The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation
Phase: NA
Conditions: End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Failure, Kidney Insufficiency, Kidney Disease, Chronic, AV Fistula, Fistulas Arteriovenous
Sponsor: C. R. Bard



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Responsibilities of the Principal Investigator 
 
The role of the Principal Investigator (PI) is to implement, oversee the management of the day-
to-day conduct of the clinical investigation as well as ensure data integrity and the rights, safety 
and well-being of the subjects (referred to as participants in this clinical investigation plan 
[CIP]) involved in this clinical investigation.  Prior to participation in this clinical investigation, 
the PI or authorized designee must indicate acceptance of this CIP by signing the signature 
page, sign the Clinical Study Agreement (CSA) and obtain written approval from the 
governing Institutional Review Board or Ethics Committee (IRB / EC). This approval must be 
dated, in the Investigator’s name and a copy provided to the Sponsor along with the IRB / EC 
approved Informed Consent Form (ICF) and the signed CIP signature page as well as CSA, 
prior to beginning enrollment. Prior to implementation of any amendments to applicable 
investigation documents, written and dated approval from the governing IRB / EC must be 
obtained, if required. The PI and operating Sub-Investigator(s) must receive training prior to 
participant screening and enrollment. Operators must also complete BD-Sponsored training 
prior to operation of the WavelinQTM EndoAVF System on any enrolled participant and only 
after approval by the Sponsor. 
The PI must also: 
• Conduct the clinical investigation in accordance and compliance with this CIP, all 
written recommendations and instructions received from the Sponsor and / or IRB / 
EC,  the CSA, the Declaration of Helsinki, Good Clinical Practice (GCP), applicable 
national privacy laws (e.g. General Data Protection Regulation (GDPR) in the 
European Union (EU)), applicable International Organization for Standardization 
(ISO) regulations (ISO 14155:2020(E)) as well as any applicable regulatory 
requirements. 
• Ensure full disclosure of all potential conflicts of interest, including financial, that can 
interfere with the conduct of the clinical investigation or interpretation of results. 
• IRB / EC Compliance and Communications: 
o Ensure prompt reporting to the IRB / EC of applicable events as required by 
this CIP and / or the requirements of the governing IRB / EC (e.g. reporting of 
applicable safety events, of applicable deviations, of suspensions, etc.) is 
documented, completed in a timely manner and documentation thereof is 
provided to the Sponsor.  
o Provide the Sponsor with copies of any clinical investigation-related 
communications between the investigational site and the IRB / EC. 
• Informed Consent: 
o Ensure that written informed consent is obtained from each participant prior to 
the conduct of any clinical investigation procedure; using the current IRB / EC 
approved ICF. 

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o Ensure compliance with the applicable regulatory requirements and ethical 
principles for the process of obtaining informed consent.  
o Ensure and document appropriate training if an authorized designee is 
appointed to conduct the informed consent process. 
• Source Documentation and Data Collection: 
o Create and maintain source documents throughout the clinical investigation and 
maintain documentation of the type and location of these source documents.  
o Ensure the accuracy, completeness, legibility (where applicable) and timeliness 
of the data reported to the Sponsor on the electronic case report forms (eCRFs) 
and in all required reports.  
o Provide all required data and reports and agree to source document verification 
of clinical investigation data with participant’s medical records during 
monitoring visits or audits.  
o Ensure the retention of all investigation-related records as specified in this CIP. 
• Deviations:  
o Propose to the Sponsor any appropriate modification(s) of the CIP or 
WavelinQTM EndoAVF System or of the use of the WavelinQTM EndoAVF 
System.  
o Refrain from implementing any modifications to the CIP without prior 
agreement from the Sponsor, EC and if required, the regulatory authorities.  
o Document and explain any deviation from the approved CIP that occurred 
during the course of the clinical investigation.  
o Determine the cause of and implement appropriate corrective and preventive 
actions to address significant noncompliance. 
• Investigational Site Team Members and Resources: 
o Provide appropriate resources to ensure compliance with all clinical 
investigation-related procedures and prompt submission of all CRFs. 
o Ensure that an adequate investigation site team and facilities exist and are 
maintained and documented during the clinical investigation.  
o Ensure adequate training and qualification of the investigation site team 
members and maintain oversight of their activities or delegated responsibilities.  
o Ensure that maintenance and calibration of the equipment relevant for the 
clinical investigation is appropriately performed and documented, where 
applicable.  
 
 

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• Investigation Device Handling: 
o Ensure that the investigation device is used according to its instructions for use 
(IFU).  
o Ensure the safe return of potentially biohazardous investigation devices to the 
Sponsor where possible in case of reported device deficiencies and collaborate 
with the Sponsor to provide the necessary information allowing an accurate 
analysis where appropriate. 
• Safety Reporting and Handling: 
o Ensuring complete and timely safety event and / or device deficiency recording, 
assessment, and reporting per the requirements of this CIP and / or the IRB / 
EC to the required parties and supplying the Sponsor upon request any 
additional documentation / information pertaining to these events.  
o Inform the participant of the nature and possible cause of any adverse event 
(AE) experienced. Provide adequate medical care to a participant during and 
after a participant’s participation in a clinical investigation in the case of AEs, 
as described in the informed consent. 
• Monitoring and Auditing: 
o Allow and support the Sponsor personnel or their designee(s), IRB / EC 
representatives as well as regulatory representatives to perform monitoring and 
/ or auditing activities and to inspect and copy any investigation related 
documents.  
o Be accessible to the monitor during monitoring visits. 
• Participant Medical Care: 
o With the support of the Sponsor as necessary, inform the participants of any 
new significant findings occurring during this clinical investigation, including 
the need for additional medical care that may be required. 
o Provide the participant with well-defined procedures for possible emergency 
situations related to this clinical investigation and make necessary arrangements 
for emergency treatment as appropriate and per standard practices of the 
treating facilities. 
o Ensure that clinical records are clearly marked to indicate that the participant is 
enrolled in this clinical investigation as allowable by local IRB / EC and within 
local privacy guidelines. 
o If appropriate, provide participants enrolled in the clinical investigation with 
some means of showing their participation, together with identification and 
compliance information for concomitant treatment measures (contact address 
and telephone numbers shall be provided). 

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o Inform, with the participant’s approval or when required by national 
regulations, the participant’s personal physician about the participant’s 
participation in this clinical investigation. 
o Make all reasonable efforts to ascertain the reason(s) for a participant’s 
premature withdrawal from the clinical investigation while fully respecting the 
participant’s rights per IRB / EC requirements. 
The PI may delegate one or more of the above functions to a Sub-Investigator provided that 
the Sub-Investigator first signs the Sub-Investigator CIP Signature Page and receives 
appropriate training as specified in this CIP. The PI may also delegate specific tasks to qualified 
members of the investigation site team. However, the PI retains overall responsibility for IRB 
/ EC approval and proper conduct of the clinical investigation. This also applies to activities 
that are outsourced to external organizations on the PI’s behalf in which case the PI shall 
implement procedures to ensure the integrity of all tasks performed and any data generated by 
this external organization.  
 

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PRINCIPAL INVESTIGATOR AGREEMENT PAGE 
I have read and understand the contents of the WAVE Global Clinical Investigation Plan (CIP). 
I agree to follow and abide by the requirements set forth in this and any supporting documents. 
I also agree to conduct the clinical investigation in accordance with the Clinical Study 
Agreement, Good Clinical Practice (GCP), applicable ISO regulations (ISO 14155:2020(E)) 
as well as any applicable EC / IRB and / or applicable regulatory requirements.  
I agree to participate in BD-Sponsored training prior to performing any data collection or 
clinical investigation-related procedures. I also agree to participate in BD-Sponsored device 
training prior to operation of the WavelinQTM EndoAVF System on any enrolled participant 
and not until being approved by the Sponsor in writing to do so. 
 
Agreed to by: 
 
 
 
 
 
 
 
 
Printed Name - Investigator 
 
Date 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
 
 
Site Name 
 
Site Number 
 
 

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SUB-INVESTIGATOR AGREEMENT PAGE 
 
I have read and understand the contents of the WAVE Global Clinical Investigation Plan (CIP). 
I agree to follow and abide by the requirements set forth in this and any supporting documents. 
I also agree to conduct the clinical investigation in accordance with the Clinical Study 
Agreement, Good Clinical Practice (GCP) as well as applicable ISO regulations (ISO 
14155:2020(E)) as well as any applicable EC / IRB and / or applicable regulatory requirements.  
I agree to receive training by the principal investigator and / or Sponsor personnel prior to 
performing any data collection or clinical investigation-related procedures.  I also agree to 
participate in BD-sponsored device training prior to operation of the WavelinQTM EndoAVF 
System on any enrolled participant and not until being approved by the Sponsor in writing to 
do so.  
 
Agreed to by: 
 
 
 
 
 
 
 
 
Printed Name – Sub-Investigator 
 
Date 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
 
 
Site Name 
 
Site Number 

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TABLE OF CONTENTS 
1 CLINICAL INVESTIGATION PLAN (CIP) SUMMARY ..............................................13 
1.1 Synopsis ...................................................................................................................13 
1.2 Schema .....................................................................................................................16 
1.3 Schedule of Activities ..............................................................................................17 
2 INTRODUCTION .............................................................................................................18 
2.1 Background ..............................................................................................................18 
2.1.1 Safety Results ................................................................................................19 
2.1.2 Effectiveness Results .....................................................................................20 
2.2 Clinical Investigation General Rationale .................................................................20 
2.3 Investigation Device Description .............................................................................20 
3 CLINICAL INVESTIGATION DESIGN .........................................................................22 
4 CLINICAL INVESTIGATION ENDPOINTS ..................................................................23 
4.1 Primary Endpoints ....................................................................................................23 
4.1.1 Primary Safety Endpoint ...............................................................................23 
4.1.2 Primary Effectiveness Endpoint ....................................................................23 
4.2 Secondary Endpoints ................................................................................................23 
4.2.1 Safety .............................................................................................................24 
4.2.2 Effectiveness ..................................................................................................24 
4.3 Exploratory Endpoints ..............................................................................................24 
4.4 Applicable Endpoint Definitions ..............................................................................27 
4.5 Scientific Rationale for Clinical Investigation Design .............................................29 
4.5.1 Endpoint Rationale ........................................................................................29 
4.5.2 Potential Influencing or Confounding Factors and Bias ...............................30 
5 CLINICAL INVESTIGATION POPULATION ...............................................................33 
5.1 Eligibility Criteria ....................................................................................................33 
5.1.1 Inclusion Criteria ...........................................................................................33 
5.1.2 Exclusion Criteria ..........................................................................................34 
5.2 Lifestyle Considerations ...........................................................................................35 
5.3 Screen Failures .........................................................................................................36 
6 CLINICAL INVESTIGATION PROCEDURES AND ASSESSMENTS ........................37 
6.1 Participant Screening, Baseline Evaluations and Enrollment ..................................37 
6.1.1 Informed Consent and Enrollment ................................................................37 
6.1.2 Eligibility .......................................................................................................37 
6.1.3 Demographic Information and Medical History ...........................................38 
6.1.4 Baseline Assessments ....................................................................................38 
6.2 Index Procedure ........................................................................................................39 
6.2.1 Clinical Investigation Treatment ...................................................................39 
6.2.2 Adjunctive Procedures ...................................................................................40 
6.3 Post-Index Procedure and Discharge .......................................................................40 
6.4 Participant Follow-Up ..............................................................................................41 
6.4.1 Follow-Up Intervals and Methods .................................................................41 
6.4.2 Unscheduled Follow-Up ................................................................................43 
6.5 Participant Investigation Completion and Premature Discontinuation ....................43 

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7 STATISTICAL METHODS ..............................................................................................45 
7.1 Overview of Clinical Investigation Design ..............................................................45 
7.2 Analysis Populations ................................................................................................45 
7.3 Sample Size Considerations .....................................................................................45 
7.4 Primary Endpoints ....................................................................................................47 
7.4.1 Primary Safety Endpoint ...............................................................................47 
7.4.2 Primary Safety Endpoint Hypothesis Test ....................................................47 
7.4.3 Primary Effectiveness Endpoint ....................................................................47 
7.4.4 Primary Effectiveness Endpoint Hypothesis Test .........................................48 
7.5 Secondary Endpoints ................................................................................................49 
7.5.1 Safety .............................................................................................................49 
7.5.2 Effectiveness ..................................................................................................49 
7.6 Exploratory Endpoints ..............................................................................................49 
7.7 General Considerations ............................................................................................49 
7.7.1 Subgroup Analyses ........................................................................................49 
7.7.2 Poolability Analysis by Geographical Region and Investigational Site ........50 
7.7.3 Handling of Missing Data .............................................................................50 
7.8 Analysis Timing .......................................................................................................50 
8 SAFETY MONITORING AND REPORTING .................................................................51 
8.1 Definitions of Events ................................................................................................51 
8.1.1 Adverse Events (AEs) ...................................................................................51 
8.1.2 Serious Adverse Events (SAEs) ....................................................................51 
8.1.3 Adverse Device Effect (ADE) .......................................................................52 
8.1.4 Serious Adverse Device Effect (SADE) or Unanticipated (Serious) Adverse 
Device Effect (UADE / USADE) .............................................................................52 
8.2 Severity of Adverse Event ........................................................................................52 
8.3 Relationship of AE to Device(s) / Procedure / AV Access Circuit ..........................53 
8.4 Reporting of Events ..................................................................................................53 
8.4.1 Non-Reportable AEs .....................................................................................54 
8.5 Participant Death ......................................................................................................54 
8.6 Device Deficiencies ..................................................................................................54 
8.7 Serious Health Threat ...............................................................................................55 
8.8 Safety Committees ...................................................................................................55 
8.8.1 Medical Monitor ............................................................................................55 
8.8.2 Clinical Events Committee (CEC) ................................................................55 
9 RISK / BENEFIT ANALYSIS ..........................................................................................57 
9.1 Risk Assessment .......................................................................................................57 
9.2 Benefit Assessment ..................................................................................................58 
9.3 Overall Benefit: Risk Conclusion ............................................................................59 
10 DATA COLLECTION AND RECORD MAINTENANCE .............................................60 
10.1 Case Report Forms (CRF) and Source Documentation ...........................................60 
10.2 Source Documentation Access .................................................................................60 
10.3 Data Management ....................................................................................................60 
10.4 Record Retention ......................................................................................................61 

