everlinQ endoAVF Post Market Study
Phase: NA
Conditions: Chronic Kidney Disease
Sponsor: C. R. Bard

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everlinQ endoAVF Post-Market Study 
 
 
 
Study Protocol: CD-0018 
Version 02 
06-March-2018 
 
 
 
Sponsor: TVA Medical, Inc. 
7000 Bee Cave Rd., Suite 250 
Austin, TX 78746 
 
 
 
 
 
 
 
 
 
 
 
 
This protocol contains confidential information and is limited in its distribution to Investigational 
Staff intending to conduct the study and Ethics Committee reviewing this study. 

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PROTOCOL SIGNATURE PAGE 
 
 
 
 
everlinQ endoAVF Post-Market Study 
Study Protocol: CD-0018 
Version 02 
06-March-2018 
 
 
 
 
 
I have read this protocol and agree to adhere to the requirements.  I will provide copies of this 
protocol and all pertinent information to the study personnel under my supervision and my hospital 
Ethics Committee.  I will discuss this material with them and ensure they are fully informed 
regarding the investigational device and the conduct of the study according to ICH Good Clinical 
Practice (GCP), ISO 14155, Declaration of Helsinki 21CFR 50, 56 and 812, and any local 
regulations. 
 
 
____________________________________________________________________________ 
Clinical Site Name (Print)  
 
 
____________________________________________________________________________ 
Site Investigator Name (Print) 
 
 
 
               
 
 
________________________________________________ 
   ____________________ 
Site Investigator Signature  
               
 
               Date (mm/dd/yyyy) 
 
 
 

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everlinQ endoAVF Post-Market Protocol Summary 
 
Title 
everlinQ endoAVF Post-Market Study 
Study Device 
Any commercially available everlinQ endoAVF System 
Study Design 
Prospective, multi-center post-market study to evaluate the everlinQ endoAVF System when 
used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular 
access for hemodialysis.   
Objective 
Collect data in an observational study on outcomes of endovascular fistula creation using the 
everlinQ endoAVF System in the post-market setting where the System is available for use. 
Enrollment 
Up to 200 treated patients at up to 20 sites 
Follow-Up 
Up to 12 months 
Outcome 
Measures 
 
Adverse events  
 
Assisted primary patency 
 
Duration of central venous catheter exposures 
 
Functional patency 
 
Intervention rate  
 
Primary patency  
 
Procedure success 
 
Secondary patency 
 
Time to endovascular fistula maturation  
Inclusion Criteria 
 
Patients must meet all inclusion criteria: 
1. Adult (age >18 years old) 
2. Currently on chronic dialysis, or expected to be started on chronic dialysis within 3 
months of planned endoAVF creation  
3. Target vein diameter(s) for fistula creation 
Venogram 
4. Target artery diameter(s) for fistula creation 
Arteriogram 
5. Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound 
arch) 

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Exclusion Criteria 
Patients will be excluded if ANY of the following criteria apply:  
1. Known central venous stenosis or central vein narrowing > 50% based on imaging on 
the same side as the planned AVF creation 
2. Absence of perforator feeding the target cannulation vein(s) via venogram 
3. Occlusion or stenosis >50% of target cannulation cephalic or basilic vein 
4. Target cannulation vein that is <2.5 mm in diameter 
5. 
in the treatment arm as determined by 
physician and imaging 
NOTE: 
arterial stenosis may undergo a Digital Brachial 
Index (DBI) test, if DBI result is <.65 patient is excluded 
6. Documented 
35% in the last 6 months 
7. Pregnant women 
8. New York Heart Association (NYHA) class III or IV heart failure 
9. Hypercoagulable state 
10. Known bleeding diathesis 
11. Documented history of drug abuse including intravenous drugs within six months of 
AVF creation 
12. 
previous major surgery within 30 days of enrollment 
13. Known allergy to contrast dye which cannot be adequately pre-medicated 
14. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-
medicated 
15. Evidence of active infections on the day of the index procedure 
16. Estimated life expectancy < 1 year 
17. Patient is not willing to provide written informed consent, is not geographically stable 
and/or not willing to comply with required follow-up 
18. Patient with a target cannulation vein that is > 6 mm deep that would require a 
transposition procedure, defined as the elevation of a target cannulation vein AND the 
creation of a new AV fistula  
19. Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of this 
protocol  
Principal 
Investigators 
Mr. Nicholas Inston 
University Hospitals Birmingham 
Queen Elizabeth Hospital 
NHS Foundation Trust 
B15 2TH 
Birmingham, England  
T: +44 0121 3713714  
Prof. Thomas Schmitz-Rixen 
University of Frankfurt 
Goethe-University Medical Center 
Theodor-Stern-Kai-7 
D-60590 
Frankfurt, Germany 
T: +49-69-6301-4136/-5349 
Sponsor  
Contact:  
TVA Medical, Inc. 
7000 Bee Cave Rd., Suite 250 
Austin, TX  78746 
T: 512-582-2460
Duplex 
Ultrasound 
Core Lab 
Vascular Ultrasound Core Laboratory 
Massachusetts General Physicians Organization, Inc. 
55 Fruit Street 
Boston MA 02114 USA 
T: 617-726-5552 F: 617-726-1977 

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ABBREVIATIONS 
ACT 
Activated clotting time 
ADE 
Adverse device effect 
AE 
Adverse event 
AVF 
Arteriovenous fistula 
AVG 
Arteriovenous graft 
CEC 
Clinical Events Committee 
CKD 
Chronic kidney disease 
CMS 
Center for Medicare and Medicaid Services 
CVC 
Central venous catheter 
DBI 
Digital brachial index 
DUS 
Duplex ultrasound 
EC 
Ethics Committee 
eCRF 
Electronic case report form 
endoAVF 
Endovascular arteriovenous fistula 
EQ VAS 
EQ visual analogue scale 
ESRD 
End stage renal disease 
FFBI 
Fistula First Breakthrough Initiative 
HRQOL 
Health Related Quality of Life 
HTN 
Hypertension 
ICF 
Informed consent form 
IFU 
Instructions for Use 
KDOQI 
National Kidney Foundation Kidney Disease Outcomes Quality Initiative 
QOL 
Quality of Life  
RF 
Radiofrequency 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SVS 
Society for Vascular Surgery 
USADE 
Unanticipated serious device effect 
USRDS 
United States Renal Data System 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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DEFINITIONS 
Access site for cannulation 
A vascular site, as a way to reach the blood for hemodialysis.  
Access site for device 
A site of catheters insertion during index procedure. 
Angiogram 
An X-ray procedure that uses contrast agent and a camera (fluoroscopy) to 
assess and capture flows or blockages in arteries and veins. 
 
