: Portal Hypertension, Liver Diseases, Ascites Hepatic, Hydrothorax, Vascular Diseases
Sponsor: Argon Medical Devices

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A Prospective, Multicenter, Randomized Study Evaluating 
Portal Vein Access Sets During Transjugular Intrahepatic 
Portosystemic Shunt (TIPS) Procedures
Short Title: Achieving Portal Access with Scorpion Post-Approval Study (APASS)
Protocol Number: SCPVA01
Revision: C
Document Date:  10 May 2023
Sponsor: Argon Medical Devices, Inc.
7800 Dallas Pkwy, Suite 200
Plano, Texas 75024
ClinicalTrials.gov Identifier: NCT05765253
Confidentiality Statement
The information provided in this document is the property of the Sponsor and is strictly confidential 
and proprietary. Information contained therein shall not be disclosed to parties other than clinical 
study staff, appropriate governmental and regulatory agencies and the Institutional Review Board 
directly involved in this clinical study. Neither the document nor the information contained therein 
shall be disclosed, disseminated, copied, or used without prior written permission from Argon 
Medical Devices, Inc.

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PROTOCOL REVISION HISTORY
The protocol shall be amended as needed throughout the clinical study. The amendments to the 
protocol shall be notified to, or approved by, the IRB and regulatory authorities, as required. 
For non-substantial changes [e.g., minor logistical or administrative changes, change of 
monitor(s), telephone numbers] not affecting the rights, safety and well-being of human subjects 
or not related to the clinical study objectives or endpoints, a simple notification to the IRB and, 
where appropriate, regulatory authorities may be sufficient. The version number and date of 
amendments shall be documented.
Version
Date
Description of Change
Brief Rationale
eQMS Workflow #
A
13 Mar 2023
Initial release
N/A
Electronic 
signature 
#CP-
2023-001
B
04 Apr 2023
1.
Clarify exclusion criteria 
(#6 & #7)
2.
Add/clarify procedure-
related data points
1.
Only active or uncontrolled 
hepatic encephalopathy 
and portal vein thrombosis 
of the main target portal 
vein will be excluded. 
2.
Ensure collection of 
required procedural data
CR02138
C
10 May 2023
1.
Update secondary 
endpoint “procedure-
related complication” to 
“device-related 
complication” within 
Synopsis
2.
Remove Duplex 
Ultrasound as one of the 
options for Imaging 
assessment in Section 
8.2
3.
Add/clarify following 
Assessments:  
Randomization,  
Concomitant 
Medications, and Study 
Exit
1.
Synopsis was in error and 
did not match the Section 
6.4.3 Table 5 Overview of 
Secondary and Exploratory 
Endpoints
2.
This was included with CT 
or MRI Imaging in error 
and did not match the 
Section 8.1 Table 6 
Schedule of Assessments 
3.
Ensure Assessment 
properly noted in Section 
8.1 Table 6 Schedule of 
Assessments
CR02285

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SPONSOR APPROVAL PAGE
Protocol Title:
A Prospective, Multicenter, Randomized Study Evaluating Portal 
Vein Access Sets During Transjugular Intrahepatic Portosystemic 
Shunt (TIPS) Procedures
Protocol Number:
SCPVA01
Revision: 
C
Document Date:
10 May 2023
Sponsor’s Statement
This document has been reviewed and approved by the individuals listed below or their authorized 
representatives. 
DEPARTMENT
NAME / TITLE
Clinical Affairs
Danyel Crout Carr
Director, Clinical Affairs
Medical Affairs
Pete Stibbs
VP, Global Medical Affairs
Regulatory Affairs
Scott Bishop
Director, Regulatory Affairs
Quality Assurance
Don Kirkland
Director of Quality Operations
Marketing
Cheyenne Ware
Product Manager
Note: Signature approvals are captured in the Sponsor’s eQMS

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PRINCIPAL INVESTIGATOR SIGNATURE PAGE
Protocol Title:
A Prospective, Multicenter, Randomized Study Evaluating Portal 
Vein Access Sets During Transjugular Intrahepatic Portosystemic 
Shunt (TIPS) Procedures
Protocol Number:
SCPVA01
Revision: 
C
Document Date:
10 May 2023
INVESTIGATOR’S STATEMENT
I have read this protocol and agree to conduct the clinical study in accordance with the design 
and specific provisions outlined herein. I understand the protocol, and I understand I am solely 
responsible to ensure the study is conducted in accordance with Good Clinical Practices (GCPs), 
applicable country regulations, the Declaration of Helsinki, and the signed clinical study 
agreement with Sponsor. I will conduct this study as outlined therein and will make reasonable 
effort to complete the study within the period designated by the Sponsor. 
I will provide copies of the protocol and all pertinent information to all individuals who will assist in 
the conduct of this study. I will discuss this material with them to ensure they are fully informed 
regarding the device and the conduct of the study. 
I will fulfill the requirements of my Institutional Review Board (IRB), or other oversight committee, 
to ensure complete and continual oversight of this clinical study. I will use an Informed Consent 
Form approved by the Sponsor and my reviewing IRB. 
I agree to report all information or data in accordance with the protocol and I agree to report any 
serious adverse events, device related adverse events, or procedure related adverse events as 
defined in this protocol to the Sponsor and comply with all adverse event reporting requirements 
of my reviewing IRB. I agree to permit the Sponsor, its authorized representatives, my reviewing 
IRB, and any regulatory authority/body access to all records relating to the clinical study. 
My signature below attests that I have read and understood this protocol, and its associated 
amendments or attachments, and will accept respective revisions or amendments provided by 
the Sponsor. 
Principal Investigator Name (print)
Signature
Date

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TABLE OF CONTENTS
PROTOCOL REVISION HISTORY ..............................................................................................................2
SPONSOR APPROVAL PAGE....................................................................................................................3
PRINCIPAL INVESTIGATOR SIGNATURE PAGE.....................................................................................4
TABLE OF CONTENTS...............................................................................................................................5
LIST OF TABLES.........................................................................................................................................8
LIST OF FIGURES.......................................................................................................................................8
ABBREVIATIONS AND ACRONYMS .........................................................................................................9
1.
KEY ROLES AND CONTACT INFORMATION .................................................................................11
1.1.
SPONSOR STUDY STAFF CONTACT INFORMATION ...........................................................................11
1.2.
LEAD PRINCIPAL INVESTIGATOR CONTACT INFORMATION.................................................................11
1.3.
PRINCIPAL INVESTIGATOR CONTACT INFORMATION .........................................................................11
2.
SYNOPSIS .........................................................................................................................................12
3.
INTRODUCTION ................................................................................................................................15
3.1.
BACKGROUND...............................................................................................................................15
3.2.
PRIOR INVESTIGATIONS .................................................................................................................16
3.3.
STUDY RATIONALE ........................................................................................................................17
4.
STUDY DEVICES...............................................................................................................................17
4.1.
INVESTIGATIONAL DEVICE..............................................................................................................17
4.1.1.
Device Manufacturer...........................................................................................................17
4.1.2.
Regulatory Status and Indications for Use..........................................................................17
4.1.3.
Device Description..............................................................................................................17
4.1.4.
Intended Purpose in the Clinical Study...............................................................................19
4.1.5.
Device Instructions for Use.................................................................................................19
4.2.
COMPARATOR DEVICE...................................................................................................................19
4.2.1.
Device Manufacturer...........................................................................................................19
4.2.2.
Regulatory Status and Indications for Use..........................................................................19
4.2.3.
Device Description..............................................................................................................19
4.2.4.
Intended Purpose for the Clinical Study..............................................................................20
4.2.5.
Device Instructions for Use.................................................................................................20
4.3.
REQUIRED TRAINING AND EXPERIENCE...........................................................................................21
5.
RISK/BENEFIT ANALYSIS................................................................................................................21
5.1.
POTENTIAL CLINICAL BENEFITS......................................................................................................21
5.2.
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY....................................................21
5.3.
POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS.............................................22
5.4.
RISK MITIGATION...........................................................................................................................22
5.5.
BENEFIT-TO-RISK RATIONALE........................................................................................................22
6.
DESIGN OF THE CLINICAL STUDY.................................................................................................22

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6.1.
STUDY OBJECTIVE ........................................................................................................................22
6.2.
STUDY HYPOTHESIS......................................................................................................................22
6.3.
STUDY DESIGN .............................................................................................................................22
6.4.
STUDY ENDPOINTS........................................................................................................................23
6.4.1.
Primary Effectiveness Endpoint..........................................................................................23
6.4.2.
Primary Safety Endpoint .....................................................................................................23
6.4.3.
Secondary and Exploratory Endpoints................................................................................23
6.5.
INVESTIGATIONAL SITES ................................................................................................................24
6.6.
TARGET ENROLLMENT...................................................................................................................24
6.7.
STUDY DURATION .........................................................................................................................24
7.
SUBJECT SELECTION .....................................................................................................................24
7.1.
STUDY POPULATION......................................................................................................................24
7.2.
INCLUSION CRITERIA .....................................................................................................................24
7.3.
EXCLUSION CRITERIA ....................................................................................................................25
7.4.
SCREENING ..................................................................................................................................25
7.5.
INFORMED CONSENT.....................................................................................................................26
7.6.
SUBJECT IDENTIFICATION ..............................................................................................................26
7.7.
RANDOMIZATION ...........................................................................................................................26
7.8.
BLINDING......................................................................................................................................27
8.
STUDY PROCEDURES .....................................................................................................................27
8.1.
SCHEDULE OF ASSESSMENTS ........................................................................................................27
8.2.
SCREENING ASSESSMENT (DAY -90 TO DAY 0)...............................................................................28
8.3.
TIPS PROCEDURE (DAY 0)............................................................................................................28
8.4.
HOSPITAL DISCHARGE...................................................................................................................29
8.5.
DAY 7 (+/- 1 DAY) FOLLOW-UP ......................................................................................................30
8.6.
DAY 30 (+/- 7 DAYS) FOLLOW UP...................................................................................................30
8.7.
STUDY COMPLETION .....................................................................................................................30
8.8.
SUBJECT WITHDRAWAL .................................................................................................................30
9.
STUDY CONDUCT.............................................................................................................................31
9.1.
INVESTIGATOR AND SITE SELECTION ..............................................................................................31
9.1.1.
Investigator Selection Criteria.............................................................................................31
9.1.2.
Site Selection Criteria .........................................................................................................32
9.1.3.
Investigator Qualifications...................................................................................................32
9.2.
SITE INITIATION.............................................................................................................................32
9.3.
ADDITIONAL SITE STAFF ACTIVATION..............................................................................................32
9.4.
SITE STAFF TRAINING REQUIREMENTS ...........................................................................................33
9.5.
CLINICAL STUDY MATERIALS AND CLINICAL STUDY-SPECIFIC EQUIPMENT ........................................33
9.6.
STUDY DEVICE SUPPLY AND ACCOUNTABILITY................................................................................33
9.6.1.
Supply of Devices ...............................................................................................................33
9.6.2.
Device Storage and Accountability .....................................................................................33
9.6.3.
Device Return Procedures..................................................................................................33
9.7.
STUDY CLOSURE AND EARLY TERMINATION....................................................................................33
9.7.1.
Routine Study Closure........................................................................................................33
9.7.2.
Early Termination................................................................................................................34