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11 QUALITY CONTROL AND ASSURANCE ...................................................................62 
11.1 Control of the Investigation Device .........................................................................62 
11.2 Monitoring ................................................................................................................62 
11.2.1 Site Initiation Visits (SIVs) ...........................................................................62 
11.2.2 Interim Monitoring Visits (IMVs) .................................................................63 
11.2.3 Final Monitoring Visit ...................................................................................64 
11.3 Audits and Inspections .............................................................................................64 
11.4 Deviations from the CIP and Medical Emergencies ................................................64 
12 ADMINISTRATIVE REQUIREMENTS .........................................................................66 
12.1 Investigator and Site Selection .................................................................................66 
12.2 Training ....................................................................................................................66 
12.3 Required Documents ................................................................................................67 
12.4 Reporting Requirements ...........................................................................................67 
12.5 Registration of the Clinical Investigation .................................................................68 
12.6 Publication Policy ....................................................................................................69 
12.7 Close-Out, Premature Termination, or Suspension of the Clinical Investigation ....69 
12.8 Amendments .............................................................................................................70 
13 ETHICAL AND REGULATORY CONSIDERATIONS .................................................71 
13.1 Regulatory Status .....................................................................................................71 
13.2 IRB / EC Approval and Communications ................................................................71 
13.3 Informed Consent and National Privacy Laws ........................................................71 
13.3.1 Special Circumstances for Informed Consent ...............................................73 
13.3.2 Confidentiality ...............................................................................................73 
13.4 Statement of Compliance .........................................................................................74 
14 REFERENCES ..................................................................................................................75 
15 APPENDICES ...................................................................................................................77 
15.1 Appendix A – Abbreviations and Acronyms ...........................................................77 
15.2 Appendix B – Definitions ........................................................................................79 
 
 
 

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Inclusion 
Criteria 
(continued): 
Anatomical Inclusion Criteria: 
The participant must have: 
5. 
Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via DUS or 
angiography. 
6. 
A target treatment artery diameter ≥ 2.0 mm as measured via DUS or angiography. 
7. 
Adequate collateral circulation to the hand, in the opinion of the Principal Investigator (PI) (or 
authorized designee). 
8. 
At least one superficial outflow vein diameter ≥ 2.5 mm as measured via DUS or angiography 
that is in communication with the target creation site via a proximal forearm perforating vein. 
 
Exclusion 
Criteria 
Clinical Exclusion Criteria: 
The participant must not have: 
1. 
Active or nontreated hypercoagulable state. 
2. 
Known bleeding diathesis. 
3. 
Insufficient cardiac output to support the maturation and use of an AVF in the opinion of the 
PI (or authorized designee). 
4. 
Known history of or current active intravenous drug abuse. 
5. 
A “planned” major surgical procedure within 6 months following index procedure or major 
surgery, in the opinion of the PI (or authorized designee), within 30 days prior to index 
procedure. 
6. 
Known allergy or hypersensitivity to contrast media which cannot be adequately treated with 
pre-medication. 
7. 
Known adverse effects to sedation and / or anesthesia which cannot be adequately treated with 
pre-medication. 
8. 
Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius 
and / or White Blood Cell (WBC) Count of ≥ 12,000 cells / μL, if collected). 
9. 
Another medical condition, which, in the opinion of the PI (or authorized designee), may cause 
him / her to be non-compliant with the CIP, confound the data interpretation, or is associated 
with a life expectancy insufficient to allow for the completion of clinical investigation 
procedures and follow-up. 
10. Current participation in an investigational drug or device clinical investigation that has not 
completed the clinical investigation treatment or that clinically interferes with the clinical 
investigation endpoints. Note: Investigations requiring extended follow-up visits for products 
that were investigational, but have since become commercially available, are not considered 
investigational. 
Anatomical Exclusion Criteria: 
The participant must not have: 
11. Central venous stenosis or central vein narrowing ≥ 50% based on imaging, or any degree of 
central venous stenosis with accompanying signs or symptoms, on the same side as the planned 
AVF creation. 
12. The absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from 
the target creation site via DUS or angiography. 
13. Occlusion or stenosis ≥ 50%, or any degree of stenosis with accompanying signs or symptoms 
of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via DUS 
or angiography and as clinically determined by PI (or authorized designee). 
14. Significantly compromised venous or arterial architecture (e.g. severe vessel calcification) or 
flow in the treatment arm as determined by the PI (or authorized designee) and DUS or 
angiography.  
15. Presence of significant calcification at the target endoAVF location that could potentially 
impact the effectiveness of endoAVF creation as determined by the PI (or authorized 
designee). 

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Primary 
Endpoints: 
• Safety 
Objective: Assess that the device continues to maintain its safety profile. 
 
Endpoint: The primary safety endpoint is the proportion of participants with freedom from 
Clinical Events Committee (CEC) adjudicated device- or procedure-related serious adverse 
events (SAEs) through 30 days. 
 
The primary safety endpoint will be evaluated against a performance goal (PG) of 82.6%, 
which was set with a 10% non-inferiority margin of the estimated 92.6% through 30 days 
derived from pre-market data from the prior clinical investigations evaluating the 
WavelinQ™ EndoAVF System. 
• Effectiveness 
Objective: Assess that the device yields an AVF that can be used for HD effectively and 
performs within clinical guideline expectations. 
 
Endpoint: The primary effectiveness endpoint will evaluate the impact of endoAVF 
creations using the WavelinQTM EndoAVF System on the number of interventions post 
creation to facilitate and / or maintain AVF use (facilitation interventions and / or 
maintenance interventions as defined in this CIP).  This endpoint will be evaluated 
including all data collected for all participants up until the timepoint of the 6-month follow-
up of the last active treated participant (i.e. including any and all data exceeding the 6-
month follow-up visit up to this timepoint). 
 
The number of facilitation and / or maintenance interventions per PY will be compared to 
a PG, that is composed of the combined targets for interventions to facilitate and maintain 
AVF use recommended by the 2019 update of the KDOQI Clinical Practice Guideline for 
Vascular Access.8 
Secondary 
Endpoints: 
 
Safety 
• Device and Procedure Related SAEs evaluated through 6- and 24-months 
 
Effectiveness 
• Physiological Maturation evaluated through 6-weeks 
• Cannulation Success evaluated through 6-months 
• Cumulative Functional Patency evaluated through 12-months 
 
Exploratory 
Endpoints:  
 
• Procedure Success 
• Adjunctive Procedures 
• Vascular Access at HD Initiation 
• Physiological Maturation*  
• Cannulation Success* 
• Functional Maturation 
• Functional HD Usability 
• Facilitation Interventions Post Creation 
• Maintenance Interventions Post Creation 
• All Interventions Post Creation 
• All Interventions Post First Use 
• Primary Patency 
 
• Cumulative Patency 
• Primary Functional Patency 
• Cumulative Functional Patency* 
• CVC Exposure / Use 
• DUS Juxta- & Peri-Anastomotic as well 
as Perforator Vein Patency 
• Wrist Arterial Procedure Access 
Considerations 
• Participant Satisfaction / Quality of Life  
• HD arteriovenous (AV) Access 
Continuity 
 
*Evaluated through additional intervals 
 
 

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Procedures: 
All participants will undergo a clinical evaluation at screening (prior to the index procedure). 
All participants that have met all eligibility criteria and into whom the WavelinQTM EndoAVF 
System was introduced will undergo a clinical evaluation prior to discharge from the procedure 
facility  
Follow-up visits for all treated participants will be conducted through in-person clinic visits at 
30-days, 6-weeks as well as 6- and 12-months as well as through phone calls and remote record 
collection (e.g. from the participants HD center) at 3-, 18- and 24-months. Refer to section 1.3 
for the Schedule of Activities. 
Participants into whom the WavelinQTM EndoAVF System was introduced but procedure 
success was not achieved will be followed through the 30-day follow-up to assess for any safety 
events and interventions.  This follow-up can be conducted by phone for these participants at 
which time their participation in the investigation will end.  
Participants into whom the WavelinQTM EndoAVF System is not introduced should be treated 
per SOC and the reason documented on the appropriate eCRF. Participation for these 
participants will end at the time of the index procedure. 
Safety 
Committees: 
A CEC will be used to adjudicate AEs throughout the course of the clinical investigation and a 
Medical Monitor (MM) will be responsible for AE trending reviews as well as for the 
identification of signals that could indicate a serious health threat. 
Regulatory 
Status: 
The WavelinQTM EndoAVF System is Conformité Européene (CE) marked and will be 
evaluated in a post-market fashion for its approved indication in the European Union (EU) and 
the United Kingdom (UK). Appropriate regulatory approvals will be obtained in other regions 
prior to initiating the clinical investigation in those regions, if applicable. 
1.2 
Schema 
 

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2 INTRODUCTION 
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-
randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creations 
by means of the WavelinQ™ EndoAVF System in patients who require vascular access for 
hemodialysis (HD). This clinical investigation will be conducted in conformance with the 
Declaration of Helsinki, applicable national privacy laws (e.g., General Data Protection 
Regulation (GDPR) in the European Union (EU)), and applicable ISO regulations (ISO 
14155;2020(E)). 
2.1 
Background 
End Stage Kidney Disease (ESKD) currently affects over 3.5 million people worldwide.1 
It is projected that the worldwide incidence of ESKD will increase dramatically over the 
next 10 years, due to the increasing incidence of an aging population, diabetes, 
hypertension, and obesity.2 Currently, Kidney Replacement Therapy (KRT) for patients 
with ESKD consists of either dialysis (HD or peritoneal dialysis [PD]) or kidney 
transplantation. The number of people receiving KRT currently exceeds 2.5 million world-
wide and this is projected to double to 5.4 million by 2030.3 Dialysis is the predominant 
form of KRT; but the relative proportions of patients on HD or PD vary widely both locally 
(i.e. by facility) and internationally (e.g. by country). According to the United States Renal 
Data System (USRDS), in 2015 around 87.3% of U.S. patients requiring KRT received 
HD, 9.6% were treated with peritoneal dialysis, and the remainder had a kidney transplant.2 
Similarly in Europe, according to the European Renal Association – European Dialysis and 
Transplant Association (ERA-EDTA) Registry Annual Report 2016, the majority of 
patients started KRT with HD (84%), while 12% of patients started with PD and 4% 
received a pre-emptive kidney transplant.4 
Vascular access is a critical component in the care of patients undergoing HD. The three 
types of vascular access are: an autogenous AVF, a prosthetic arteriovenous graft (AVG) 
or a central venous catheter (CVC).5 The AVF has been associated with superior outcomes 
compared to AVG and CVC access in terms of both mortality and morbidity.6,7 This 
association has led to numerous initiatives worldwide to increase the creation and use of 
AVF as the preferred form of vascular access in patients requiring HD. The new National 
Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines 
continue to support the AVF as the preferred vascular access in eligible patients according 
to their ESKD Life-Plan.8 These and other guidelines have stressed the importance of 
proactive identification of patients requiring HD and have described procedures and quality 
initiatives to maximize vascular access longevity. The Society of Vascular Surgery (SVS) 
has also approved and sponsored initiatives around the development and publication of 
reporting standards for HD access and the development of practice guidelines for HD 
access.9 Subsequently, a special issue published by the Clinical Journal of the American 
Society of Nephrology highlighted standardized definitions which could be used for 
clinical trials specifically designed for the development and assessment of innovations in 

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vascular access.10 Authors of these papers included multidisciplinary clinicians (academic 
and community practice), patients, industry partners and regulatory partners (FDA). 
Clearly, the multi-faceted vascular access community recognizes the importance of the 
AVF and the need for clinical trials to support technology, innovation, and progress to 
improve AVF outcomes. 
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 (DUS) imaging, allowing for pre-operative vessel 
diameter measurement and vessel selection. Typically, the radial artery or brachial artery 
and the cephalic vein or basilic vein 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 DUS, and the incision is closed. Over the course of the following–1 – 3 months, the 
vein dilates due to the increased flow, maturing to allow for sufficient 2-needle cannulation 
and the acceptance of blood flow rates required to provide HD. 
Though the AVF is the preferred vascular access, 28 – 60% of AVFs do not successfully 
mature and are rendered unusable for HD.11,12 This has unintended consequences for 
patients who need HD, since a tunneled CVC must then be inserted to provide HD. CVCs 
are associated with higher morbidity, mortality, and costs compared to other forms of 
vascular access and are therefore considered a last resort.13 
The WavelinQ™ EndoAVF System was developed to decrease the invasiveness of the 
AVF creation procedure by creating an endovascular AVF (endoAVF). Prior clinical 
investigations on both a 6F and 4F version have demonstrated that endoAVFs created using 
the WavelinQ™ EndoAVF Systems have high technical success rates, high patency, low 
complication rates, and low intervention rates.14,15  These investigations are further 
supported by a global analysis including pooled data from three additional clinical 
investigations of the 4F device through 6-months for a total of 91 additional participants.  
These results are summarized subsequently. 
2.1.1 Safety Results 
In total, 22.0% (20/91) of participants experienced a significant event, defined as 
device- or procedure-related AEs that either could be limb-threatening if not promptly 
identified or treated, or required additional therapy to reestablish patency of the 
endoAVF access circuit, irrespective of whether they met the criteria for an SAE. These 
significant events included stenosis, occlusion, thrombosis, and pseudoaneurysm of the 
access circuit and / or endoAVF, as well as one participant with abandonment of the 
endoAVF after a cannulation induced brachial artery injury. 