The interval from access placement to thrombosis or abandonment; not 
triggered by access circuit interventions performed in the absence of 
occlusion.
Bleeding Diathesis 
Is a disorder that involves the tendency to hemorrhage, or bleed.  
Hypercoagulability causes this condition.  This condition is also known as 
bleeding tendency or predisposition.
Chronic Kidney Disease 
An unusual susceptive condition due to hypercoagulability, usually caused 
by a defect in coagulation.  A term that includes stages such as mild, 
moderate and severe loss of kidney function based on the 
glomerular filtration rate (GFR). 
Dialysis Patient 
Patient who was receiving hemodialysis at the time of enrollment. 
endoAVF abandonment  
terminal use of endoAVF 
The endoAVF is considered abandoned if any of the following occur: 
 
The endoAVF is occluded and patency cannot be restored by any 
intervention, including medical, surgical, radiological or rest 
through the last follow-up. 
 
The endoAVF is deemed inadequate for dialysis (for example, it 
never matures or is too deep for needle access) and the associated 
problem cannot be corrected by any intervention, including 
medical, surgical, radiological or rest. 
 
The endoAVF is ligated. 
An endoAVF is not considered abandoned when it is not cannulated in 
subjects with a successful renal transplantation or when reasons of subject 
preference alone preclude cannulation.
End Stage Renal Disease 
Last stage of Chronic Kidney Disease. When the kidneys stop working well 
enough to meet the needs of daily life.  
Functional Cannulation 
Defined as 2-needle access of the endoAVF access circuit with performance 
-minute dialysis sessions through the endoAVF access 
circuit over a continuous 28-day period.    
Functional Patency 
The interval of time from the first 2-needle dialysis utilizing the access until 
access abandonment.  
Hypercoagulable State 
Blood clotting disorder. 

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DEFINITIONS 
Intervention Rate 
Rate of all interventions (and specific interventions) will be reported.  All 
interventions that occur during the index procedure and during follow-up 
will be reported.  
 
Interventions to maintain or restore patency of the endoAVF, 
including endovascular and surgical procedures designed to address 
occlusive thrombosis (resulting in absence of thrill or bruit at 
endoAVF) and clinically significant occlusive stenosis at or near 
endoAVF site.   
 
Interventions to support maturation of the arterialized vein 
segments, including endovascular procedures such as secondary 
coil embolization to facilitate flow into the target cannulation veins. 
 
Interventions to support cannulation of the arterialized vein 
segments, including procedures such as a superficialization or 
elevation where the target cannulation vein is brought closer to the 
skin surface to enable cannulation, without the creation of a new 
AV fistula. 
 
Any intervention to address any complications or adverse events of 
the access circuit.
Maturation of endoAVF 
Successful hemodialysis using 2- needle cannulation OR Vascular accesses 
that is free of stenosis or thrombosis, with brachial artery flow of at least 
500 ml/min and at least a 4.0 mm vein diameter as measured via duplex 
ultrasound.
Maturation time 
The number of days between the date of AVF creation and the date of 
endoAVF maturation (based on primary efficacy endpoint definition of 
maturation). 
Occlusion 
The blockage of a blood vessel. 
Operator 
Person who conducts index procedure. 
Pre-dialysis Patient 
Patient who was not receiving dialysis at the time of enrollment. 
Primary patency 
The interval from the time of access placement until any intervention 
designed to maintain or re-establish patency, access thrombosis, access 
abandonment, or the time of measurement of patency. 
Procedure duration 
The sum of the venography time, endoAVF creation time, coil and closure 
time.
Protocol deviation 
Deviation from the approved Study Protocol. 
Secondary Patency 
The interval from the time of access placement until access abandonment, 
loss to thrombosis, or the time of patency measurement including 
intervening manipulations (surgical or endovascular interventions) designed 
to re-establish functionality in thrombosed access.  
Stenosis 
The abnormal narrowing of the blood vessel. 
Thrombosis 
The formation or presence of a blood clot within a blood vessel.  
Venogram 
An X-ray procedure that uses contrast agent and a camera (fluoroscopy) to 
assess and capture flows or blockages in veins. 
 

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TABLE OF CONTENTS 
1
INTRODUCTION ......................................................................................................................................... 10
2
Device Descriptions ........................................................................................................................................ 11
3
RISKS/BENEFITS ........................................................................................................................................ 11
3.1
Benefits ............................................................................................................................................................ 11
3.2
Risks ................................................................................................................................................................ 12
3.3
Minimization of Risk ....................................................................................................................................... 13
4
STUDY METHODOLOGY .......................................................................................................................... 13
4.1
Study Design .................................................................................................................................................... 13
4.2
Study Objective ............................................................................................................................................... 15
4.3
Study Outcome Measures ................................................................................................................................ 15
4.4
Site Selection ................................................................................................................................................... 16
4.5
Study Population .............................................................................................................................................. 17
4.5.1
Inclusion Criteria ....................................................................................................................................................................................... 17
4.5.2
Exclusion Criteria ..................................................................................................................................................................................... 17
4.5.3
2nd-Stage Procedure ................................................................................................................................................................................. 18
5
STUDY SCREENING AND FOLLOW-UP PROCEDURES .................................................................... 18
5.1
Informed Consent ............................................................................................................................................ 18
5.2
Screening Evaluation ....................................................................................................................................... 18
5.2.1
Duplex Ultrasound .................................................................................................................................................................................... 19
5.3
Medications ..................................................................................................................................................... 19
5.3.1
Intra-Procedure ......................................................................................................................................................................................... 19
5.3.2
tudy Procedure ....................................................................................................................................................................................... 19
5.3.3
Post-Treatment .......................................................................................................................................................................................... 20
5.4
Follow-Up Visits ............................................................................................................................................. 20
5.4.1
Dialysis Access Data ................................................................................................................................................................................ 20
5.5
Unscheduled Visit ............................................................................................................................................ 20
5.6
Lost to follow-up ............................................................................................................................................. 20
5.7
Patient Withdrawal from the Study.................................................................................................................. 21
5.8
End of Study .................................................................................................................................................... 21
6
Adverse Events ............................................................................................................................................... 22
6.1
Relationship to Device or Procedure ............................................................................................................... 23
7
DATA ANALYSIS ......................................................................................................................................... 23
8
REGULATORY OBLIGATIONS ............................................................................................................... 24
8.1
Responsibilities of the EC/EC Approval .......................................................................................................... 24
8.2
Sponsor Obligations......................................................................................................................................... 24
8.3
Clinical Events Committee (CEC) Obligations ............................................................................................... 24
8.4
Investigator Obligations ................................................................................................................................... 24
8.4.1
 ......................................................................................................................................................................... 25
8.5
Records and Reports ........................................................................................................................................ 25
8.5.1
 ............................................................................................................................................................................... 25
8.5.2
 ..................................................................................................................................................................................... 26
8.6
Site Training .................................................................................................................................................... 26
8.7
Protocol Deviations ......................................................................................................................................... 26

