A Prospective, Multi-Center, Single-Arm Clinical Study of the Pristine™ Long-Term Hemodialysis Catheter
Phase: NA
Conditions: Kidney Failure, Chronic, Hemodialysis Complication, Hemodialysis Catheter Infection, Hemodialysis Access Failure, Central Venous Catheter Related Bloodstream Infection, End Stage Renal Disease
Sponsor: C. R. Bard

Protocol Number: BDPI 21-001 
 
Version: 1.0 
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Date: 01/19/2022 
 
 
 
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                                                          Clinical Investigational Protocol 
 
Protocol Title:  
A Prospective, Multi-Center, Single-Arm Clinical Study of 
the Pristine™ Long-Term Hemodialysis Catheter  
 
Short Title: 
 
 
 
Pristine Post-Market Study 
 
Protocol Number: 
 
 
BDPI-21-001 
 
Version Date:  
 
 
19 January 2022 
 
Version Number: 
 
 
1.0 
 
Study Device:   
 
 
Pristine™ Long-Term Hemodialysis Catheter 
 
Study Type:   
 
 
Post-Market 
 
Sponsor Name:  
 
 
Becton, Dickinson and Company (BD) 
 
Legal Registered Address:    
Bard Peripheral Vascular, Inc. 
1625 West 3rd Street 
Tempe, AZ 85281, USA 
 
Sponsor Contact: 
 
 
Joshua Black 
 
 
 
 
 
Associate Clinical Project Manager 
520-599-6124 
Joshua.black@bd.com 
 
 
Regulatory Agency Identifier Number(s) 
N/A. Clinicaltrials.gov NCT ID # will be added before study start.  
 
Approval Date: 02/04/2022 
 
 
 

Protocol Number: BDPI 21-001 
 
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PRINCIPAL INVESTIGATOR AGREEMENT PAGE 
   
Investigator Responsibilities 
 
1. Prior to participation in this study, the Investigator or Institution must sign the Clinical 
Study Agreement (CSA) and obtain written approval from the appropriate Institutional 
Review Board (IRB)/Ethics Committee (EC). 
2. The Investigator must receive BD-sponsored training prior to site activation. The 
Investigator is responsible for ensuring that all Sub-Investigators and clinical staff are 
adequately trained prior to performing any data collection or study-related procedures.   
3. The Principal Investigator shall ensure that the study is conducted in accordance with 
the study protocol, any modifications as requested by the IRB/EC, the signed CSA, the 
ethical principles of the Declaration of Helsinki, Good Clinical Practice (ICH E6) / ISO 
14155:2020), and applicable national/regional regulations and laws. 
4. If applicable, ensure that written informed consent is obtained from each participant 
prior to the conduct of any study procedure, using the current IRB/EC approved 
Informed Consent Form. 
 
 
I have read and understand the contents of this study protocol. I agree to follow and abide by 
the requirements set forth in this document. I agree to conduct the trial in accordance with 
the study protocol, the signed Clinical Study Agreement, and Good Clinical Practice (GCP) as well 
as applicable FDA and ISO regulations (e.g., 21 CFR Parts 50, 54, 56, and 812; ISO 14155:2020). I 
agree to participate in BD-Sponsored training prior to performing any data collection or study-
related procedures. 
 
 
Agreed to by (Investigator):  
  
_______________________________________________  
Printed Name – Investigator   
  
_______________________________________________  
Signature – Investigator  
 
_______________________________________________  
 Site Number 
 
_______________________________________________  
Date  
 
 

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Table of Contents 
Clinical Investigational Protocol..................................................................................................... 1 
Abbreviations .................................................................................................................................. 8 
1 
PROTOCOL SUMMARY ...................................................................................................... 9 
1.1 
Synopsis ........................................................................................................................... 9 
1.2 
Schedule of Activities .................................................................................................... 16 
2 
INTRODUCTION ................................................................................................................ 17 
2.1 
Background .................................................................................................................... 17 
2.2 
Rationale ......................................................................................................................... 18 
2.3 
Risk/Benefit Assessment ................................................................................................ 19 
2.3.1 
Risk Assessment ..................................................................................................... 19 
2.3.2 
Benefit Assessment ................................................................................................. 21 
2.3.3 
Overall Benefit: Risk Conclusion ........................................................................... 21 
3 
OBJECTIVES AND ENDPOINT ........................................................................................ 22 
3.1 
Primary Endpoint ........................................................................................................... 22 
3.2 
Secondary Endpoints ...................................................................................................... 22 
3.3 
Exploratory Endpoints .................................................................................................... 23 
4 
STUDY DESIGN.................................................................................................................. 23 
4.1 
Overall Design ................................................................................................................ 23 
4.2 
Scientific Rationale for Study Design ............................................................................ 24 
4.3 
Potential Influencing or Confounding Factors and Bias ................................................ 25 
4.4 
End of Study Definition ................................................................................................. 25 
5 
STUDY POPULATION ....................................................................................................... 25 
5.1 
Inclusion Criteria ............................................................................................................ 26 
5.2 
Exclusion Criteria ........................................................................................................... 26 
5.3 
Lifestyle Considerations ................................................................................................. 27 
5.4 
Screen Failures ............................................................................................................... 27 
6 
STUDY TREATMENT ........................................................................................................ 28 
6.1 
Pristine™ Long-Term Hemodialysis Catheter ............................................................... 28 
7 
STUDY PROCEDURES AND ASSESSMENTS ................................................................ 28 
7.1 
Screening and Enrollment .............................................................................................. 29 
7.1.1 
Informed Consent.................................................................................................... 29 
7.1.2 
Enrolled Participants ............................................................................................... 29 

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7.1.3 
Demographics and Medical History ....................................................................... 29 
7.1.4 
Physical Exam ......................................................................................................... 30 
7.1.5 
Lab Tests ................................................................................................................. 30 
7.1.6 
Eligibility Assessment ............................................................................................ 30 
7.2 
Index Procedure Visit ..................................................................................................... 30 
7.2.1 
Clinical Procedure ................................................................................................... 30 
7.2.2 
Adjunctive Procedures ............................................................................................ 31 
7.3 
Post-Index Procedure and Discharge ............................................................................. 31 
7.4 
Participant Follow-Up .................................................................................................... 31 
7.4.1 
Follow-Up Intervals and Methods .......................................................................... 31 
7.4.2 
Unscheduled Follow-up .......................................................................................... 32 
7.5 
Participant Investigation Completion and Premature Discontinuation .......................... 32 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL.................................................. 33 
8.1 
Discontinuation/Withdrawal .......................................................................................... 33 
8.1.1 
Lost to Follow-Up ................................................................................................... 33 
9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES....................................................... 34 
9.1 
Definitions of Events ...................................................................................................... 34 
9.1.1 
Adverse Events (AEs) ............................................................................................. 34 
9.1.2 
Serious Adverse Events (SAEs) .............................................................................. 34 
9.1.3 
Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) .............. 34 
9.1.4 
Unanticipated (Serious) Adverse Device Effect (UADE/USADE) ........................ 35 
9.1.5 
Device Deficiencies ................................................................................................ 35 
9.2 
Severity of Adverse Events ............................................................................................ 36 
9.3 
Relationship of Adverse Event to Device(s)/Procedure ................................................. 36 
9.4 
Reporting of Events ........................................................................................................ 37 
9.5 
Safety Committees ......................................................................................................... 39 
9.5.1 
Medical Monitor ..................................................................................................... 39 
10 STATISTICAL METHODS ................................................................................................. 39 
10.1 Overview of Study Design ............................................................................................. 39 
10.2 Sample Size Considerations ........................................................................................... 39 
10.3 Analysis Population ........................................................................................................ 40 
10.4 General Considerations .................................................................................................. 41 
10.4.1 Handling of Missing Data ....................................................................................... 41 

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10.5 Primary Endpoint ........................................................................................................... 41 
10.6 Secondary Endpoint(s) ................................................................................................... 42 
10.7 Tertiary/Exploratory Endpoint(s) ................................................................................... 42 
10.8 Interim Analysis ............................................................................................................. 42 
11 DATA COLLECTION AND RECORD MAINTENANCE ................................................ 42 
11.1 Case Report Forms ......................................................................................................... 42 
11.2 Source Documentation ................................................................................................... 43 
11.3 Data Management .......................................................................................................... 43 
11.4 Record Retention ............................................................................................................ 43 
12 QUALITY CONTROL AND ASSURANCE ...................................................................... 44 
12.1 Control of Investigational Device .................................................................................. 44 
12.2 Monitoring ...................................................................................................................... 44 
12.3 Audits and Inspections ................................................................................................... 45 
12.4 Protocol Deviations ........................................................................................................ 45 
13 ADMINISTRATIVE REQUIREMENTS ............................................................................ 46 
13.1 Investigator and Site Selection ....................................................................................... 46 
13.2 Training .......................................................................................................................... 46 
13.3 Required Documents ...................................................................................................... 46 
13.4 Publication Policy .......................................................................................................... 47 
13.5 Study Registration .......................................................................................................... 47 
13.6 Termination of Study ..................................................................................................... 47 
14 ETHICAL AND REGULATORY CONSIDERATIONS .................................................... 48 
14.1 IRB Approval ................................................................................................................. 48 
14.2 Informed Consent and Confidentiality ........................................................................... 48 
14.2.1 Confidentiality ........................................................................................................ 49 
14.3 Regulatory Status ........................................................................................................... 49 
14.4 Statement of Compliance ............................................................................................... 49 
15 REFERENCES ..................................................................................................................... 51 
16 APPENDICES ...................................................................................................................... 52 
 