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10.
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES ..................35
10.1.
DEFINITIONS .................................................................................................................................35
10.1.1.
Adverse Event.....................................................................................................................35
10.1.2.
Serious Adverse Event .......................................................................................................35
10.1.3.
Device Deficiency ...............................................................................................................35
10.1.4.
Serious Health Threat.........................................................................................................36
10.1.5.
Adverse Device Effect.........................................................................................................36
10.1.6.
Serious Adverse Device Effect ...........................................................................................36
10.1.7.
Unanticipated Serious Adverse Device Effect ....................................................................36
10.2.
CAUSALITY ...................................................................................................................................36
10.3.
SEVERITY .....................................................................................................................................38
10.4.
ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS ....................................................38
10.4.1.
Anticipated Adverse Events................................................................................................38
10.4.2.
Anticipated Adverse Device Effects....................................................................................39
10.5.
REPORTING REQUIREMENTS..........................................................................................................39
10.5.1.
Site AE Reporting Requirements........................................................................................39
10.5.2.
Reporting Device Deficiencies............................................................................................40
11.
STATISTICAL CONSIDERATIONS...............................................................................................40
11.1.
STATISTICAL DESIGN AND METHODOLOGY......................................................................................40
11.1.1.
Descriptive Results .............................................................................................................40
11.1.2.
Exploratory Comparisons....................................................................................................40
11.2.
SAMPLE SIZE ................................................................................................................................41
11.3.
ANALYSIS SETS.............................................................................................................................41
11.3.1.
Intent-to-Treat Set...............................................................................................................41
11.3.2.
Primary Effectiveness Set...................................................................................................41
11.3.3.
Safety Population................................................................................................................41
11.4.
MISSING DATA ..............................................................................................................................41
11.5.
INTERIM ANALYSIS.........................................................................................................................42
11.6.
STATISTICAL DEVIATIONS ..............................................................................................................42
11.7.
POOLED DATA ..............................................................................................................................42
12.
DATA MANAGEMENT...................................................................................................................42
12.1.
DATA ENTRY AND COLLECTION ......................................................................................................42
12.2.
DATA REVIEW AND CLEANING ........................................................................................................42
12.3.
SOURCE DATA REQUIREMENTS......................................................................................................42
12.4.
SUBJECT CONFIDENTIALITY ...........................................................................................................43
12.5.
DATA PROTECTION........................................................................................................................43
12.6.
PROTOCOL AMENDMENTS AND DEVIATIONS....................................................................................43
12.6.1.
Amendments.......................................................................................................................44
12.6.2.
Deviations ...........................................................................................................................44
12.6.3.
Reporting ............................................................................................................................44
13.
STUDY ADMINISTRATION............................................................................................................45
13.1.
REGULATORY COMPLIANCE ...........................................................................................................45
13.2.
SPONSOR RESPONSIBILITIES .........................................................................................................45
13.3.
INVESTIGATOR RESPONSIBILITIES...................................................................................................45

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13.4.
RETENTION OF STUDY RECORDS ...................................................................................................45
13.5.
STUDY FUNDING ...........................................................................................................................46
13.6.
CLINICAL STUDY AGREEMENT........................................................................................................46
13.7.
SUBJECT COMPENSATION..............................................................................................................46
13.8.
INSURANCE...................................................................................................................................46
13.9.
PUBLICATION POLICY ....................................................................................................................47
13.9.1.
Study Registration...............................................................................................................47
13.9.2.
Clinical Study Report ..........................................................................................................47
13.9.3.
Use of Information and Publications ...................................................................................47
13.10.
MINIMIZATION OF BIAS...............................................................................................................47
13.11.
POTENTIAL CONFOUNDING FACTORS .........................................................................................47
13.12.
SCIENTIFIC ROBUSTNESS ..........................................................................................................48
13.13.
MONITORING.............................................................................................................................48
13.14.
OTHER ASPECTS OF CLINICAL QUALITY ASSURANCE...................................................................48
14.
REFERENCES ...............................................................................................................................49
LIST OF TABLES
Table 1. Components of the Scorpion Sets.................................................................................18
Table 2. Scorpion Portal Vein Access Kit Part Numbers.............................................................19
Table 3. Components of the Transjugular liver access sets........................................................20
Table 4. Transjugular Liver Access Set Part Numbers ...............................................................20
Table 5. Overview of Secondary and Exploratory Endpoints......................................................23
Table 6. Schedule of Assessments .............................................................................................27
LIST OF FIGURES
Figure 1. SCORPION puncture tool configurations.....................................................................18

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ABBREVIATIONS AND ACRONYMS 
ADE
Adverse Device Effect
AE
Adverse Event
CBC
Complete Blood Count
CIP
Clinical Investigation Plan
CFR
Code of Federal Regulations
CMP
Comprehensive Metabolic Panel
CO2
Carbon Dioxide
COV
Close-out Visit
CRO
Contract Research Organization
CSA
Clinical Study Agreement
CSR
Clinical Study Report
CT
Computed Tomography
CV
Curriculum Vitae
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
EU
European Union
F
French
FDA
Food and Drug Administration
ga
Gauge
HIPAA
Health Insurance Portability and Accountability Act of 1996
HPVG
Hepatic Venous Pressure Gradient
HV
Hepatic Vein
ICE
Intracardiac Echocardiography
ICF
Informed Consent Form
ICU
Intensive Care Unit
IFU
Instructions for Use
INR
International Normalized Ratio
IRB
Institutional Review Board
ISF
Investigator Site File
ISO
International Standards Organization
ISO 14155  
Clinical Investigation of Medical Devices for Human Subjects - Good clinical 
practice
IVUS
Transabdominal Intravascular Ultrasound
LAR
Legally Authorized Representative
MELD
Model for End-Stage Liver Disease
mGy
Milligray
mL
Milliliter
mm Hg
Millimeters of Mercury
MPA
Multipurpose Angiographic
MRI
Magnetic Resonance Imaging
PD
Protocol Deviation

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PEEK
Polyether Ether Ketone
PI
Principal Investigator
PT
Prothrombin Time
PTFE
Polytetrafluoroethylene
PV
Portal Vein
PVA
Portal Vein Access
PVPC
Portal Vein Puncture-related Complications
SADE
Serious Adverse Device Effect
SAE
Serious Adverse Event
SIV
Site Initiation Visit
TIPS
Transjugular Intrahepatic Portosystemic Shunt
TMF
Trial Master File
US
United States
USADE
Unanticipated Serious Adverse Device Effect

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1. KEY ROLES AND CONTACT INFORMATION 
1.1.
Sponsor Study Staff Contact Information
Sponsor:
Sponsor Address:
Argon Medical Devices Inc.
7800 Dallas Pkwy, Suite 200
Plano, Texas 75024
Phone: 1-800-927-4669
Sponsor Contact:
Phone:
Email:
Danyel Crout Carr, Director of Clinical Affairs
469-731-1421
Danyel.carr@argonmedical.com 
Contract Research Organization 
(CRO)
CRO Address:
Avania LLC.
100 Crowley Drive, Suite 210
Marlborough, MA 01752
1.2.
Lead Principal Investigator Contact Information
Lead Principal Investigator:
Institution:
Telephone:
Email:
Venkatesh P. Krishnasamy, MD
New York Presbyterian – Columbia University Medical 
Center, Department of Radiology
330-701-6765
vpk2113@cumc.columbia.edu 
1.3.
Principal Investigator Contact Information
Each investigational site will have one physician designated as Principal Investigator (PI). Any 
other physicians involved in the study will be documented and referred to as a Sub-Investigator. 
A current list of all investigational sites and Principal Investigators (including their roles, 
responsibilities, and qualifications) will be maintained separately from the protocol within the Trial 
Master File (TMF).

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2. SYNOPSIS
Protocol SCPVA01
Title
A Prospective, Multicenter, Randomized Study Evaluating Portal 
Vein Access Sets During Transjugular Intrahepatic Portosystemic 
Shunt (TIPS) Procedures
Short title 
Achieving Portal Access with Scorpion Post-Approval Study 
(APASS)
Protocol Number
SCPVA01
Investigational Device 
Name
Scorpion® Portal Vein Access Set
Scorpion®X Portal Vein Access Set
Intended Use
The Scorpion and Scorpion X Portal Vein Access Sets are intended 
for transjugular liver access in diagnostic and interventional 
procedures.
Comparator Device 
Manufacturer
Cook Medical Inc.
Name
Rösch-Uchida Transjugular Liver Access Set
Ring Transjugular Intrahepatic Access Set
Indication for Use
The Rösch-Uchida Transjugular Liver Access Set and Ring 
Transjugular Intrahepatic Access Set is intended for transjugular 
liver access in diagnostic and interventional procedures.
Sponsor
Name
Argon Medical Devices Inc.
Contact Details
7800 Dallas Pkwy, Suite 200
Plano, Texas 75024
Phone: 1-800-927-4669
Fax: 903-677-9396
Investigational Sites 
Number of Sites
Up to 6 investigational sites
Location of Sites
United States (US)
Clinical Study Design
Design
This is a prospective, multicenter, randomized, comparative, post-
market clinical study
Objective
To evaluate the safety and effectiveness of portal vein access sets 
during TIPS procedures with the goal of creating the parenchymal 
tract for indicated interventional procedures. Preliminary safety, 
effectiveness, and performance data for the Scorpion Portal Vein 
Access sets will be compared to the Cook Transjugular Liver 
Access sets.
Hypothesis
No formal statistical hypothesis will be tested
Primary Effectiveness Endpoint
Procedural success, which is defined as creation of the 
parenchymal tract between the hepatic vein and an intrahepatic 
branch of the portal vein confirmed by portogram (CO2/contrast)

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Primary Safety Endpoint
Major complications associated with the device/procedure, which 
are defined as complications resulting in an unplanned increase in 
the level of care, prolonged hospitalization, permanent adverse 
sequelae, or death
Secondary Endpoints
•
Portal vein access (PVA) time defined as the time between initial 
needle throw to portal vein access confirmed by portogram
•
Technical success defined as creation of a shunt (stent bridging) 
between the portal and systemic veins
•
Number of needle passes
•
Procedure duration defined as the interval from the first jugular 
access for TIPS creation to removal of catheters from the 
subject
•
Fluoroscopy Time
•
Device-Related Complications, in the judgment of the Principal 
Investigator
Exploratory Endpoints
•
Change in Model for End-Stage Liver Disease (MELD)/Child-
Pugh score
•
Radiation dosage measured in Air kerma (mGy)
•
Contrast volume used
•
Length of hospital stay and number of ICU days
•
Change in hepatic venous pressure gradient (HPVG)
Arms and Interventions 
Two Arms: 
1.
Procedure with the Scorpion Portal Vein Access Kit
2.
Procedure with the Cook Transjugular Liver Access Set
Intervention:
Subjects will undergo a transjugular intrahepatic portosystemic 
shunt procedure during which portal vein access will be obtained 
using the Scorpion (Group 1) or Cook (Group 2) device.
Follow-up Visits
Subjects will be evaluated at:
•
Screening
•
TIPS Procedure
•
Discharge
•
Day 7 post-procedure
•
Day 30 post-procedure
Evaluation includes the following procedures/assessments:
-
Medical history
-
Physical examination
-
Laboratory values (e.g., complete blood count, 
comprehensive metabolic panel, prothrombin time, and 
international normalized ratio)
-
MELD score
-
Child-Pugh Score
-
TIPS Procedure information
-
Imaging (i.e., ultrasound, computed tomography or 
magnetic resonance imaging, and echocardiogram)
-
Adverse events assessment