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SAEs were reported in 26.4% (24/91) of the population. Of these events, 18/24 (75.0%) 
were unrelated to the device and unrelated to the procedure. There were 3 device-
related SAEs reported in the investigations (3/91, 3.3%) and included 1 thrombosis of 
the endoAVF, 1 stenosis of the endoAVF, and 1 access circuit false aneurysm. There 
were 5 procedure related SAEs reported in 5.5% (5/91) of the population. None of the 
SAEs were related to the method of arterial access for the procedure. There were no 
reports of Unanticipated Adverse Device Effects (UADEs). There were no closure 
device-related SAE’s or coil related SAE’s reported. 
2.1.2 Effectiveness Results 
Procedural success, defined as the successful creation of an endoAVF with blood flow 
confirmed intraoperatively by fistulography or postoperative duplex ultrasonography, 
was achieved in 96.7% (88/91) of the population. Using Kaplan-Meier (KM) point 
estimates at month 6, the cannulation success rate was 84.9% ± 5.3% for participants 
in the HD subset. The mean time to cannulation was 2.0 ± 1.6 months.  
Primary patency and cumulative patency were determined using the KM point 
estimates at month 6. Primary patency was 72.4% ± 5.2% and cumulative patency was 
77.3% ± 5.0%. Functional patency was 100% through 6 months in the population who 
used their endoAVF for HD. 
2.2 
Clinical Investigation General Rationale 
The purpose of this clinical investigation is to provide clinical evidence to further 
demonstrate reasonable assurance of safety and effectiveness of the WavelinQ™ 
EndoAVF System for endovascular fistula (endoAVF) creations in a post-market 
confirmatory interventional fashion. See Section 3 for specific objectives and Section 4.5 
for endpoint rationales.  
2.3 
Investigation Device Description 
The WavelinQ™ EndoAVF System, manufactured by the Sponsor, is indicated for the 
cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation 
of an AVF used for HD. The device is intended to be used in patients suffering from chronic 
kidney disease requiring HD by physicians trained and experienced in endovascular 
techniques (Refer to Section 12.2 for training requirements). The WavelinQTM EndoAVF 
System will be used for these intended purposes as part of this clinical investigation 
according to its IFU. 
The WavelinQ™ EndoAVF System consists of two 4 Fr, single-use, disposable, magnetic, 
hydrophilic coated catheters: (1) a venous catheter powered by an Electrosurgical Unit 
(ESU) and (2) an arterial catheter. The system has been developed for use with 
commercially available accessories including the ESU, an electrosurgical pencil, 
grounding pads, an arm board, fixation straps, and a remote hand switch.  

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The venous catheter is a flexible magnetic catheter that contains a radiofrequency (RF) 
electrode, a hemostasis valve crosser for interfacing with the introducer sheath on the distal 
end and features a cable and plug for the delivery of RF energy on the proximal end. RF 
energy is delivered by connecting the venous catheter to the ESU via the electrosurgical 
pencil and is used with standard grounding pads.  
The arterial catheter is a flexible magnetic catheter which contains the backstop for 
receiving the electrode from the venous catheter.  
When placed in proximity, the magnets contained in each catheter attract each other, while 
aligning the electrode with the backstop. Rotational indicators are present in each catheter 
for use to accurately position the catheters. Once correctly aligned, RF energy can then be 
delivered through the electrode for cutting and / or coagulating tissue to create the 
endoAVF. The full procedural steps and associated information are detailed in the device 
IFU.  
NOTE: If the participant has more than one brachial vein, embolization of one of 
the brachial veins is recommended to divert flow to the superficial veins to facilitate 
maturation of the endoAVF. 
 
 

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3 CLINICAL INVESTIGATION DESIGN  
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-
randomized, single-arm, clinical investigation to further demonstrate the safety and 
effectiveness of the WavelinQ™ EndoAVF System for endovascular fistula creations in the 
ulnar and radial vessels when accessed from the wrist (and / or upper arm) arteries and 
concomitant veins in the parallel or anti-parallel configuration.  
 
Safety objective: The safety outcome of participants receiving treatment with the 
WavelinQ™ EndoAVF System will be compared to a Performance Goal (PG) derived 
from the prior clinical investigations evaluating the WavelinQ™ EndoAVF System to 
confirm that the safety profile of the device is maintained.  
 
Effectiveness objectives: The effectiveness measure evaluated through the primary 
effectiveness endpoint will be used to assess the performance of the WavelinQTM 
EndoAVF System when used in the creation of AVFs in a post-market fashion. The 
clinical investigation will aim to evaluate the number of interventions per patient year 
(PY) to facilitate (facilitation interventions) and maintain (maintenance interventions) 
use of the AVF and compare this to clinical guideline recommendations.  Non-
hypothesis tested secondary endpoints will evaluate the performance of the 
endovascularly created AVFs with respects to short-term (maturation / cannulation) 
and long-term (functional cumulative patency) performance characteristics. 
 
A total of approximately one-hundred and fifty (150) treated participants will be included.  
Note that as per the definition of treated participant (refer to Section 6.2), this number does not 
include the participants into whom the WavelinQTM EndoAVF System was introduced but in 
whom procedure success (as defined in Section 4.3) was not achieved (estimated to total 
approximately ten [10] participants).  
 
Under the current enrollment assumptions, a target of approximately 15 investigational sites 
(up to a maximum of 30 investigational sites) may participate globally. This investigation will 
enroll participants who are either already receiving HD at the time of screening (prevalent 
participants), regardless of access type (CVC, AVF, and / or AVG), or those who are  not yet 
receiving HD but are in need of a vascular access as determined by the referring clinician 
(incident participants). 
 
Treated participants will be followed for 24-months post index procedure. The enrollment 
period is estimated to last about 18 months and the total clinical investigation duration is 
estimated to last 3.5 years from the enrollment of the first participant to the last follow-up visit 
of the last active treated participant. The primary endpoints will be analyzed when the last 
active treated participant has completed their 6-month follow-up. A final analysis will be 
completed when all participants have completed, or prematurely discontinued before, their 24-
month follow-up.  
 
 

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4 CLINICAL INVESTIGATION ENDPOINTS 
4.1 
Primary Endpoints  
There are two co-primary endpoints for this clinical investigation: An endpoint to evaluate 
safety and another to evaluate effectiveness. These endpoints are defined in this section. 
4.1.1 Primary Safety Endpoint 
Safety through 30 Days 
The primary safety endpoint is the proportion of participants with freedom from 
Clinical Events Committee (CEC) adjudicated device- or procedure-related serious 
adverse events (SAEs) through 30 days. 
The primary safety endpoint will be evaluated against a PG of 82.6%, which was set 
with a 10% non-inferiority margin of the estimated 92.6% through 30 days derived 
from premarket data from the prior clinical investigations evaluating the WavelinQ™ 
EndoAVF System. 
4.1.2 Primary Effectiveness Endpoint 
Interventions Post Creation to Facilitate AVF Use and / or Maintain AVF Use 
(Facilitation and / or Maintenance Interventions) through the Timepoint of the 6-
Month Follow-Up of the Last Active Treated Participant 
The primary effectiveness endpoint is the number of interventions post creation to 
facilitate and / or maintain AVF use (facilitation interventions and / or maintenance 
interventions as defined in Section 4.4). The procedures that will be evaluated as part 
of this endpoint are indicated in Table 1 in Section 4.4 and exclude adjunctive and 
second stage procedures.  
The number of facilitation and / or maintenance interventions per PY will be compared 
to a PG that is composed of the combined targets for interventions to facilitate and 
maintain AVF use recommended by the 2019 update of the KDOQI Clinical Practice 
Guideline for Vascular Access.8 This endpoint will be evaluated including all data 
collected for all participants up until the timepoint of the 6-month follow-up of the last 
active treated participant (i.e. including any and all data exceeding the 6-month follow-
up visit up to this timepoint).  
4.2 
Secondary Endpoints 
The secondary endpoints will be evaluated in a descriptive fashion and will be analyzed 
through the timepoints specified for each endpoint below.  These endpoints will be reported 
at the timepoints specified in Section 7.9. 

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4.2.1 Safety 
• Device and Procedure Related SAEs 
The proportion of participants with freedom from CEC adjudicated device-related 
or procedure-related SAEs (refer to Section 8 for definitions). This endpoint will 
be assessed through 6- and 24-months post creation.  
4.2.2 Effectiveness 
• Physiological Maturation 
The proportion of participants with AVFs that meet the definition of physiological 
maturation. Physiological maturation is defined as an AVF having at least 500 mL 
/ min of flow in the brachial artery and an outflow vein diameter of ≥ 4 mm as 
measured by DUS.16,17 Participants with AVFs that meet the definition of functional 
maturation (Refer to Section 4.3) will automatically meet physiological maturation.  
This endpoint will be assessed through 6-weeks post creation. 
• Cannulation Success 
The interval of time between HD arteriovenous (AV) access creation to first 
successful use for HD using 2-needle cannulation and proportion of participants 
with successful first use for HD using 2-needle cannulation. This endpoint will be 
assessed through 6-months post creation.  
• Cumulative Functional Patency  
The time from first successful HD AV access use for HD using 2-needle 
cannulation to access abandonment, when the access reaches an access censoring 
event as specified a priori in this CIP, or analysis timepoint / clinical investigation 
end.  This endpoint will be assessed through 12-months post creation.  
4.3 
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 these endpoints. 
• Procedure Success  
The proportion of participants with successful endoAVF creation using the 
WavelinQTM EndoAVF System as confirmed via intraprocedural angiography and / or 
verified via DUS.  
• Adjunctive Procedures  
The number of adjunctive procedures performed (see Section 4.4 for definition).  
 
 

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• Vascular Access at HD Initiation 
The vascular access HD modality used at the initiation of HD following the index 
procedure (CVC, AVG, clinical investigation AVF, or alternate AVF). Use of the 
clinical investigation AVF at initiation includes both one- and two-needle cannulation 
and may be presented as a combined total as well as by type of needle access.  This 
endpoint applies to the incident participant population only.  
• Physiological Maturation 
As defined for the secondary endpoint (see Section 4.2.2) evaluated through additional 
time intervals.  
• Cannulation Success 
As defined for the secondary endpoint (see Section 4.2.2) evaluated through additional 
time intervals.  
• Functional Maturation  
The proportion of participants with successful prescribed HD with 2-needle 
cannulation of the AVF for three (3) continuous weeks. Additionally, the time from 
HD AV access creation to the first day of the 3-week period. 
• Functional HD Usability  
The proportion of participants dialyzed using successful 2-needle access of the AVF 
created as part of this clinical investigation for ≥ 75% of HD sessions over a continuous 
28-day period. Additionally, the time from HD AV access creation to the first day of 
the 28-day period.  
• Interventions 
Intervention related endpoints are categorized as follows: 
 Interventions Post Creation to Facilitate AVF Use (Facilitation Interventions) 
As defined for the primary effectiveness endpoint (see Section 4.1.2) evaluated 
separately. 
 Interventions Post Creation to Maintain AVF Use (Maintenance Interventions) 
As defined for the primary effectiveness endpoint (see Section 4.1.2) evaluated 
separately. 
 All Interventions Post Creation (Facilitation, Maintenance and HD Continuity 
Interventions) 
For this endpoint, the number of interventions post creation will include all 
interventions (facilitation, maintenance, and HD continuity interventions) in Table 
1 of Section 4.4 but exclude adjunctive and second stage procedures.  

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 All Interventions After First Use (Facilitation, Maintenance and HD Continuity 
Interventions) 
As defined for the exploratory endpoint directly above with duration of evaluation 
adjusted to start from first successful HD AV access use.  
• Primary Patency  
The time from HD AV access creation to the first one of the following events: access 
thrombosis; any facilitation or maintenance intervention intended to support maturation 
or cannulation, as well as those to maintain, or re-establish functionality*; access 
abandonment (as defined in Section 4.4); the access reaches an access censoring event 
as specified a priori in this CIP; or analysis timepoint / clinical investigation end.18 
*Excludes adjunctive and second stage procedures. 
• Cumulative Patency  
The time from HD AV access creation to access abandonment, when the access reaches 
an access censoring event as specified a priori in this CIP, or analysis timepoint / 
clinical investigation end.18  
• Primary Functional Patency  
The time from first successful HD AV access use for HD using 2-needle cannulation 
to the first one of the following events: access thrombosis; any facilitation or 
maintenance intervention intended to support maturation or cannulation as well as those 
to maintain or re-establish functionality*; access abandonment (as defined in Section 
4.4); the access reaches an access censoring event as specified a priori in this CIP; or 
analysis timepoint / clinical investigation end. *Excludes second stage procedures. 
• Cumulative Functional Patency 
As defined for the secondary endpoint (see Section 4.2.2.2) evaluated through 
additional time intervals.  
• CVC Exposure / Use   
Data will be collected regarding CVC exposure and use.  
 For participants with a CVC in place at the index procedure, data will be collected 
after HD AV access creation to investigate the duration of CVC use.  
 For all participants, data will be collected to determine frequency of CVC 
placements, time to CVC removal, total days of CVC exposure, and total days of 
CVC use.  
 