 
 

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Abbreviations 
 
ADE 
Adverse device effect 
AE 
Adverse event 
Bard 
C. R. Bard, Inc. 
BD 
Becton Dickinson and Company 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CIP 
Clinical Investigation Protocol 
CRBSI 
Catheter-related Blood Stream Infection 
CRF 
Case Report/Record Form 
CRO 
Contract Research Organization 
CVC 
Central Venous Catheter 
DFMEA 
Design failure mode and effect analysis 
DOPPS 
Dialysis Outcomes and Practice Patterns Study 
eCRF 
Electronic Case Report Form 
ESRD 
End-Stage Renal Disease 
EtO 
Ethylene Oxide 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA  
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonization 
IFU 
Instructions for Use 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
KDOQI 
Kidney Disease Outcomes Quality Initiative 
LTF 
Lost-to follow-up 
NKF 
National Kidney Foundation 
SADE 
Serious adverse device effect 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SoA 
Schedule of Activities 
SOC 
Standard of Care 
UADE 
Unexpected Adverse device effect 
UFMEA 
User Failure Mode Effects Analysis 
 
 

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Study 
Population: 
Approximately 142 male or non-pregnant female participants in the US, ≥18 
years of age who meet indications for use of the Pristine™ Catheter will be 
enrolled and have the Pristine™ Catheter placed in the United States (US). 
Eligibility 
Criteria: 
Clinical Inclusion Criteria 
A participant must meet ALL the following criteria to be enrolled in the 
study: 
 
1) The participant or legally designated representative must voluntarily 
sign and date the approved Informed Consent Form (ICF) prior to 
collection of study-specific data or performance of study-specific 
procedures. 
 
2) The participant must be willing and able to comply with protocol 
requirements, including all study visits and procedures. 
 
3) The participant must be either a male or non-pregnant female ≥18 
years of age.  
 
4) The participant must have a diagnosis of End Stage Renal Disease 
with indication for a tunneled dialysis catheter creation. 
 
5) Participant must require chronic hemodialysis treatments 3 times 
per week with intended use of the Pristine™ Long-Term Hemodialysis 
Catheter. 
 
6) The participant meets the indications for hemodialysis use and does 
not meet any of the contraindications per the Pristine Instructions 
for Use (IFU). 
 
7) The participant must have a patent jugular vein or subclavian vein. 
 
Clinical Exclusion Criteria 
A participant must NOT meet ANY of the following criteria to be enrolled in 
the study: 
 
1) The participant has known central venous stenosis 
 
2) Based on the local primary investigator’s discretion, the patient 
would not be an appropriate study candidate.  

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3) The participant has already undergone an AVF or AVG procedure 
and is awaiting maturation.  
 
4) The participant has an active infection at the time of study 
enrollment. 
 
5) The participant has a presence of bacteremia or infection within 7 
days prior to enrollment. 
 
6) The participant has a history neutropenia or a history of severe 
immunodeficiency disease. 
 
7) The participant has uncontrolled abnormal coagulation parameters 
and are at additional risk for clotting or excessive bleeding at time 
of enrollment per physicians opinion. 
 
8) The participant has a known allergy, intolerance or sensitivity to 
heparin, or previous incidence of heparin-induced 
thrombocytopenia. 
 
9) The participant has a known allergy or hypersensitivity to any of 
the device materials or Ethylene oxide (EtO).  
 
10) The participant has another medical condition or treatment, which 
in the opinion of the investigator, the participant may be non-
compliant with the protocol, confound the data interpretation, or 
is associated with a life expectancy insufficient to allow for 
completion of study procedures and follow-up. 
 
11) The participant is currently participating in an investigational drug 
or another device study that has not completed the study 
treatment or that clinically interferes with the study endpoints. 
Note: Studies requiring extended follow-up visits for products that 
were investigational but have since become commercially 
available, are not considered investigational studies. 
 
Study 
Methodology: 
All participants will undergo a clinical evaluation at the Screening Visit (prior 
to Index Procedure). Participants that meet Eligibility Criteria will be 
consented, have the Pristine™ Long-Term Hemodialysis Catheter placed, 

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Statistical 
Methods: 
Primary Endpoint: 
The combined primary endpoint is the overall rate of infectious 
complications and non-infectious complications requiring revision to 
maintain patency and improve access performance at 3 months. Based 
on the DOPPS study data, competitor control devices had an average 
incidence rate of 31.5 complications per 1000 patient days. To show 
non-inferiority of the Pristine™ Catheter, a 5 complications per 1000 
patient days non-inferiority margin is used to establish a performance 
goal (PG) of 36.5 events per 1000 patient days. 
The analysis of the primary endpoint will be based on the following test 
of Poisson rate: 
H0: The complication rate through 3 month is greater than or equal to 
36.5 events per 1000 patients days at 3 months. 
H1: The complication rate through 3 month is less than 36.5 events per 
1000 patient days at 3 months. 
That is: 
H0: λ ≥ λ0  
H1: λ < λ0 
Where λ0 is the PG of 36.5 events per 1000 patient days. 
A one-sided p-value will be derived based on an Poisson distribution. 
The Pristine™ Catheter will be considered to have achieved the primary 
endpoint objective if the one-sided p-value is less than 0.025. 
Conditioned on the success of the above test, a superiority test will be 
conducted to show that the Pristine™ Catheter is superior to the 
performance goal. The above test will be repeated with a PG of 31.5 
events per 1000 patient days. 
The analyses of the primary endpoint will be based on the ITT 
population and repeated with per-protocol population as sensitivity 
analyses. 
Sample Size: 
Based on hypothesis test of Non-inferiority  
• Assumptions: 
o The complication rate of our PG is estimated at 31.5 events 
per 1000 patient days with a 90 days follow-up based on 

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DOPPS study data. The complication rate for Pristine is 
expected to be similar. 
o The PG is set at 36.5 events per 1000 days using a 5 events 
per 1000 days non-inferiority margin; 
o The attrition through 90 days is assumed to be 15% 
o The Type 1 error is 0.025 (one-sided). 
o The Type 2 error is 0.2. 
• Sample Size: 
o Total required exposure is 12765 patient days which 
translates to 142 subjects with average exposure of 90 days 
(PASS 2019). 
Based on hypothesis test of Superiority  
• Assumptions: 
o The complication rate of our PG is estimated at 31.5 events 
per 1000 patient days with a 90 days follow-up based on 
literature review, which is set as the PG. 
o The complication rate for the Pristine™ Catheter is assumed 
to be 26.5 events per 1000 patient days. 
o The attrition through 90 days is assumed to be 15% 
o The Type 1 error is 0.025 (one-sided). 
• Sample Size: 
o Total exposure of 12765 patient days (which translates to 
142 subjects with average exposure of 90 days) will provide 
85% power of the test (PASS 2019). 
Principal 
Investigator 
and Study 
Location(S): 
National Principal Investigator: 
• Jeffrey Hoggard, MD   
Site Locations:  
• All, up to 15, sites will be located in the United States. 
Regulatory 
Status: 
The BD Pristine™ Long-Term Hemodialysis Catheter has been cleared by the 
Food and Drug Administration (FDA) on 02 April 2021. The BD Pristine™ 
Long-Term Hemodialysis Catheter is not anticipated to receive CE Mark 
(European Conformity) before initiation of the clinical trial. The Pristine 
study will be a Post-Market evaluation in accordance with the study 
protocol, any modifications as requested by the IRB/EC, the ethical 
principles of the Declaration of Helsinki, Good Clinical Practice (ICH E6) / ISO 
14155:2020), and all applicable national/regional regulations and laws. 

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2 
INTRODUCTION 
 
The Pristine™ Post-Market study is a prospective, multi-Center, single-arm clinical study to 
evaluate the safety and performance of the BD Pristine™ Long-Term Hemodialysis Catheter. 
This study will be conducted in conformance with the Declaration of Helsinki, applicable national 
privacy laws (e.g., Health Insurance Portability and Accountability Act (HIPAA) requirements in the 
U.S.), applicable Food and Drug Administration (FDA) regulations (21 Code of Federal Regulations 
(CFR) Parts 11, 50, 54, 56, and 812), Institutional Review Board (IRB) requirements, and 
International Organization for Standardization (ISO) 14155:2020 standards.  
 
2.1 Background 
 
With introduction of hemodialysis as a feasible and effective treatment in the early 1940s, 
the grim outlook of death evolved to a prospect of survival for patients with advancing 
kidney failure. By reducing the time and effort required by the patient and caregivers, 
technological advancements have gradually transformed hemodialysis from an intensive 
bedside therapy to a more streamlined treatment, sometimes even self-administered in the 
comfort of patient’s home. Standards have been established and guidelines were put in 
place to efficiently care for large numbers of patients with a balance of resources and 
patient time. 
 