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Total Duration
Estimated enrollment period: Approximately 6 months
Study duration for the subject: Approximately 1 month
Total study duration: Approximately 7 months
Clinical Study Population
Population
The study population will consist of subjects undergoing a TIPS 
procedure for refractory variceal bleeding, refractory ascites and/or 
hydrothorax. The planned sample size is 60 subjects (30 per 
group). The planned sample size is empirical, as no formal 
statistical hypothesis will be tested.
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
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 
Statistical Analysis 
Statistical Methodology
Study outcomes will be presented descriptively for each treatment 
group. In addition, outcomes by baseline demographic and clinical 
characteristics will be presented. No formal study hypothesis will be 
tested, however, between-group differences in study endpoints will 
be assessed with comparative tests, for exploratory purposes.

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3. INTRODUCTION
Argon Medical Devices Inc. (“Argon”) has developed the Scorpion® Portal Vein Access Set 
(“Scorpion set”) to create a pathway through the liver parenchyma through which an 
endoprosthesis can be delivered. The objective of this post-market clinical study is to evaluate 
the safety and effectiveness of Scorpion compared to Cook Transjugular Liver Access Set during 
transjugular intrahepatic portosystemic shunt procedures. This is a post approval study being 
conducted in the US and will be used to support initial CE mark approval in the EU. 
3.1.
Background
Portal hypertension is high blood pressure in the portal vein located in the abdomen. The portal 
vein returns blood from the digestive system to the liver for the purpose of cleaning and filtering 
waste from the blood. This condition is the most frequent cause of hospitalization, variceal bleed, 
liver transplantation, and death in patients with cirrhosis.1
Elevated pressures in the portal venous system will manifest as abdominal ascites, hepatic 
hydrothorax, hepatorenal syndrome, portal hypertensive gastropathy and gastro-esophageal 
varices with or without bleeding, which are markers of decompensation and associated with 
significant morbidity and mortality.
Transjugular intrahepatic portosystemic shunt (TIPS) is a well-established percutaneous modality 
for decreasing portal hypertension by creating a shunt through the hepatic parenchyma to connect 
the hepatic vein to the portal vein. Although the major clinical indications for TIPS include 
refractory variceal hemorrhage and refractory ascites, the full list of TIPS indications includes:2
1.
Uncontrollable variceal hemorrhage
2.
Current or prior variceal hemorrhage that is not amenable to initial or continued 
endoscopic therapy
3.
Prophylaxis against recurrent variceal bleed in high-risk patients
4.
Portal hypertensive gastropathy 
5.
Refractory ascites
6.
Hepatic hydrothorax
7.
Budd-Chiari syndrome
8.
Hepatopulmonary syndrome
9.
Hepatorenal syndrome
10. Decompression of portosystemic collaterals prior to abdominal surgical procedures
Overall, the TIPS procedure is one of the most challenging procedures performed by 
interventional radiologists, and the most difficult and time-consuming step in the procedure is 
accessing the portal vein. Many techniques for accessing the portal vein have been described in 
literature and they fall into three broad categories:
•
Fluoroscopically guided TIPS creation with the use of landmarks or portography 
(wedged hepatic vein portography with CO2 umbilical venography)
•
Transabdominal ultrasound – guided placement of a portal vein target via transhepatic or 
transplenic access to facilitate subsequent fluoroscopically guided access

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•
Transabdominal intravascular ultrasound (IVUS), or intracardiac echocardiography (ICE) 
guidance3
ICE uses a low-frequency, side-firing intravascular transducer and is more commonly used for 
intracardiac procedures. However, in this application in can be used to depict the central portion 
of the liver, which permits visualization of the needle and the PV target without the use of 
fluoroscopy or contrast medium.
Cam et al.4 reported that ultrasound-guided PV access and percutaneous PV guidewire 
placement for fluoroscopic targeting during TIPS creation are associated with shorter procedure 
and fluoroscopic times and potentially decreased complications. Many of the procedure-related 
complications of TIPS creation, such as arterial injury, biliary injury, and extracapsular puncture 
may occur during attempted portal vein access. As the number of needle passes for successful 
PV access increases, so may the potential for puncture-related complications.
Historically, the most performed technique for portal venous access involved wedge hepatic 
venography with carbon dioxide to visualize the portal vein followed by passing the needle under 
fluoroscopic guidance. In the last 10 years, imaging guidance options have evolved beyond 
traditional wedge carbon dioxide portography to include ultrasound-guided options such as 
transabdominal, intravascular and intracardiac echocardiography  to help with visualization and 
portal vein cannulation. Portal vein access may require multiple needle passes and is considered 
the riskiest step in TIPS creation with possible incidence of portal vein puncture-related 
complications (PVPC).5 Complications result from inadvertent injury to non-target vessels and 
include damage to the hepatic artery or extrahepatic portal vein, transcapsular puncture and 
laceration of the liver capsule, all of which can result in life-threatening hemorrhage.6
3.2.
Prior Investigations
The Rosch-Uchida and Colapinto sets manufactured by Cook Medical (Bloomington, Indiana, US) 
are two different needle sets currently available and most encountered. A recent systematic 
review of literature showed that the overall incidence of PVPC with the Cook sets was 3.6%.6 The 
procedure duration varies in literature due to protocol differences and imaging techniques used. 
David et al.7 reported a mean procedure duration of 86.2 minutes using ultrasound guidance. In 
a study evaluating time to portal vein access, mean time to portal venous access was statistically 
significant between conventional fluoroscopy at 46 minutes and intravascular US-guided TIPS at 
31 minutes.8
In the paucity of studies available which focus on portal vein access in TIPS interventions, there 
are few that demonstrate significant differences between the number of needle passes. The data 
is incomplete because fewer than half of conventional TIPS cases in literature included a 
recording of the actual number of passes. The Scorpion devices allow for bi-directional positioning 
of the needle or stylet for precise placement during portal vein puncture. 
In a retrospective study of 15 cases with Scorpion X (Needle model), technical success was 
achieved in 100% of cases with an average of 2.7 passes, and because of the bi-directional 
needle, no cases required adjustment to the curvature of the needle.9

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3.3.
Study Rationale
The aim of this study is to collect real-world data on safety, effectiveness, and performance of the 
Scorpion Portal Vein Access Sets in subjects undergoing a TIPS procedure. The study supports 
post-market surveillance and will serve to provide clinical data for the initial CE Mark application. 
In addition, the study will allow the collection of preliminary clinical performance data compared 
to competitor devices. 
4. STUDY DEVICES
4.1.
Investigational Device
4.1.1.
Device Manufacturer
Argon Medical Devices Inc. (Plano, Texas, US) is the legal manufacturer of the Scorpion 
Portal Vein Access Sets. The company address is as follows: 
Argon Medical Devices, Inc.
7800 Dallas Parkway, Suite 200
Plano, TX 75024
USA
4.1.2.
Regulatory Status and Indications for Use
The Scorpion Portal Vein Access Sets received initial clearance in the US on 15 January 
2021 under 510(k) number K202141 and was subsequently modified under 510(k) number 
K213002. The devices are intended for transjugular liver access in diagnostic and 
interventional procedures. 
In the US, the Scorpion Portal Vein Access Sets are classified as Class II devices. The device 
common name is catheter introducer per regulation number 21 CFR 870.1340 and product 
code DYB.
4.1.3.
Device Description
There are two models of the Scorpion Portal Vein Access Sets: Scorpion and Scorpion X. 
The Scorpion model has a stylet as the puncture tool and the Scorpion X model has a 17 ga 
needle as the puncture tool (Figure 1). 
A. Scorpion Nitinol Stylet

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B. Scorpion X Nitinol 
Needle
FIGURE 1. SCORPION PUNCTURE TOOL CONFIGURATIONS
In addition to the puncture tool, each Scorpion set contains an MPA catheter, a stiffening 
cannula, a cannula sheath, and a PEEK catheter (see Table 1). The Scorpion® Portal Vein 
Access Set does not contain medicinal substances, human, or animal tissues or their 
derivatives, or other biologically active substances.
The Scorpion set is used to gain access to the hepatic vein and guide the puncture tool (stylet 
or needle) through the liver parenchyma. The puncture tool makes a pathway between the 
hepatic vein and the portal vein. The choice of stylet or needle is physician preference based 
on training and the subject case. This will not have an impact on the endpoints of this clinical 
study and, as such, there is no requirement that the same number of both models is used 
during the study.
The Scorpion set is compatible with the 10F Flexor® Check-Flo® Introducer Set 
manufactured by Cook Medical and is typically in use up to four hours. 
TABLE 1. COMPONENTS OF THE SCORPION SETS
Scorpion 
Scorpion X
Function / Description
0.040” Nitinol Stylet
17ga Nitinol Needle
5F PEEK Catheter
6.2F PEEK 
Catheter
The stylet/needle and PEEK catheter assembly is 
used to navigate the liver parenchyma and make a 
pathway from the hepatic vein to the portal vein.
Spacer Clip
Spacer Clip
The spacer clip is placed between the PEEK Catheter 
and the stylet/needle when assembled to prevent 
premature puncture prior to proper orientation with the 
portal vein.
5F MPA Catheter
5F MPA Catheter
The MPA catheter is used for angiographic 
procedures to deliver radiopaque media.
14ga Stiffening 
Cannula
13ga Stiffening 
Cannula
7F Cannula Sheath
8F Cannula Sheath 
The cannula and cannula sheath assembly is used for 
bi-directional steering through the liver parenchyma 
into the hepatic vein to orient toward the portal vein.
MPA = Multipurpose Angiographic

