A Retrospective Data Collection Evaluating Portal Vein Access Sets For Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures
Conditions: Portal Hypertension, Liver Diseases, Ascites Hepatic, Hydrothorax, Vascular Diseases
Sponsor: Argon Medical Devices

 
Clinical Investigation Plan (CIP) 
CP-2024-001: Achieving Portal Access with Scorpion Post-Approval Study 2 
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A Retrospective Data Collection Evaluating Portal Vein Access Sets For 
Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures 
Short Title: Achieving Portal Access with Scorpion Post-Approval Study 2 (APASS2) 
 
Protocol Number: SCPVA02 
Revision: B 
Document Date:  20 September 2024 
 
Sponsor: Argon Medical Devices, Inc. 
7800 Dallas Pkwy, Suite 200 
Plano, Texas 75024 
 
 
 
 
 
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. 
Version 
Date 
Description of Change 
Brief Rationale 
eQMS Workflow # 
A 
13 Mar 2024 
Initial release 
N/A 
Electronic signature 
#CP-2024-001 
B 
18 Sep 2024 
1. Update technical success, 
procedural 
success, 
and 
PVA time definitions 
2. Update 
TIPS 
procedure 
window start date and 
enrollment cap wording 
3. Specify 
additional 
datapoints 
within 
procedural information and 
follow up information that 
will be collected 
1. Clarify primary and secondary 
endpoint definitions on how 
the data will be collected 
2. Site had data prior to March 
1, 2022 so TIPS procedure 
start window was updated to 
February 1, 2022 plus the 
enrollment cap was reworded 
to at least 50 eligible cases 
3. Clarify what datapoints will 
be collected in the raw data  
CR #05204 
 
 

 
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SPONSOR APPROVAL PAGE 
 
Protocol Title: 
A Retrospective Study to Assess the Safety and Efficacy of Scorpion for 
Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures 
Protocol Number: 
SCPVA02 
Revision:  
B 
Document Date: 
20 September 2024 
 
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 
Sr. Director, Clinical Affairs 
Medical Affairs 
Pete Stibbs 
VP, Global Medical Affairs 
Regulatory Affairs 
Scott Bishop 
VP, Regulatory Affairs 
Quality Assurance 
Edward Bottomley 
Sr. Director, Global Quality 
Marketing 
Jenson Winkler 
Product Manager 
Note: Signature approvals are captured in the Sponsor’s eQMS 
 
 

 
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INVESTIGATOR STATEMENT OF COMPLIANCE 
Protocol Title: 
A Retrospective Study to Assess the Safety and Efficacy of Scorpion for 
Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures 
Protocol Number: 
SCPVA02 
Revision:  
B 
Document Date: 
20 September 2024 
INVESTIGATOR’S STATEMENT 
I have read this protocol and agree to conduct and/or supervise the Study in accordance with this Clinical 
Investigational Plan, the device Instructions for Use (IFU), and in accordance with accepted Good Clinical 
Practice principles. 
I agree to obtain Institutional Review Board (IRB) approval prior to initiation of the Study and ensure 
prompt reporting to the IRB of any changes in research activity. 
I agree to ensure that all associates, colleagues, and other Study personnel assisting in the conduct of the 
Study are informed about their obligations in meeting the above commitments. 
I agree to maintain adequate and accurate records and to make those records available for inspection to 
both Argon Medical Devices Inc. and applicable regulatory bodies in accordance with local and national 
regulations. 
My signature below attests that I have read and understood the contents of this Protocol.  I hereby 
confirm and agree to comply with the clinical investigational plan as presented including all statements 
regarding confidentiality, and according to local legal and regulatory requirements, applicable U.S. Federal 
Regulations, and International Standards Organization (ISO) Good Clinical Practice (GCP) guidelines. 
 