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8.8
Site Non-Compliance ....................................................................................................................................... 26
8.9
Electronic Case Report Form (eCRF) Completion .......................................................................................... 26
8.10
Monitoring Procedures .................................................................................................................................... 27
REFERENCES ................................................................................................................................................................. 28
 

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1 
INTRODUCTION 
End Stage Renal Disease (ESRD) currently affects over 2 million people worldwide.1 It is projected that 
the worldwide incidence of ESRD will increase dramatically over the next 10 years, due to the 
increasing incidence of an aging population, diabetes, hypertension, and obesity.2 Currently, Renal 
Replacement Therapy for patients with ESRD consists of either hemodialysis or peritoneal dialysis.  
The rates of implementation of either hemodialysis or peritoneal dialysis vary widely per country.  
According to the United States Renal Data System (USRDS), in 2006 hemodialysis accounted for 
around 60% of Renal Replacement Therapy patients in the US, while peritoneal dialysis accounted for 
6-7% of patients in the US and the remainder is kidney transplant patients.2 
Vascular access is a critical component in the care of patients undergoing hemodialysis. The three 
methods of long term vascular access available to a patient requiring hemodialysis are:  an autogenous 
arteriovenous access or native arteriovenous fistula (AVF), a prosthetic arteriovenous graft (AVG) or a 
tunneled dialysis catheter.3   The AVF has been shown to be superior to AVG and superior to catheter 
access in terms of both mortality and morbidity.4,5   In fact, the focus of numerous initiatives worldwide 
has been to increase the implementation of AVF as the preferred method of vascular access in patients 
requiring hemodialysis.  In 1997, the National Kidney Foundation Kidney Disease Outcomes Quality 
Initiative (KDOQI) guidelines were published to highlight the importance and to promote the increased 
placement of AVF.6    These guidelines and subsequent versions have stressed the importance of 
proactive identification of patients requiring hemodialysis, and have described procedures and quality 
initiatives to maximize access longevity.  In 2006, the updated KDOQI Guidelines recommended that 
AVF be constructed in at least 65% of prevalent hemodialysis patients.7   In addition, the AV Fistula 
First Breakthrough Initiative (FFBI), a coalition lead by the Center for Medicare and Medicaid 
Services (CMS) has set a formal goal for AVF construction of 65% in prevalent patients by 2009.8   
The Society for Vascular Surgery (SVS) has also approved and sponsored initiatives around the 
development and publication of reporting standards for hemodialysis access and the development of 
practice guidelines for hemodialysis access.9 
An AVF is traditionally created during a surgical procedure under general anesthesia.  A surgical 
incision is made in the forearm or upper arm, followed by identification of target arteries and veins for 
surgical connection.  Frequently, prior to the procedure, the vessels are mapped using duplex 
ultrasound imaging, allowing for pre-operative vessel diameter measurement and vessel selection.  
Typically, the radial artery or brachial artery and the cephalic vein or basilic veins are selected.  The 
target vessels are carefully dissected and mobilized, and the vein is transected.  An arteriotomy is 
created, and an anastomosis is sewn between the vein and the artery.  After completion, the flow is 
verified using palpation and ultrasound, and the incision is closed.  Over the course of the following 1 
- 3 months, the AVF gradually matures, that is, the vein dilates and accepts increased flow sufficient 
for hemodialysis. 
Though there is widespread agreement that the AVF is the preferred method of vascular access, 28  
60% of AVFs do not successfully mature and are rendered unusable for hemodialysis.10, 12   This has 
unintended consequences for patients in immediate need of hemodialysis, since a tunneled dialysis 
catheter must often be placed.  Catheters are associated with higher morbidity, mortality, and costs 
and are therefore considered a last resort.11 
 

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To improve on these results, and decrease the invasiveness of the procedure, a new tool and method 
for creation of an AVF has been developed, called everlinQ endoAVF System. The system uses two 
devices, one inserted into an artery and the other inserted into a closely-positioned vein.  The devices 
contain magnets that bring a pair of electrodes into alignment. Radiofrequency energy is delivered to 
the electrodes, cutting and/or coagulating the tissue between the electrodes, creating an endovascular 
arteriovenous fistula (endoAVF).  The procedure is facilitated using fluoroscopy and ultrasound 
imaging, to assist in vessel selection and to verify creation of the AVF. Because the vessels are not 
dissected and not mobilized, leaving the surrounding tissues intact, the vessels do not need to be sewn 
together with a traditional surgical technique. This proposed method may facilitate the creation of 
AVF, while reducing the trauma to the vessel wall potentially leading to reduction in future venous 
stenosis thought to arise from surgical trauma. In particular, the goal is to reduce the surgical 
manipulation of the blood vessels, particularly the veins in the arm, which typically exhibit intimal 
hyperplasia in surgical AVF.  Intimal hyperplasia is believed to be a root cause of failure in surgical 
AVF and AVG, and this technology and method may help improve the patency and maturity of AVF 
in patients with ESRD. 
The family of everlinQ endoAVF Systems  manufactured by TVA Medical, titled the everlinQ 
endoAVF System (e.g., everlinQ endoAVF System, everlinQ S endoAVF System, everlinQ endoAVF 
4 System, etc.). Any commercially available system (i.e., system that received CE mark) may be 
introduced into the study. This clinical study is being conducted to gather information on endovascular 
fistula creation using the everlinQ endoAVF Systems. 
 
 
Any of the everlinQ endoAVF Systems, include a single-use disposable device that consists of two (2) 
flexible, magnetic catheters. One (venous) catheter contains an electrode to deliver radiofrequency 
(RF) energy and a second (arterial) catheter.  Once the catheters are properly inserted and aligned, the 
magnets contained in each catheter attract to one another, approximating the vessels.  RF energy is 
delivered to the electrode whereby the AVF is created. 
For additional details regarding the device or its principle of operation, please refer to the most current 
Instruction for Use (IFU) for the appropriate system selected for use as described above. For clarity 
and consistency, the study device will remain referenced as 
   
3 
RISKS/BENEFITS 
3.1 
Benefits 
The everlinQ endoAVF System may facilitate a less-invasive and more reproducible AVF 
procedure while minimizing surgical incisions as compared to conventional surgical AVF 
creation.  This endovascular approach may lower the risk of procedural infections as compared 
to surgical AVF creation.  Due to the less-invasive nature of the procedure with the everlinQ 
endoAVF System, the endoAVF may exhibit improved maturation and patency characteristics 
compared to historical maturation and patency data.  In addition, patient recovery time may be 
decreased, and anesthesia may be minimized compared to a conventional surgical AVF 
procedure. 
 