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4.1.4.
Intended Purpose in the Clinical Study
The Scorpion Portal Vein Access Sets (Scorpion Set) are being used in accordance with the 
cleared indication for use in this clinical study for transjugular liver access in an interventional 
procedure.
The intended purpose of the Scorpion set is to create the parenchymal tract between the 
hepatic vein and an intrahepatic branch of the portal vein during the TIPS procedure in 
subjects being treated for refractory variceal bleeding, refractory ascites and/or hydrothorax.
4.1.5.
Device Instructions for Use
The Scorpion sets will be used in accordance with current Instructions for Use (IFU) included 
in the device packaging.
The Scorpion Portal Vein Access Kits are identified with part number and lot number.
TABLE 2. SCORPION PORTAL VEIN ACCESS KIT PART NUMBERS
Part Number
Description
TPS005
Scorpion® Portal Vein Access Set
TPS006
Scorpion®X Portal Vein Access Set
All components of the Scorpion set are supplied sterile and are intended for single use only. 
The devices must not be re-sterilized.
4.2.
Comparator Device
4.2.1.
Device Manufacturer
Cook Medical Inc. is the legal manufacturer of the comparator devices, the Cook Transjugular 
Liver Access Sets. The company address is as follows:
Cook Medical, Inc.
750 Daniels Way
Bloomington, IN 47404
USA
4.2.2.
Regulatory Status and Indications for Use
The Transjugular Liver Access Sets received clearance in the US on 09 March 2018 under 
510(k) number K171820. The devices are intended for transjugular liver access in diagnostic 
and interventional procedures. 
In the US, the Transjugular Liver Access Sets are classified as Class II devices. The device 
common name is catheter introducer per regulation number 21 CFR 870.1340 and product 
code DYB.
4.2.3.
Device Description

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The Transjugular Liver Access Sets are comprised of various components that facilitate 
transjugular access to the liver for the purpose of performing diagnostic and interventional 
procedures. There are two models of the Transjugular Liver Access Sets: Ring Transjugular 
Intrahepatic Access Set and the Rösch-Uchida Transjugular Liver Access Set. 
Each set includes a core component comprised of a combination of either a stiffening 
cannula/Teflon catheter or needle stylet/Teflon catheter that facilitates access into the 
hepatic vasculature and the creation of a pathway into the portal vein. Other components 
included in some of these sets are a Check-Flo Introducer Set, selective catheters, and wire 
guides (Table 3).
The Ring Transjugular Intrahepatic Access Set’s core component is a Colapinto Needle and 
Catheter Assembly. The Rösch-Uchida Transjugular Liver Access Set’s core component is 
a Stylet and Catheter Assembly that functions coaxially with a stiffening access cannula 
which provides access and support for the needle stylet/catheter assembly. 
TABLE 3. COMPONENTS OF THE TRANSJUGULAR LIVER ACCESS SETS
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4.2.4.
Intended Purpose for the Clinical Study
The Transjugular Liver Access Sets are being used in accordance with the cleared indication 
for use in this clinical study for transjugular liver access in an interventional procedure.
The intended purpose of the Transjugular Liver Access Set is to create the parenchymal tract 
between the hepatic vein and the intrahepatic branch of the portal vein during the TIPS 
procedure in subjects being treated for refractory variceal bleeding, refractory ascites and/or 
hydrothorax.
4.2.5.
Device Instructions for Use
The Transjugular Liver Access Sets will be used in accordance with current Instructions for 
Use (IFU) included in the device packaging.

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Transjugular Liver Access Sets are identified by an order number, reference part number 
and lot number.
TABLE 4. TRANSJUGULAR LIVER ACCESS SET PART NUMBERS
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4.3.
Required Training and Experience
Investigators participating in this study must be physicians with the appropriate qualifications 
required to perform a TIPS procedure.2 At a minimum, Investigators should have performed at 
least 50 TIPS to demonstrate proficiency with the procedure. 
All Investigators must have experience using the Scorpion Portal Vein Access Set and the Cook 
Transjugular Liver Access Set and be willing to use either set to participate in this study. Given 
the novelty and recent introduction of the Scorpion sets, Investigators will be required to 
demonstrate proficiency with the device as part of Argon’s certification program.
5. RISK/BENEFIT ANALYSIS  
5.1.
Potential Clinical Benefits
The study devices facilitate transjugular liver access and portal vein access in TIPS procedures. 
The design of the Scorpion set should improve the physician’s ability to navigate through the liver 
parenchyma and reduce the number of attempts necessary to establish access to the portal vein, 
particularly in diseased livers where irregular anatomy is frequently observed. There are no 
guaranteed benefits from participation in this study; however, potential clinical benefits may 
include:

Shorter procedure duration

Shorter fluoroscopic times

Improved navigation control

Reduced needle passes for successful PV access

Decreased puncture-related complications
Information gained from the conduct of this study may be a benefit to physicians and other 
persons with the same medical condition.
5.2.
Risks Associated with Participation in the Clinical Study

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This clinical study involves the use and disclosure of health information. It collects only information 
relevant to the subject’s condition and its treatment. Neither the device, nor the procedures and 
tests conducted, as part of the study are investigational or outside of the standard of care.
The study involves the collection of specific information for research purposes only. Investigators 
participating in this study are expected to review the indications, contraindications, warnings, 
precautions, and potential complications described in the IFU. The treating physician is expected 
to counsel the subject on the risks and benefits specific to the planned treatment and to obtain 
procedure-related informed consent per institutional policy and procedure.

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5.3.
Possible Interactions with Concomitant Medical Treatments
Use of additional devices or specific medications is not required as part of this study. If additional 
devices and/or medications are used per physician discretion in the treatment of a study subject, 
information on their use will be collected.
5.4.
Risk Mitigation
The study is designed to minimize risk through strict selection criteria for investigational sites and 
Investigators, previous experience with the procedure and devices, and adherence to standard of 
care with post-procedure evaluations.
Since the study was designed to collect real-world data following use of the portal vein access 
sets, the risk of providing this health information is believed to be minimal as information directly 
identifying the subject will not be collected in the study database.
5.5.
Benefit-to-Risk Rationale
Any potential risk presented by this clinical study has been minimized and adequate testing, 
safeguards, and safety monitoring have been incorporated into the clinical study to further 
minimize and mitigate the risks. Based on the review of all risks, residual risks, and risks resulting 
from risk mitigation, Argon has determined that the risks to participate are acceptably low. The 
devices will be used in accordance with their approved indications and standard of care for the 
subject population is being followed. The potential benefits outweigh the potential risks of using 
the Scorpion set and participating in this study.
6. DESIGN OF THE CLINICAL STUDY
6.1.
Study Objective
The primary objective of this clinical study is to evaluate the safety and effectiveness of portal 
vein access sets during TIPS with the goal of creating the parenchymal tract for indicated 
interventional procedures. The study will collect safety and effectiveness data on the Scorpion set 
which will be compared to data collected on the Cook Transjugular Liver Access Set.
6.2.
Study Hypothesis
No formal study hypothesis will be tested, but it is expected that the safety and effectiveness of 
the Scorpion set are similar to the Cook Transjugular Liver Access Set.
6.3.
Study Design
This is a prospective, multicenter, randomized comparative post-market study in the United States 
(US). The study consists of a one-day intervention in subjects indicated to undergo a TIPS 
procedure with the aim of collecting real world safety and effectiveness data on the Scorpion set 
and comparator devices. 
The Cook Transjugular Liver Access set was chosen as the comparator device because it is 
commonly used.  

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6.4.
Study Endpoints
6.4.1.
Primary Effectiveness Endpoint
The primary effectiveness endpoint is procedural success defined as creation of the 
parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein and 
confirmed by portogram (CO2/contrast).
Failure to create the parenchymal tract between the hepatic vein and the portal vein with the 
randomized assignment will be considered a treatment failure. A minimum of 5 needle 
passes should be attempted before selecting the alternative set.
In the event of a treatment failure, the physician will follow their standard of care procedures 
and/or use another commercially available product. The patient should be followed in the 
study through hospital discharge for adverse event monitoring.
6.4.2.
Primary Safety Endpoint
The primary safety endpoint is a composite of 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.10
6.4.3.
Secondary and Exploratory Endpoints
The secondary and exploratory endpoints of this clinical study are outlined in Table 5.
TABLE 5. OVERVIEW OF SECONDARY AND EXPLORATORY ENDPOINTS
Endpoint
Description / Definition
Secondary Endpoints
Portal Vein Access (PVA) time
Time (in minutes) from initial needle throw to portal vein access as 
confirmed by portogram
Technical success
Creation of a shunt (stent bridging) between the portal and 
systemic veins
Number of needle passes
Count of needle throws between the hepatic and portal vein to 
create the parenchymal tract
Procedure duration
Interval (in minutes) from first jugular access for TIPS creation to 
removal of catheters from subject
Fluoroscopy time
Measured in minutes
Device-related complications
Incidence of complications related to the device as judged by the 
Principal Investigator
Exploratory Endpoints

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Change in MELD score
Change in Child-Pugh score
Change in score from Screening to Day 30
Radiation dosage
Measured in air kerma (mGy)
Contrast volume used
Measured in mL
Length of Hospital Stay
Measured in days
Number of ICU days
Measured in days
Change in HPVG
Measured in mm Hg
MELD = Model for End-Stage Liver Disease; ICU = Intensive Care Unit; HPVG = Hepatic Venous Pressure 
Gradient
6.5.
Investigational Sites
The clinical study will be conducted at up to six (6) investigational sites in the US. Sites will have 
a clinical environment that is representative of the normal conditions of use of the study devices 
in the target population. The governing Institutional Review Board (IRB) for each participating site 
will review and approve the protocol, informed consent form, and any other applicable study-
related documents prior to enrolling subjects. Additional information on site selection is included 
in Section 9.1.
A site contact list containing contact information for site staff participating in this study will be 
maintained in the Investigator Site File (ISF) and Trial Master File (TMF).
6.6.
Target Enrollment
Approximately 60 subjects (30 per group) indicated to undergo a TIPS procedure who are eligible 
for the study and agree to participation will be enrolled. Subjects will be enrolled in the study once 
and have one TIPS procedure.
Each investigational site will be limited to enroll up to 16 subjects.
6.7.
Study Duration
The study enrollment period is anticipated to take approximately 6 months. Enrolled subjects are 
followed for 30 days from the TIPS procedure requiring individual subject participation for 
approximately 1 month.
Upon completion of all enrolled subjects, study closure, including data analysis and preparation 
of the clinical study report, is estimated to take up to an additional 6 months. 
Total study duration is expected to be approximately 13 months.
7. SUBJECT SELECTION
7.1.
Study Population

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Subjects undergoing an interventional TIPS procedure for refractory variceal bleeding, refractory 
ascites, and/or hydrothorax are the target population for this study because cases tend to be non-
emergent and scheduled. 
The study population represents the intended population for the study devices in terms of age 
(adult population), sex (both male and female), procedure (transjugular liver access for diagnostic 
or interventional procedures). 
7.2.
Inclusion Criteria
Subjects must meet all inclusion criteria listed below to be eligible for enrollment in the study:
1.
At least 18 years of age at the time of the TIPS procedure
2.
TIPS 
procedure 
initiated 
for 
refractory 
variceal 
bleeding 
and/or 
refractory 
ascites/hydrothorax
3.
Willing and able to provide written informed consent and Health Insurance Portability and 
Accountability Act (HIPAA) authorization, either individually or through a legally authorized 
representative (LAR)
4.
Willing and able to comply with the study procedures and follow up schedule
7.3.
Exclusion Criteria
Subjects meeting any of the following exclusion criteria will not be eligible for enrollment in the 
study:
1.
Known active malignancy
2.
Model for End-Stage Liver Disease (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
7.4.
Screening
Potential subjects will be identified from non-emergent cases scheduled for a TIPS procedure. All 
potential subjects will be contacted remotely or in-person by the treating physician (i.e., the PI) or 