According to the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative, 
(2015 NKF KDOQI) over 400,000 patients are currently treated with hemodialysis in the 
United States, with Medicare spending reportedly approaching $90,000 per patient per year 
of care in 2012. In 2012, the European Renal Association - European Dialysis and Transplant 
Association reported a prevalence of 372 patients per million in the United Kingdom.1, 2 
 
Appropriate care of hemodialysis patients requires constant maintenance of vascular access 
patency and function, to accommodate for a flow rate to the dialyzer that is adequate for 
the dialysis prescription. The failure of access is a major cause of morbidity for patients on 
hemodialysis therapy, with a number of reports indicating that a high percentage of 
hospitalizations for patients with chronic kidney disease were caused by vascular access 
complications. The United States Renal Data System (USRDS) reported that hemodialysis 
access failure was the most frequent cause of hospitalization for patients with stage 5 
chronic kidney disease and, in some centers, it accounted for the largest number of hospital 
days. Ideally, vascular access has a long use-life, and has a low rate of complications. The 
surgically created arteriovenous fistula has shown the best 4- to 5-year patency rates and 
has required the fewest interventions compared with other access types. However, use of 
grafts and cuffed central venous catheters (CVCs) for permanent hemodialysis access is 
common, accompanied by an increased rate of access related complications. 
 

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Despite the burden of catheter-associated conditions and risks for patients, the use of cuffed 
tunneled central venous catheters is frequently vital as a standalone treatment modality of 
acute and chronic renal failure and serves as a bridge until recovery of renal function, 
maturation of fistula, or finding a donor organ. The need for better performing hemodialysis 
catheters still exists. 
 
Catheter design can impact performance. Some hemodialysis catheters have side holes in 
their distal lumens. These side holes, which were intended to increase inflow and reduce risk 
of blockage, have been shown to be prone to clot formation. Under electron microscopy side 
holes have been shown to have rough edges where thrombi can attach. Due to the side 
holes flow, anticoagulant given at the end of dialysis may not be able to reach the tip of the 
catheter. 
 
The Pristine™ Long-Term Hemodialysis Catheter, is an innovative split, symmetrical, side-
hole–free tip. The Pristine™ Catheter’s side-hole free tip is designed to help minimize 
thrombus adhesion that can be associated with hemodialysis catheters that have side holes.    
 
In a previous feasibility study, the primary objective was to observe the performance of the 
Pristine™ Long-Term Hemodialysis Catheter in participants with End-Stage Renal Disease or 
Acute Renal Failure. The study was performed at a single investigation site in the Dominican 
Republic. Forty-five (45) participants (males or non-pregnant females with ESRD or ARF 
requiring hemodialysis treatment) received the current 15.5F Pristine™ catheter. The 
primary endpoint was primary patency, prespecified for evaluation at 30 days post-catheter 
implantation and was defined as a catheter that provided adequate hemodialysis (flow 
>300mL/min) without the need for additional interventions (i.e., TPA infusions or fibrin 
sheath stripping or catheter exchange) to maintain flow or correct device failure.3  
 
Participants were followed for 6 months post-catheter implantation at four sites that were 
affiliated with the placement institution. All catheters (n=44) were patent at 30 days post 
implantation. Primary patency at 60- and 180- days post procedure was 100.0% and 90.9%, 
respectively. The following adverse events (AE) were reported in accordance with MedDRA 
v. 22.1. There were 9 infections, 6 of which were reported as device-related and 3 (2 
pneumonia and 1 abdominal abscess) were reported as not related to the study device. 
There were 2 cardiac disorders and 2 vascular disorders, none of which were reported as 
device related. There were 6 general disorder and access site conditions, 2 of which were 
reported as device related. There were 9 deaths reported in the study, none of which were 
reported as related to the device or procedure.3  
 
2.2 Rationale 
 
The purpose of this clinical investigation is to provide clinical evidence to further 
demonstrate reasonable assurance of safety and performance of the Pristine™ Long-Term 

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Hemodialysis Catheter to provide immediate hemodialysis access. The Pristine™ Catheter 
has already been cleared by the FDA and is currently on the market in the United States. 
 
2.3 Risk/Benefit Assessment 
 
The risks associated with the use of Pristine™ Long-Term Hemodialysis Catheters have been 
identified by performing a Design Failure Mode and Effects Analysis (DFMEA) and a Use Failure 
Mode and Effects Analysis (UFMEA). At the completion of the DFMEA and UFMEA, a Risk 
Management Report was generated to summarize the risk analysis process and provide 
documented evidence that the risks associated with the study device are acceptable. Prior to 
any study procedure, the Investigator (or designee) must explain to each participant in 
layman’s terms, the nature of the study, its purpose, expected duration, and the risks and 
benefits of study participation. 
 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events of Pristine™ Long-Term Hemodialysis Catheters may be found in 
the Instructions for Use (IFU). 
 
2.3.1 
Risk Assessment 
 
The known possible risks associated with the use of the BD Pristine™ Long-Term 
Hemodialysis Catheter are listed below. The study involves only the collection of data, the 
only risk of taking part is the possible loss of confidentiality of your information collected 
in the study. None of the procedures or devices in this study are considered experimental.  
 
Potential complications and Adverse Events (AEs) associated with the use of the Pristine™ 
Long-Term Hemodialysis Catheter may include the usual complications associated with 
central venous catheter procedures. These complications can occur singularly or 
collectively, and may include the following: 
 
• 
Air Embolism 
• 
Hemothorax 
• 
Arterial Puncture 
• 
Hydrothorax 
• 
Brachial Plexus Injury 
• 
Inferior Vena Cava Injury 
• 
Cardiac Arrhythmia 
• 
Intolerance Reaction to Implanted Device 
• 
Cardiac Tamponade 
• 
Lower Extremity Ischemia 
• 
Catheter Erosion or Extrusion Through Skin 
• 
Catheter Infection 
• 
Mediastinal Widening 
• 
Pneumothorax 
• 
Pulmonary Emboli 
• 
Pulmonary Embolism 
• 
Retroperitoneal Bleed 
• 
Right Atrial Puncture 
• 
Sepsis 
• 
Catheter Occlusion or Breakage 
• 
Catheter Thrombosis 
• 
Catheter Tip Migration or Malposition 
• 
Deep Vein Thrombosis – Lower Extremity 
• 
Endocarditis  

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There are minimal additional risks for enrolled participants due to the study being post-
market. All procedures will be performed per standard of care treatment in the US with 
an FDA cleared device.  
 
2.3.2 
Benefit Assessment 
 
You will not receive any direct benefit from being in the study. However, the information 
gained from your taking part in this study may help others in the future. Potential benefits 
that may result from the Pristine™ Catheter and procedure may include: 
• Reduce the risk of infection and reduced chance of thrombi formation. 
• Higher likelihood of a lasting usable catheter for hemodialysis. 
• Vascular access for hemodialysis treatment. 
   
2.3.3 
Overall Benefit: Risk Conclusion 
 
This protocol is specifically designed to manage and minimize risks through careful 
participant selection, training of Investigators, adherence to the pre-determined time 
points to assess participant clinical status and regular clinical monitoring visits by Sponsor-
appointed monitoring personnel. 
 
The Risk Management Report and the results of non-clinical (e.g. bench testing, 
biocompatibility, etc.) and pre-clinical testing did not reveal any unacceptable residual 
risks. 
 
Taking into consideration the measures to minimize risk to participants in this study, the 
potential risks identified in association with treatment using the BD Pristine™ Long-Term 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for 
Risk 
 
Mitigation Strategy 
• Hemothorax 
• Infection 
• Migration 
• Pneumothorax 
• Venous injury 
 
(as applicable) must be 
experienced in the field of 
application. 
• The CIP required follow-up 
ensures close participant 
monitoring for AEs 
throughout the course of the 
investigation (Section 9). 

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Hemodialysis Catheter are justified by the anticipated benefits that may be afforded to 
participants with End-Stage Renal Disease. 
 
 
 
 
3 
OBJECTIVES AND ENDPOINT 
 
 
The objective of this study is to assess the safety and performance of the BD Pristine™ Long-Term 
Hemodialysis Catheter for attaining vascular access for hemodialysis. The information obtained 
from the study is intended to be reported in the device’s labeling. 
 
 
 
3.1 Primary Endpoint 
 
Primary Safety and Performance Endpoint 
 
This study has a combined Safety and Performance endpoint derived from the Dialysis 
Outcomes and Practice Patterns Study (DOPPS) data. The combined Primary Endpoint will be 
overall complications including infectious and non-infectious complications at 3 months.  
 
Infectious Complications are defined as: 
Complications due to any documented diagnosis of access infection requiring medical 
intervention (managed in an outpatient or inpatient setting) or sepsis as diagnosis in the 
hospitalization file whether access related or not.4 
 
Non-infectious complications are defined as: 
Complication due to any noninfectious cause (thrombosis of the access, fibrin material 
within or around a catheter, catheter migration, central vein stenosis or thrombosis) 
requiring a revision procedure to maintain patency or improve access performance (i.e., 
thrombolysis, angioplasty, or surgical correction) in an inpatient or outpatient setting or 
removal or abandonment with creation of a new access that was not due to an access-
related infection).4 
 
3.2 Secondary Endpoints 
The following secondary endpoints will be evaluated using descriptive statistics to provide 
further information related to the safety and performance of the Pristine™ Long-Term 
Hemodialysis Catheter. All secondary endpoints will be summarized with descriptive statistics. 
 