 

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3.2 
Risks 
Most of the potential risks and complications associated with the everlinQ endoAVF System and 
procedure are similar to the risks expected for Chronic Kidney Disease (CKD) patients 
undergoing surgically created AVF or AVG procedures.  The potential risks related to the 
everlinQ endoAVF Systems and procedure include but are not limited to: 
 
Aborted or longer procedure 
 
Additional procedures (interventions) 
 
Bleeding, hematoma (a solid swelling of clotted blood within the tissues) or 
hemorrhage (an escape of blood from a ruptured blood vessel) 
 
Bruising 
 
Burns 
 
Compartment syndrome (excessive bleeding, a hematoma that worsens and causes 
increased pressure in a muscle compartment within the access arm)  
 
Death (mostly due to CKD related complications not the everlinQ endoAVF device 
or procedure) 
 
Electrocution 
 
Embolism (blood clot or device piece) 
 
Failure to mature (AVF can never be used) 
 
Fever (pyrogenic reaction) 
 
Heart problems such as arrhythmias (abnormal beats) that can be caused due to high 
levels of potassium in the blood (mostly due to CKD and not the everlinQ endoAVF 
device or procedure) 
 
Increased risk of congestive heart failure (heart fails due to increased flow from 
AVF) 
 
Infection (local or in the blood (bacteremia)) 
 
Numbness, tingling and/or coolness in the fistula extremity  
 
Occlusion 
 
Problem due to sedation or anesthesia 
 
Pseudoaneurysm (leaking hole in artery that forms blood clot on outside of it) 
 
Sepsis (systemic inflammatory reaction) 
 
Steal syndrome or ischemia (not enough blood flow to hand) 
 
Stenosis 
 
Swelling, irritation or pain 
 
Thrombosis  
 
Toxic or allergic reaction 
 
Venous hypertension (arm swelling) 
 
Vessel, nerve or AVF damage or rupture 
 
Wound problem 
 
Cannulation risks that may occur in endo AVF are similar to the cannulation risks expected for 
patients undergoing surgically created AVF or AVG procedures. (e.g., fistula infiltration injury 
due to needle cannulation, clotting, etc.) 
There may also be other potential risks related to use of the everlinQ endoAVF System and 
procedure that are unforeseen at this time.  
 

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3.3 
Minimization of Risk 
To minimize the risks, the everlinQ endoAVF Systems have undergone pre-clinical testing and 
clinical testing. In addition, all Investigators participating in this clinical trial will be trained on 
the everlinQ procedure which will contribute to minimizing risks associated with the use of the 
device. 
Qualified physicians trained on the study protocol will also utilize the established eligibility 
criteria to select appropriate patients to participate in the study. 
4 
STUDY METHODOLOGY 
4.1 
Study Design 
This is a prospective, multi-center study to evaluate the everlinQ endoAVF System when used 
to create an endoAVF for patients who require vascular access for hemodialysis.  This study is a 
post-market study, and will be available to sites in selected regions where the product is 
available for use and properly registered or licensed (i.e. CE Mark, Health Canada License).   
The study may have up to 20 active sites participating in order to enroll up to 200 patients that 
undergo endoAVF creation with the everlinQ endoAVF System.  All patients who meet study 
inclusion criteria and no exclusion criteria will be considered a study candidate.   Study 
candidates who undergo the everlinQ procedure (catheter insertion and delivery of RF energy) 
will be enrolled in the study.  Study candidates who do not undergo the everlinQ procedure will 
be treated per physician and hospital guidelines and will not be considered enrolled in the study.  
All enrolled patients are expected be followed up to 12 months.   Refer to Figure 1 for a 
flowchart overview of the study, and Table 2 for Withdrawal and Follow-Up Requirements. 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1: Study 
Flowchart
 
 
 
 
 
 
 

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4.2 
Study Objective 
Collect data in an observational study on outcomes of endovascular fistula creation using the 
everlinQ endoAVF System in the post-market setting where the System is available for use.  Data 
collected in the study may support future reimbursement and publications. 
4.3 
Study Outcome Measures 
All patients enrolled in the study and do not have a renal transplant, will be included in these 
outcome measurements unless otherwise noted. 
Primary Patency:  The interval from the time of access placement until any intervention 
designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time 
of measurement of patency.  
 endoAVF abandonment definition:  
The endoAVF is considered abandoned if any of the following occur: 
 
The endoAVF is occluded and patency cannot be restored by any intervention, 
including medical, surgical, radiological or rest through the last follow up;
 
The endoAVF is deemed inadequate for dialysis (for example, it never matures or is 
too deep for needle access) and the associated problem cannot be corrected by any 
intervention, including medical, surgical, radiological or rest;
 
The endoAVF is ligated.
 
An endoAVF is not considered abandoned when it is not cannulated in subjects with a 
successful renal transplantation or when reasons of subject preference alone preclude 
cannulation. 
 
Assisted Primary Patency:  The interval from access placement to thrombosis or abandonment; 
not triggered by access circuit interventions performed in the absence of occlusion.  
Secondary Patency:  The interval from the time of access placement until access abandonment, 
loss to thrombosis, or the time of patency measurement including intervening manipulations 
(surgical or endovascular interventions) designed to re-establish functionality in thrombosed 
access.   
Functional Patency:  The interval of time from the first 2-needle dialysis utilizing the access 
until access abandonment.   
 
Procedure Success:  The successful creation of an endoAVF with blood flow confirmed 
intraoperatively by fistulography or by duplex ultrasound postoperatively.   
Time to Endovascular Fistula (endoAVF) Maturation (Vascular Access Usability):  Total 
time (number of days) from successful endoAVF creation to one of the following: 
 
Successful hemodialysis using 2 needle cannulation OR
 
Vascular accesses that is free of stenosis or thrombosis, with brachial artery flow of 
at least 500 ml/min and at least a 4.0 mm vein diameter as measured via duplex 
ultrasound.

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Time to Cannulation:  The time (number of days) from the index procedure (successful 
endoAVF creation) to the first use of the endoAVF for cannulation will be reported. 
 