Investigator Name (print) 
 
 
Investigator Signature  
 
 
 
 
 
 
Date (dd/MMM/yyyy) 

 
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TABLE OF CONTENTS 
PROTOCOL REVISION HISTORY ........................................................................................................................... 2 
SPONSOR APPROVAL PAGE ................................................................................................................................ 3 
INVESTIGATOR STATEMENT OF COMPLIANCE ..................................................................................................... 4 
TABLE OF CONTENTS .......................................................................................................................................... 5 
LIST OF TABLES ................................................................................................................................................... 6 
1. 
ABBREVIATED TERMS AND DEFINITIONS .................................................................................................... 7 
2. 
KEY ROLES AND CONTACT INFORMATION .................................................................................................. 8 
2.1. 
SPONSOR STUDY STAFF CONTACT INFORMATION .................................................................................................... 8 
2.2. 
LEAD PRINCIPAL INVESTIGATOR CONTACT INFORMATION .......................................................................................... 8 
3. 
SYNOPSIS ................................................................................................................................................... 9 
4. 
INTRODUCTION ........................................................................................................................................ 11 
4.1. 
BACKGROUND ................................................................................................................................................ 11 
4.2. 
PRIOR INVESTIGATIONS .................................................................................................................................... 12 
4.3. 
STUDY RATIONALE ........................................................................................................................................... 13 
5. 
DEVICE DESCRIPTION AND INTENDED USE ................................................................................................. 13 
5.1. 
GENERAL DEVICE DESCRIPTION .......................................................................................................................... 13 
5.2. 
INDICATIONS FOR USE ...................................................................................................................................... 14 
5.3. 
DEVICE IDENTIFICATION AND TRACKING ............................................................................................................... 14 
5.4. 
INSTRUCTIONS FOR USE .................................................................................................................................... 14 
6. 
RISK ANALYSIS AND RISK ASSESSMENT ..................................................................................................... 15 
6.1. 
ANTICIPATED BENEFITS .................................................................................................................................... 15 
6.2. 
RISKS AND FORESEEABLE ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS ................................................................ 15 
7. 
STUDY OBJECTIVE ..................................................................................................................................... 15 
7.1. 
OUTCOME MEASUREMENTS .............................................................................................................................. 15 
7.1.1. 
Primary Outcome ............................................................................................................................... 16 
7.1.2. 
Secondary Outcomes ......................................................................................................................... 16 
8. 
STUDY DESIGN .......................................................................................................................................... 16 
8.1. 
OVERVIEW ..................................................................................................................................................... 16 
8.2. 
ELIGIBILITY CRITERIA ........................................................................................................................................ 16 
8.2.1. 
Inclusion Criteria ................................................................................................................................ 16 
8.2.2. 
Exclusion Criteria ............................................................................................................................... 16 
9. 
STUDY ENDPOINTS .................................................................................................................................... 16 
9.1. 
PRIMARY ENDPOINTS ....................................................................................................................................... 16 
9.2. 
SECONDARY AND EXPLORATORY ENDPOINTS ......................................................................................................... 17 

 
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10. 
STUDY PROCEDURES ............................................................................................................................. 17 
10.1. 
INFORMED CONSENT ....................................................................................................................................... 17 
10.2. 
PATIENT SELECTION ......................................................................................................................................... 17 
10.3. 
DATA COLLECTION .......................................................................................................................................... 18 
10.3.1. 
Baseline Information ......................................................................................................................... 18 
10.3.2. 
Procedural Information ..................................................................................................................... 18 
10.3.3. 
Follow up Information ....................................................................................................................... 19 
11. 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE DEFICIENCIES .............................................. 19 
11.1. 
DEFINITIONS .................................................................................................................................................. 19 
11.2. 
REPORTING .................................................................................................................................................... 19 
11.3. 
PROCEDURE-RELATED COMPLICATIONS ............................................................................................................... 20 
12. 
STATISTICAL CONSIDERATIONS ............................................................................................................. 20 
12.1. 
GENERAL ....................................................................................................................................................... 20 
12.2. 
SAMPLE SIZE DETERMINATION ........................................................................................................................... 20 
12.3. 
ANALYSIS POPULATION .................................................................................................................................... 21 
12.4. 
STATISTICAL ANALYSES ..................................................................................................................................... 21 
13. 
QUALITY CONTROL AND QUALITY ASSURANCE ...................................................................................... 21 
13.1. 
DATA ENTRY AND QUALITY ASSURANCE .............................................................................................................. 21 
13.2. 
MONITORING ................................................................................................................................................. 21 
13.3. 
AUDITS ......................................................................................................................................................... 22 
13.4. 
PATIENT CONFIDENTIALITY ................................................................................................................................ 22 
13.5. 
INSTITUTIONAL REVIEW BOARD ......................................................................................................................... 22 
13.6. 
EARLY TERMINATION OF STUDY ......................................................................................................................... 22 
14. 
DATA MANAGEMENT ........................................................................................................................... 22 
14.1. 
RECORD RETENTION ........................................................................................................................................ 22 
14.2. 
PUBLICATION POLICY ....................................................................................................................................... 22 
15. 
ETHICAL CONSIDERATIONS ................................................................................................................... 23 
16. 
REFERENCES ......................................................................................................................................... 24 
 