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investigational site staff. During this contact, the PI will verify eligibility of the subject based on the 
inclusion and exclusion criteria listed in Sections 7.2 and 7.3. 
Eligibility of potential subjects can be determined from historical laboratory, imaging, and 
echocardiography results previously taken per standard of care. Labs must have been taken 
within 30 days prior to the scheduled TIPS procedure. Imaging and echocardiography must have 
been obtained within 90 days prior to the scheduled TIPS procedure.
Subjects that fail to meet the study screening criteria will be documented as a screen failure on 
the study screening and enrollment log. Screen failures can be re-screened for study eligibility at 
the discretion of the Investigator. If a subject is re-screened, a new entry should be recorded on 
the study screening and enrollment log.
7.5.
Informed Consent
Subjects must be fully counseled and informed of their study options, risks, and benefits, and 
have every opportunity to ask questions about participation in this study. The subject will sign the 
IRB-approved ICF prior to initiation of the TIPS procedure. For subjects who are unable to provide 
written consent, consent may be obtained from the subject’s legally authorized representative 
(LAR) per the institution/IRB policies, if allowed.
A copy of the signed statement of informed consent will be provided to the subject and/or LAR. 
The PI or qualified designee is responsible for obtaining written informed consent from each 
subject prior to participation in the clinical study. Should the Investigator delegate the 
responsibility of conducting the informed consent process to a designee, the Investigator must 
ensure and document appropriate training of the authorized designee. 
If new information regarding the investigational device becomes available and/or changes to the 
protocol affect a subject's future health and medical care, subjects will be provided with the 
information and may be asked to sign a revised informed consent form.
The consent process must be documented in the subject’s medical record. The original, fully 
signed consent form will be kept in the site’s study file or subject medical record per the institution 
policy. A fully signed copy must also be provided to the subject and/or LAR.
Subjects that decline participation in the study, do not provide consent, or withdraw consent prior 
to initiation of the TIPS procedure will be documented as a screen failure on the study screening 
and enrollment log.
Once the study-specific informed consent form (ICF) is signed, the subject is considered enrolled.
7.6.
Subject Identification
Enrolled subjects will be assigned a unique subject identification (ID) number. The subject ID 
number will be included on all study documentation relating to that subject. If an enrolled subject 
is withdrawn, the subject ID number will not be re-used in this study.
The investigational site will maintain a study screening and enrollment log linking the assigned 
study subject ID and the subject’s name, alternative identification (e.g., medical record number) 

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and/or contact information. This log will be maintained only at the investigational site and used 
during monitoring to assure the correct identity of the subject records used for source document 
verification.
7.7.
Randomization
Randomization will occur after an eligible subject has signed the ICF and prior to initiation of the 
TIPS procedure. Subjects will be randomly assigned at a 1:1 ratio into one of the two study groups 
(Scorpion or Cook) via a centralized randomization service.
Once the randomization assignment is received, the physician will determine the model he/she 
wants to use based on preference, training, and the subject case before beginning the procedure. 
7.8.
Blinding
This is an open-label study. Blinding is not utilized.
8. STUDY PROCEDURES
8.1.
Schedule of Assessments
The procedures and assessments for this study are outlined in the schedule of assessments 
(Table 6). 
Study data will be collected at the following 5 time points: screening, TIPS procedure, hospital 
discharge, Day 7 follow up, and Day 30 follow up. Subjects will be exited from the study following 
completion of the Day 30 follow up visit or when they withdraw from the study. More detailed 
descriptions of the assessments are provided in subsequent sections.

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Table 6. Schedule of Assessments
Procedure / Assessment
Screening 1
(Day -90 to 
Day 0)
TIPS 
Procedure 
(Day 0)
Hospital 
Discharge
Day 7 7 
(± 1 day)
Day 30
(± 7 days)
Informed Consent
X
Demographic Data
X
Inclusion/Exclusion Criteria
X
Medical History
X
Physical Exam
X
X
X
Labs: CBC, CMP, PT, INR
X2
X
X
MELD Score
X
X
X
Child-Pugh Score
X
X
X
Randomization
X4
TIPS procedure
X
Duplex Ultrasound
X
CT or MRI
X3
Echocardiography
X3
Portogram
X5
AE Assessment
X6
X
X
X
Concomitant Medications
X
X
X
X
Study Exit
X8
1 Assessments to be done prior to any study related procedure
2 Within 30 days prior to the procedure
3 Preprocedural imaging via standard of care obtained within 90 days prior to the procedure
4 Randomization must be completed prior to TIPS procedure
5 At portal vein access and following stent deployment
6 Adverse Events will be assessed during and after the procedure
7 Phone call if subject has been discharged, in-person if subject is still in the hospital on Day 7
8 Study Exit may occur prior to Day 30 as Early Exit 
8.2.
Screening Assessment (Day -90 to Day 0)

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The data captured for the Screening assessment may be gathered over the course of more than 
one day. However, the data must be obtained within 90 days prior to the TIPS procedure date 
except as noted below. All data must be documented in the subject’s medical record and reported 
on the appropriate eCRF.
The following activities will be performed for the Screening assessment:

Collection of demographic information

Review of inclusion/exclusion criteria

Collection of clinically significant medical history data, including indications for the 
procedure 

Perform physical examination, including at a minimum:
o
Evaluation for hepatic encephalopathy
o
Evaluation for presence of ascites 

Perform blood draw, if not performed as standard of care within 30 days prior to the 
procedure, for clinical evaluation of the following labs:
o
Complete Blood Count (CBC)
o
Comprehensive Metabolic Panel (CMP)
o
Prothrombin Time (PT)
o
International Normalized Ratio (INR)

Determine MELD Score

Determine Child-Pugh Score

Perform radiologic evaluation to assess hepatic venous patency, portal venous patency, 
and hepatic arterial patency and excluding potential masses in the liver.
o
Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) obtained 
within 90 days prior to the procedure can be used.

Perform Echocardiography, if not performed as standard of care within 90 days prior to 
the procedure, to assess cardiopulmonary status

Record Concomitant Medications (only rifaximin, lactulose, and medications which are an 
anticoagulant, antiplatelet, or diuretic will be recorded)
8.3.
TIPS Procedure (Day 0)
The TIPS procedure will be completed in a clinical setting with adequate angiographic equipment 
and institutional facilities, physiologic monitoring equipment, and support personnel.
Transjugular liver access will be obtained using either the Scorpion set or Cook set per 
randomization assignment and physician choice of model. The procedure will be performed in 
accordance with the Scorpion IFU or the Cook IFU. Refer to the current IFU included with the 
device for techniques and methods for pre-procedure preparation and directions for use. The 
specific model and treatment details (e.g., access site, access side, stent, etc.) will be determined 
by the physician based on the condition of the subject.

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A minimum of 5 needle passes should be attempted with the initial device assigned through 
randomization before selecting the alternative manufacturer set. If an alternative manufacturer 
set is selected, the information will be recorded as part of the study records. 
The following procedure data are to be collected and recorded in the subject’s medical record or 
other applicable source documents which will be reported on the appropriate eCRF:

Jugular access site

Number of needle passes

Hepatic vein used for access

Access device used

Portal vein access site

Imaging used

Alternate access sites/techniques used

Sheath used

Stent used, dilated to what size

Pressure gradient measurements: pre- and post-delivery of stent

Presence of residual varices 

Adverse events (during and post procedure)

Record Concomitant Medications (only rifaximin, lactulose, and medications which are an 
anticoagulant, antiplatelet, or diuretic will be recorded)
A portogram must be obtained to confirm creation of the parenchymal tract between the hepatic 
vein and an intrahepatic branch of the portal vein upon portal vein access and following stent 
deployment.
8.4.
Hospital Discharge
At discharge from the hospital, usually between 1-7 days post TIPS procedure, subjects will be 
evaluated, and the following activities will be performed:

Physical examination, including at a minimum: 
o
Evaluation for hepatic encephalopathy
o
Evaluation for presence of ascites 

Blood draw, for clinical evaluation of the following labs: 
o
Complete Blood Count (CBC)
o
Comprehensive Metabolic Panel (CMP)
o
Prothrombin Time (PT)
o
International Normalized Ratio (INR)

Determine MELD Score

Determine Child-Pugh Score

Adverse event assessment

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Record Concomitant Medications (only rifaximin, lactulose, and medications which are an 
anticoagulant, antiplatelet, or diuretic will be recorded)
All data must be documented in the subject’s medical record and reported on the appropriate 
eCRF.
8.5.
Day 7 (+/- 1 Day) Follow-Up
Adverse events will be assessed seven days (± 1 day) after the TIPS procedure. New adverse 
events or updates to previously reported adverse events will be documented in the subject’s 
medical record and reported on the appropriate eCRF.
If the subject has been discharged from the hospital, the 7 Day post-procedure follow up will be 
conducted via phone call with designated study staff. 
If the subject remains in the hospital, the 7 Day post-procedure assessment can be done in person 
by designated study staff. 
If the visit window overlaps with hospital discharge, the 7 Day follow up assessment of adverse 
events should be done as part of hospital discharge. 
8.6.
Day 30 (+/- 7 days) Follow Up
The 30 Day follow up assessment will be the final study visit and subjects will exit the study after 
completion of this follow up visit. 
Thirty days (± 7 days) after the TIPS procedure, subjects will return to the clinic for a follow up 
visit during which the following activities will take place:

Physical examination, including at a minimum: 
o
Evaluation for hepatic encephalopathy
o
Evaluation for presence of ascites

Blood draw, for clinical evaluation of the following labs: 
o
Complete Blood Count (CBC)
o
Comprehensive Metabolic Panel (CMP)
o
Prothrombin Time (PT)
o
International Normalized Ratio (INR)

Determine MELD Score

Determine Child-Pugh Score

Duplex Ultrasound to assess hepatic venous patency, portal venous patency, and shunt 
status

Adverse event assessment

Record Concomitant Medications (only rifaximin, lactulose, and medications which are an 
anticoagulant, antiplatelet, or diuretic will be recorded)
8.7.
Study Completion 