 

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• DUS Juxta/Peri-Anastomotic Area and Perforator Vein Patency 
Data will be gathered using DUS examinations to evaluate the presence and 
characteristics of thrombosis and stenosis within the juxta-anastomotic area (defined as 
the arterial area extending 5cm before and the venous area extending 5cm after the 
anastomosis) and peri-anastomotic area (defined as the venous area extending from the 
juxta-anastomosis area to the start of the perforating vein) as well as within the 
perforator vein for all participants through 6 weeks. 
• Wrist Arterial Procedure Access Considerations 
Data will be gathered using DUS examinations to evaluate the presence and 
characteristics of thrombosis and stenosis in arteries at the wrist used for procedure 
access during the index procedure. Images from these DUS examinations will be 
submitted to the Core Lab for review and assessment. Additionally, data will be 
captured for these participants on procedure-related AEs that are attributable to arterial 
access at the wrist as adjudicated by the CEC. 
• Participant Satisfaction and Quality of Life (QOL): 
The Short Form-Vascular Access Questionnaire (SF-VAQ) and the European Quality 
of Life-5 Dimensions (EQ-5D) will be used to gather data on the participants QOL at 
the time points specified in Section 1.3 and Section 6.   
• HD AV Access Continuity 
HD AV access continuity is defined as the ability for a participant to receive an 
alternate HD AV access in the same arm as the index AVF.    This endpoint applies to 
participants for whom their index AVF is abandoned. The alternate type(s) of HD AV 
access(es) placed in these participants will be collected. 
4.4 
Applicable Endpoint Definitions 
Access Abandonment (permanent abandonment) is defined as the point at which the access 
can no longer be used for one or two needle prescribed HD as it may be unable to provide 
adequate flows and / or is deemed unsafe for the participant, and the associated problem 
cannot be corrected by any further intervention, including medical, surgical, or 
endovascular interventions or rest.8,19 Participants with an abandoned index AVF will 
continue with follow-up through 24-months and data will be collected on safety and 
interventions.   
A HD AV access is not considered abandoned: 
• If the participant discontinues use of the AV access due to kidney transplant, initiation 
of PD, or participant preference.  
• During the maturation period or while waiting for a second stage procedure unless the 
principal investigator (PI) determines the participant requires and they then receive an 
alternative HD vascular access. 

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• During planned interventions, including transposition. 
• If all reasonable efforts have not been attempted (and documented) to improve the 
condition of the access for it to be used. 
A discontinuation of use of the clinical investigation AVF for any reason that does not meet 
this definition of access abandonment will be considered a temporary interruption. 
Access Circuit Censoring Events include participant transfer to PD, kidney transplantation 
or the event of a participants premature discontinuation in the investigation due to 
withdrawn consent, withdrawal by PI, Lost to Follow-Up (LTF), or participant death (refer 
to Section 6.5 for definitions). 
Adjunctive Procedure(s): Procedure(s) completed during the index procedure (prior to 
leaving the procedure room) as part of Standard-of-Care (SOC) procedures. These may 
include procedures to facilitate maturation and / or cannulation of the AVF, procedures to 
maintain use of the AVF, procedures to ensure HD continuity, as well as procedures to 
address AEs. 
Second Stage Procedure(s): Facilitation Interventions (as defined below) intended to 
support the cannulation  of arterialized vein segments that are determined to be needed  a 
priori to or at the time of the index procedure (i.e. pre-planned facilitation interventions 
intended to support cannulation). Second stage procedures will not count against the 
intervention or patency endpoints and will require completion of the Second Stage 
Procedures eCRF. 
Intervention(s): Clinical investigation participants may require procedures that are not pre-
determined or planned that are performed after the index procedure (adjunctive procedures 
are those performed during the index procedure and second stage procedures are expected 
procedures that are determined a priori or at the time of the index procedure). Interventions 
require the completion of the Intervention eCRF. For this clinical investigation, 
interventions are further classified as follows and delineated by endpoint in Table 1: 
• Facilitation Intervention(s): Defined as those procedures that are intended to 
facilitate functionality of the index AVF (i.e. those intended to support the 
maturation or cannulation of arterialized vein segments) and / or a procedure to 
address an AE related to the facilitation of index AVF functionality.  
 
• Maintenance Intervention(s): Defined as those procedures that are intended to 
maintain / re-establish functionality of the index AVF and / or a procedure to 
address an AE related to the maintenance of index AVF functionality. 
 
• 
HD Continuity Intervention(s): Defined as those procedures that are intended to 
ensure the continuity of HD (not including diagnostic studies) other than those 
related to the facilitation or maintenance of index AVF functionality and / or a 

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non-hypothesis tested secondary endpoint the safety of the device will be investigated 
over the long-term. 
The primary effectiveness endpoint and the non-hypothesis tested secondary endpoints 
provide a means to describe the performance of AVF created using the WavelinQ™ 
EndoAVF System throughout its life cycle. When combined, these endpoints follow 
the performance of the endoAVF in all phases of development and use.  
The primary effectiveness endpoint which assesses the number of interventions per PY 
to facilitate and maintain AVF use provides a means to understand the performance of 
the AVF compared to guideline recommendations.  The number of interventions per 
PY give an indication of the burden on both the patient and the healthcare system in 
facilitating and maintaining a functional vascular access. Examples of patient burden 
include direct pain and discomfort associated with the intervention, inconvenience, 
reduced satisfaction with their vascular access or reduced QOL. Interventions are 
associated with resource and time related burdens to the healthcare system. 
Demonstrating that the number of post creation interventions per PY required to attain 
and / or maintain functionality for the endoAVFs created using the WavelinQTM 
Endovascular System are less than the target recommended by the KDOQI guidelines 
as evaluated through this endpoints would indicate that the endoAVF is able to provide 
a reliable access modality to patients with a level of  burden that is considered 
acceptable by these society guidelines and recommendations. The guideline 
recommendations were selected as the effectiveness target as a means to evaluate the 
performance of the AVF against clinical expectations in absence of a direct comparator 
due to the novel nature of the AVF creation technique and unique resultant anatomical 
location. The endpoint is inclusive of the incident as well as prevalent populations 
allowing this investigation to examine the impact in a representative patient cohort. The 
2019 update of the KDOQI Clinical Practice Guideline for Vascular Access use the 
number of interventions as the single critical target or measuring AVF utility and 
thereby this endpoint would be the most aligned to the latest update.8   
The remaining descriptive secondary endpoints evaluated as part of this investigation 
will provide additional data to complete the picture of the safety and performance of 
endoAVFs created using the WavelinQTM EndoAVF System from creation through 
abandonment and are in line with those previously assessed in prior clinical 
investigations pertaining to the device. 
4.5.2 Potential Influencing or Confounding Factors and Bias 
Known foreseeable factors that could potentially compromise the outcome of the 
investigation or interpretation of the results or introduce bias into the study are 
delineated in this section.   

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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 
WavelinQTM EndoAVF system 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 12.2 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.   
 
A factor that could impact the timeliness of endoAVF cannulation may be due to 
participant preference.  Participants may be apprehensive towards cannulation of their 
access whether due to fear of needles, prior bad experiences (e.g. infiltration injury), 
among other reasons. This factor could be particularly prominent in those participants 
that initiate dialysis with a CVC or those that have switched to CVCs in the interim and 
become accustomed to a comparatively more comfortable HD experience.   As a result, 
this may delay or prevent cannulation of the AVF upon attainment of maturity.  This 
factor is difficult to proactively mitigate.  A good relationship between the participant 
and their nephrologist is essential to provide the necessary education about the benefits 
of using an AV access for HD versus a CVC. 
 
 

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5 CLINICAL INVESTIGATION POPULATION 
The WavelinQ™ EndoAVF System is indicated for the creation of an AVF in patients with 
chronic kidney disease that are in need of receiving HD. Specifically, adult patients with 
established, non-reversible kidney failure who are on HD (prevalent participants) or not yet on 
HD but are in need of a vascular access as determined by the referring clinician (incident 
participants) may be screened for enrollment in this clinical investigation. This clinical 
investigation is designed to include patients that are representative of the target patient 
population. Enrollment will continue until approximately 150 treated participants at a target of 
approximately 15 investigational sites (up to a maximum of 30 investigational sites) are 
included in this clinical investigation. No site will be allowed to treat more than 30% of the 
overall number of participants to ensure the clinical investigation is reasonably well balanced. 
The following describe the clinical eligibility (inclusion and exclusion) criteria for the clinical 
investigation.  
5.1 
Eligibility Criteria 
Only participants that meet all the inclusion criteria, that cannot be precluded from 
participation based on any of the exclusion criteria, and that have signed the ICF may be 
considered for participation. 
5.1.1 Inclusion Criteria 
A participant must meet the following criteria to be enrolled in this clinical 
investigation: 
 
Clinical Inclusion Criteria: 
 
The participant must: 
1. 
Be able to comprehend, voluntarily sign and date the ICF prior to collection of 
clinical investigation data or performance of clinical investigation procedures (or 
where allowable the participant’s legally authorized representative (LAR) on 
behalf of the participant). 
2. 
Be able to and willing to comply with the CIP requirements, including clinical 
follow-up. 
3. 
Be male or non-pregnant female ≥ 18 years of age with an expected lifespan 
sufficient (≥ 24 months) to allow for completion of all clinical investigation 
procedures. 
4. 
Have established, non-reversible kidney failure, who are currently on HD at 
screening or are in need of a vascular access for HD as determined by the referring 
clinician. 

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Anatomical Inclusion Criteria: 
 
The participant must have: 
5. 
Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via 
DUS or angiography. 
6. 
A target treatment artery diameter ≥ 2.0 mm as measured via DUS or 
angiography. 
7. 
Adequate collateral circulation to the hand, in the opinion of the PI (or authorized 
designee). 
8. 
At least one superficial outflow vein diameter ≥ 2.5 mm as measured via DUS or 
angiography that is in communication with the target creation site via a proximal 
forearm perforating vein. 
5.1.2 Exclusion Criteria 
A participant must not be able to be precluded by any of the following criteria to be 
enrolled in this clinical investigation: 
 
Clinical Exclusion Criteria: 
 
The participant must not have: 
1. 
Active or nontreated hypercoagulable state. 
2. 
Known bleeding diathesis. 
3. 
Insufficient cardiac output to support the maturation and use of an AVF in the 
opinion of the PI (or authorized designee). 
4. 
Known history of or current active intravenous drug abuse. 
5. 
A “planned” major surgical procedure within 6 months following index 
procedure or major surgery, in the opinion of the PI (or authorized designee), 
within 30 days prior to index procedure. 
6. 
Known allergy or hypersensitivity to contrast media which cannot be adequately 
treated with pre-medication. 
7. 
Known adverse effects to sedation and / or anesthesia which cannot be adequately 
treated with pre-medication. 

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8. 
Evidence of active infection on the day of the index procedure (temperature of ≥ 
38.0° Celsius and / or White Blood Cell (WBC) Count of ≥ 12,000 cells / μL, if 
collected). 
9. 
Another medical condition, which, in the opinion of the PI (or authorized 
designee), may cause him / her to be non-compliant with the CIP, confound the 
data interpretation, or is associated with a life expectancy insufficient to allow for 
the completion of clinical investigation procedures and follow-up. 
10. Current participation in an investigational drug or device clinical investigation 
that has not completed the clinical investigation treatment or that clinically 
interferes with the clinical investigation endpoints. Note: Investigations requiring 
extended follow-up visits for products that were investigational, but have since 
become commercially available, are not considered investigational. 
Anatomical Exclusion Criteria: 
 
The participant must not have: 
11. Central venous stenosis or central vein narrowing ≥ 50% based on imaging, or 
any degree of central venous stenosis with accompanying signs or symptoms, on 
the same side as the planned AVF creation. 
12. The absence of a proximal forearm perforating vein feeding the target cannulation 
vein(s) from the target creation site via DUS or angiography. 
13. Occlusion or stenosis ≥ 50%, or any degree of stenosis with accompanying signs 
or symptoms of target cannulation vein(s) such as cephalic, median cubital, 
basilic, etc. assessed via DUS or angiography and as clinically determined by PI 
(or authorized designee). 
14. Significantly compromised venous or arterial architecture (e.g. severe vessel 
calcification) or flow in the treatment arm as determined by the PI (or authorized 
designee) and DUS or angiography.  
15. Presence of significant calcification at the target endoAVF location that could 
potentially impact the effectiveness of endoAVF creation as determined by the PI 
(or authorized designee).  
5.2 
Lifestyle Considerations 
There are no investigation specific lifestyle considerations or modifications for participants 
outside of those required by the investigational sites SOC. 

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5.3 
Screen Failures 
A screen failure is defined as a participant who has enrolled in this investigation (consented 
to participate) but is excluded due to one or more of the eligibility criteria. Such 
participants’ clinical investigation participation will end at the time of eligibility failure. 
These participants should be treated according to the investigational site’s SOC practices. 
Screen failures will not be considered in the intent to treat (ITT) group of the clinical 
investigation. Data collected for screen failures will be limited to the participant’s 
demographics and the reason for eligibility failure. 
 