Number of Patients Who Met Functional Cannulation:  Functional Cannulation is defined as 
2-
 minute 
dialysis sessions through the endoAVF access circuit over a continuous 28-day period.  
Central Venous Catheter (CVC) Exposure:  CVC exposure will be analyzed at the follow-up 
time points, presenting the number/percent of patients reporting CVC use and the number/percent 
reporting dialysis access through other means, as well as the number/percent of subjects not yet 
on dialysis.  
Adverse Events:  Rate of serious procedure or device related Adverse Events (AEs) throughout 
the study period.  The relevant events and rates of occurrence will be analyzed with a time 
component, to analyze procedural AEs and post-procedural AEs.   
Intervention Rate:  The percentage of patients requiring intervention will be calculated at 3, 6 
and 12 months follow-up visits post index procedure.  The rate of interventions that occurred 
during the index procedure and during short term follow-up will also be calculated.   
The endoAVF-related interventions include: 
 
Interventions to maintain or restore patency of the endoAVF, including endovascular 
and surgical procedures designed to address occlusive thrombosis (resulting in 
absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at 
or near endoAVF site.   
 
Interventions to support maturation of the arterialized vein segments, including 
endovascular procedures such as secondary coil embolization to facilitate flow into 
the target cannulation veins. 
 
Interventions to support cannulation of the arterialized vein segments, including 
procedures such as a superficialization or elevation where the target cannulation vein 
is brought closer to the skin surface to enable cannulation, without the creation of a 
new AV fistula.  
 
Any intervention to address any complications or adverse events of the access 
circuit. 
 
Note: Any additional procedure performed at the time of the index procedure to address an 
adverse event will require a Post-Procedure Intervention eCRF to be completed.  
Note: Diagnostic fistulagram, angiogram or duplex ultrasound will not be considered an 
intervention for the purpose of this study. 
4.4 
Site Selection 
Investigational sites selected to participate in this clinical study will be dependent on the 
Investigator at the site having the necessary resources to fulfill the clinical research 
requirements outlined in the protocol.  These resources include adequate patient population, 
facilities and support staff to perform the clinical evaluation according to all applicable 
requirements.  Sites must reside in a region or country where the System is available for use and 
properly registered or licensed (i.e. CE Mark, Health Canada License). 

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4.5 
Study Population 
Candidates for this trial are patients being evaluated for placement of vascular access for chronic 
hemodialysis. Only patients meeting all of the inclusion and none of the exclusion criteria who 
signed the Informed Consent Form (ICF) may be considered for participation.  
4.5.1 Inclusion Criteria 
1. Adult (age >18 years old) 
2. Currently on chronic dialysis or expected to be started on chronic dialysis within  
3 months of planned endoAVF creation.  Target treatment vein diameter(s) for fistula 
creation 
as measured via Duplex Ultrasound or Venogram 
3. Target treatment artery diameter(s) for fistula creation 
as measured via 
Duplex Ultrasound of Arteriogram 
4. Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound 
 
4.5.2 Exclusion Criteria 
1. Known central venous stenosis or central vein narrowing > 50% based on imaging on 
the same side as the planned AVF creation 
2. Absence of perforator feeding the target cannulation vein(s) via Venogram 
3. Occlusion or stenosis >50% of target cannulation cephalic or basilic vein 
4. Target cannulation vein that is <2.5 mm in diameter 
5. Significantly comprom
physician and imaging 
arterial stenosis may undergo a Digital Brachial Index 
(DBI) test, if DBI result is <.65 patient is excluded 
6. Documented ejection fracti
35% in the last 6 months 
7. Pregnant women 
8. New York Heart Association (NYHA) class III or IV heart failure 
9. Hypercoagulable state 
10. Known bleeding diathesis 
11. Documented history of drug abuse including intravenous drugs within six months of 
AVF creation 
12. 
previous major surgery within 30 days of enrollment 
13. Known allergy to contrast dye which cannot be adequately pre-medicated 
14. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-
medicated 
15. Evidence of active infections on the day of the index procedure 
16. Estimated life expectancy < 1 year 
17. Patient is not willing to provide written informed consent, is not geographically stable 
and/or not willing to comply with required follow-up 
18. Patient with a target cannulation vein that is > 6 mm deep that would require a 
transposition procedure, defined as the elevation of a target cannulation vein AND the 
creation of a new AV fistula  
19. Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of this 
protocol  
 

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4.5.3 2nd-Stage Procedure 
Study patients may require secondary procedure(s), also known as 2nd-stage procedures. 
These are procedures that are performed AFTER the endoAVF index procedure. Such 
procedures are considered interventions and require completion of the Post-Procedure 
Intervention eCRF. These procedures may include but are not limited to the following:
 
Procedures to support maturation of the arterialized vein segments (i.e. secondary coil 
embolization);
 
Procedures to support cannulation of the arterialized vein segments (i.e. elevation or 
superficialization of a target cannulation vein);
 
Procedures to maintain or restore patency of the AVF (i.e. balloon angioplasty). 
5 
STUDY SCREENING AND FOLLOW-UP PROCEDURES 
Patients are required to undergo a thorough screening evaluation prior to the index procedure 
and return for evaluations according to the study follow-up schedule.  Table 5-1: Schedule of 
Study Procedures outlines the required testing and follow-up required for each study interval.  
Study data will be collected on electronic case report forms (eCRFs) provided by the Sponsor. 
Table 5-1: Schedule of Study Procedures 
Assessment 
Screening 
Index 
Procedure 
Post Index Procedure 
0-10 Days 
Visit 1   
1 Month 
Visit 2
3 Month 
Visit 3
6 Month 
Visit 4
12 Month 
Visit 5
Compliance Window 
-60 days 
day 0 
0-10 days 
21-45 days 
Anniversary date +14 days 
Informed Consent 
X 
 
 
 
 
 
 
History, Physical 
Exam, Pregnancy Test
X 
 
 
 
 
 
 
Blood Pressure 
X 
X 
X 
X 
X 
X 
X 
HTN Medications 
X 
X 
X 
X 
X 
X 
X 
DUS Evaluation 
X 
X1 
X 
X 
X 
X 
X 
Angio/Venography  
 
X 
 
 
 
 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
Allen s Test 
/Palmar Arch
X 
X 
X 
X 
X 
X 
X 
Dialysis Access Data 
 
 
 
X2 
X2 
X2 
X2 
QOL Questionnaire 
X 
 
 
 
X 
X 
X 
1 Recommended post-procedure to confirm absence of bleeding or hematoma formation 
2 All efforts by the site must be undertaken to provide this data to the sponsor, minimally over a continuous 28-day period. 
5.1 
Informed Consent 
Prior to any non-standard-of-care procedures, the patient must sign the Informed Consent Form 
(ICF) approved by the Ethics Committee (EC).  All patients will be informed in detail about the 
nature of the clinical investigation, as well as its risks, potential benefits, and any anticipated 
discomforts. The Investigator or assigned designee must administer the ICF to each prospective 
study patient, and obtain the patient's signature or a legally authorized representative signature 
along with the date of consent. Proper informed consent should be obtained in accordance with 
local/country guidelines as needed. 
5.2 
Screening Evaluation 