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A subject will exit the study after completion of the Day 30 follow up assessments or an event that 
precludes further participation in the study. 
The clinical study will be considered completed when all subjects have exited the study.
8.8.
Subject Withdrawal
Subjects have the right to withdraw from the clinical study at any time and for any reason without 
prejudice to their future medical care by the investigational site staff or institution. If a subject 
decides to withdraw, all study-specific procedures will be stopped. The data captured for those 
participants up to the day of withdrawal will be kept in the database, as permitted by national laws 
and regulations. Whenever possible, the site staff should obtain written documentation from the 
subject that wishes to withdraw consent for future study activities and contacts. If the site staff is 
unable to obtain written documentation, all information regarding the subject’s withdrawal must 
be documented in the subject’s medical record and reported on the appropriate eCRF.
Withdrawal of a subject from the study may also occur at the discretion of the Principal Investigator 
or the Sponsor. Reasons for physician and/or Sponsor-directed subject withdrawal include, but 
are not limited to:
•
The subject is not adhering to the study requirements
•
Subject enrollment in another study that conflicts with this study’s outcomes
•
It is in the best interest for the safety or welfare of the subject to be withdrawn
If a subject is amenable at the time of withdrawal, the assessments specified at the final study 
visit (Day 30) should be collected and documented in the subject’s medical record and reported 
on the appropriate eCRF. 
In general, any ongoing or unresolved AEs/SAEs at study end will proceed with standard of care 
per institution policy. 
9. STUDY CONDUCT
9.1.
Investigator and Site Selection
9.1.1.
Investigator Selection Criteria
The role of the Principal Investigator is to implement and manage the day-to-day conduct of 
the Study at the investigational site as well as ensure data integrity and the rights, safety and 
well-being of the subjects involved in the Study. The Principal Investigator is responsible for 
assuring the Study is conducted according to all protocol requirements and applicable 
regulations. Refer to Section 13.3 for more information on Principal Investigator 
responsibilities.
The following requirements will be evaluated for each Principal Investigator considered for 
participation in the Study:
•
Interest in participating in medical device studies
•
Experience conducting clinical studies

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•
Expertise in performing TIPS procedures
•
Availability to oversee study execution
•
No conflicts of interest
9.1.2.
Site Selection Criteria
The following requirements will be evaluated for each clinical Site considered for participation 
in the clinical Study:
•
Experience of site staff in conducting clinical studies
•
Adequate resources (including study coordinator(s), facilities, and administrative 
support) for the total duration of the study
•
Site has the capacity to recruit enough qualified subjects for the study
•
Computer with internet access for EDC system (ensuring authorized access in case 
of firewall)
9.1.3.
Investigator Qualifications
A copy of the current medical license and Curriculum Vitae (CV) will be obtained from all 
Investigators participating in this clinical study as listed on the study delegation log. The CV 
should be an up to date signed and dated document evidencing any required qualifications 
and including the Investigator’s current position at the investigational site. The signature on 
the CV must be dated within two years of site activation.
9.2.
Site Initiation
Prior to the initiation of this clinical study, each Principal Investigator will approve the protocol by 
signing the signature page which confirms that the clinical study will be performed in compliance 
with the current protocol. 
A Site Initiation Visit (SIV) will be conducted by the Sponsor or designee in-person or via 
teleconference to ensure proper training of the investigational site staff participating in the study, 
including principal Investigators, Sub-Investigators, study coordinators and any other site 
personnel pivotal to the conduct of the clinical study prior to enrollment of the first study subject. 
Training will include at least the following: procedures outlined in this protocol, key principles of 
Good Clinical Practices for Medical Devices (ISO 14155), instructions on completion of the case 
report forms (eCRF), content of the Investigator Site File, safety reporting, and management of 
device deficiencies.
Once all required site training and required documentation has been received, reviewed, and 
approved, the Sponsor or designee will issue written approval of site activation to the Principal 
Investigator to begin study enrollment. 
9.3.
Additional Site Staff Activation
Any additional site staff added to the study after the site initiation will receive an individual written 
approval from the Sponsor or designee once their training and other required documentation have 
been received, reviewed, and approved.

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9.4.
Site Staff Training Requirements
Prior to investigational site activation or subsequent involvement in clinical study activities, the 
Sponsor or designee will provide study training relevant and pertinent to the involvement of the 
Site staff conducting Study activities. 
Study staff training must be documented on a written training record, including at a minimum: the 
training content, the date of the training, and the trainee’s signature.
In the case of non-compliance with the study protocol or other study requirements, study staff 
may be retrained on pertinent information or documents. Re-training must also be documented 
on a written training record, including at a minimum: the training content, the date of the training 
and the trainee’s signature.
9.5.
Clinical Study Materials and Clinical Study-Specific Equipment
The Sponsor or designee will provide necessary study documentation (e.g., Investigator Site File, 
eCRF access, Study worksheets, etc.) to the investigational site. The investigational site staff are 
responsible to acknowledge receipt to the Sponsor or designee after receipt. Computer and 
internet access is required and is a pre-requisite for site participation.
9.6.
Study Device Supply and Accountability
9.6.1.
Supply of Devices
The Scorpion Portal Vein Access Kits and the Cook Transjugular Liver Access Sets are 
marketed products. The devices used in this study will be “off the shelf”. No special labeling 
is required for the devices used in the study. Marketed devices are identified with part and 
lot numbers included in the device packaging and labeling that will be recorded as part of the 
study data collection.
9.6.2.
Device Storage and Accountability
Devices will be stored according to the requirements described in the current Scorpion set 
or Cook set IFU. No study-specific device accountability processes are required for this 
study.
9.6.3.
Device Return Procedures
Not applicable. Investigational sites will dispose of used devices in accordance with the 
labeling and their institution policies. 
9.7.
Study Closure and Early Termination
9.7.1.
Routine Study Closure
When investigational sites are ready to be closed, the Principal Investigator will be notified 
by the Sponsor or designee. Appropriate notification to IRBs and regulatory authorities, as 
applicable, will also occur.

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A study close-out visit (COV) will be conducted for each site. The purpose of the COV is to 
collect all outstanding study documents, ensure that the Investigator Site File is accurate and 
complete, review record retention requirements with the Principal Investigator, and ensure 
that all applicable requirements are met for the study.
After study closure at the site, the follow up medical care for subjects will continue as per 
standard of care at the institution.
9.7.2.
Early Termination
The Sponsor has the right to terminate the study at any time.  Situations that could warrant 
study termination include, but are not limited to: 

Increased incidence of adverse experiences and/or the severity of such, suggestive 
of a potential, device-related health hazard

Insufficient subject enrollment

Recurrent protocol non-compliance, violations, or deviations

Inaccurate, incomplete, and/or untimely data recording (>2 business days) on a 
recurrent basis

Lack of cooperation with monitoring visits (e.g., failure to adequately prepare for visits, 
address action items from one visit to the next, or provide access to medical records) 
If the Sponsor suspends or terminates the study prematurely, the Sponsor will send a report 
outlining the circumstances to the IRBs, regulatory authorities as applicable, and all Principal 
Investigators.  Notification of suspension or termination will occur no later than 5 business 
days after the Sponsor makes the determination.  The Principal Investigator should follow 
subjects per standard of care at the institution.
The Sponsor reserves the right to terminate an Investigator and/or an investigational site for 
any of the following reasons:

Repeated failure to secure subject informed consent including protection of personal 
data prior to enrollment.

Failure to report safety events in a timely manner.

Failure to report serious adverse device effects within 24 hours of discovery.

Repeated protocol deviations.

Repeated failure to complete case report forms.

Failure to enroll an adequate number of subjects.
The Principal Investigator may terminate the study at his site at any time. If the Principal 
Investigator chooses to terminate the study at his site, close out procedures will be arranged 
on an individual basis after review and consultation by both parties.  In terminating the clinical 
study, the Sponsor and the Principal Investigator will assure that adequate consideration is 
given to the protection of subjects. 

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A suspended or terminated Study may not be reinitiated without approval of the reviewing 
IRBs, and regulatory authority, as applicable.  

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10.
 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE 
DEFICIENCIES 
10.1. Definitions 
The definitions and reporting requirements described in this section cover the requirements 
outlined in ISO 14155:2020.
10.1.1.
Adverse Event
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other 
persons, whether related to the investigational medical device and whether anticipated or 
unanticipated. 
This definition includes events related to the investigational medical device or the 
comparator; events related to the procedures involved.
10.1.2.
Serious Adverse Event
A serious adverse event (SAE) is an adverse event that leads to any of the following: 
a) death 
b) serious deterioration in the health of the subject, users or other persons as defined 
by one or more of the following: 
a.
a life-threatening illness or injury, or
b.
a permanent impairment of a body structure or a body function including 
chronic diseases, or 
c.
in-patient or prolonged hospitalization, or
d.
medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function 
c)
fetal distress, fetal death or a congenital abnormality or birth defect including physical 
or mental impairment 
Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, 
without serious deterioration in health, is not considered a serious adverse event. 
10.1.3.
Device Deficiency
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, usability, safety, or performance. 
Device deficiencies include malfunctions, use errors, and inadequacy in the information 
supplied by the manufacturer including labelling. This definition includes device deficiencies 
related to the investigational medical device or the comparator.

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10.1.4.
Serious Health Threat
A serious health threat is a signal from any adverse event or device deficiency that indicates 
an imminent risk of death or a serious deterioration in the health in subjects, users, or other 
persons, and that requires prompt remedial action for other subjects, users, or other persons. 
This includes events that are of a significant and unexpected nature such that they become 
alarming as a potential serious health hazard or possibility of multiple deaths occurring at 
short intervals.
10.1.5.
Adverse Device Effect
An adverse device effect (ADE) is an adverse event related to the use of an investigational 
medical device. 
This definition also applies to the comparator medical device and includes: 

adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the medical 
device. 

any event resulting from use error or from intentional misuse of the medical device. 
10.1.6.
Serious Adverse Device Effect
A serious adverse device effect (SADE) is an adverse device effect that has resulted in any 
of the consequences characteristic of a serious adverse event as defined in Section 10.1.2.
10.1.7.
Unanticipated Serious Adverse Device Effect
An unanticipated serious adverse device effect (USADE) is a serious adverse device effect 
which by its nature, incidence, severity, or outcome has not been identified in the current risk 
assessment. 
10.2. Causality 
Each adverse event will be classified according to one of four different levels of causality to the 
study device and/or procedure: 

Not related 

Possible 

Probable 

Definite
Not related: relationship to the device, comparator or procedures can be excluded when: 
-
the event has no temporal relationship with the use of the investigational device or the 
procedures to application of the investigation device
-
the adverse event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible

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-
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or increase of 
the level of activation/exposure), do not impact on the serious adverse event
-
the event involves a body-site or an organ that cannot be affected, the adverse event can 
be attributed to another cause (e.g., an underlying or concurrent illness/ clinical condition, 
an effect of another device, drug, treatment, or other risk factors)
-
the event does not depend on a false result given by the investigational device used for 
diagnosis1, when applicable
-
harms to the subject are not clearly due to use error
-
the event depends on a false result given by the investigational device used for diagnosis1, 
when applicable
Possible: the relationship to the investigational device or comparator or the relationship to the 
study procedure is weak but cannot be ruled out completely. Alternative causes are also possible 
(e.g., an underlying or concurrent illness/ clinical condition or/and an effect of another device, 
drug, or treatment). Cases where relatedness cannot be assessed, or no information has been 
obtained should also be classified as possible. 
Probable: the relationship to the investigational device or comparator or the relationship to the 
study procedure seems relevant and/or the event cannot reasonably be explained by another 
cause.
Definite: the adverse event is associated with the investigational device, comparator, or study 
procedure beyond reasonable doubt when: 
-
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures 
-
the event has a temporal relationship with investigational device use/application or 
procedures
-
the event involves a body site or organ that 

the investigational device or procedures are applied to

the investigational device or procedures have an effect on
-
the adverse event follows a known response pattern to the medical device (if the response 
pattern is previously known)
-
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically feasible)
-
other possible causes (e.g., an underlying or concurrent illness/ clinical condition or/and 
an effect of another device, drug, or treatment) have been adequately ruled out
-
harm to the subject is due to error in use 
1 If an investigational device gives an incorrect diagnosis, the subject might, for example, receive an unnecessary 
treatment and incur all the risks that accompany that treatment, or might be incorrectly diagnosed with a serious 
disease. In other cases, the subject might not receive an effective treatment (thereby missing out on the benefits that 
treatment would confer) or might not be diagnosed with the correct disease or condition.