• Rate of freedom from catheter-related bloodstream infection (CRBSI), defined by 2019 
KDOQI Guidelines for CRBSI through 1-month, 3-months, 6-months, and 12 months 
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• Rate of freedom from Device and/or Procedure-related adverse events, at 1-month, 3-
months, 6-months, and 12 months post-index procedure. 
• Rate of Technical Success, defined as the successful placement of the Pristine™ Long-
Term Hemodialysis Catheter, as assessed by the Investigator during the Index 
Procedure. 
• Overall Participant Survival Rate at 1-month, 3-months, 6-months, and 12 months post-
index procedure, defined as the proportion of participants that have not died from any 
catheter related complication.  
• Overall Catheter Survival Rate at 1-month, 3-months, 6-months, and 12 months post-
index procedure, defined as the proportion of Pristine™ Catheters that have not been 
removed for any cause. 
• Overall Patency Rate, at 1-month, 3-month, 6-months, and 12-months post-index 
procedure, defined as the Pristine™ catheter having the ability to achieve a mean 
dialysis blood flow of ≥300mL/min without need for additional interventions. 5,6 
 
3.3 Exploratory Endpoints 
 
The following endpoints may be evaluated in an exploratory fashion. Data will be collected 
throughout the course of the investigation in support of this endpoint. 
 
• Kit Component Safety and Performance, defined as the overall rate of the catheter’s 
procedure kit component complications from time of procedure to discharge. 
 
4 
STUDY DESIGN 
 
4.1 Overall Design 
 
This is a prospective, multi-center, post market, single-arm study designed to assess the 
safety and performance of the Pristine™ Long-Term Hemodialysis Catheter. The primary 
objective of this study is to assess the overall complication rate of the Pristine™ Catheter 
against an overall hemodialysis catheter complication rate derived from clinical literature. 
 
A total of 142 patients will be enrolled and have the Pristine™ Long-Term Hemodialysis 
Catheter placed. Under the current enrollment assumptions, up to 15 investigational sites in 
the United States (US) will participate. The study will be enrolling male or non-pregnant 
female participants ≥18 years of age meeting study inclusion/exclusion and labeled 
indication for hemodialysis for adequate completion of study procedures and collection of 
data. Eligible participants will have End Stage Renal Disease requiring hemodialysis through a 
tunneled dialysis catheter. Follow-up for all enrolled participants will be performed at 1-
month, 3-months, 6-months, and 12-months post-Index Procedure. No site will be allowed 
to enroll more than 20% of the overall number of participants to ensure a reasonably well-
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For this study, we have a combined Safety and Performance endpoint derived from the 
Dialysis Outcomes and Practice Patterns Study (DOPPS) data.4 Our combined Primary 
Endpoint will be overall complications including non-infectious and infectious at 3 months. 
 
4.2  Scientific Rationale for Study Design 
 
The combined safety and performance primary endpoint is compared to a performance goal 
of 31.5 complications per 1000 catheter days derived from the Dialysis Outcomes and 
Practice Patterns Study (DOPPS).5 The DOPPS data was chosen due to it’s significant sample 
size of tunneled catheters (n=4207) and it’s clear definition of non-infectious and infectious 
complications. DOPPS I-III enrolled 27, 129 participants that provided access data. DOPPS I 
enrolled within France, Germany, Italy, Japan, Spain, the United Kingdom, and the United 
States. DOPPS II and DOPPS III enrolled in Australia, Belgium, Canada, New Zealand, and 
Sweden.5 There have been few hemodialysis catheter studies performed in the last 10 years 
with many lacking sufficient sample size for statistically powered endpoints. The 
hemodialysis catheter studies that report ‘complication’ rates or infection rates have a 
significant variance in definitions. The KDOQI guidelines have stated a need for consistent 
definitions and outcomes between tunneled catheter studies.6 DOPPS is a globally renowned 
study providing clinically meaningful definitions with a significant sample size not seen in 
other studies.  
 
The primary endpoint for this study is a combined complication rate of non-infectious and 
infectious complications. Non-infectious complications are defined as, complications due to 
any noninfectious cause (thrombosis of the access, fibrin material within or around a 
catheter, catheter migration, central vein stenosis or thrombosis) requiring a revision 
procedure to maintain patency or improve access performance (i.e., thrombolysis, 
angioplasty, or surgical correction) in an inpatient or outpatient setting or removal or 
abandonment with creation of a new access that was not due to an access-related infection). 
This definition of non-infectious provides the clinically relevant point of re-intervention. 
Thrombosis, fibrin material, and catheter migration are all common events for tunneled 
catheters. When these events start to disrupt dialysis treatment, they require re-
intervention thus putting more burden on the patient and healthcare system. The other part 
is infectious complications defined as, complications due to any documented diagnosis of 
access infection requiring medical intervention (managed in an outpatient or inpatient 
setting) or sepsis as diagnosis in the hospitalization file whether access related or not. 
Infection rate for catheters is arguably the most crucial reported value being the main cause 
of catheter related deaths. The infectious complications defined include exit site infections 
and all blood stream infections causing sepsis.  
 

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Showing a statistically significant difference by our powered primary endpoint against the 
performance goal will attest to the performance, safety, and clinical benefits of the Pristine™ 
Catheter. 
 
4.3  Potential Influencing or Confounding Factors and Bias 
 
Another potential foreseeable factor pertains to the global nature of this investigation and 
the varying practice patterns across the regions that may participate. These differences 
could stem for example from differing surveillance programs, differing criteria for initiating 
CVC hemodialysis, among others. This factor is mitigated through CIP stipulated training 
requirements, as well as maximum enrollment limitations on any single site, and 
standardization for follow-up interval timing and pertinent requirements. Subgroup analyses 
between regions may be conducted to explore regional differences for standard of care 
differences. This could also be expanded to inter-region subgroup analyses should there be 
differences in institution types (e.g. public versus private) that participate within a region.  
 
In addition to region and institution type, the training and level of experience with the 
Pristine™ Long-Term Hemodialysis Catheter as well as the specialty of the operator could 
also be a foreseeable factor that could impact the study outcomes. As a mitigation of this 
factor the training and operator approval requirements delineated in Section 13.2 are 
implemented. Subgroup analyses looking at the experience level and / or specialty of the 
operator may also be performed to investigate the impact on results. 
 
4.4  End of Study Definition 
 
A participant is considered to have completed the study upon conclusion of the 12-Month (±1 
month) follow-up visit. The end of the study is defined as the date of the last visit of the last 
participant in the study. 
 
 
5 
STUDY POPULATION 
 
Study population includes participants with end stage renal disease requiring hemodialysis 
through a tunneled dialysis catheter. All participants must meet all inclusion and exclusion 
criteria.  
 
Participants will be recruited for enrollment in the study from each site’s existing pool of 
patients. Enrollment of participants will continue until a total of 142 patients at up to 15 sites 
have been enrolled and undergo the placement procedure successfully of the BD Pristine™ 
Long-Term Hemodialysis Catheter. It is anticipated that enrollment will be approximately 12 
months in duration. The following describes the clinical eligibility (inclusion and exclusion) 
criteria for this study: 

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5.1  Inclusion Criteria 
 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
 
1. The participant or legally designated representative must voluntarily sign and date the 
approved Informed Consent Form (ICF) prior to collection of study-specific data or 
performance of study-specific procedures. 
 
2. The participant must be willing and able to comply with protocol requirements, including 
all study visits and procedures. 
 
3. The participant must be either a male or non-pregnant female ≥18 years of age.  
 
4. The participant must have a diagnosis of End Stage Renal Disease with indication for a 
tunneled dialysis catheter creation. 
 
5. Participant must require chronic hemodialysis treatments 3 times per week with intended 
use of the Pristine™ Long-Term Hemodialysis Catheter. 
 
6. The participant meets the indications for hemodialysis use and does not meet any of the 
contraindications per the Pristine Instructions for Use (IFU). 
 
7. The participant must have a patent jugular vein or subclavian vein. 
 
5.2 Exclusion Criteria 
 
A participant must NOT meet ANY of the following criteria to be enrolled in the study: 
 
1. The participant has known central venous stenosis 
 
2. Based on the local primary investigator’s discretion, the patient would not be an 
appropriate study candidate.  
 

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3. The participant has already undergone an AVF or AVG procedure and is awaiting 
maturation.  
 
4. The participant has an active infection at the time of study enrollment. 
 
5. The participant has a presence of bacteremia or infection within 7 days prior to 
enrollment. 
 
6. The participant has a history neutropenia or a history of severe immunodeficiency 
disease. 
 
7. The participant has uncontrolled abnormal coagulation parameters and are at additional 
risk for clotting or excessive bleeding at time of enrollment per physicians’ opinion. 
 
8. The participant has a known allergy, intolerance or sensitivity to heparin, or previous 
incidence of heparin-induced thrombocytopenia. 
 
9. The participant has a known allergy or hypersensitivity to any of the device materials or 
Ethylene oxide (EtO).  
 
10. The participant has another medical condition or treatment, which in the opinion of the 
investigator, the participant may be non-compliant with the protocol, confound the data 
interpretation, or is associated with a life expectancy insufficient to allow for completion 
of study procedures and follow-up. 
 
11. The participant is currently participating in an investigational drug or another device 
study that has not completed the study treatment or that clinically interferes with the 
study endpoints. Note: Studies requiring extended follow-up visits for products that 
were investigational but have since become commercially available, are not considered 
investigational studies. 
 
 
5.3 Lifestyle Considerations 
 
No lifestyle restrictions are required for this study. 
 
5.4 Screen Failures 
 
Individuals that consent to participate in the study but subsequently fail to meet eligibility 
criteria and do not undergo treatment with the study device at the Index Procedure will be 
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eligibility failure and these individuals may not be rescreened. Documentation of the 
reason(s) for screen failure should be present in the participant’s medical record and/or 
source documents. 
 