LIST OF TABLES 
Table 1. Components of the Scorpion Sets ................................................................................................. 14 
Table 2. Scorpion Portal Vein Access Kit Part Numbers.............................................................................. 15 
Table 3. Overview of Secondary and Exploratory Endpoints ...................................................................... 17 
Table 4. SIR Standards of Practice Committee Classification of Complications by Outcome ..................... 20 
 

 
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1. ABBREVIATED TERMS AND DEFINITIONS 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CIP 
Clinical Investigation Plan 
CO2 
Carbon Dioxide 
F 
French 
ga 
Gauge 
HPVG 
Hepatic Venous Pressure Gradient 
HV 
Hepatic Vein 
ICE 
Intracardiac Echocardiography 
ICU 
Intensive Care Unit 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Standards Organization 
ISO 14155   
Clinical Investigation of Medical Devices for Human Subjects - Good clinical practice 
MELD  
Model for End-Stage Liver Disease 
mGy 
 
Milligray 
mL 
 
Milliliter 
mm Hg  
Millimeters of Mercury 
MPA 
Multipurpose Angiographic 
PEEK 
Polyether Ether Ketone 
PI 
Principal Investigator 
PTFE 
Polytetrafluoroethylene 
PV 
Portal Vein 
PVA 
Portal Vein Access 
PVPC 
Portal Vein Puncture-related Complications 
SAE 
Serious Adverse Event 
TIPS 
Transjugular Intrahepatic Portosystemic Shunt 
US 
United States 
 
 

 
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2. KEY ROLES AND CONTACT INFORMATION  
2.1. 
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: 
Brent McClean, Clinical Affairs Manager 
317-752-5424 
Brent.McClean@argonmedical.com  
2.2. 
Lead Principal Investigator Contact Information 
Lead Principal Investigator: 
Institution: 
 
 
Telephone: 
Email: 
Peter J Park, MD 
Emory University, Department of Radiology 
1364 Clifton Rd NE 
Atlanta, GA 30322 
404-778-9729 
peter.ju.park@emory.edu  
 
 
 

 
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3. SYNOPSIS 
Protocol SCPVA02 
Title 
A Retrospective Study to Assess the Safety and Efficacy of Scorpion for 
Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures 
Short title  
Achieving Portal Access with Scorpion Post-Approval Study 2 (APASS2) 
Protocol Number 
SCPVA02 
Study 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. 
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 
1 site 
Location of Sites 
United States (US) 
Clinical Study Design 
Design 
Retrospective, single center, single arm design. 
Objective 
To evaluate the safety and effectiveness of Scorpion Portal Vein Access 
Kits for TIPS procedures with the goal of creating the parenchymal tract 
for indicated interventional procedures. Safety, effectiveness, and 
performance data for the Scorpion Portal Vein Access sets will be 
collected 
Hypothesis 
No formal statistical hypothesis will be tested 
Primary Effectiveness Endpoint 
Technical 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) 
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 
• Procedural success defined as successful delivery of the shunt 
• Device-Related Complications, in the judgment of the Principal 
Investigator 

 
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Exploratory Endpoints 
• 
Portal vein access (PVA) time defined as the time from 
hepatic vein access to portal vein access 
• 
Procedure duration defined as the interval from the first 
jugular access for TIPS creation to removal of catheters 
from the subject 
• 
Fluoroscopy Time 
• 
Change in Model for End-Stage Liver Disease (MELD) 
and 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) 
Clinical Study Population 
Population 
All patients who underwent a TIPS procedure between February 1, 2022, 
and February 29, 2024 will be considered for enrollment in the study. 
Procedural data will be collected from patient medical records through 
hospital discharge. 
 
Each TIPS procedure that was completed using one of the Scorpion Portal 
Vein Access Kits will be considered as an individual case. Cases that meet 
all inclusion criteria and do not meet any exclusion criteria will be 
considered eligible for enrollment. 
Inclusion Criteria 
1. Scorpion or Scorpion X kit introduced into the vasculature as the 
initial device for portal vein access. 
Exclusion Criteria 
1. TIPS procedure was not initiated and/or no portion of the kit was 
introduced into the vasculature. 
2. Inaccessible medical records. 
Statistical Analysis  
Statistical Methodology 
Patient demographics and performance parameters will be summarized 
with mean, standard deviation, median, and range for continuous 
variables and with frequencies and percentages for discrete variables. 
Sub-group analysis will be conducted when sample size permits.  
 