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-
the event depends on a false result given by the investigational device used for diagnosis2, 
when applicable
To establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious adverse event.
The Sponsor and the Principal Investigators will distinguish between the serious adverse events 
related to the study device and those related to a study-specific procedure(s).
An adverse event can be related both to the procedure and the study device. If a causal 
relationship is established, the adverse event can be classified as an adverse device effect. 
Complications caused by concomitant treatments not imposed by the protocol are Not related. 
Similarly, several routine diagnostic or subject management procedures are applied to subjects 
regardless of the protocol. If routine procedures are not imposed by the protocol, complications 
caused by them are also considered not related.  
In some cases, the event may not be adequately assessed because information is insufficient or 
contradictory and/or the data cannot be verified or supplemented. The Sponsor and the Principal 
Investigators will make the maximum effort to define and categorize the event and avoid these 
situations. Cases where event relatedness cannot be assessed, or no information has been 
obtained should be classified as “possible”.
10.3. Severity
Adverse events will be classified according to one of three levels of severity. The Investigators 
will use the following definitions to assess the severity of the adverse event:
Mild: The event does not result in limitation of usual daily activities and/or does not require therapy 
or only symptomatic therapy is required to treat the injury or illness. 
Moderate: The event results in some limitation of usual daily activities and/or requires specific 
therapy to treat the injury or illness.
Severe: The event interrupts the subject’s usual daily activities, requires specific therapy and/or 
is incapacitating leading to hospitalization, emergency treatment, life threatening events, or death.
10.4. Anticipated Adverse Events and Adverse Device Effects
Risks associated with the study devices and the related procedure are based on the current state 
of the art and an objective review of published data.
10.4.1.
Anticipated Adverse Events
The following adverse events may occur and are typically associated with the TIPS 
procedure:
2 If an investigational device gives an incorrect diagnosis, the patient might, for example, receive an unnecessary 
treatment and incur all the risks that accompany that treatment, or might be incorrectly diagnosed with a serious 
disease. In other cases, the patient might not receive an effective treatment (thereby missing out on the benefits that 
treatment would confer) or might not be diagnosed with the correct disease or condition.

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Hepatic encephalopathy

Infection/Sepsis

Liver failure

Contrast induced nephropathy

Allergic reaction to contrast utilized intra-procedurally

Adverse reactions associated with administration of general anesthesia or conscious 
sedation

Death
10.4.2.
Anticipated Adverse Device Effects
Adverse events related to the use of the Scorpion set or Cook Transjugular Liver Access set 
may include the following:

Intraperitoneal hemorrhage or hemoperitoneum

Puncture site hematoma

Cardiac arrhythmia

Cardiac tamponade

Arteriovenous fistula or other arterial injury

Arterio-biliary fistula or biliary tract injury

Extrahepatic Organ Injury

Capsular Perforation

Needle/catheter/guidewire fracture

Foreign body retention
10.5. Reporting Requirements 
10.5.1.
Site AE Reporting Requirements
Adverse event reporting will start at the time of the TIPS procedure (on Day 0). Adverse 
events that occur between the signing of the informed consent form and the initiation of the 
TIPS procedure will not be reported on the eCRF. Underlying diseases are not reported as 
adverse events unless the condition worsens or re-appears. Adverse event information, 
including but not limited to the occurrence date, the reported date, procedures, and 
medications must be recorded in the subject’s medical record and reported as part of the 
study adverse event report. Adverse event information will be collected for all subjects and 
assessed at every encounter with the subject. 
The AE information submitted on the eCRF should include where possible:

Severity of the event

Causality of the event (in relation to the device and/or procedure)

Seriousness of the event

Outcome of the event

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Adverse events should be reported by the site on the appropriate eCRF in the EDC system 
in a timely fashion from discovery by the site.
Serious Adverse Events and Adverse Device Effects must be reported to the Sponsor or 
designee within 5 working days by the Principal Investigator or designated study staff of 
discovery.
It is also the responsibility of the Principal Investigator or designee to inform the IRB of 
adverse events as required per the IRB policies and procedures and, because the study 
devices are commercially available, Principal Investigators must comply with any institutional 
user reporting requirements.
10.5.2.
Reporting Device Deficiencies
All device deficiencies related to the identity, quality, durability, reliability, safety, or 
performance of the investigational device shall be documented throughout the clinical study 
and appropriately managed by the Sponsor. Device deficiencies should be reported by the 
site by recording them in the EDC within 5 working days of discovery by the site.
It is also the responsibility of the Principal Investigator or designee to inform the IRB of 
deficiencies, failures, and malfunctions as required per the IRB policies and procedures.
Investigational devices involved in deficiencies, failures, or malfunctions should be retained 
for return to Argon, where possible. Following the deficiency, failure or malfunction report to 
Argon, product return information will be provided.
11.
STATISTICAL CONSIDERATIONS
11.1. Statistical Design and Methodology
For this post approval study, no formal study hypothesis will be tested. Study outcomes will be 
presented using descriptive statistics for each treatment group. In addition, outcomes by 
demographic and clinical characteristics will be presented. For exploratory purposes, between-
group differences in study endpoints will be assessed with comparative tests. Statistical analyses 
will be performed using SAS (SAS Institute, Cary, NC, USA). 
11.1.1.
Descriptive Results
Unless otherwise specified, for continuous variables, descriptive statistics will include the 
number of subjects/procedures (N), mean, standard deviation, median, minimum, and 
maximum values. Categorical variables will be summarized using frequency and 
percentages. 
11.1.2.
Exploratory Comparisons
Between-group comparisons will be conducted using Student’s t-test for continuous variables 
and Pearson’s Chi-square test for categorical variables. Comparability analysis between two 
study groups will be first conducted based on demographic and clinical parameters. 

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Appropriate statistical methods will be employed to explore the correlation and impact of the 
unbalanced baseline variable, if any, on the study results. When necessary, advanced 
statistical method such as mixed linear models will be employed to justify the impact.
When sample size permits, the outcomes will be reported for sub-groups such as by gender, 
age group (≤ 50 years vs > 50 years), type of image used, or operation experience.
11.2. Sample Size
No formal statistical hypothesis is to be tested for this post approval study. The planned sample 
size is empirical.
11.3. Analysis Sets
11.3.1.
Intent-to-Treat Set
The intent-to-treat set will include all procedures/patients with an attempted TIP procedure 
using a study device regardless it is successful, or an alternative device is needed.
This set will be the base for assessment of technical success rate and overall procedure 
success rate, as well as overall device safety.
11.3.2.
Primary Effectiveness Set
The primary effectiveness set will include procedures/patients who have a successful 
procedure with only a study device (i.e., no need of an alternative device).
This set will be the base for assessment of cannulation time, fluoroscopy time, procedure 
duration, as well as other device-specific outcomes.
11.3.3.
Safety Population
Safety set will include all procedures/patients defined in the intent-to-treat set.
This set will be the base for the overall study safety assessment.
For study device-specific post-operation safety assessment, only those included in the 
primary effectiveness set will be used.
Comparability analyses between the two study groups will be conducted on the Intent-to-
Treat analysis set.
11.4. Missing Data
Missing data will not be imputed unless otherwise specified.
For categorical variable, if unknown and missing data may be presented as a separate category 
and the denominator might include unknown and missing category where deems appropriate.
11.5. Interim Analysis

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One interim analysis will be conducted when the first 15 cases in each group complete the study 
procedure. The main purpose of the interim analysis is to more accurately fine tune the study 
design based on study-specific data. The interim analysis will focus on the impact of the primary 
imaging techniques on procedural success. If imaging technique is a significant factor, stratified 
randomization by primary imaging techniques will apply for future included participants. 
Justification for multiplicity is unnecessary as no formal statistical hypothesis will be tested.
11.6. Statistical Deviations
Any post hoc or unplanned analyses not identified in this protocol will be clearly identified in the 
Clinical Study Report.
11.7. Pooled Data
The proposed study will be conducted in up to 60 participants at up to 6 investigational sites. The 
final number of participating investigational sites and number of participants treated at each site 
will be determined by the enrollment status. The number of participants in each study group 
enrolled by each investigator at each investigational site in this study is expected to be too small 
to provide valid statistical meaningful conclusions. Therefore, no formal site pooling justification 
analysis is planned. Data from all sites will be pooled together in analyses.
12.
DATA MANAGEMENT 
12.1.Data Entry and Collection
An electronic data capture (EDC) system with electronic Case Report Forms (eCRFs) will be used 
for the purposes of this study. The handling of data from the eCRF will be the responsibility of the 
Sponsor or designee. Study data will be subject to periodic quality control reviews and checks as 
documented in the Data Management Plan for this study.
12.2.Data Review and Cleaning
All data in the EDC system will be fully validated using study-specific range and consistency 
checks and database listings. Queries will be issued to the investigational site via the EDC system 
and are to be resolved by the Investigator or designee. Data validation will be completed on a 
regular basis. The entire database will be re-validated to ensure that there are no outstanding 
data discrepancies prior to database lock. Any changes to the database after database lock will 
require written approval by the Sponsor.
12.3.Source Data Requirements
The Investigator or designee will perform primary data collection drawn from original documents 
(printed, optical or electronic document containing source data). Data collected for purposes of 
the clinical study must not be entered directly into the eCRF before being recorded first in the 
source documents. All source documentation must be available for review by the study monitor 
during monitor visits. Source data are defined as all information in original records, certified copies 
of original records of clinical findings, observations, or other activities in a clinical study, necessary 