6 
STUDY TREATMENT 
 
All participants will undergo a clinical evaluation at the Screening Visit (prior to Index 
Procedure). Participants that meet Eligibility Criteria will have the BD Pristine™ Long-Term 
Hemodialysis Catheter placed and will undergo additional follow-ups. Follow-up for all enrolled 
participants will be performed via in-person or telephone screen to the participant and dialysis 
center at 1-month, 3-months, 6-months, and 12-months post-Index Procedure.   
 
 
6.1 Pristine™ Long-Term Hemodialysis Catheter 
 
The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting 
of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term 
vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter 
features two color coded luer adapters. The luer adapters are connected to clear extension 
tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation 
and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen 
catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of 
the catheter’s distal tip includes a split, symmetric Y-Tip™ with notches and without side-
holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal 
ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a 
sterile, single use device, and is sterilized using a validated ethylene oxide process. 
 
The Pristine™ Long-Term Hemodialysis Catheter is FDA cleared and will be evaluated in a 
post-market fashion for its approved indication in the USA. Sites are to use the product off-
the-shelf. The product shall be used in accordance with its IFU. The device will be identified 
using its product code and lot number for traceability. Please refer to the standard medical 
device reporting for any failed or malfunctioned Pristine™ Catheters. 
 
 
7 
STUDY PROCEDURES AND ASSESSMENTS 
 
Study procedures, assessments, and their timing are summarized in the Schedule of Activities 
(SoA) in Section 1.2. Protocol waivers or exemptions are not allowed. Adherence to the study 
design requirements, including those specified in the SoA, is essential and required for study 
conduct. All study procedures must be documented in the participant’s medical record and/or 
source documents as well as in the electronic Case Report Forms (eCRFs). 
 

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Prior to the collection of any study-specific data, the participant must voluntarily sign and date 
the IRB approved ICF. All participants will undergo an in-office clinical evaluation at the Screening 
Visit (prior to Index Procedure). Participants that meet Eligibility Criteria will be treated with the 
Pristine™ Long-Term Hemodialysis Catheter and will undergo additional follow-ups. Follow-up 
for all enrolled participants will be performed via in-person or telephone screen to the participant 
and dialysis center at 1-month, 3-months, 6-months, and 12-months post-Index Procedure.   
 
7.1 Screening and Enrollment 
 
During the recruitment and screening process, the Investigator (or authorized designee) will 
be responsible for describing the nature of the study to the participant, verifying that initial 
eligibility criteria have been met, obtaining Informed Consent, collecting participant 
information, and performing relevant screening procedures. The following procedures will be 
conducted and documented during the screening process: 
 
7.1.1 
Informed Consent 
 
The background and purpose of the study, participation requirements, and the potential 
benefits and risks of the procedure(s) must be explained to the participant in layman’s 
terms. Prior to the collection of any study-specific data or the conduct of any protocol-
specific assessments, the participant or the legally designated representative must 
voluntarily provide Informed Consent and comply with applicable federal and state privacy 
laws (e.g. HIPAA requirements in the US). Documentation of the Informed Consent process 
along with the signed Informed Consent Form should be present with the participant’s 
source documents and dated prior to initiation of study-specific assessments. Procedures 
conducted as part of the participant’s routine clinical management (e.g. imaging, labs, etc.) 
and obtained before signing of the ICF may be utilized for Screening purposes provided the 
procedures meet the protocol-specified criteria and were performed within the time frame 
defined in the SoA. Please refer to Section 14.2 for additional details on informed consent.  
 
7.1.2 
Enrolled Participants 
 
Individuals that consent to participate in the study will be considered ENROLLED. 
Participants that fail to meet eligibility criteria post-consent and prior to undergoing device 
placement with the study device will be considered SCREEN FAILURES per Section 5.4. 
 
7.1.3 
Demographics and Medical History 
 
The following demographic and medical history information must be collected and 
documented during the Screening Visit: 
 
▪ Demographics 

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o Age, Sex, Race, and Ethnicity 
▪ Relevant Medical History and Risk Factors including, but not limited to: 
o Renal disease Diagnosis 
o Etiology of End-Stage Renal disease  
o History of kidney-related medical conditions, treatments, and 
procedures. 
o History of other relevant medical conditions, treatments, and 
procedures. 
 
7.1.4 
Physical Exam 
 
A physical examination must be conducted or documented within 30 days prior to Index 
Procedure in accordance with each investigational site’s standard of care and must include: 
 
▪ Height and Weight 
 
7.1.5 
Lab Tests 
 
No lab tests are required for study participation.  
 
7.1.6 
Eligibility Assessment 
 
The participant’s eligibility for treatment with Pristine™ Long-Term Hemodialysis Catheter 
will be reviewed and source documentation should indicate that the participant met all 
study eligibility criteria prior to the Index Procedure treatment. Refer to Section 5.4 if 
eligibility criteria are not met. 
 
7.2 Index Procedure Visit 
 
The Index Procedure should be conducted per the investigational site’s standard practices for 
hemodialysis catheter procedures, medication therapy, patient monitoring, sterile operative 
techniques, and within the bounds and requirements of the Pristine™ Long-Term 
Hemodialysis Catheter IFU. The following must be documented at the Index Procedure Visit: 
 
7.2.1 
Clinical Procedure 
 
After the PI, or authorized designee(s), has determined that the participant is eligible for 
participation based on the criteria listed in Section 5.1 and 5.2, the participant may be 
enrolled and undergo the Pristine™ Catheter placement procedure. Examinations, 
evaluations, procedural preparation, angiography, treatment, and hospital / facility 
discharge procedures will be conducted per the investigational site’s SOC. 
 

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The placement of the Pristine™ Catheter, will be per the investigational site’s SOC and 
must adhere to the device IFU. Operators of the Pristine™ Catheter must be approved by 
the Sponsor as an operator in writing before conducting an index procedure on enrolled 
participants (refer also to Section 13.3). For detailed information on device use and 
procedural medication recommendations, reference the IFU. 
 
Enrolled participants will continue clinical participation through the 12-month follow-up 
period. Participants into whom the Pristine™ Catheter was not introduced should be 
treated per SOC and the reason documented on the appropriate eCRF. Participation for 
these participants will end at time of the index procedure. 
 
7.2.2 
Adjunctive Procedures 
 
Adjunctive procedures during the index procedure, as part of SOC is allowed. All 
adjunctive procedures will be documented on the appropriate eCRF. 
 
7.3 Post-Index Procedure and Discharge 
 
Medication therapy and medical treatment will be conducted at the discretion of the PI per 
the investigational site’s SOC. Participants will be treated and discharged according to the 
site’s SOC. Prior to discharge, the following data will be collected and documented on the 
appropriate eCRF for participants into whom the Pristine™ Catheter was placed: 
• Documentation of Adverse Events (AEs): Documentation of AEs (refer to Section 9) that 
have occurred since the start of the index procedure (defined to begin at the time of the 
initial skin puncture to gain vessel access). 
• Documentation of Re-Interventions: Any additional interventions the participant has 
undergone since the completion of the index procedure (defined to end at the time of 
leaving the operating room). 
 
7.4 Participant Follow-Up 
 
7.4.1 
Follow-Up Intervals and Methods 
 
Enrolled participants will have follow-up visits at 1-month, 3 months, 6-months, and 12-
months via either in person visit or telephone call. For participants into whom the 
Pristine™ Catheter was introduced during the index procedure, but procedure success 
was not achieved, only the procedure eCRF will be collected and limited to the collection 
of safety events and interventions for up to 30 days.  
 
Follow-up windows will be calculated from the index procedure date. Refer to Section 1.2 
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following data will be collected and documented on the appropriate eCRF for each follow-
up unless otherwise specified for treated participants: 
 
• Hemodialysis Catheter Assessment: 
o Document how the participant has been receiving hemodialysis and 
document the date of the participant’s last HD session.  
• Dialysis Session Blood Flow Rate: 
o If dialyzing through the Pristine™ Catheter, document the reported 
dialysis sessions and details such as date of dialysis session, average 
blood flow rate, number of line reversals, and length of dialysis session. 
• If Needed: 
o Documentation of any protocol deviations that have occurred since the 
last follow-up. 
o Documentation of occurrence and / or status of AEs since the last follow 
up (refer to Section 9). 
o Any catheter reinterventions the participant has undergone since the 
prior follow-up. 
7.4.2 
Unscheduled Follow-up 
 
An unscheduled visit eCRF should also be completed for participants who return for 
additional unscheduled examination(s) pertaining to their HD vascular access. The 
participant will be required to complete the next scheduled follow-up visit if the 
unscheduled visit is out of the CIP allotted follow-up window or if the required elements 
of the respective follow-up were not completed as part of the unscheduled visit.  
 
If the participant is treated by a health-care professional other than the PI for treatment 
related complications during the course of the follow-up period, the PI or authorized 
designee should request copies of the medical records and, if necessary, complete the 
appropriate eCRFs. 
 
7.5 Participant Investigation Completion and Premature Discontinuation 
 
Following the index procedure, every participant into whom the Pristine™ Catheter was 
placed should remain in the study until completion of the required follow-up period or until 
day of remove of the Pristine™ Catheter. The follow-up period for this clinical investigation is 
12 months (365 ± 30 days) for participants who had the Pristine™ Catheter successfully 
placed. An enrolled participant is considered to have completed the study if the participant 
has completed the formal follow-up period associated with this clinical investigation through 
the 12-Month follow-up as described in the Schedule of Activities (Section 1.3).  
 