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6 CLINICAL INVESTIGATION PROCEDURES AND ASSESSMENTS 
The Schedule of Activities Table (Section 1.3) displays the required schedule for participant 
screening, treatment, and follow-up. This schedule is consistent with standard clinical care pre- 
and post-interventional procedures. Note that sponsor representatives may be present at the 
investigational site to offer case support during the screening and / or index procedure as well 
as for support during the cannulation of the endoAVF. 
6.1 
Participant Screening, Baseline Evaluations and Enrollment 
The site may begin screening and perform baseline evaluations only after the Site Initiation 
Visit (SIV) has been completed and authorization to enroll from the Sponsor has been 
received. During the screening and recruitment process, the PI (or authorized designee) 
will be responsible for describing the nature of the clinical investigation to the patient, 
obtaining informed consent, verifying that the eligibility criteria have been met, as well as 
obtaining and documenting the necessary baseline data.  All clinical investigation 
procedures will be documented in the participant’s medical record and / or source 
document(s) as well as on clinical investigation eCRFs. The following procedures will be 
conducted and documented. 
6.1.1 Informed Consent and Enrollment 
After completion of SOC evaluations and prior to the initiation non-SOC, CIP-specific 
activities and evaluations (including any non-SOC procedure performed to determine 
participant eligibility); the background and purpose of the clinical investigation, 
participation requirements, as well as the potential benefits and risks of the procedure(s) 
must be disclosed to the participant.  The process of obtaining informed consent shall 
be documented by the site and the completed, voluntarily signed and dated ICF retained 
in the participant’s records. For a detailed summary of the informed consent 
requirements, refer to Section 12.3. The point at which the ICF is signed and dated is 
considered the point of enrollment for that participant in this clinical investigation and 
all participants who have signed an ICF will be considered enrolled participants. 
6.1.2 Eligibility 
The participant’s eligibility for clinical investigation enrollment must be determined 
and documented. The documentation must indicate that the participant met all the 
clinical investigation inclusion criteria and could not be precluded from participation 
based on any of the exclusion criteria prior to the point of treatment with the 
WavelinQTM EndoAVF System.  
 
Enrolled participants who are excluded from this clinical investigation, based on 
eligibility criteria listed in Section 5.1, are considered screen failures and will be 
handled as described in Section 5.3. 

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6.1.3 Demographic Information and Medical History 
The participant’s demographic information must be collected and documented (i.e., 
gender, age, race, etc.). Additionally, the participant’s applicable medical history, 
including but not limited to pre-existing medical conditions, and treatments received 
up to the time of the index procedure must be collected and documented. 
6.1.4 Baseline Assessments 
Each participant will have the following baseline assessments performed prior to the 
index procedure: 
• DUS: A DUS assessment per the Ultrasound Guidelines must be performed. At 
minimum, images including the following characteristics are required and must be 
submitted to the Sponsor / Core Lab as per the details specified in the 
investigational site’s regulatory binder: 
 
o Arteries and veins of the AVF target vessels:  Patency (including 
characterization of each stenosis, if present), calcification, and inner diameters. 
Brachial artery volume flow. 
o Cannulation veins: Patency (including characterization of each stenosis, if 
present), calcification and inner diameters of the cannulation veins. 
o Perforator vein: Patency (including characterization of each stenosis, if 
present), calcification, and shape as well as inner diameter (with and without 
tourniquet) and length. 
o Procedure access wrist artery / arteries: Patency (including characterization of 
each stenosis, if present), confirmation of flow, and inner diameter. 
 
• Clinical Exam: Overall health and assessment of target vessels must be evaluated 
and documented with a physical exam conducted by the PI or authorized designee 
in accordance with each investigational site’s SOC. 
 
• HD History and Status: Current HD access status as well as CVC, AVF, and AVG 
history must be collected and documented. 
 
• SF-VAQ and EQ-5D Surveys: All participants will complete a participant 
satisfaction and health status survey. Surveys will be completed by the participant 
or verbally read and documented by an authorized delegated investigation site team 
member for completion. 
 

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6.2 
Index Procedure 
If the participant presents for the index procedure with any medical condition that precludes 
treatment, the procedure should be delayed until the medical condition is treated and 
resolved. The participant must be re-consented if the index procedure cannot occur within 
60 days of consent. 
6.2.1 Clinical Investigation Treatment  
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, has completed all of the 
required baseline procedures, the participant may be treated using the WavelinQTM 
EndoAVF System. It is recommended that  eligibility for all participants (including 
DUS and determination of any central venous lesions) be verified at the time of the 
index procedure prior to the point of treatment with the WavelinQTM EndoAVF System 
if anatomical eligibility verification was originally completed prior to the index 
procedure. 
Examinations, evaluations, procedural preparation, angiography, treatment, and 
hospital / facility discharge procedures will be conducted per the investigational site’s 
SOC. 
The treatment using the WavelinQ™ EndoAVF System, will be per the investigational 
site’s SOC and must adhere to the device IFU. Operators of the WavelinQ™ EndoAVF 
System must complete BD-Sponsored device training and must be approved by the 
Sponsor as an operator in writing before conducting a clinical investigation index 
procedure on enrolled participants (refer also to Section 12.2). For detailed information 
on device use and procedural medication recommendations, reference the IFU.  
 
NOTE: If the participant has more than one brachial vein, embolization of one 
of the brachial veins is recommended to divert flow to the superficial veins to 
facilitate maturation of the endoAVF. 
 
NOTE: Angiographic images collected during the index procedure including 
documentation of the final result must be submitted to the Sponsor. Refer to the 
investigational site’s regulatory binder for guidelines on the collection of all 
DUS and angiographic images captured during the index procedure and details 
on submission of these images to the Sponsor / Core Lab. 
 
A treated participant in this clinical investigation is defined as a participant that has 
met all eligibility criteria (as listed in Section 5.1), into whom the WavelinQTM 
EndoAVF system was introduced, and in whom procedure success was achieved (as 
defined in Section 4.3). Treated participants will continue clinical investigation 
participation through the clinical investigation’s 24-month follow-up period.  

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Participants into whom the WavelinQ™ EndoAVF System was introduced but 
procedure success was not achieved will be followed through the 30-day follow-up to 
assess for any safety events and interventions.  
Participants into whom the WavelinQ™ EndoAVF System 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. 
6.2.2 Adjunctive Procedures 
Adjunctive procedures to the index access circuit after creation of the AVF, but prior 
to leaving the procedure room, as part of SOC procedures are allowed. All adjunctive 
procedures (i.e. embolization, new CVC placement) will be documented on the 
appropriate eCRF.  
NOTE: If the participant has more than one brachial vein, embolization of one 
of the brachial veins is recommended to divert flow to the superficial veins to 
facilitate maturation of the endoAVF. 
6.3 
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 WavelinQTM EndoAVF system was 
introduced: 
• Clinical Exam: Overall health and assessment of AV access function must be evaluated 
and documented with a physical exam conducted by the PI or authorized designee in 
accordance with each investigational site’s SOC. 
 
• Documentation of Adverse Events (AEs): Documentation of AEs (refer to Section 8) 
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 Interventions: Any access circuit interventions the participant has 
undergone since the completion of the index procedure (defined to end at the time of 
last sheath removal – start of access site closure). 
Note that for participants into whom the WavelinQ™ EndoAVF System was introduced 
but procedure success was not achieved, the clinical exam at discharge will review the 
health and assessment of the vessels interacted with during the index procedure.  These 
vessels should also be imaged prior to discharge to confirm the absence of any AEs. 

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6.4 
Participant Follow-Up 
6.4.1 Follow-Up Intervals and Methods 
All participants are to be followed according to the investigational site’s SOC practices. 
In addition to the SOC visits, treated participants will have an investigation follow-up 
visit at 30-days and 6-weeks as well as 6- and 12-months post index procedure and will 
have a phone call follow-up at 3-, 18- and 24-months. For participants into whom the 
WavelinQ™ EndoAVF System was introduced during the index procedure but 
procedure success was not achieved, only the follow up at 30-days will be completed 
and limited to the collection of safety events and interventions.  This follow-up may be 
conducted by phone for these participants and investigation participation for these 
participants will end upon completion of this follow-up.  
 
All follow-up must be performed by authorized delegated clinical investigation site 
team members. Follow-up windows will be calculated from the index procedure date. 
Refer to Section 1.3 for an overview of follow-up window time frames and 
requirements for each visit. The following data will be collected and documented on 
the appropriate eCRF for each follow-up unless otherwise specified for treated 
participants: 
 
• DUS: A DUS assessment per the Ultrasound Guidelines must be performed at the 
follow-up visits at 30-days and 6-weeks for all treated participants and again at 6- 
and 12-months for participants not yet successfully dialyzing with the AVF created 
as part of this clinical investigation using 2-needle cannulation. The 6- and 12-
month DUS are also required for participants that are using the AVF created as part 
of this clinical investigation but for whom procedure access was obtained at the 
wrist artery during the index procedure.  The DUS for these participants will be 
limited to the examinations of the artery that was accessed during the index 
procedure.  At minimum, images including the following characteristics are 
required and must be submitted to the Sponsor / Core Lab as per the details 
specified in the investigational site’s regulatory binder: 
 
o Arteries and veins of the AVF: Patency (including characterization of each 
stenosis, if present), and inner diameters.  Brachial artery volume flow. 
o AV-anastomosis & juxta-anastomotic area: Patency (including characterization 
of each stenosis, if present). 
o Cannulation veins: Patency (including characterization of each stenosis, if 
present) and inner diameters. 
o Perforator vein: Patency (including characterization of each stenosis, if 
present), as well as inner diameter and length. 
o Procedure access wrist artery (if used during index procedure): Patency 
(including characterization of each stenosis, if present), confirmation of flow, 
and inner diameter. 

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• Clinical Exam: Overall health and assessment of AV access function must be 
evaluated and documented with a physical exam conducted by the PI or authorized 
designee in accordance with each investigational site’s SOC. 
 
• HD History and Status:  Determine and document if and how the participant has 
been and / or is receiving HD (AVF, CVC, etc.), and document the date of the 
participant’s last HD session. Once HD (1- or 2-needle cannulation) is initiated via 
the AVF created as part of this investigation, HD details must be documented and 
detailed HD access data (e.g., cannulation logs) will be provided to the Sponsor or 
designee for review and analysis as follows:  
 
o Detailed HD access data will be collected to indicate whether the participant 
successfully dialyzes with 2-needle AVF cannulation for at least 75% of HD 
sessions for three (3) continuous weeks and / or within 28 consecutive days. For 
the functional maturation and functional HD usability assessments, source 
documentation indicating HD success and vascular access used will be 
documented and collected until the endpoints are met (Sponsor verification is 
required before the clinical investigational site may stop collecting this HD 
access information).  
 
o Thereafter determine and document if and how the participant has been and / or 
is receiving HD and whether the participant continues to be successfully 
dialyzed through the index AVF (the AVF created as part of the index procedure 
of this investigation) and document the date of the participant’s last HD session. 
• SF-VAQ and EQ-5D Surveys: Surveys will be completed by the participant or 
verbally read and documented by an authorized delegated investigation site team 
member for completion during the 6-week as well as 6-, 12- and 24-month follow-
ups. 
• Documentation of AEs: Documentation of occurrence and / or status of AEs since 
the last follow up (refer to Section 8).  
• Documentation of Interventions: Any access circuit interventions the participant 
has undergone since the index procedure and / or prior follow-up. 
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 must request copies of the medical records and, if necessary, complete the 
appropriate eCRFs. 

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6.4.2 Unscheduled Follow-Up 
An unscheduled visit follow-up eCRF should also be completed for participants who 
return for additional non-investigation scheduled follow-up examinations pertaining to 
their HD vascular access. The participant will be required to return for 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 (e.g. DUS, SF-VAQ and EQ-5D Surveys, etc.). 
Assessments completed and information obtained during an unscheduled visit may 
include: 
 
• Clinical Exam: Overall health and assessment of AV access function should be 
evaluated and documented with a physical exam in accordance with each 
investigational site’s SOC. 
 
• HD History and Status: Determine and document if and how the participant has 
been and / or is receiving HD (AVF, CVC, etc.). Refer to Section 6.4.1 for HD data 
to be collected. 
 
• Documentation of AEs: Documentation of occurrence and / or status of AEs since 
the last follow up (refer to Section 8). 
 
• Documentation of Interventions: Any access circuit interventions the participant 
has undergone since the index procedure and / or prior follow-up. 
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. 
6.5 
Participant Investigation Completion and Premature Discontinuation 
Following the index procedure, every participant into whom the WavelinQTM EndoAVF 
System was introduced should remain in the clinical investigation until completion of the 
required follow-up period. The follow-up period for this clinical investigation is 24 months 
(730 ± 30 days) for treated participants and 30 days (± 5 days) for participants into whom 
the WavelinQ™ EndoAVF System was introduced during the index procedure but 
procedure success was not achieved. A treated participant is considered to have completed 
the investigation if the participant has completed the formal follow-up period associated 
with this clinical investigation through the 24-Month follow-up as described in the 
Schedule of Activities (Section 1.3).   
However; a participant’s participation may be prematurely discontinued. Additional 
participants will not be enrolled to replace those who withdraw from the clinical 

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investigation. Potential reasons for discontinuation may include, but are not limited to the 
following: 
• Withdrawn Consent: The participant may at any time request to discontinue their 
participation in the clinical investigation. The PI must attempt to identify and 
document the reasons for discontinuation. 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. 
• Withdrawal by PI: Participation may be immediately discontinued by the PI if, in 
the opinion of the PI, the participant would be exposed to inappropriate risk by 
continuing in the clinical investigation. Additionally, the PI may discontinue a 
participant’s participation with prior written approval from the Sponsor if the 
participant is repeatedly noncompliant with clinical investigation procedures. 
• Lost to Follow-Up (LTF): A participant may be considered LTF if the investigation 
site team members are unable to locate the participant despite three documented 
attempts to notify the participant via telephone and, if necessary, a certified letter 
to the participant’s last known mailing address or local equivalent methods. This 
does not apply to missed visits, where the participant misses one of the follow up 
contact time points but completed a subsequent one (when participant misses two 
consecutive follow-ups and is unable to be contacted with the documented attempts 
outlined before, the participant may be considered LTF and withdrawn from the 
clinical investigation). The site should also contact the HD center to ascertain the 
participant’s status. Before the site considers a participant LTF, written agreement 
should be obtained from the Sponsor.  
• Participant Death: The participant becomes deceased. If known, the cause of death 
must be documented and an AE eCRF must be completed. 
• Clinical Investigation Termination: The clinical investigation is terminated by the 
Sponsor (see Section 12.9). 
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. 
 