 
 

 
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4. INTRODUCTION  
4.1. 
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 
• 
Transabdominal intravascular ultrasound (IVUS), or intracardiac echocardiography (ICE) 
guidance3 

 
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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 
4.2. 
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 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 
The APASS prospective study had three cases, but the study was early terminated due to slow enrollment 
accrual.  Two cases were Scorpion, while the remaining one was Cook.  Procedural success was achieved 
in 100% of cases. 
 
 
 

 
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4.3. 
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 who underwent a TIPS procedure. The study supports post-market 
surveillance and will serve to provide clinical data for the initial CE Mark application. 
Findings from this study will provide valuable clinical evidence to ensure that Argon’s standard Portal Vein 
Access Sets are in line with state of the art and our established acceptance criteria for safety and 
performance when used as intended. 
5. DEVICE DESCRIPTION AND INTENDED USE 
5.1. 
General 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 
 
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. 

 
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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 
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. 
5F PEEK Catheter 
6.2F PEEK Catheter 
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 
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. 
7F Cannula Sheath 
8F Cannula Sheath  
MPA = Multipurpose Angiographic 
 
5.2. 
Indications for Use 
The Scorpion Portal Vein Access Sets are intended for transjugular liver access in diagnostic and 
interventional procedures.  
5.3. 
Device Identification and Tracking 
As commercially available devices, Scorpion® Portal Vein Access Set and Scorpion®X Portal Vein Access 
Set were obtained by the site through normal commercial procurement methods and stored and 
accounted for following site-specific policies.  
5.4. 
Instructions for Use 
The Scorpion sets will be used in accordance with current Instructions for Use (IFU) included in the device 
packaging.  The manufacturer’s IFU for each Portal Vein Access Set contains the following information: 
• 
Complete instructions including storage and handling requirements, preparation for use, pre-use 
checks, precautions to be taken after use, and disposal. 
• 
Complete summary of the necessary training and experience required for use of these devices. 
• 
Complete description of the procedures involved in the use of these devices. 
The Scorpion Portal Vein Access Set are identified with part number and lot number. 
 
 

 
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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. 
6. RISK ANALYSIS AND RISK ASSESSMENT 
6.1. 
Anticipated Benefits 
Safe and effective creation of parenchymal tract between the hepatic vein and an intrahepatic branch of 
the portal vein. 
6.2. 
Risks and Foreseeable Adverse Events and Adverse Device Effects 
The following foreseeable adverse events, which are captured in the IFU of these commercially available 
devices, may be considered as potential risks to patients undergoing TIPS procedures with an Argon Portal 
Vein Access Set: 
• 
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 
There is no additional risk associated with this clinical study since the patient was treated according to 
standard of care. 
7. STUDY OBJECTIVE 
The objective of this retrospective data collection is to evaluate the safety and effectiveness of Scorpion 
portal vein access sets during TIPS with the goal of creating the parenchymal tract for indicated 
interventional procedures.  
7.1. 
Outcome Measurements 
The data collected will be used to analyze the following outcome measures: 

 
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7.1.1. 
Primary Outcome  
a. Technical success defined as creation of the parenchymal tract between the hepatic vein and 
an intrahepatic branch of the portal vein and confirmed by portogram 
7.1.2. 
Secondary Outcomes 
a. Procedural success defined as successful delivery of the shunt 
b. Incidence of procedural complications defined as the total occurrence of complications 
8. STUDY DESIGN 
8.1. 
Overview 
The planned sample size is to enroll at least 50 eligible cases at a single center in the United States.  Clinical 
data will be retrospectively collected on eligible cases that underwent attempted TIPS procedures with 
one of Argon’s standard Portal Vein Access Set between February 1, 2022 and February 29, 2024. 
The participating center will be identified by a site number, and eligible cases will be sequentially assigned 
a unique 3-digit study identification (ID) number.  The ID number will be a combination of the site number 
followed by a 2-digit number sequentially assigned based on eligibility (e.g. 101, 102, 103). 
8.2. 
Eligibility Criteria 
8.2.1. 
Inclusion Criteria 
1. Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein 
access 
8.2.2. 
Exclusion Criteria 
1. TIPS procedure was not initiated and/or no portion of the kit was introduced into the 
vasculature 
2. Inaccessible medical records 
9. STUDY ENDPOINTS 
9.1. 
Primary Endpoints 
The primary effectiveness endpoint is technical 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). 
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 