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All patients considered for enrollment must undergo a thorough screening evaluation prior to the 
scheduled vascular access creation procedure.  The screening evaluation includes:  
 Collection of demographic data; 
 A medical history and physical exam;  
 A duplex ultrasound and optional angiography/venography assessment; 
 Pregnancy test (if of child bearing potential (urine or blood)) 
 
There will be a final determination of the patient  study eligibility due to vascular anatomy 
made at the time of the index procedure and thus, there may be some consented patients who 
are determined to be ineligible to participate in the study thus who will not undergo the 
everlinQ endoAVF procedure.  All patients that sign the study ICF and do not undergo the 
everlinQ procedure will be considered screen failures. 
The status of all patients screened should be captured on the study Subject Screening Log for 
tracking and reporting purposes. 
5.2.1 Duplex Ultrasound 
A duplex ultrasound (DUS) assessment of the flow rates and inner diameters of the arteries 
and veins of the target vessels must be performed per the study Duplex Ultrasound 
Guidelines.  Sites should ensure that only DUS operators who are trained on the protocol and 
DUS guidelines are performing these tests. 
5.3 
Medications 
There are no required medications in the study however, it is recommended that an antiplatelet 
medication be administered as a loading dose prior to the study procedure and continue daily for 
at least 1-month post study procedure. 
 
A Medication Log (eCRF) will be completed and maintained from Screening through 12 month 
follow up on the use of Hypertension Medications. 
 
5.3.1 Intra-Procedure 
All patients must receive adequate anticoagulation according to hospital standard practice.  It 
is recommended that an activated clotting time (ACT) test be administered after the initial 
dose of anticoagulant 
 225 seconds prior to the insertion of the 
study device.   
 
5.3.2 Study Procedure 
If a study candidate presents for the index procedure with any medical condition that 
precludes treatment, the procedure should be delayed until the infection or medical 
condition is treated and resolved. 
The everlinQ endoAVF System should be used per package labeling and the most current 
Instruction for Use (IFU) for the system selected.  Procedural steps for the everlinQ 
procedure are outlined in the specific IFU and supporting training materials.  All elements 
of the procedure are consistent with other endovascular procedures. 

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Only about 10cc of diluted contrast agent is required for the entire everlinQ procedure 
which is similar to other AVF interventions performed on pre-dialysis patients. 
Alternatively, CO2 contrast can be used for venography/angiography as determined by the 
treating physician. 
5.3.3 Post-Treatment 
After the treatment with the everlinQ endoAVF system, the arterial and venous puncture sites 
should be closed per standard hospital procedures, and it is recommended that manual 
compression is held for 20 minutes. 
Note: TVA Medical does not recommend the use of arterial closure devices to obtain 
hemostasis in subjects treated with the everlinQ system. 
5.4 
Follow-Up Visits 
All enrolled patients that undergo a successful endoAVF creation will return for follow-up at 0-10 
days post index procedure, then again at 21-45 days, 3, 6, and 12 months post index procedure.  
Refer to Table 1 for required testing at each follow-up visit. 
5.4.1 Dialysis Access Data 
Once hemodialysis is first initiated via the endoAVF (1 or 2- needle cannulation), detailed 
dialysis access data will be collected until 2/3 of the dialysis sessions are successfully 
performed using the endoAVF with 2- needle cannulation for over a continuous 28-day period. 
 
5.5 
Unscheduled Visit 
In addition to scheduled follow-up visits, the patient should be instructed to contact the 
Investigator at any time during the follow-up period if he/she has questions or concerns relating 
to the procedure or the vascular access.  If the patient returns to the clinic for evaluation related to 
his/her participation in the study between scheduled follow-up visits (i.e., not a study required 
visit): 
 No adverse events noted during unscheduled visit  no forms need to be completed. 
 Adverse event noted  The Adverse Event (AE) eCRF is required to be completed for 
each event. 
 Intervention to maintain or restore patency of the fistula, to support maturation of the 
arterialized vein segments, or to support cannulation of the arterialized vein segments  
the Post-Procedure Intervention eCRF must be completed. 
The patient will still be required to return for the next scheduled follow-up visit if the 
unscheduled visit is out of the compliance follow-up window. 
If the patient is treated by a health-care professional other than the Investigator for treatment-
related complications, the Investigator must request copies of the medical records and, if 
necessary, complete the appropriate eCRFs. 
5.6 
Lost to follow-up 
If an enrolled patient fails to comply with follow-up evaluations and misses two (2) consecutive 
follow-up visits with failure of all contact attempts, the patient may then be considered lost to 
follow-up and exited from the study.  Please contact TVA Medical to discuss any patients who 

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may be lost to follow-up, prior to exiting the patient from the study.  Data collected prior to the 
study exit will be included in the analysis.  All missed follow-up visits must be documented on a 
Protocol Deviation eCRF.   
5.7 
Patient Withdrawal from the Study 
Patients can voluntarily withdraw from the study at any time for any reason; the reason for 
withdrawal will be documented on the End of Study eCRF.  All available data at the time of 
withdrawal (if any) will be used for analysis.  Table 5-2: Withdrawal and Follow-Up 
Requirements summarizes the required actions and follow-up for patients who may have to be 
withdrawn from the study for varied reasons. 
 
Table 5-2: Withdrawal and Follow-Up Requirements 
If 
Action Item 
ICF was signed and the study catheter was not 
inserted.  
The patient is not considered enrolled.  Complete 
the Subject Screening Log as a screen failure.
The study catheter was inserted but RF energy 
was not delivered and therefore, the patient did 
not undergo endoAVF procedure (e.g., index 
procedure was aborted or converted to other 
surgical methods for AVF creation). 
The patient is not considered enrolled.  Complete 
the Subject Screening Log as a screen failure. 
The study catheter was inserted and RF energy 
was delivered but the endoAVF was not 
created, with or without a reportable adverse 
event(s). 
Patient is considered enrolled.  Follow patient 
until protocol reportable AE resolves. 
Collect all baseline-procedure and adverse event 
data and exit the patient (end date = date of AE 
resolution).  
The study catheter was inserted and RF energy 
was delivered and endoAVF was successfully 
created.
Patient is considered enrolled. Follow all required 
visits per Study Protocol.  
endoAVF was successfully created (patient  
enrolled) and there is a permanent loss or 
abandonment of the endoAVF
Patient participation ends.  Complete Follow up 
forms as appropriate until loss of endoAVF, then 
complete an End of Study eCRF.
5.8 
End of Study 
The End of Study eCRF is required to be completed whenever a patient exits the study.  This 
includes patients enrolled in the study who: 
 Complete the study protocol, after 12 months of follow up 
 Voluntarily withdraw from the study 
 Withdrawn by the study Investigator 
 Met the definition of endoAVF abandonment (see Section 4.3) 
 Lost to follow-up 
 Deceased 
 Other reason(s) for exiting the study 
 