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7 STATISTICAL METHODS 
This section includes a summary of the planned statistical analyses and an overview of the 
statistical methods. The Statistical Analysis Plan (SAP) will be finalized prior to Database 
Lock and will include the technical and detailed descriptions of the statistical analyses 
summarized herein. 
7.1 
Overview of Clinical Investigation Design 
This clinical investigation will be a global, multi-center, prospective, post-market, 
confirmatory, interventional, non-randomized, single arm clinical investigation to further 
evaluate the safety and effectiveness of the WavelinQ™ EndoAVF System for 
endovascular fistula creations in the ulnar and radial vessels when accessed from the wrist 
(and / or upper arm) arteries and concomitant veins in the parallel or anti-parallel 
configuration.   
7.2 
Analysis Populations 
The analysis populations will be defined as follows:  
 
• The ITT population will consist of all participants into whom the WavelinQTM 
Endovascular System was introduced including those in whom procedure success was 
not achieved.  
 
• An As-Treated (AT) population will include all treated participants, which includes all 
ITT participants but excludes those into whom the WavelinQTM Endovascular System 
was introduced but procedure success was not achieved. 
o The AT population is composed of two subpopulations: The incident population 
and the prevalent population as defined in Section 4.5.2. 
 
• 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 AT 
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.  
All effectiveness endpoints will be analyzed primarily based on the AT population. All 
safety endpoints will be analyzed primarily based on the ITT population. PP analyses may 
also be performed for the primary endpoints. They will only serve as sensitivity analyses 
for the primary analyses. 
7.3 
Sample Size Considerations 
The sample size for the study of one-hundred and fifty (150) treated participants was 
established to assure adequate power for the primary safety and effectiveness endpoints as 

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well as to result in a sufficient sample size (when accounting for attrition) for assessment 
of the secondary and exploratory endpoints, specifically for those that only apply to subsets 
of the overall population (i.e. the incident population and wrist arterial procedure access 
population).  
1) Primary Safety Endpoint – The proportion of participants with freedom from device- 
or procedure-related SAEs through 30 days (ITT Population). 
• Assumptions: 
o The freedom from device- or procedure-related SAE rate for AVFs created 
using the WavelinQTM EndoAVF System is estimated at 92.6% through 30 days 
based on pre-market data; 
o The PG is set at 82.6% using a 10% non-inferiority margin; 
o The rate of attrition through 30 days is assumed to be 10%; and 
o The Type 1 error is 0.05 (two-sided). 
• Sample Size: 
o A sample size of 150 treated participants [135 evaluable] will give over 
92.5% power with a two-sided type I error of 0.05 as calculated using PASS 
2019 (One Proportion Exact Test). 
2) Primary Effectiveness Endpoint – Interventions Post Creation to Facilitate AVF Use 
and / or Maintain AVF Use (Facilitation and / or Maintenance Interventions) through 
the Timepoint of the 6-Month Follow-Up of the Last Active Treated Participant (AT 
Population) 
• Assumptions: 
o The number of interventions post creation to facilitate AVF use and / or 
maintain AVF use after AVF creation using the WavelinQTM EndoAVF System 
is estimated at 3.0 / PY, a conservative assumption based on pre-market data; 
o The PG is set at 5 / PY to align with the targets and recommendations of the 
2019 update of the KDOQI Clinical Practice Guideline for Vascular Access of 
≤ 2 interventions to facilitate and ≤ 3 interventions to maintain AVF use; 
o The rate of attrition through 6-, 12-, and 24-months, including lost to follow-
up, death, and other clinical investigation premature withdrawals is assumed to 
be 20%, 40%, and 60%, respectively; and 
o The Type 1 error is 0.05 (two-sided). 
• Sample Size: 
o A sample size of 150 treated participants, yielding more than 100 PY by the 
time the last active treated participant completes their 6-month follow-up, will 
give over 99% power with a two-sided type I error of 0.05 as calculated using 
PASS 2019 (One-Sample Poisson Rate Test). 
Hence, the sample size of 150 treated participants will provide approximately 
92.5%*99%= 91.5% power for the co-primary endpoints. 

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7.4 
Primary Endpoints  
7.4.1 Primary Safety Endpoint 
The primary safety endpoint is the proportion of AVF with freedom from device-
related or procedure-related SAE through 30 days as defined in Section 4.1.1. 
7.4.2 Primary Safety Endpoint Hypothesis Test 
Objective:  To assess if the 30 day primary safety rate endpoint for the WavelinQTM 
EndoAVF System is greater than the safety PG. 
The primary safety endpoint will be evaluated by the following hypothesis: 
H0:   The primary safety endpoint of proportion of AVF with freedom from SAE 
for the WavelinQ™ EndoAVF System treated participants through 30 days 
(PWS) is less than or equal to that of the PG of 82.6%. 
H1:    The primary safety endpoint of proportion of AVF with freedom from SAE 
for the WavelinQ™ EndoAVF System treated participants through 30 days 
(PWS) is greater than that of the PG of 82.6%. 
That is: 
H0:  PWS ≤82.6% 
H1:  PWS > 82.6% 
Rejection of the null hypothesis will signify that the 30 day safety of the WavelinQ™ 
EndoAVF System is greater than the safety PG of 82.6%.   
The primary safety analysis will be conducted on the ITT population. A two-sided p-
value will be derived based on an exact binomial test comparing to the PG of 82.6% 
and the 95% confidence interval (CI) will be provided. The WavelinQTM EndoAVF 
System will be considered to have achieved the safety objective and will reject the null 
hypothesis if the two-sided p-value is less than 0.05, equivalently, the lower bound of 
the 95% CI is greater than 82.6%. 
7.4.3 Primary Effectiveness Endpoint 
The primary effectiveness endpoint of the clinical investigation is an effectiveness 
measure based on the number of interventions post creation to facilitate AVF use and / 

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or maintain AVF use through the timepoint of the 6-month follow-up of the last active 
treated participant as defined in Section 4.1.2.    
7.4.4 Primary Effectiveness Endpoint Hypothesis Test 
Objective:  To assess if the number of interventions post creation to facilitate AVF use 
and / or maintain AVF use (Facilitation and / or Maintenance Interventions) per PY for 
the WavelinQTM EndoAVF System is less than the PG. 
The primary effectiveness endpoint will be evaluated by the following hypothesis: 
H0:   The number of interventions post creation to facilitate AVF use and / or 
maintain AVF use (Facilitation and / or Maintenance Interventions) per PY 
of participants treated with the WavelinQTM EndoAVF System (RWE) is 
greater than or equal to that of the PG of 5 post creation facilitation and 
maintenance interventions / PY. 
H1:   The number of interventions post creation to facilitate AVF use and / or 
maintain AVF use (Facilitation and / or Maintenance Interventions) per PY 
of participants treated with the WavelinQTM EndoAVF System (RWE) is less 
than that of the PG of 5 post creation facilitation and maintenance 
interventions / PY. 
That is: 
H0:  RWE ≥ 5 post creation facilitation and maintenance interventions / PY  
H1:  RWE < 5 post creation facilitation and maintenance interventions / PY  
Rejection of the null hypothesis will signify that the number of interventions post 
creation to facilitate AVF use and / or maintain AVF use (Facilitation and / or 
Maintenance Interventions) per PY of AVFs created using the WavelinQ™ EndoAVF 
System is less than the PG of 5 post creation facilitation and maintenance interventions 
/ PY.   
The primary effectiveness analysis will be conducted on the AT population after the 
last active treated participant completes their 6-month follow-up; by this time, all 
participants still in the clinical investigation will have at least 6-months of data. The 
number of Facilitation and / or Maintenance Interventions per PY will be estimated by 
Poisson regression model with only the intercept term, and the estimate and 95% CI 
will be provided, and the p-value comparing to the PG will be calculated by a chi-
square test. 

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7.5 
Secondary Endpoints 
The secondary endpoints will be summarized with descriptive statistics (without formal 
statistical hypothesis testing) using the ITT population for the safety endpoints and the AT 
population for the effectiveness endpoints. For time-to-event endpoints, the KM production 
limit method will be used to determine the rate. For categorical variables, summary 
statistics will include frequency counts and percentages. For rate variables, summary 
statistics including number of event / PY. For continuous variables, summary statistics will 
include mean, standard deviation, minimum, median, and maximum. CIs (95%) will be 
provided using appropriate assumptions based on the variable type. Refer to Section 4.2 
for any applicable definitions. 
7.5.1 Safety 
• Device- and Procedure-Related SAEs evaluated through 6- and 24-months. 
7.5.2 Effectiveness 
• Physiological Maturation evaluated through 6-weeks. 
• Cannulation Success assessed through 6-months.  
• Cumulative Functional Patency evaluated through 12-months. 
7.6 
Exploratory Endpoints 
The exploratory endpoints may or may not be presented in the clinical investigation report. 
If reported, the descriptive statistics will be presented. 
7.7 
General Considerations 
7.7.1 Subgroup Analyses 
Primary and secondary endpoints may be explored by subgroup, including but not 
limited to: 
• Sex; 
• Age; 
• Site of anastomosis (ulnar-ulnar; radial-radial; other); and 
• Location of arterial procedure access (wrist; upper arm). 
 
A full list of subgroups will be detailed in the Statistical Analysis Plan, which will be 
approved prior to database lock. The subgroup analyses will be summarized using 
descriptive statistics. 

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7.7.2 Poolability Analysis by Geographical Region and Investigational Site 
A poolability analysis by geographical region and by investigational sites will be 
performed on the primary endpoints.  Sites with less than 10 treated participants will 
be pooled by site number to form combined site(s) with at least 10 treated participants. 
7.7.3 Handling of Missing Data 
Investigation 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. 
For the primary safety endpoint, a conservative approach will be used for the handling 
of missing data: If a participant has a specified event (device-related or procedure-
related SAE), the participant will be included irrespective of if the participant 
prematurely discontinues prior to the 30 day timepoint; if a participant prematurely 
discontinues before 30 days without the occurrence of a specified event, the participant 
will be considered not evaluable and will not be included in the primary safety endpoint 
analysis. 
For the primary effectiveness endpoint, the Poisson regression model will be used to 
analyze the data. In the Poisson regression model, missing data handling is a standard 
part of the analysis: If a treated participant prematurely discontinues prior to the data 
cut, that participant’s study duration will be considered as the period of time between 
the index procedure and their premature discontinuation, and the corresponding 
number of facilitation and/or maintenance interventions in that specific duration will 
be used for analysis. 
7.8 
Analysis Timing 
The primary reporting will occur when the last active treated participant has completed 
their 6-month follow-up. A final analysis will be completed when all participants have 
completed, or prematurely discontinued before, their 24-month follow-up. Note that to 
support regulatory submissions in the U.S. pertaining to the procedure access at the wrist 
arteries exploratory endpoint and ad-hoc analyses may be conducted at intervals other than 
those defined in this section looking specifically at data pertaining to arterial procedure 
access at the wrist. 
 

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8 SAFETY MONITORING AND REPORTING 
The PI is responsible for the detection, documentation and reporting of events and any new 
information concerning reported events to the Sponsor that meet the criteria and definitions set 
forth in this section. These events will be collected for ITT participants and collection thereof 
will begin immediately following the start of the index procedure (defined to start at the time 
of the initial skin puncture to gain vessel access).  Events occurring prior to the index 
procedure, will be documented as medical history.  Events and the status thereof will be 
collected through the final investigation required participant follow-up visit or premature 
discontinuation. 
8.1 
Definitions of Events 
8.1.1 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 the WavelinQTM EndoAVF System 
and whether anticipated or unanticipated. This definition includes events related to the 
procedures involved. For users or other persons, this definition is restricted to events 
related to the use of the WavelinQTM EndoAVF System.  
8.1.2 Serious Adverse Events (SAEs) 
Each AE will be assessed to determine whether it is serious or non-serious. (Note: The 
term serious is not synonymous with severity, which may be used to describe the 
intensity of an event experienced by the participant or user). An SAE is an AE that led 
to any of the following: 
• Death; or 
• Serious deterioration in the health of the participant, users or other persons as 
defined by one or more of the following: 
- 
A life-threatening illness or injury; or 
- 
A permanent impairment of a body structure or a body function 
including chronic diseases; or 
- 
In-patient or prolonged existing hospitalization; or 
- 
Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function; or 
• Fetal distress, fetal death or a congenital abnormality or birth defect including 
physical or mental impairment. 
 