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Upon investigation completion or premature discontinuation (in the situations where 
applicable), the participant’s continued care should be administered per SOC at the 
discretion of the PI and / or their primary care physician.  
 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL  
   
8.1 Discontinuation/Withdrawal 
 
• A participant may withdraw from the study at any time at his/her own request 
(Withdrawal of Consent) or may be withdrawn at any time at the discretion of the 
investigator (Investigator’s Decision) or sponsor (Sponsor’s Decision) for safety, 
behavioral, compliance, or administrative reasons. 
• Once a participant discontinues from the study, no further data will be collected. 
• If the participant withdraws consent for disclosure of future information, the 
sponsor may retain and continue to use any data collected before such a withdrawal 
of consent. 
• If a participant withdraws from the study, the reason for withdrawal must be 
documented.  
 
8.1.1 
Lost to Follow-Up 
 
A participant will be considered Lost to Follow-Up (LTFU) if he/she repeatedly fails to 
return for/complete scheduled visits and is unable to be contacted by the investigational 
site. This does not apply to missed visits, where the participant misses one (1) follow-up 
visit but completes a subsequent one. 
 
The following actions must be taken if a participant fails to return for/complete a 
required study visit: 
 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to 
and/or should continue in the study. 
• Before a participant is deemed LTFU, the investigator or designee must make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the 
participant’s medical record and source documents. 
• Should the participant continue to be unreachable, he/she will be considered LTFU 
effective the date of the final failed contact attempt. 

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9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES 
 
9.1 Definitions of Events 
 
9.1.1 
Adverse Events (AEs) 
 
An AE is defined as any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in participants, users or 
other persons, whether or not related to study device [ISO14155:2020(E)].   
 
Pre-existing conditions should be considered as part of the participant’s medical history 
and should not be reported as an AE unless there is a substantial increase in severity or 
frequency of the condition. Likewise, planned hospital visits and/or hospital stays should 
not be considered as adverse events.  Exacerbation of an existing condition should be 
reported as an AE if the event meets the protocol definition of an AE. 
 
The clinical course of the event will be followed according to accepted standards of 
medical practice until the event resolves, stabilizes, or in the opinion of the Investigator, 
is no longer considered clinically significant.  The Investigator must supply the Sponsor 
with information concerning the follow up and/or resolution of the AE. 
 
9.1.2 
Serious Adverse Events (SAEs) 
 
A serious adverse event (SAE) is defined by ISO 14155:2020 and/or 21 CFR 803.3 as an 
adverse event that:  
a. Led to death;  
b. Led to serious deterioration in health that resulted in life-threatening 
illness or injury, resulted in permanent impairment;  
c. Required inpatient hospitalization/prolonged hospitalization, or resulted 
in medical/surgical intervention to prevent life-threatening illness/injury 
or permanent impairment; or  
d. Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
 
9.1.3 
Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) 
 
An adverse device effect (ADE) is defined as any adverse event that is considered to be 
related to the use of an medical device. This definition includes any event resulting from 
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operation or any malfunction of the investigational device (study device) and includes any 
event that is a result of a user error. 
 
A serious adverse device effect (SADE) is defined as an ADE that has resulted in any of the 
consequences characteristic of an SAE. 
 
9.1.4 
Unanticipated (Serious) Adverse Device Effect (UADE/USADE) 
 
An unanticipated (serious) adverse device effect (UADE/USADE) is any (serious) 
adverse device effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a study device, which by its nature, incidence, severity, or outcome 
has not been identified in the current instructions for use and/or current version of the 
risk analysis report, or any other unanticipated serious problem associated with a device 
that relates to the rights, safety or welfare of participants. 
 
UADEs/USADEs will be reported to FDA as required by 21 CFR Part 822 and to the 
appropriate governing body per ISO 14155:2020. 
 
9.1.5 
Device Deficiencies 
 
The Investigator will record a device deficiency if a device used in the study procedure 
failed to meet its performance specifications whether due to mechanical failure, 
malfunction, or defect.  Device deficiencies also include use errors and inadequate 
labeling.  This applies to: devices used to treat the participant, or devices in which the 
package was opened, but the device was not used for treatment, or devices with which 
treatment was attempted, but the device did not remain through the entire study 
procedure/period. 
 
All mechanical failures, malfunctions, missing components, and defects of the study 
devices will be recorded on the appropriate Case Report Form and will be promptly 
reported to the Sponsor. The device(s) should be returned to the Sponsor as outlined in 
the site’s regulatory binder. 
 
If the device deficiency was associated with an AE, the reporting provisions for AEs, ADEs, 
SAEs, SADEs and UADEs/USADEs apply. 
 
Reported deficiencies will be investigated and reported under 21 CFR part 803 Medical 
Device Reporting by the Sponsor if necessary.  The site may be contacted to provide 
additional information to allow the Sponsor to conduct a thorough investigation. 
 
It is the responsibility of the Investigator to notify the IRB of such device deficiencies in 
accordance with the local IRB’s requirements. 

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Notice of 
Inspection or 
Audit by the 
Health Authorities 
Sponsor 
As soon as possible after becoming aware of the 
impending inspection / audit. 
 
 
 
It is the responsibility of the Investigator to report adverse events to individual Institutional 
Review Boards (IRBs) according to the local governing IRB’s requirements. 
 
9.5 Safety Committees 
 
9.5.1 
Medical Monitor 
 
The Medical Monitor (MM) will be responsible for AE trending review as well as for 
the identification of signals that could indicate a serious health threat as specified in the 
Safety Management Plan. 
 
 
10 STATISTICAL METHODS 
 
10.1 Overview of Study Design 
 
This is a prospective, multi-center, single-arm study designed to assess the safety and 
performance of the Pristine™ Long-Term Hemodialysis Catheter for Attaining Vascular 
Access for Hemodialysis by comparison to a performance goal derived from the Dialysis 
Outcomes and Practice Patterns Study data.  
 
10.2 Sample Size Considerations 
 
The primary objective of the study is to show the overall complication rate for Pristine is 
non-inferior to the performance goal at 3 months. If successful, the next step is to show 
superiority of Pristine at 3 months. 
 
Based on hypothesis test of Non-inferiority  
• Assumptions: 
o The complication rate of our performance goal is estimated at 31.5 events per 
1000 patient days with a 90 days follow-up based on DOPPS study data. The 
complication rate for Pristine is expected to be similar. 
o The performance goal is set at 36.5 events per 1000 days using a 5 events per 
1000 days non-inferiority margin; 
o The attrition through 90 days is assumed to be 15% 
o The Type 1 error is 0.025 (one-sided). 

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o The Type 2 error is 0.2. 
• Sample Size: 
o Total required exposure is 12765 patient days which translates to 142 
participants with average exposure of 90 days (PASS 2019). 
Based on hypothesis test of Superiority  
• Assumptions: 
o The complication rate of our performance goal is estimated at 31.5 events per 
1000 patient days with a 90 days follow-up based on literature review, which is 
set as the performance goal. 
o The complication rate for the Pristine™ Catheter is assumed to be 26.5 events 
per 1000 patient days. 
o The attrition through 90 days is assumed to be 15% 
o The Type 1 error is 0.025 (one-sided). 
• Sample Size: 
o Total exposure of 12765 patient days (which translates to 142 participants with 
average exposure of 90 days) will provide 85% power of the test (PASS 2019). 
 
10.3 Analysis Population 
 
Sites will be limited to enrolling 20% (28) of the total sample size. The following populations 
are defined: 
 
Table 5: Analysis Population List 
Population 
Description 
Enrolled 
All participants who sign the ICF will be classified as enrolled.  
Intent-to-Treat (ITT)  
The intent-to-treat population will consist of all participants into 
whom has signed the ICF, met all inclusion/exclusion criteria, 
and the Pristine™ Catheter was placed. 
Per-Protocol 
A Per-Protocol (PP) population may be created if there are 
participants who have any major deviations. The PP population 
will consist of any participants in the ITT population who do not 
have any major deviations. The deviations that are considered 
to have a “major” grade will be defined a priori in the SAP. 
 
 

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10.4 General Considerations 
 
10.4.1 Handling of Missing Data 
 
Study endpoints may have missing data due to a participant’s withdrawal of consent, the 
withdrawal of a participant by the PI, a participant loss to follow-up and the death of a 
participant. Data may also be missing from investigation endpoints due to deviations and 
/ or missing data collection. It is important to minimize missing data by all means and to 
always record the reason for omission. 
 
 
10.5 Primary Endpoint 
The combined primary endpoint is the overall rate of infectious complications and non-
infectious complications requiring revision to maintain patency and improve access 
performance at 3 months. Based on the DOPPS study data, competitor control devices had 
an average incidence rate of 31.5 complications per 1000 patient days. To show non-
inferiority of the Pristine™ Catheter, a 5 complications per 1000 patient days non-inferiority 
margin is used to establish a performance goal (PG) of 36.5 events per 1000 patient days. 
The analysis of the primary endpoint will be based on the following test of Poisson rate: 
H0: The complication rate through 3 month is greater than or equal to 36.5 events per 1000 patients 
days at 3 months. 
H1: The complication rate through 3 month is less than 36.5 events per 1000 patient days at 3 
months. 
That is: 
H0: λ ≥ λ0  
H1: λ < λ0 
Where λ0 is the PG of 36.5 events per 1000 patient days. 
A one-sided p-value will be derived based on an Poisson distribution. The Pristine™ Catheter 
will be considered to have achieved the primary endpoint objective if the one-sided p-value 
is less than 0.025. 
Conditioned on the success of the above test, a superiority test will be conducted to show 
that the Pristine™ Catheter is superior to the performance goal. The above test will be 
repeated with a PG of 31.5 events per 1000 patient days. 
The analyses of the primary endpoint will be based on the ITT population and repeated with 
per-protocol population as sensitivity analyses. 
 