 
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9.2. 
Secondary and Exploratory Endpoints 
The secondary and exploratory endpoints of this clinical study are outlined in Table 3. 
Table 3. Overview of Secondary and Exploratory Endpoints 
Endpoint 
Description / Definition 
Secondary Endpoints 
Procedural success 
Successful delivery of the shunt 
Device-related complications 
Incidence of complications related to the device as judged by the 
Principal Investigator 
Exploratory Endpoints 
Portal Vein Access (PVA) time 
Time (in minutes) from hepatic vein access to portal vein access 
Procedure duration 
Interval (in minutes) from first jugular access for TIPS creation to removal 
of catheters from subject 
Fluoroscopy time 
Measured in minutes 
Change in MELD score 
Change in Child-Pugh score 
Change in score from Baseline Characteristics to Follow Up Data 
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 
 
10. STUDY PROCEDURES 
10.1. Informed Consent 
Since the data for this retrospective review already exists, we request that the IRB waive the consent 
requirement.  Any patient who has previously refused to participate in a study will not have his or her 
data included in the study.  The data will be de-identified and no personal identifying information will be 
disclosed or compromised. 
10.2. Patient Selection 
Electronic Medical Records (EMR) will be used to identify patients who underwent a TIPS procedure using 
Scorpion® Portal Vein Access Set or Scorpion®X Portal Vein Access Set with standard techniques from 
February 1, 2022, through February 29, 2024, by searching for Current Procedural Terminology (CPT) 
codes 37182 and 37183 within the study period. 
Suitable cases identified during the study period will be evaluated for eligibility.  Eligible cases will be 
assigned a sequential 3-digit number as the case ID.  Each TIPS procedure attempt will be considered as 
an individual case with different case ID.  The patient log will be retained at the site and filed with the 
study records at the conclusion of the study. 

 
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10.3. Data Collection 
For eligible cases, clinical data related to the TIPS procedure will be extracted from the medical records 
and captured into a Data Collection Tool by trained study staff: 
Electronic medical records (Epic, Verona, Wisconsin) and the picture archiving and communication system 
(PACS) database will be reviewed for patient demographic data, applicable TIPS datapoints, and the 
primary Argon device used for TIPS procedure.  Complications will be categorized according to the Society 
of Interventional Radiology Quality Improvement guidelines.10 
10.3.1. 
Baseline Information 
Demographics including age, sex, height, weight, race, and ethnicity will be captured.  BMI will be 
calculated using the patient’s height and weight.  Initial indication for TIPS plus MELD and Child-Pugh Score 
will be collected.  Standard-of-Care imaging will be reviewed.   
10.3.2. 
Procedural Information 
The information of each eligible case that has gone under the TIPS procedure will be captured.  
Information such as the following will be collected and recorded: 
• 
Procedure date 
• 
Scorpion® Portal Vein Access Set or Scorpion®X Portal Vein Access Set Used 
• 
Jugular access site 
• 
Sheath used 
• 
Imaging used 
• 
Fluoroscopy time 
• 
Radiation dosage measured in Air kerma (mGy) 
• 
Contrast volume used 
• 
Portal vein access (PVA) time 
• 
Hepatic vein used for access 
• 
Portal vein access site 
• 
Pressure gradient measurements: pre- and post-delivery of stent 
• 
Stent used and stent count 
• 
Presence of residual varices 
• 
Procedure duration 
• 
Technical success 
• 
Procedural success  
• 
Length of hospital stay 
• 
Number of ICU days 
• 
AE assessment 
 