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8.1.3 Adverse Device Effect (ADE) 
An ADE is an AE that is considered to be related to the use of the WavelinQ™ 
EndoAVF System. This includes AEs resulting from insufficient or inadequate IFU, 
operation, or any malfunction of the WavelinQTM EndoAVF System.  Additionally, 
this definition includes any event resulting from use error or from intentional misuse 
of the WavelinQTM EndoAVF System.   
Note that a use error is defined as a user action or a lack of user action while using the 
medical device that leads to a different result than intended by the manufacturer or 
expected by the user.  User error includes the inability of the user to complete a task.  
User errors can result from a mismatch between the characteristics of the user, user 
interface, task or use environment.  Users might be aware or unaware that a use error 
has occurred.  An unexpected physiological response of the participant is not by itself 
considered a use error.  A malfunction of a medical device that causes an unexpected 
result is not considered a use error. 
8.1.4 Serious Adverse Device Effect (SADE) or Unanticipated (Serious) Adverse 
Device Effect (UADE / USADE) 
A Serious Adverse Device Effect (SADE) is an ADE that has resulted in any of the 
consequences that are characteristic of a SAE. 
An Unanticipated (Serious) Adverse Device Effect (UADE / USADE) is any (serious) 
ADE on health or safety or any life-threatening problem or death caused by, or 
associated with, the WavelinQTM EndoAVF System, which by its nature, incidence, 
severity, or outcome has not been identified in the IFU and/or current risk assessment, 
or any other unanticipated serious problem associated with a device that relates to the 
rights, safety or welfare of participants. 
8.2 
Severity of Adverse Event 
PIs will assess each AE for its severity (intensity) as experienced by the participant or user 
according to the following criteria: 
• Mild: Awareness of a sign or symptom that does not interfere with the participant’s 
activity or is transient and is resolved without treatment or additional sequelae. 
• Moderate: Interferes with the participant’s usual activity and / or requires additional 
intervention and / or treatment and may have additional sequelae. 
• Severe: Symptom(s) causing severe discomfort to the participant and / or significant 
impact on the participant’s usual activity. Additional intervention and / or treatment is 
necessary. Additional sequelae occur. 

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8.3 
Relationship of AE to Device(s) / Procedure / AV Access Circuit 
PIs will assess each AE for its relationship to the WavelinQTM EndoAVF System, index 
procedure or the access circuit as follows: 
• Device Related: AEs directly attributable to the WavelinQTM EndoAVF System used 
as part of the index procedure. 
• Procedure Related: AEs directly attributable to the index procedure. 
o Wrist Arterial Procedure Access Related: Procedure related AEs directly 
attributable to wrist arterial access if used during the index procedure.  
• AV Access Circuit Related: This category should be restricted to AEs directly 
associated with the index AV access circuit defined as the continuum from the heart 
and the arterial inflow through the AV access to the venous outflow back to the heart.8 
The following categories should be used for assigning the certainty of the relatedness: 
• Definitely Related: An AE is definitely related if it is obvious, certain or there is little 
doubt regarding the relationship. 
• Possibly Related: An AE is possibly related if it is capable of being related but 
relatively unlikely or there is insufficient information to determine if the AE is related 
to the device or procedure. 
• Not Related: An AE is not related if it is determined that there is no plausible 
association. 
8.4 
Reporting of Events 
All AEs should be promptly recorded on the appropriate eCRF (including information on 
the date of the AE, treatment, resolution, and assessment of relatedness). The clinical 
course of the AE will be followed according to accepted SOC until the event resolves, 
stabilizes, or in the opinion of the PI, is no longer considered clinically significant. The PI 
must supply the Sponsor with information concerning the follow up and / or resolution of 
the AE. The additional reporting requirements for device- / procedure-related AEs / SAEs 
or UADEs / USADEs are as follows:  
• Device- / procedure-related AEs / SAEs, as well as ADEs / SADEs or UADEs / 
USADEs must be reported to Sponsor within one (1) working day of the site 
becoming aware of the event(s). 
o De-identified copies of all relevant documentation (i.e., procedure reports, 
physician / nurses’ notes, discharge summary, etc.) should be submitted to 

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the Sponsor within 72 hours of knowledge of a UADE or death, as 
appropriate. 
• It is the responsibility of the PI to notify the IRB / EC of applicable AEs in 
accordance with the governing IRB / EC requirements and / or regulatory 
authorities according to the local regulations in each participating country.  
• UADEs / USADEs will be evaluated and assessed / escalated by the Sponsor per 
ISO 14155:2020(E) and as per local regulations. 
8.4.1 Non-Reportable AEs 
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, which has not been attributed to natural history. 
Exacerbation of an existing condition should be reported as an AE if the event meets 
the CIP definition of an AE. 
Planned hospital visits and / or hospital stays, or procedures required by this CIP 
(including subsequent interventions assessed in the clinical investigation endpoints), 
without serious deterioration in health should not be considered SAEs.   
8.5 
Participant Death 
Participant death, for any reason during the clinical investigation, must be reported to the 
Sponsor within one (1) working day of the investigational site becoming aware of the event.  
Notification of death must include a brief statement of the pertinent details. All available 
medical records related to the participant’s death must be maintained.  
8.6 
Device Deficiencies 
A device deficiency is any inadequacy of a medical device with respects to its identity, 
quality, durability, reliability, usability, safety, or performance. Device deficiencies 
include malfunctions, use errors, and inadequacy in the information supplied by the 
manufacturer including labeling. A device malfunction is defined as a failure of a medical 
device to perform in accordance with its intended purpose when used in accordance with 
the IFU or CIP. Device deficiencies are only applicable to the WavelinQTM EndoAVF 
System. All device deficiencies will be recorded on the appropriate eCRF page and be 
promptly reported to the Sponsor.  The device(s) should be returned to the Sponsor as 
outlined in the investigational site’s regulatory binder. The site may also be contacted to 
provide additional information to allow the Sponsor to conduct a thorough investigation. 
This applies to:  
 
• WavelinQTM EndoAVF Systems used in the participant; or 

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• WavelinQTM EndoAVF Systems in which the package was opened, but the device 
was not used; or  
• WavelinQTM EndoAVF Systems with which insertion attempts were made, but the 
WavelinQTM EndoAVF System was not used in the participant. 
 
If the device deficiency was associated with an AE, the reporting provisions for AEs, 
ADEs, SAEs, SADEs and UADEs / USADEs apply (see Section 8.4 and 12.4). Any device 
deficiency that did not lead to an AE but could have led to a SADE, if suitable action had 
not been taken, if intervention had not been made or if circumstances had been less 
fortunate must be reported to the Sponsor within one (1) working day of the event (see 
Section 12.4). It is the responsibility of the PI to notify the IRB / EC of such device 
deficiencies as, and if, applicable in accordance with the IRB / EC requirements and / or 
the Regulatory Authority’s local regulations. 
8.7 
Serious Health Threat  
A serious health threat is a signal from any AE or device deficiency that indicates an 
imminent risk of death or a serious deterioration in the health in participants, users or other 
persons, and that requires prompt remedial action for other participants, users or other 
persons. This would include events that are of significant and unexpected nature such that 
they become alarming as a potential serious health hazard or possibility of multiple deaths 
occurring at short intervals.  Serious health threats will be reported as per IRB / EC and 
regulatory requirements, if applicable. 
8.8 
Safety Committees 
8.8.1 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. 
8.8.2 Clinical Events Committee (CEC)  
The CEC will be comprised of at least two (2) members (interventional radiologists, 
non-interventional / interventional nephrologists, or surgeons) who are not directly 
involved in the conduct of this clinical investigation. The CEC is responsible for the 
development of specific criteria used for the categorization of clinical events and 
clinical endpoints in the clinical investigation as determined by the CEC charter. The 
CEC will meet regularly to review and adjudicate all AEs defined in the charter. The 
CEC will have access to the eCRF associated with the reported AE for each participant.  
The Sponsor will forward all associated relevant de-identified documents (i.e., 
physician notes, operative reports, imaging, etc.) to the CEC upon request. The CEC 
will forward an adjudication report of AEs to the Sponsor in a timely fashion.  Minutes 

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of all meetings will be recorded and distibuted as appropriate. The Sponsor will ensure 
that if applicable, appropriate information is provided to the Regulatory Authorities, 
the PIs, and all reviewing IRB / ECs. 
 
 

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9 RISK / BENEFIT ANALYSIS 
9.1 
Risk Assessment 
The known possible risks associated with the use of the WavelinQ™ EndoAVF System 
are listed below and have been made available to the PI(s) in the IFU. Complications that 
may be associated with AEs, medical intervention and / or death that could occur with use 
of the WavelinQ™ EndoAVF System may include: 
• 
aborted or longer procedure; 
• 
additional procedures;  
• 
bleeding, hematoma or hemorrhage;  
• 
bruising;  
• 
burns;  
• 
death;  
• 
electrocution;  
• 
embolism;  
• 
failure to mature;  
• 
fever;  
• 
increased risk of congestive heart failure;  
• 
infection;  
• 
numbness, tingling, and / or coolness;  
• occlusion / stenosis;  
• problems due to sedation or anesthesia; 
• pseudoaneurysm;  
• aneurysm;  
• sepsis;  
• steal syndrome or ischemia;  
• swelling, irritation, or pain;  
• thrombosis;  
• toxic or allergic reaction;  
• venous hypertension (arm swelling); 
• vessel, nerve, or AVF damage or rupture;  
• wound problem 
 
The risks associated with use of the WavelinQ™ EndoAVF System have been identified 
by performing a Use Failure Mode and Effects Analysis as well as a Design Failure Mode 
and Effects Analysis (UFMEA and DFMEA) on the system and its use. The Sponsor also 
conducted non-clinical testing as well as clinical investigations to confirm that the 
WavelinQ™ EndoAVF System has element safety and effectiveness to create endoAVFs. 
A Risk-Benefit Analysis (RBA) was then subsequently performed. At the completion of 
the UFMEA, DFMEA and RBA, a Risk Management Report was generated to summarize 
the risk analysis process and provide documented evidence that all individual and 
cumulative risks associated with the use of the WavelinQTM EndoAVF System have been 
adequately managed and reduced as low as possible.  Any residual risks identified with the 
investigation intervention that are identified in the device RBA are also captured and 
tracked along with their mitigation strategies for this investigation using the investigation’s 
Risk Analysis.  Risks identified for associated / concomitant procedures are identified in 
Table 3 alongside their mitigation strategies.    
 
 

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• Higher likelihood of a usable AVF, as less trauma to the vessels may reduce adverse 
or abnormal inflammatory and healing responses within the vessel wall resulting in 
lower rates of stenosis and thrombosis which are the leading causes for failure in AVFs 
created using traditional surgical methods. 
• Reduced risk of infection, reduced participant discomfort, and reduced cosmetic 
deformation since no incision or prosthetic materials (including stitches) are required 
to create the endoAVF. 
• Shorter endoAVF maturation / HD suitability time potentially leading to earlier 
endoAVF cannulation commencement and decreased CVC exposure time. 
9.3 
Overall Benefit: Risk Conclusion 
Neither the risk management output, including the results of non-clinical testing (bench 
testing, biocompatibility testing), prior clinical investigations nor the market surveillance 
history reveal any unacceptable residual risks and these risks have been disclosed through 
the IFU (and herein in Section 9.1).   
Furthermore, this CIP is specifically designed to manage and minimize risks through 
careful participant selection, thorough training of investigators, adherence to the pre-
determined timepoints to assess participant clinical status and regular clinical monitoring 
visits by Sponsor appointed monitoring personnel. Additional risks identified during the 
clinical investigation will be assessed, evaluated, and reported by the Sponsor (if 
applicable). Prior to clinical investigation participation, the PI must explain to each 
participants the risks and benefits of this clinical investigation.  
Taking into consideration the measures taken to minimize risk to participants in this clinical 
investigation, the potential risks identified in association with the WavelinQTM EndoAVF 
System are justified by the anticipated benefits that may be afforded to participants with 
established non-reversible kidney failure that are in need of receiving HD. 
 
 

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10 DATA COLLECTION AND RECORD MAINTENANCE 
10.1 
Case Report Forms (CRF) and Source Documentation 
The PI is responsible for and will assure the accuracy, attribution, completeness, legibility 
and timeliness of all clinical investigation documentation and data. Source documents shall 
be created and maintained by the investigation site team throughout the clinical 
investigation as well as documentation of the type and location of these source documents. 
All copies of the retained original source document shall be certified, as indicated by a 
dated signature by a member of the investigation site team. 
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. 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.  
10.2 
Source Documentation Access 
Auditors, monitors, the Sponsor, and Regulatory Authorities may have access to the 
medical records related to this clinical investigation. Original or certified copies of all 
relevant clinical findings, observations, and other activities throughout the clinical 
investigation must be recorded and maintained in the medical file of each enrolled 
participant. 
The PI will permit clinical investigation related monitoring, audits, IRB / EC 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).  
10.3 
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 

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developed that outlines the procedures including but not limited to those used for CRF 
tracking, data review, database cleaning, and issuing/resolving data queries. Procedures for 
validations and data storage will also be contained within the DMP. 
10.4 
Record Retention 
The PI shall retain all clinical investigation records for a minimum of ten (10) years after 
the date on which the clinical investigation is terminated / completed. The data for some of 
these records may be available in computerized form but the final responsibility for 
maintaining clinical investigation records remains with the PI. 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. 
The PI 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 applicable 
regulatory authority not later than ten (10) working days after the transfer occurs. 
 