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for the reconstruction and evaluation of the clinical study. This includes source data initially 
recorded in an electronic format. 
The Investigator will ensure the accuracy, completeness, legibility, and timelines of the data 
reported in eCRF and in all required documentation. Data reported in the eCRF shall be supported 
by the source documents with any discrepancies being explained. Any corrections made to 
documents will be done according to Good Documentation Practices. The Principal Investigator 
must sign the eCRFs to validate that the observations and findings recorded on the eCRFs are 
complete and accurate. Failure to meet documentation requirements may lead to the 
disqualification of an Investigator and/or investigational site.
12.4. Subject Confidentiality
Subject confidentiality will be maintained throughout the clinical study in a way that ensures the 
information can always be tracked back to the source data. For this purpose, a unique subject 
identification code will be used that allows identification of all data reported for each subject. Data 
relating to this clinical study might be made available to third parties (i.e., regulatory or IRB 
inspection) provided the data are treated confidentially and that the subject’s privacy is 
guaranteed.
12.5. Data Protection
Subject confidentiality and privacy are strictly held in trust by the Investigators, their staff, and the 
Sponsor, their staff, and contractors. Subject confidentiality is extended to cover processing of 
biological samples (i.e., blood) in addition to the clinical information relating to subjects. Therefore, 
the protocol, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study, or the data will be released to any unauthorized 
third party without prior written approval of the Sponsor.
All research activities will be conducted in as private a setting as possible.
The study monitor, other authorized representatives of the Sponsor, representatives of the IRBs, 
regulatory agencies and/or company supplying study product may inspect all documents and 
records required to be maintained by the Investigator, including but not limited to, medical records 
(office, clinic, or hospital) and pharmacy records for the subjects in this study. The investigational 
site will permit access to such records.
The original consent forms will be kept at the investigational site and a copy will be given to the 
subject. All study records will be kept in a locked file cabinet and logs linking a subject’s name to 
the study subject ID will be stored separately. Clinical information will not be released without 
written permission of the subject, except as necessary for monitoring by FDA. The PI must also 
comply with all applicable privacy regulations (e.g., HIPAA).
12.6. Protocol Amendments and Deviations
12.6.1.
Amendments 

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Investigators may not modify (amend) this study protocol without obtaining prior written 
approval from the Sponsor, IRB, and applicable regulatory authorities. In the instance where 
a substantial protocol amendment is initiated by the Sponsor, the amended protocol will not 
be implemented at the investigational site until documented approval from the IRB has been 
obtained.  The Principal Investigator will acknowledge the amendment by signing the 
Investigator signature page of the amended protocol.  As appropriate, training on the protocol 
amendment will be provided by the Sponsor or designee.
New findings or the reasons for any amendments to the study protocol that affect the 
subject’s continued participation shall be made available to the participant.
12.6.2.
Deviations
A protocol deviation (PD) is the non-adherence to or divergence from any protocol 
requirements, processes, or procedures.  The Principal Investigator and investigational site 
staff should avoid protocol deviations. Emergency deviations (deviations from the study 
protocol to protect the life or physical well-being of a subject) are allowed per physician 
discretion. The use of waivers from the protocol is prohibited. 
PD records will be reviewed throughout the conduct of the Study. The Sponsor or designee 
will address any deviations and work with the Principal Investigator and investigational site 
staff to determine appropriate corrective and preventative actions. In addition, deviations 
occurring across investigational sites will be reviewed by the Sponsor on a periodic basis to 
determine if more global preventive actions may be required.
The Sponsor will determine the effect of the PDs on the scientific soundness of the clinical 
study and subject safety to determine if additional reports or actions are required.  Additional 
action may include investigational site staff re-training and/or site suspension or termination. 
The Sponsor will consider terminating or suspending the participation of a particular 
investigational site or Principal Investigator in the Study if monitoring or auditing identifies 
serious or repeated deviations.
12.6.3.
Reporting
All deviations will be documented in the appropriate eCRF and should be entered soon after 
the deviation is recognized. Emergency deviations that occur must be reported to the Sponsor 
or designee within 1 working day and to the IRB per the applicable IRB requirements. Non-
emergency deviations that occur must be reported to the Sponsor or designee within 5 
working days and to the IRB, if required. Investigators will also adhere to procedures for 
reporting deviations to the involved IRBs in accordance with their specific reporting policies 
and procedures.  

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13.
STUDY ADMINISTRATION
13.1. Regulatory Compliance
This clinical study will be performed in accordance with all stipulations of the protocol. The study 
will be conducted in accordance with the ethical principles that have their origin in the latest 
version of the Declaration of Helsinki. The clinical study protocol was written in compliance with 
ISO 14155:2020. Study conduct will comply with 21 CFR Parts 50, 54, 56, 803, and 11 and 
HIPAA. 
The clinical study will not be initiated until approval has been obtained from the governing IRB. 
Any additional requirements imposed by the IRB will be followed, as appropriate. No deviation 
from the clinical study protocol will be implemented without the prior written approval of the 
Sponsor and IRB except when necessary to eliminate an immediate hazard to a subject. 
13.2. Sponsor Responsibilities
The Sponsor is responsible for selecting qualified Investigators and providing them with the 
information they need to conduct the study properly, ensuring appropriate monitoring of the study, 
ensuring that IRB review and approval are obtained as required and ensuring that any reviewing 
IRB or regulatory agency is promptly informed of significant new information regarding the study.
Clinical specialists employed by the Sponsor can provide technical assistance to the Investigators 
and other health care personnel, as needed, during the study which may include device training 
or addressing questions related to operation of the study device. 
13.3. Investigator Responsibilities 
The Principal Investigator responsibilities include, but are not limited to, the following:

Conducting the study in accordance with this protocol, the signed clinical study agreement, 
and applicable regulations protecting the rights and safety of study subjects

Ensuring that informed consent is obtained for each study subject in accordance with the 
protocol

Ensuring that IRB approval is secured prior to starting the study and ensuring continuing 
review as required throughout the study

Ensuring all associates, colleagues, and investigational site staff assisting in the conduct 
of the study are provided with the required study documentation, informed about their 
obligations, are adequately qualified and trained, and meet their commitments

Maintaining adequate and accurate records and ensuring those records are available for 
inspection at any time

Ensuring that conducting the study does not give rise to conflict of interest
13.4. Retention of Study Records
The Principal Investigator must maintain adequate records on all aspects of the study, including 
the following: 

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IRB approvals

Subject withdrawal information

Subject Informed Consent Forms

Protocol deviations

Electronic Case Report Forms 

Study correspondence

Device use

Source documents
The Principal Investigator or investigational site should retain all clinical study data for at least 15 
years. The investigational site may also transfer the clinical study records to the Sponsor. 
If the Principal Investigator moves, retires, etc., the investigational site must provide the Sponsor 
with the name and address of the person who will be responsible for the study records or arrange 
for transfer of the records to the Sponsor.
13.5. Study Funding
The clinical study is funded and sponsored by Argon Medical Devices. Funding provided to the 
Investigator/investigational site is detailed for each investigational site in their Clinical Study 
Agreement.
13.6. Clinical Study Agreement
A Clinical Study Agreement (CSA) will be put in place for each investigational site, signed by the 
appropriate representative of the investigational site and Sponsor prior to initiation of the clinical 
study at the investigational site. The CSA will be amended as needed during the clinical study.
Each Principal Investigator and Sub-Investigator will provide a signed financial disclosure form to 
the Sponsor or designee to disclose any financial conflict of interest prior to activation of the 
Investigator. A new financial disclosure form must be provided promptly if there is a change in 
previously reported disclosures.
13.7. Subject Compensation
The Sponsor will provide information to subjects regarding the Sponsor’s liability to compensate 
for any injury sustained due to participation in this clinical study in accordance with local and 
national guidelines.
Subject compensation for study participation and reimbursement of travel fees for study-specific 
visits may be provided by the Sponsor if required by local regulations and/or approved by the IRB.
13.8. Insurance
Insurance for the study will be maintained by the Sponsor.

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13.9. Publication Policy
13.9.1.
Study Registration
This study will be registered in the publicly accessible database, ClinicalTrials.gov. The study 
information and results will be provided and updated as per the database requirements. 
Study subjects will be informed of the registration in the study informed consent form.
13.9.2.
Clinical Study Report
Results from the clinical study will be summarized in a clinical study report (CSR) following 
study closure. The final CSR will be compiled and written by the Sponsor or designee and 
reviewed, approved, and signed off by the Sponsor and the Lead Principal Investigator.
13.9.3.
Use of Information and Publications
All information concerning this protocol, the data generated from the protocol, Sponsor 
operations, and basic scientific data supplied by Sponsor to the Investigator and not 
previously published, is considered confidential and remains the sole property of Sponsor.
At the conclusion of the study, a multi-center abstract and/or manuscript may be prepared 
for publication reporting the primary results from the study. Publication of the principal results 
from any single-site experience within the study is not allowed until the preparation and 
publication of the multi-center results unless prior approval from the Sponsor is given. 
The Sponsor must receive any proposed publication and/or presentation materials in 
compliance with the Sponsor’s publication policy set forth in the Clinical Study Agreement. 
13.10.Minimization of Bias
The following activities are intended to reduce the risk of bias:

Randomized study

Objective methodology to evaluate endpoints

Stratified randomization (if applicable after the interim analysis)
Furthermore, potential for bias has been minimized with a well-controlled design, expected 
conduct under the terms of the approved protocol, use of specific inclusion and exclusion criteria, 
careful definitions for study procedures and outcomes, and prospectively defined methods of data 
analysis. 
13.11.Potential Confounding Factors
The inclusion and exclusion criteria ensure that possible potential confounding factors (in terms 
of participant characteristics) are minimized. Potential confounding factors include:

Active variceal bleeding

Hepatic tumors

Polycystic liver disease

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Underlying liver failure/ high MELD score

Heart failure/ pulmonary hypertension

Biliary obstruction

Lack of adequate portal vein target or patency
In addition, all Investigators will be trained on the protocol requirements and required safety and 
efficacy assessments prior to initiation of the study.
13.12.Scientific Robustness
This is a well-designed, multicenter, post approval study that will be conducted by qualified and 
trained Investigators. Scientific validity and robustness of the study are demonstrated by the study 
design and using validated and objective statistical methodology to evaluate the primary endpoint. 
The data that will be generated through this clinical study are therefore considered to be robust 
and accurately reflect the safety and effectiveness of the Scorpion set.
13.13.Monitoring
The Sponsor will ensure that adequate monitoring at each investigative site is completed. The 
Principal Investigator and investigative site staff will ensure all study documents and source data 
are up-to-date and available for review. 
The Principal Investigator will permit the Sponsor or designee to inspect all study-related 
documentation, including case report forms and source documents, at regular intervals 
throughout conduct of the study. Appropriately trained personnel will conduct monitoring of 
investigative sites and details of the monitoring activities will be outlined in a separate study-
specific monitoring plan. 
13.14.Other Aspects of Clinical Quality Assurance
The Sponsor or designee may conduct audits at the investigational sites. Audits may include, but 
are not limited to, device supply, presence of required documents, the informed consent process, 
and comparison of CRFs with source documents. The Investigator agrees to participate with 
Sponsor audits and regulatory inspections.

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14.
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