 

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An Adverse event (AE) will be defined as any adverse medical change (i.e., de novo or increased 
severity in a preexisting condition) from the 
baseline condition that occurs during the course 
of the clinical study, after starting treatment, whether considered treatment-related or not. 
includes all commercially-approved products administered according to the study protocol and specific 
Instruction for use (IFU) documents. 
Any pre-planned procedures (refer to Section 4.5.3- 2nd-Stage Procedures), or additional interventions, 
will not be considered AEs for this study. In addition, normally expected symptoms caused by the 
treatment that do not prolong or affect patient discharge, or are managed with observation alone and do 
not require intervention (e.g., medical, endovascular, surgical) are not considered an AE for this study.   
These may include but are not limited to: 
 
Transient arterial spasm resolving spontaneously OR with medication only 
 
Minor discomfort or bruise at the arterial access site 
 
Small amount of bleeding at point of arterial access 
 
Transient numbness, tingling or coolness that resolved within 4 weeks post index 
procedure 
 
Bruising at the AVF creation site 
 
Side effects of standard-of-care medications  
 
Hematoma at the arterial and/or venous access site(s) and did not require 
endovascular or surgical intervention nor adversely affected discharge.  
 
Only AEs that are relevant to index procedure, study device, access site or the endoAVF will be 
collected in the study. For example, if the subject has knee replacement or undergoes a hysterectomy, 
these events will be considered as non-study related and will not be required to be recorded via 
Adverse Event eCRF.  
         Table 6-1: Adverse Event Type
AE Type
Definition
Serious Adverse 
Event (SAE) 
AE that: 
 
led to death, 
 
led to serious deterioration in the health of the patient, that either 
resulted in: 
 a life-threatening illness or injury, or 
 a permanent impairment of a body structure or a body 
function, or 
 in-patient or prolonged hospitalization, or 
 medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body 
structure or a body function, 
 
led to fetal distress, fetal death or a congenital abnormality or birth 
defect
Adverse Device 
Effect (ADE) 
AE related to the use of study device.  
 
NOTE:  This definition includes adverse events resulting from insufficient 
or inadequate IFU, deployment, installation, operation, or any malfunction 
of the study device. In addition to any event resulting from use error or 
from intentional misuse of the study device.

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Serious ADE 
(SADE) 
ADE that has resulted in any of the consequences characteristic of a SAE. 
Unanticipated 
SADE (USADE) 
USADE which by its nature, incidence, severity or outcome has not been 
identified in the current version of the study protocol, IFU, or other study 
documentation. 
6.1 
Relationship to Device or Procedure 
The Investigator will also evaluate the relationship of the adverse event to the everlinQ endoAVF 
System or procedure according to the following definitions: 
Definite (YES): 
The AE follows a reasonable timing from treatment (or attempted 
treatment) with the device and the possibilities of factors other than the 
device or the index procedure, such as underlying disease, concomitant 
drugs, or concurrent treatment can be excluded.  This includes an AE that 
occurs during the index (endoAVF creation) procedure. 
 
Probable (YES): 
The AE follows a reasonable timing from treatment (or attempted 
treatment) with the device and the probability of device or procedure 
involvement cannot be excluded.  However, other factors such as 
underlying disease, concomitant medications, or concurrent treatment may 
be possible. 
 
Unlikely (NO): 
The AE follows an unlikely timing relationship from treatment (or 
attempted treatment) or is more likely due to other factors and there is no 
definitive information suggesting that it was related to the device or 
procedure.    
 
 Not Related (NO):  The AE has no timing relationship from treatment (or attempted treatment) 
or it can be explained by other factors, including underlying disease, 
concomitant medication, or concurrent treatment. 
 
The Investigator will evaluate the relationship to the everlinQ device portion of the procedure using the 
yes/no definitions above.  The everlinQ device portion of the procedure only includes insertion, 
deployment and removal of the everlinQ catheters.  
All reported adverse events will be reviewed and adjudicated by an independent Clinical Events 
Committee (CEC).   
7 
DATA ANALYSIS 
The study will be observational in nature and will not involve the formulation or statistical testing of 
study hypotheses. 
Variables that are categorical in nature (such as gender) will be summarized by frequencies and 
percentages while those that are continuous in nature (such as age) will be summarized by the mean, 
standard deviation, minimum and maximum values. Continuous variables that appear not to be normal 
in distribution will also be described by the median value. 

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Variables involving time (such as primary patency) will be analyzed using the Kaplan-Meier product 
limit approach.  This approach yields cumulative probabilities of having an endoAVF for a given 
period of time without the occurrence of some specified terminal event, such as endoAVF thrombosis.  
The analysis requires both a time variable and a variable indicating whether or not the event of interest 
has occurred.  Results of these analyses will be presented both graphically and in tabular form.   
8 
REGULATORY OBLIGATIONS 
8.1 
Responsibilities of the EC/EC Approval 
Each site must obtain EC approval and any other regulatory 
as required by 
local or country guidelines prior to study initiation.  A copy of the approval notification and 
the approved study specific patient informed consent must also be kept on file at the site and a 
copy provided to Sponsor prior to the enrollment of patients. If applicable, written EC approval 
of any 
 information materials or any advertisement must also be attained prior to their 
use. 
8.2 
Sponsor Obligations 
The Sponsor must assume responsibilities that are not limited to the following: 
 Provide the Investigator with the necessary information (protocol and IFU) and training 
required to conduct the investigational study 
 Inform study Investigators of any new information 
 Conduct an evaluation of any USADE and report the result of such evaluation to all 
reviewing ECs and all participating Investigators within 10 working days of first receiving 
notice of the event. 
 
8.3 
Clinical Events Committee (CEC) Obligations 
The CEC will be an independent group of physicians experienced in vascular access that will be 
responsible for the review and adjudication of the adverse events.   
 
8.4 
Investigator Obligations 
Upon signing the Study Agreement, the Investigator agrees to assume the following 
responsibilities, to keep the required records, and to file the required reports in a timely manner. 
The Investigator agrees to: 
 Conduct the investigation in compliance with the signed agreement, study protocol, and 
applicable regulations.  Changes to the protocol will only be made after approval by the 
sponsor and the reviewing EC, or when necessary to protect the safety, rights or welfare 
of a patient. 
 Conduct the investigation in compliance with the EC and other applicable Regulatory 
agencies. 
 Personally, conduct or supervise the investigation. 
 Ensure that all associates, colleagues and employees assisting in the conduct of the study 
are informed about their obligations. 
 Protect the rights, safety and welfare of research patients. All patients must be informed 
that the device is being used for investigational purposes. 
 Assure initial and continuing review of the investigation by an EC. 