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10.6 Secondary Endpoint(s) 
 
The secondary endpoints will be summarized with descriptive statistics (without formal 
statistical hypothesis testing) using the ITT population. For categorical variables, summary 
statistics will include frequency counts and percentages. For continuous variables, summary 
statistics will include mean, standard deviation, minimum, median, and maximum. CIs (95%) 
will also be provided.  
 
10.7 Tertiary/Exploratory Endpoint(s) 
 
The exploratory endpoints may or may not be presented in the clinical investigation report. 
If reported, the descriptive statistics will be presented. 
 
10.8 Interim Analysis 
 
An interim analysis will be conducted after all eligible patients have completed their 3-
month follow-up visit. The Primary endpoint of combined complications will be analyzed and 
reported. Secondary endpoints will be reported with descriptive statistics.  
 
11 DATA COLLECTION AND RECORD MAINTENANCE 
 
11.1 Case Report Forms 
 
The Investigator is responsible for ensuring the completeness and accuracy of all study 
documentation. 
 
All required clinical data will be collected/documented in sponsor-provided electronic Case 
Report Forms (CRFs).  Corrections should be made using the principles of Good 
Documentation Practice. FDA 21 CFR 11 is followed as well as other applicable legislation on 
the handling of electronic data. Modification of the CRFs will only be made if deemed 
necessary by the Sponsor and/or the appropriate regulatory body. 
 
All required clinical data for this trial will be collected in web-based standardized eCRFs. 
The eCRFs are designed to accommodate the specific elements of this clinical investigation 
and it is the responsibility of the PI to confirm that the data is completely and accurately 
entered in the appropriate sections of the eCRF. Data reported on these eCRFs shall be 
derived from, and be consistent with, source documents and will be approved by the PI. An 
audit trail of changes or corrections to eCRFs will be maintained. Discrepancies between the 
source documents and the eCRFs shall be explained in writing. Modification of the eCRF will 
only be made if deemed necessary by the Sponsor and / or the appropriate regulatory body. 

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ISO 14155:2020(E) shall be followed as well as other applicable legislation on the handling of 
electronic data.  
 
Participant personal information will be pseudonymized. Site numbers and participant 
numbers will be used to track participant information throughout the clinical investigation. 
The link between the participant number and each participant shall be retained by the PI in a 
secure location. 
 
11.2 Source Documentation 
 
Original or certified copies of all relevant clinical findings, observations, and other activities 
throughout the clinical investigation must be recorded and maintained in the study file of 
each enrolled participant. Where there is no prior written or electronic record of data, such 
as for subjective data (questionnaires), these data may be recorded directly on the CRF(s) 
and the CRF is then considered to be the source.   
 
The PI will permit clinical investigation related monitoring, audits, IRB review and authority 
inspections by allowing direct access to the source data. In case of electronic source data, 
access must be allowed, or certified printouts should be available prior to the monitoring or 
audit visits. Printouts will not be limited to the index AVF only but will include all available 
data related to the identified participant(s). 
 
11.3 Data Management 
 
Data management is the responsibility of the Sponsor.  Data from completed CRFs will be 
managed in a secured, controlled database. A Data Management Plan (DMP) will be 
developed that outlines the procedures used for data review, database cleaning and 
issuing/resolving data queries. Procedures for validations and data storage will also be 
contained within the DMP. 
 
11.4 Record Retention 
 
The Investigator shall retain all study records for a minimum of two (2) years after the later 
of the following two dates: the date on which the study is terminated/completed or the date 
that the records are no longer required for purposes of supporting a pre-market approval 
application or a notice of completion of a product development protocol (21 CFR Part 
812.140). The data for some of these records may be available in computerized form but the 
final responsibility for maintaining study records remains with the Investigator. All PIs must 
contact the Sponsor prior to destroying or archiving off site any records or reports pertaining 
to the clinical investigation to ensure they are no longer needed to be maintained on-site. 
 

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The Investigator may withdraw from the responsibility to maintain records for the period 
required by transferring custody of the records to any other person who will accept 
responsibility for retaining them. Notice of a transfer shall be given to the Sponsor and FDA, 
if applicable, not later than ten (10) working days after the transfer occurs. 
 
12 QUALITY CONTROL AND ASSURANCE 
 
12.1 Control of Investigational Device 
 
The Pristine™ Catheter has been cleared by the FDA and will be evaluated in a post-market 
fashion in accordance with its labeled indication in the United States (US). Sites are to use 
the product off-the-shelf. The product shall be used according to the supplied IFU. The 
device will be identified using its product code and lot number for traceability.  
 
Any Pristine™ Catheters that have failed or malfunctioned should be returned to the 
Sponsor. If the malfunctioned Pristine™ Catheter has been used (examples including, but not 
limited to, the sterile barrier opened and exposed to the participant) should be placed in a 
biohazard bag, labeled “Biohazard”, and returned to the Sponsor. Please refer to the 
investigational site regulatory binder for return instructions.  
 
12.2 Monitoring 
 
The Sponsor will designate trained and qualified personnel to monitor the progress of this 
clinical study in accordance with established standard operating procedures and the study-
specific Monitoring Plan.   
 
Prior to study start, a study initiation visit (SIV) will be conducted to review with the 
Investigator(s) and staff the provisions and proper conduct of this study. This visit will 
include a detailed review of this protocol, verification that all necessary documents are on 
file at the investigational site and confirmation of IRB/EC approvals.   
 
During the study, routine monitoring visits (RMVs) will be conducted to assure the site 
continues to adhere to the protocol, the investigator agreement, and regulations regarding 
conduct of clinical studies.  The Sponsor-Monitor will confirm that the ICF to be used is the 
version approved by the IRB/EC, confirm the applicable national privacy laws have been 
followed, verify that all necessary documents are on file at the investigational site and 
confirm that there are provisions to continue and maintain all documents and records 
throughout the study as required by applicable regulations. These monitoring visits will 
assess continued protocol compliance, adequate participant enrollment, accurate data 
reporting, monitoring of participant safety through identification and/or review of any 
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calibration of study-specific equipment (if applicable), and continued IRB/EC acceptance of 
the study. 
 
At the completion of the study, the Sponsor-Monitor will conduct a final close-out visit or 
COV. The purpose of this visit may include but is not limited to collecting all outstanding 
study data documents, confirming that the Investigator’s files are accurate and complete, 
reviewing the record retention requirements with the Investigator, providing for the return 
of unused devices to the Sponsor, reviewing records which account for device shipments and 
ensuring that all applicable requirements for closure of the study are met.  
 
12.3 Audits and Inspections 
 
If the study is selected for audit by the Sponsor or if there is an inspection by the appropriate 
Health Authorities, the Investigator and his team will make themselves available during the 
visit.  The Investigator must agree to the inspection of all study related records and give the 
auditor/inspector direct access to source documents for verification of data on CRFs.  The 
participant’s anonymity must be ensured, and data checked during the audit must remain 
confidential. 
 
As soon as the Investigator is aware of an upcoming inspection/audit by the Health 
Authorities, he/she will promptly inform the Sponsor.  As agreed with the Investigator, 
Sponsor personnel may be present at the site during the inspection. 
 
12.4 Protocol Deviations 
 
A protocol deviation is defined as an event where the Investigator or site personnel did 
not conduct the study according to the protocol. 
 
Except when necessary to protect the life or physical well-being of a participant, protocol 
deviations are not permitted.  The Sponsor and the investigational site’s IRB/EC must be 
notified immediately if an emergency situation arises in which the safety of a participant 
may require immediate intervention different than that defined in the protocol.  This must 
be followed by written confirmation that describes the emergency action and outcomes, 
within five (5) working days from the date of the emergency action in accordance with the 
governing IRB/EC’s requirement.   
 
It is the Investigator’s responsibility to ensure that there are no deviations from the 
Protocol. Except in an emergency, when a protocol deviation is planned or anticipated, the 
Sponsor should be contacted for approval.  Any and all deviations must be recorded on the 
appropriate CRF regardless of whether medically justifiable or sponsor approved.  Upon 
evaluation by the Sponsor, actions may be required to prevent additional deviations, such as 
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monitoring.  If these steps fail, more serious measures, up to and including termination of 
enrollment at the site. 
 
13 ADMINISTRATIVE REQUIREMENTS 
 
13.1 Investigator and Site Selection 
 
The Investigator must be of good standing as an Investigator and knowledgeable in relevant 
areas of clinical research to ensure adherence to the requirements of this 
protocol, including the protection of human participants. Other site personnel must have 
appropriate research experience and infrastructure to ensure adherence to this protocol and 
enrollment of sufficient numbers of evaluable participants. The curriculum vitae (CV) of the 
Investigator(s), Sub-Investigator(s) and Study Coordinator(s) will be maintained in the 
Sponsor’s files as documentation of qualification by training and experience. 
 