 
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10.3.3. 
Follow up Information 
Follow up information will be collected within 30 days post-procedure.  Information such as the following 
will be collected and recorded: 
• 
Follow up visit date 
• 
MELD and Child-Pugh Score 
• 
Patency assessment 
• 
Clinical assessment including status and evaluation for encephalopathy 
• 
Clinical improvement (Yes, No, Unknown) 
• 
AE assessment 
Standard-of-Care imaging (e.g. Doppler Ultrasound) will be reviewed for TIPS patency, if available.   
11. ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE DEFICIENCIES 
11.1. Definitions 
An adverse event (AE) is defined as any undesirable clinical occurrence or change from the patient’s 
baseline condition, whether it is considered device related or not. 
A serious adverse event (SAE) is defined as any untoward/undesirable adverse experience that results in 
any of the following outcomes: 
a) Death 
b) A life-threatening illness or injury 
c) Inpatient or prolonged hospitalization 
d) A permanent impairment of a body structure or a body function 
e) Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function 
f) Congenital abnormality or birth defect 
An adverse device effect (ADE) is an adverse event that, when in the judgement of the Investigator has a 
reasonable time sequence associated with use of the device and it is believed that the device directly 
caused or contributed to the adverse event. 
A device deficiency is defined as an inadequacy of the medical device related to its identity, quality, 
durability, safety or performance, such as malfunction, misuse or use error and inadequate labeling. 
11.2. Reporting 
This investigation is performed using marketed product thus requiring reporting of device-related serious 
adverse events and deficiencies to the manufacturer via Argon’s policy and procedures for complaints and 
issues handling which is implemented for all products as part of our mandated post market vigilance.  Due 
to the retrospective approach, incidents may have already been reported as part of the hospital’s routine. 

 
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The collection of adverse events in this study will be limited due to the retrospective nature of the design.  
Adverse events that will be captured in this study are those believed to be consistent with commercially 
available TIPS devices.  As such, only procedure-related complications will be captured from the medical 
records and recorded in the study database which may occur at any time during the procedure or within 
30 days following the procedure. 
Each adverse event will be assessed by the Investigator for severity, seriousness, relationship to the 
device/procedure, action taken, and outcome.  Events will be categorized as defined per Society of 
Interventional Radiology guidelines.10 
Table 4. SIR Standards of Practice Committee Classification of Complications by Outcome 
Minor Complications 
A. No therapy, no consequence. 
B. Nominal therapy, no consequence; includes 
overnight admission for observation only. 
Major Complications 
C. Require therapy, minor hospitalization (< 48 
hours). 
D. Require major therapy, unplanned increase in level 
of care, prolonged hospitalization (> 48 hours). 
E. Permanent adverse sequelae 
F. Death 
 
11.3. Procedure-related Complications 
Based on state of the art for TIPS procedures and similar devices, the following adverse events may be 
considered procedure-related complications: 
• 
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 
12. STATISTICAL CONSIDERATIONS 
12.1. General 
All data processing, analyses, and reporting will be performed by an independent biostatistician who 
otherwise is not involved in the chart review or data collection.  The analysis will be conducted using SAS 
(PC Version 9.4 or higher).   
12.2. Sample Size Determination 

 
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No formal sample size calculation was performed.  All eligible cases will be enrolled in the study.  Per 
preliminary estimation and historical sales report, we anticipate that there will be at least 50 cases for this 
study at 1 clinical site in the US. 
12.3. Analysis Population 
Due to the nature of this retrospective study, all eligible cases will be analyzed for safety and effectiveness 
on an ‘as-treated’ basis. 
12.4. Statistical Analyses 
Unless otherwise specified, for continuous variables, descriptive statistics will include the number of 
patients/procedures, mean, standard deviation, median, minimum, and maximum values.  Categorical 
variables will be summarized using frequency and percentages.  All comparative tests are 2-sided with the 
confidence level set to 95%. 
Given the retrospective nature of this protocol, there may be missing or incomplete data, thus not all may 
be available for all patients.  Unless otherwise stated, missing data will be handled as it is, except for dates 
that are required for calculating event time, the partial dates will have either ‘01’ or ‘Jan’ imputed with 
an exception for dates related to the event where the date closest to the last event (visit date, procedure 
date, etc.) should be used rather than arbitrary ‘01’ of that month and year. 
The analytical unit is TIPS procedure.  No formal statistical hypothesis will be tested for this single-arm 
study. 
Sub-group analysis (e.g. by gender, age group, or Portal Vein Access Set type) may be conducted if the 
sample size in each subgroup is sufficient.  Student’s t-test will be employed for continuous variables and 
Pearson’s chi-square test for categorical variables. 
13. QUALITY CONTROL AND QUALITY ASSURANCE 
13.1. Data Entry and Quality Assurance 
Each Investigator or appropriately trained designee shall document the clinical data into the electronic 
data capture system.  Investigators will provide all applicable clinical data and documentation to the 
sponsor.  The data required for this protocol will be collected from patient medical records (Epic Systems, 
Verona, Wisconsin) and recorded on a Data Collection Tool. 
All data and information collected will be considered confidential.  All data used in the analysis and 
summary will be anonymous, and without reference to specific patients.  Files will be kept in a locked area 
with restricted access to authorized personnel or designee, the Investigator, site research staff, and 
authorized regulatory authorities. 
13.2. Monitoring 