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8.4.1 
 
The following documents will be provided to the study Sponsor by the Investigator prior to 
initiation of the study. 
 
A signed and dated Study Agreement.
 
Current (within one year) curriculum vitae of the Principal Investigator and all Co-
Investigators. 
 
A copy of the approval letter by the EC for the study protocol and the ICF.
 
8.5 
Records and Reports 
All records and reports pertaining to this protocol are subject to inspection by regulatory 
agencies and must be retained for at least two years after the date on which the study is 
terminated or completed or for two years after the date that the records are no longer 
required for the purpose of supporting an application to regulatory agencies for 
commercial approval of the therapy/claims, or per local regulations, whichever is later. 
8.5.1 Investigator  Reports 
The Investigator is responsible for the preparation and submission of the reports listed in     
Table 8-1: Investigator Reports.   
 
    Table 8-1: Investigator Reports
Report
Submitted To
Description
Unanticipated Serious 
Adverse Device Events 
and Serious Adverse 
Device Effects 
Sponsor & EC 
The I
 report on any 
unanticipated serious adverse device 
event (USADE) or serious adverse 
device effect (SADE) must be submitted 
within 10 working days after the 
Investigator first learns of the event. 
Deviations from study 
protocol 
All deviations must be documented on a 
Protocol Deviation Form. 
Serious Adverse Events 
Sponsor 
The I
Adverse Events (SAEs) must be 
submitted within 10 working days after 
the Investigator first learns of the event 
Withdrawal of  
EC approval 
The Investigator must report a withdrawal of
reviewing EC approval within 5 working 
days. 

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8.5.2 Sponsor  Reports 
Sponsor is responsible for the preparation and submission of the reports listed in Table 
8-2: Sponsor Reports. 
 
Table 8-2: Sponsor Reports
Report
Submitted To
Description
Unanticipated Serious 
Adverse Device Effects 
(USADE) 
EC & 
Investigators 
Sponsor will report on any unanticipated 
serious adverse device effect evaluation 
within 10 working days after receiving 
notice of the effect. 
Notification of 
Termination or 
Completion 
Notification will be made within 30 
working days of completion or 
termination of the investigation. 
 
8.6 
Site Training 
Sponsor representative(s) will be responsible for site personnel training to ensure that all site 
personnel have a thorough understanding of the protocol, case report forms and associated study 
requirements. 
A Sponsor  representative(s) will meet with the Investigator at each study site prior to the 
enrollment of patients for the purpose of reviewing and discussing the protocol and supporting 
documentation to assure total understanding of the requirements involved in performing the 
clinical evaluation. 
8.7 
Protocol Deviations 
A Protocol Deviation eCRF must be completed for each deviation from the study protocol that 
occurred at the site (e.g., failure to obtain informed consent, enrolling a patient who does not 
meet inclusion/exclusion criteria, not performing required testing, repeatedly missed DUS 
measurements, missed follow-up visits, etc.). 
8.8 
Site Non-Compliance 
Repeated serious protocol deviations will be closely monitored.  If excessive deviations or a 
failure to reduce deviations is noted, the Sponsor reserves the right to suspend study enrollment 
or terminate the site from the study until a sufficient system is in place at the site to reduce 
further deviations.  
8.9 
Electronic Case Report Form (eCRF) Completion 
All required clinical data for this study will be collected in web-based eCRFs.  All data collected 
in the study must be supported by source documentation. Source documentation may include, 
but not necessarily be limited to: patient medical record notes, patient history questionnaires, 
physical examination forms, DUS data, radiology reports, operative summaries or other 
documentation that is pertinent to the 
 participation in the study.  In addition to existing 
patient records, eCRF worksheets for the study may be used to directly record study data and 
serve as source documentation.   
 

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8.10 
Monitoring Procedures 
The Sponsor or a Sponsor representative will monitor the progress of the study as required by 
GCP.  The study data will also be monitored. The Sponsor will request the source documents to 
be submitted in de-identified manner (
name and other personal identifiers must be 
removed and replaced with the study patient identification (ID) number). These source 
documents may include but not limited to: 
 Admission, procedural and discharge reports/notes 
 Any documentation relevant to SAE and procedure and device-related AEs 
Monitoring will be performed by qualified and appropriately trained monitors onsite and/or 
remotely. The monitors 
resentatives.  
On-site visits may be performed as needed based on enrollment, data integrity and site 
compliance (e.g. repeated and serious non-compliance by the site, such as significant number of 
data queries at the site, etc.). Each remote and on-site monitoring visit will be documented.  
 

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 2005  A Worldwide 
 Wolfgang Meichelboeck, 4th International 
Congress of the Vascular Access Society, Berlin, Germany, 2005. 
www.vascularaccesssociety.com 
2. 
United States Renal Data System (USRDS) 2008 Annual Report. 
3. 
Sidway, A.N. et al. Recommended standards for reports dealing with arteriovenous 
hemodialysis access. J. Vasc. Surgery Vol 35(3): 603-610 March 2002. 
4. 
Xue, J.L. et al. The association of initial hemodialysis type with mortality outcomes in 
elderly Medicare ESRD patients. Am J Kidney Disease Nov;42(5): 1013-9, 2003. 
5. 
Dhingra, R.K. Type of vascular access and mortality in U.S. hemodialysis patients 
Kid Int Vol 60: 1443-1451, 2001. 
6. 
National Kidney Foundation. KDOQI guidelines. 
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7. 
National Kidney Foundation KDOQI 2006 Vascular Access Guidelines. Am J Kidney 
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8. 
Fistula First National Vascular Access Improvements Initiative. Available at: 
http://www.fistulafirst.org/. Accessed August 30, 2009. 
9. 
Sidway A.N. et al. The Society for Vascular Surgery: Clinical practice guidelines for 
surgical placement and maintenance of arteriovenous hemodialysis access. J Vasc 
Surgery Vol 48(5S): 2S-25S, 2008. 
10. Asif, Roy-Chaudhury, Beathard, G.  Early Arteriovenous Fistula Failure: A Logical 
Perspective of How and Why to Intervene.  Clin J Am Soc Nephrol 1: 332 339, 2006. 
11. Schwab, J., Beathard, G. The hemodialysis catheter conundrum: Hate living with 
them, but 
 live without them. Kidney International Vol 56:1-17, 1999. 
12. Dember, L., Beck, G., Allon, M., et al. Effect of Clopidogrel on Early Failure of 
Arteriovenous Fistulas for Hemodialysis: A Randomized Controlled Trial.  JAMA 
299(18):2164-2171, 2008.