The Principal Investigator will sign the Investigator Agreement pages of this protocol, 
agreeing to comply with all applicable regulations and the requirements of this study as 
per the clinical study agreement. Federal databases will be searched to ensure that the 
Investigator(s) and/or the site are not prohibited from engaging in federally sponsored 
clinical research. 
 
Any site that is deactivated prior to initial enrollment, either by the Sponsor or by the 
individual site itself, may be replaced. 
 
13.2 Training 
 
In addition to each Investigator and appropriate site personnel being trained on this 
protocol and study procedures during the Site Initiation Visit, product training will be 
provided by the Sponsor or designee and is required for each Investigator. Additional study 
staff (e.g., Sub-Investigator(s)) will also require device training provided from the Sponsor or 
proctoring by the PI. All training will be documented and filed at the investigational site and 
with the Sponsor. 
 
13.3 Required Documents 
 
An Investigator may not screen or enroll participants until authorized to do so by the 
Sponsor. At a minimum, the following documentation should be received by the Sponsor 
prior to the commencement of study activities: 
 
• Fully executed Non-disclosure Agreement (NDA) between PI/site and Sponsor; 
• CVs, signed and dated within 2 years of study start for the PI and Sub-
Investigator(s); 

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• CVs for Study Coordinator(s); 
• Signed CSA by PI/site (or designee); 
• Signed Investigator Agreement Page by PI and Sub-Investigator(s); 
• Signed Financial Disclosure Statement by PI and Sub-Investigator(s); 
• Completed and Signed Training Log by PI and Sub-Investigator(s); 
• Study Personnel Identification list; 
• Written approval from the IRB/EC of both the protocol and ICF, and any other 
• applicable protocol specific material; and 
• IRB/EC Membership List, Assurance of Compliance Form, or equivalent. 
• Statement of completing at least two prior Pristine Catheter placements. 
 
13.4 Publication Policy 
 
The sponsor believes that results of applicable clinical studies should be published in peer-
reviewed literature in a timely, accurate, complete and balanced manner, regardless of 
study outcomes, whenever possible.  As such, at the conclusion of this study, an article may 
be prepared for publication in a reputable scientific journal.  Formal presentation(s) or 
publication(s) of data collected from this study will be considered as a joint publication by 
the investigator(s) and the appropriate personnel of the Sponsor. Authorship will be based 
on generally accepted criteria of the ICMJE (International Committee of Medical Journal 
Editors) and determined by mutual agreement. 
 
The publication of the principal results from any single-center experience within the study is 
not allowed until the preparation and publication of the multicenter results. Exceptions to 
this rule require the prior approval of the Sponsor. The analysis of other pre-specified and 
non-pre-specified endpoints will be performed by the Sponsor or its designee. Such analyses, 
as well as other proposed investigations or manuscripts will require the approval of the 
Sponsor. 
 
13.5 Study Registration 
 
In compliance with Title VIII of Public Law 110-85, known as FDA Amendments Act of 2007 
(FDAAA), the Sponsor will register this study studies and disclose study results in a publicly 
accessible database (i.e., ClinicalTrials.gov).  This study will be registered no later than 21 
days after commencing enrollment.  Study results will be posted to the website within 12 
months of the last participant visit for collection of primary endpoint data.  
 
 
13.6 Termination of Study 
 
The Sponsor reserves the right to suspend enrollment or terminate the study at any time for 
any reason.  The Sponsor may suspend enrollment or terminate the study at a 

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specific investigational site for reasons including, but not limited to, inadequate data 
collection, low participant enrollment rate, achievement of the total enrollment, conditions 
imposed by the reviewing IRB/EC and/or non-compliance with this protocol or other clinical 
research requirements. Written notice will be submitted to the Investigator in advance of 
such termination.  
 
In the event of study suspension or termination, the Sponsor will send a report outlining 
the circumstances to the IRB/EC, and all Investigators and Regulatory Authorities as 
required by regulation.  
 
 
14 ETHICAL AND REGULATORY CONSIDERATIONS 
 
14.1 IRB Approval 
 
Investigators or designees must submit the study protocol, Informed Consent Form (if 
applicable), and all other locally required documentation to an appropriate IRB and obtain 
study-specific written approval (favorable opinion) before being allowed to participate in the 
study. Before commencement of the study, the Investigator or designee must provide the 
Sponsor with written documentation of such approval.  The IRB must give written renewal of 
the original approval at least annually to continue the study. A copy of the written renewal 
must be provided to the Sponsor. 
 
The IRB will be notified of any amendments to the protocol, as well as possible associated 
information and consent form changes, where applicable, and written approval (favorable 
opinion) will be obtained prior to implementation, as applicable. 
 
The Investigator or designee is responsible for fulfilling any conditions of approval imposed 
by the IRB, such as regular safety reporting, study timing, etc. The Investigator or designee 
will provide the Sponsor with copies of such reports. 
 
14.2 Informed Consent and Confidentiality  
 
Prior to any study procedure, the Investigator (or designee) must explain to each participant 
in layman’s terms, the nature of the study, its purpose, expected duration, and the risks and 
benefits of study participation. Also, participant will be informed of uses and disclosures of 
their medical information for research purposes, and their rights to access information about 
them. All applicable national privacy laws (e.g., HIPAA requirements in the U.S.) will be 
followed in this study. The participants must be informed of their right to withdraw from the 
study at any time and for any reason without sanction, penalty, or loss of benefits to which 
they are otherwise entitled, and that withdrawal from the study will not jeopardize their 
future medical care. Participants will be informed of their right to new information and/or 

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findings relating to the clinical study, and the process by which this information is made 
available. After this explanation, given sufficient time to decide whether to participate, 
before any study procedure is conducted, and before entering the study, the participant 
must voluntarily provide consent in accordance with 21 CFR Parts 50 and 56 and ISO 
14155:2020.  
 
14.2.1 Confidentiality 
 
Participant confidentiality must be strictly held in trust by the Investigator, study staff, 
and the Sponsor.  Participant confidentiality and anonymity will be maintained by 
removal of identifiers from any data, documentation, or clinical samples submitted to the 
Sponsor. 
 
Any data collected meeting the definition of protected/confidential health information or 
personal identifying information will be collected and maintained using the designated 
authorizations and following privacy procedures as specified in the applicable health 
authority regulations.   
 
The Sponsor-Monitor, authorized representatives of the sponsor, and/or applicable 
Health Authorities may inspect all documents and records required to be maintained by 
the Investigator.  The Investigator/Site will permit access to such records.  
 
14.3 Regulatory Status 
 
The Pristine™ Long-Term Hemodialysis Catheter is FDA approved and will be evaluated in a 
post-market fashion for its approved indication in the US. Sites in these regions are to use 
the product off-the-shelf. The product shall be used according to the supplied IFU. 
 
14.4 Statement of Compliance 
 
This clinical investigation will be conducted in compliance with the protocol and following 
regulatory requirements: 
• 21 CFR 50, 54, 56 and 822; 
• ISO 14155:2020 and/or 21 CFR 812.28(a)(1) (Good Clinical Practice); 
• Ethical principles of the Declaration of Helsinki, in its current revision; and 
• Applicable sections of the national laws and regulations. 
 
The clinical investigation will not commence at a clinical site until approval (favorable 
opinion) from the respective IRB/EC has been received. All additional requirements imposed 
by the IRB/EC(s) will be followed. Involvement of the national competent authorities (e.g. by 
notification, seeking authorization) will be accomplished as required by national laws and 
regulations. 

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15 REFERENCES 
 
1. Daugirdas JT, Depner TA, Inrig J, et al. KDOQI Clinical Practice Guideline for Hemodialysis 
Adequacy: 2015 Update. American Journal of Kidney Diseases, Volume 66, Issue 5, 2015, 
Pages 884-930. ISSN 0272-6386. https://doi.org/10.1053/j.ajkd.2015.07.015. 
2. Pippias M, Stel VS, Abad Diez JM, et al. Renal replacement therapy in Europe: a 
summary of the 2012 ERA-EDTA Registry Annual Report. Clin Kidney J. 2015;8(3):248-
261. doi:10.1093/ckj/sfv014 
3. Tal MG, Yevzlin AS. Catheter-related blood stream infection in hemodialysis patients 
with symmetric tunneled non-side-hole hemodialysis catheters. The Journal of Vascular 
Access. July 2021. doi:10.1177/11297298211027058 
4. Ravani P, Gillespie BW, Quinn RR, et al. Temporal risk profile for infectious and 
noninfectious complications of hemodialysis access. J Am Soc Nephrol. 
2013;24(10):1668-1677. doi:10.1681/ASN.2012121234 
5. Lok CE, Huber TS, Lee T, et al. KDOQI Clinical Practice Guideline for Vascular Access: 
2019 Update [published correction appears in Am J Kidney Dis. 2021 Apr;77(4):551]. Am 
J Kidney Dis. 2020;75(4 Suppl 2):S1-S164. doi:10.1053/j.ajkd.2019.12.001 
6. Allon M, Brouwer-Maier DJ, Abreo K, et al. Recommended Clinical Trial End Points for 
Dialysis Catheters. Clin J Am Soc Nephrol. 2018;13(3):495-500. 
doi:10.2215/CJN.12011116 
 
 
 

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16 APPENDICES 
 
Appendix A - Study Definitions 
Appendix B - IFU 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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16.1 Appendix B – IFU 
Will attach as PDF.