 
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Monitoring may be performed by the Sponsor for clinical quality assurance based on random sampling.  
During data collection, the Investigator shall permit the monitor to verify the progress of data collection 
as frequently as necessary. 
The Investigator/institution will permit direct access to source data and documents for data-related 
monitoring and, if applicable, audits, and regulatory inspections to be performed. 
13.3. Audits 
Data may be reviewed by the Sponsor’s Quality Assurance Department or an independent designee 
and/or by Regulatory Authorities.  This implies that auditors/inspectors will have the right to inspect the 
site at any time during and/or after completion of the data collection and will have access to source 
documents including the patient’s file and local standard operation procedures (SOPs).  By participating 
in this data collection, Investigator agrees to this requirement. 
13.4. Patient Confidentiality 
Only de-identified data will be collected in the study database.  Personal information will be treated as 
strictly confidential and will not be made publicly available.  For any data transfer, measures will be taken 
to protect patient data against disclosure to unauthorized third parties.  Every precaution will be taken to 
protect the patient privacy and confidentiality of their personal information.  All data used in the analysis 
and summary will be anonymous, and without reference to specific patients.   
13.5. Institutional Review Board 
The Institutional Review Board (IRB) will review and approve the study protocol, and protocol 
amendments if applicable.  After approval by the IRB, documentation of approval will be sent to Argon 
Medical and maintained with the study records. 
13.6. Early Termination of Study 
For reasonable cause, either the investigator or the Sponsor, may terminate the investigator’s 
participation in this protocol.  In addition, the Sponsor may terminate the Protocol at any time upon 
immediate notice for any reason. 
14. DATA MANAGEMENT 
14.1. Record Retention 
The investigator must retain all study records until notified by the Sponsor that they are no longer to be 
retained.  The investigator will also notify the Sponsor in the event he/she relocates, or for any reason 
desires to dispose of the records. 
14.2. Publication Policy 

 
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Argon Medical Devices recognizes the importance of communication of medical protocol data and 
encourages the publication of such data in reputable scientific journals and the presentation of such data 
at scientific seminars and conferences. 
Any proposed publication of presentation of the data generated from this study must be provided to 
Argon Medical Devices for timely review in accordance with the terms of the agreement.  Argon Medical 
Devices shall not, in its scientific publications or promotional material, quote from publications by the 
investigator without full acknowledgement of the source. 
15. ETHICAL CONSIDERATIONS 
This retrospective clinical study will be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki and in accordance with applicable laws and regulations including ISO 
14155 GCP standard. 
The investigator is responsible for obtaining approval of this clinical study from the relevant IRB at his 
associated institution and is responsible for complying with requirements imposed by their IRB and/or 
regulatory authority.  Furthermore, the investigator will ensure that local regulations concerning data 
protection are followed. 
 
 

 
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2. ACR–SIR–SPR. Practice Parameter for the Creation of a Transjugular Intrahepatic Portosystemic Shunt 
(TIPS). Accessed August 15, 2022. https://www.acr.org/-/media/ACR/Files/Practice-Parameters/TIPS.  
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Procedural Metrics During TIPS Creation. J Vasc Interv Radiol. 2016;27(8):1140-1147. doi: 
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5. Win AZ. Image Guided Portal Vein Access Techniques in TIPS Creation and Considerations Regarding 
Their Use. Ann Transl Med. 2016;4(11). doi:10.21037/atm.2016.05.43 
6. Cannataci C, Cimo B, Mamone G, et al. Portal Vein Puncture-Related Complications During 
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9. Sankhla T, Park P, Loya M, et al. P-570/Image Guided Portal Vein Access in Transjugular Intrahepatic 
Portosystemic Shunt (TIPS) Creation: Initial Experience with Argon Scorpion X® Access Kits. Book of 
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10. Dariushnia SR, Haskal ZJ, Midia M, et al. Quality Improvement Guidelines for Transjugular Intrahepatic 
Portosystemic Shunts. J Vasc Interv Radiol. 2016;27(1):1-7. doi:10.1016/j.jvir.2015.09.018