 

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11 QUALITY CONTROL AND ASSURANCE 
11.1 
Control of the Investigation Device 
The WavelinQTM EndoAVF System is Conformité Européene (CE) marked and will be 
evaluated in a post-market fashion for its approved indication in the EU, the United 
Kingdom (UK). Sites in these regions 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 WavelinQTM EndoAVF Systems that have failed or malfunctioned should be returned 
to the Sponsor. If the malfunctioned WavelinQTM EndoAVF System has been used (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. 
11.2 
Monitoring 
Monitoring shall be conducted according to the monitoring plan as well as in accordance 
with established standard operating procedures and is intended to verify that the rights and 
well-being of the participants are protected, that the reported data are accurate, complete, 
and verifiable from source documents, and that the conduct of the investigation complies 
with this CIP, any amendments (if applicable), in addition to applicable standards, 
regulations, and IRB / EC requirements. The clinical investigation monitors are designated 
as trained and qualified agents of the Sponsor and are assigned to oversee the conduct and 
progress of the clinical investigation. The clinical investigation monitors will be the 
principal communication link between the Sponsor and the PI and shall be independent 
from the investigational sites.  
The clinical investigation monitors may assist in pre-qualifying potential investigational 
sites. Upon investigational site selection, the clinical investigation monitors will 
periodically conduct on-site inspection and monitoring of sites and records, to ensure 
continued compliance with this CIP and adequacy of the PI and the site to conduct the 
clinical investigation. In addition, the monitor will verify that the WavelinQTM EndoAVF 
System is being used in accordance with the CIP instructions and IFU. A summary of 
monitoring visits is provided in the subsequent sections. It is important that the PI(s) and 
the relevant investigational site team members are available during the monitoring visits 
and that sufficient time is devoted to the process. 
11.2.1 Site Initiation Visits (SIVs) 
Before the clinical investigation may commence at an investigational site, the monitor 
will conduct a SIV. The purpose of this visit is to ensure the PI and clinical investigation 
site team understand the proper conduct of and required provisions for this clinical 
investigation as well as their responsibilities. As such, this visit will include a detailed 

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review of this CIP and associated documents. Additionally the visit serves as a means 
to verify that all necessary documents (refer to Section 12.3) and materials are on file 
at the investigational site, that investigation device training has been completed (as per 
Section 12.2), and confirm that IRB / EC approval has been received.  
11.2.2 Interim Monitoring Visits (IMVs) 
After initiation of the clinical investigation at an investigational site, the monitor will 
maintain personal contact with the PI and investigation site team through routine 
monitoring activities as specified in the monitoring plan for this clinical investigation.  
These routine monitoring activities will serve as a means for the monitor to assess 
continued compliance to this CIP and associated documents as well as compliance to 
standards and regulatory requirements. These activities will verify that: 
• Only authorized members of the investigation site team are participating in the 
clinical investigation according to their delegated responsibilities; 
• The WavelinQTM EndoAVF System is being used according to the CIP and IFU;  
• There are adequate provisions to continue and maintain all documents and records 
throughout the duration of this clinical investigation as required by applicable 
regulations and that there are adequate investigation site resources and materials; 
• There is adequate participant enrollment and access to an adequate number of 
potential participants; 
• Signed and dated ICFs are obtained for each participant (or if applicable, their 
legally authorized representative (LAR)) before any clinical investigation-related 
procedures are undertaken and that the ICF used for this process is the version 
approved by the IRB / EC for the specific investigational site;  
• There is accurate and complete data reporting and documentation (including the 
comparison and up to 100% verification of eCRFs with source documentation for 
critical fields); 
• CRFs, queries, and appropriate corrections are complete, recorded in a timely 
manner and consistent with source documents and CIP requirements;  
• Participant accountability and compliance is maintained and documented; 
• There is complete and timely safety event monitoring, collection, and reporting per 
CIP requirements; 
• Deviations have been appropriately recorded and reported; 
• All required and necessary clinical investigation documents, reports, notifications, 
applications, submissions, approvals, as well as correspondence and the most 
updated versions thereof are maintained in the investigational site’s files and are 
accurate, complete, timely, legible, dated and identify the clinical investigation; 
• There is continued maintenance and calibration of clinical investigation-specific 
equipment and documentation thereof (if applicable); 

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• Any corrective and preventative actions have been implemented and are effective 
(if applicable); 
• Applicable national privacy laws have been and are being followed; and 
• There is continued IRB / EC acceptance of this clinical investigation. 
The monitor will evaluate and summarize the results of each visit in written reports, 
identifying any ongoing issues with any investigational site and specifying 
recommendations for resolution of noted deficiencies. 
11.2.3 Final Monitoring Visit 
At the completion of the clinical investigation, the clinical investigation monitor will 
conduct a final site close-out visit (COV). The purpose of this visit may include but is 
not limited to collecting all outstanding clinical investigation data documents, 
confirming that the PI’s files are accurate and complete, reviewing the record retention 
requirements with the PI, and ensuring that all applicable requirements for closure of 
the clinical investigation are met. The actions and observations made at this visit will 
be recorded and filed. 
11.3 
Audits and Inspections 
The investigational sites may also be subject to quality assurance audit by personnel of the 
Sponsor (and its affiliates), as well as by regulatory representatives and other applicable 
authorities. If the site is selected for an audit, the PI(s) and the relevant investigational site 
team members will make themselves available during the visit.  The PI must agree to the 
inspection of all clinical investigation 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 PI is aware of an upcoming inspection / audit by the Health Authorities, the 
PI will promptly inform the Sponsor.  As agreed with the PI, Sponsor personnel may be 
present at the site during the inspection. 
11.4 
Deviations from the CIP and Medical Emergencies 
A deviation is defined as an event where the PI or investigation site team members did not 
follow, intentionally or unintentionally, the requirements of this CIP. 
 
Except when necessary to protect the life or physical well-being of a participant, deviations 
from the CIP are not permitted.  It is the PI’s responsibility to ensure that there are no 
deviations from this CIP, except when necessary to protect the life or physical wellbeing 
of a participant in an emergency or unanticipated circumstance. Except in emergency 
situations, a deviation requires prior approval by the Sponsor. If the deviation affects the 

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scientific soundness of this CIP or the rights, safety, or welfare of a participant, prior IRB 
/ EC approval is required.  
Any and all deviations must be recorded on the appropriate eCRF regardless of whether 
medically justifiable, Sponsor approved or taken to protect the participant in an emergency. 
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 
alternative intervention followed by written confirmation that describes the emergency 
action and outcomes, within five (5) working days from the date of the emergency action 
or in accordance with the governing IRB / EC’s requirement, whichever is more stringent.   
Significant deviations must be reported to the Sponsor within five (5) working days. 
Significant deviations are defined as deviations that occur to protect the life or physical 
well-being of a participant in an emergency, or deviations that may affect the scientific 
soundness of the clinical investigation, or deviations pertaining to the rights, safety or 
welfare of human participants. PIs will also adhere to procedures for reporting clinical 
investigation deviations to and obtaining approval from their IRB / EC in accordance with 
their specific IRB / EC reporting policies and procedures. Refer to Section 12.4 for the 
deviation reporting requirements. 
Upon evaluation by the Sponsor of the deviation(s), corrective and preventative actions 
may be required to prevent additional deviations, such as retraining of the investigational 
site, implementation of additional investigational site procedures, and more frequent 
monitoring.  If these steps fail, more serious measures may be taken, up to and including 
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12 ADMINISTRATIVE REQUIREMENTS 
12.1 
Investigator and Site Selection 
The PIs selected for this clinical investigation must be of good standing as an investigator 
and knowledgeable in relevant areas of clinical research (including with the methods to 
obtain informed consent) to ensure adherence to the requirements of this CIP, the 
referenced standards and applicable national regulations, including the protection of human 
participants.  The PI as well as any additional operators (as applicable) must also be 
experienced in the field of application and operators must be trained in the use of the 
WavelinQTM EndoAVF System (refer to Section 12.2).  Other investigation site team 
members must have appropriate  qualifications, training, and experience to assume 
responsibility for the proper conduct of this clinical investigation and the site must have 
the infrastructure available to ensure adherence to this CIP and enrollment of sufficient 
numbers of evaluable participants.  The curriculum vitae (CV) of the PI(s), Sub-
Investigator(s) and Research Coordinator(s) will be maintained in the Sponsor’s files as 
documentation of qualification by training and experience. 
The PI will sign the Investigator Agreement pages of this CIP, agreeing to comply with all 
applicable government regulations and the requirements of this clinical investigation. The 
PIs and Sub-Investigators shall also disclose potential conflicts of interest, including 
financial, that can interfere with the conduct of the clinical investigation or interpretation 
of results. 
Federal databases will be searched to ensure that the PIs, Sub-Investigators, and / or the 
site are not prohibited from engaging in federally sponsored clinical research. Any site that 
becomes deactivated prior to initial enrollment, either by the Sponsor or by the individual 
site itself, may be replaced. 
New members of the investigation site team may be added throughout the course of the 
clinical investigation, but these new members shall only start their assignment after 
receiving adequate training on the clinical investigation requirements and documentation 
thereof (Note EC approval of new members of the investigation site team can also be 
required before commencement of their responsibilities).  
12.2 
Training 
In addition to each PI and applicable clinical investigation team member being trained on 
this CIP and clinical investigation procedures during the SIV, device training will be 
provided by the Sponsor. This device training is required for each PI and Sub-Investigator 
that will operate the WavelinQ™ EndoAVF System. Operators are not permitted to use the 
WavelinQ™ EndoAVF System on enrolled participants in this clinical investigation if they 
have not completed the training and been approved in writing as an operator by the 
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(e.g., Title VIII of Public Law 110-85 as FDA Amendments Act of 2007 (FDAAA) / ISO 
14155). This content shall be updated as required per applicable national regulations. 
12.6 
Publication Policy 
At the conclusion of this clinical investigation, an article may be prepared for publication 
in a reputable scientific journal. Formal presentation(s) or publication(s) of data collected 
from this clinical investigation will be considered as a joint publication by the PI(s) and 
the appropriate personnel of the Sponsor.  Authorship will be based on the generally 
accepted criteria of the International Committee of Medical Journal Editors (ICMJE) and 
determined by mutual agreement.  
The publication of the principal results from any single-center experience within the 
clinical investigation 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.  
12.7 
Close-Out, Premature Termination, or Suspension of the Clinical 
Investigation 
The completion of this clinical investigation shall coincide with the last visit of the last 
active treated participant upon the completion of follow up. The Sponsor shall notify all 
PIs and if required, the Regulatory Authorities of the completion of this investigation. PIs 
or authorized designees shall notify their respective IRB / EC of the clinical investigation 
completion and forward documentation of this notification to the Sponsor.  
The Sponsor reserves the right to suspend enrollment or prematurely terminate the clinical 
investigation at any time as set forth in the CSA. If suspicion of an unacceptable risk, 
including serious health threat, to participants arises during the clinical investigation, or 
when so instructed by the IRB / EC or regulatory authorities, the Sponsor shall suspend the 
clinical investigation while the risk is assessed. The Sponsor shall terminate the clinical 
investigation if an unacceptable risk which cannot be mitigated is confirmed.  
In the event of suspension of enrollment or premature termination of the clinical 
investigation, the Sponsor will send a report outlining the circumstances to the IRB / EC, 
and all PIs and Regulatory Authorities (if applicable). A suspended or terminated clinical 
investigation may not be reinitiated without approval of the reviewing IRB / EC and 
Regulatory Authorities (if applicable). In the event of clinical investigation premature 
termination or suspension, treated participants should be followed through the 24-month 
follow-up period or as deemed appropriate for the circumstances of premature termination 
or suspension.  The specific follow-up requirements will be communicated along with the 
notice of premature termination or suspension. 

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The Sponsor may also suspend enrollment or terminate the clinical investigation at a 
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 CIP or other clinical 
research requirements. Written notice will be submitted to the PI in advance of such 
termination or suspension. In the event of clinical investigation premature termination or 
suspension at a site, treated participants at that site should be followed through the 24-
month follow-up period or as deemed appropriate for the circumstances of premature 
termination or suspension. The specific follow-up requirements will be communicated 
along with the notice of premature termination or suspension. 
In the event of suspension of the clinical investigation at a specific site, the Sponsor will 
send notification to the site, the regulatory authority (if applicable) and the site must report 
the suspension to the IRB / EC. Documentation of the IRB / EC communication must be 
provided to the Sponsor.  The clinical investigation may not be reinitiated at the site without 
written approval of the Sponsor and without approval of the reviewing IRB / EC and 
regulatory authority (if applicable). The written approval of the IRB / EC must be provided 
to the Sponsor prior to reinitiating the clinical investigation. The Sponsor will notify other 
site PIs if the premature termination or suspension at the site was for safety reasons.  
If deemed appropriate, the PI or authorized designee shall promptly inform enrolled 
participants of suspension or premature termination and once again in the event of clinical 
investigation resumption. The PI must notify the IRB / EC in writing as soon as possible 
but no later than within ten (10) working days if the premature termination is related to 
safety or compliance issues.  
12.8 
Amendments  
The CIP and associated clinical investigation documentation shall be amended as needed 
throughout the clinical investigation in accordance with the Sponsor’s written procedures 
for the control of documents and document changes. 
If the amendment impacts the integrity of the clinical investigation, the data collected 
before and after the amendment shall be analyzed statistically to assess the effect of the 
amendment on performance, effectiveness, or safety analysis. This analysis shall be 
included in the clinical investigation report. Note that for each amendment of the CIP, the 
CRFs shall be evaluated to determine if an amendment of these documents is also 
necessary. 
 
 

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13 ETHICAL AND REGULATORY CONSIDERATIONS 
13.1 
Regulatory Status 
The WavelinQTM EndoAVF System is CE marked and will be evaluated in a post-market 
fashion for its approved indication in the EU and the UK. Appropriate regulatory approvals 
will be obtained in other regions prior to initiating the clinical investigation in those 
regions, if applicable. 
13.2 
IRB / EC Approval and Communications 
PIs or authorized designees must submit this CIP together with all locally required 
documentation (at minimum the CIP, ICF, patient facing materials (if any), participant 
recruitment procedures / advertising materials (if any), and CVs of the PI(s)) to an 
appropriate IRB / EC and obtain clinical investigation-specific written approval (favorable 
opinion) before being allowed to participate in the clinical investigation.  Before 
commencement of the clinical investigation, the PI or authorized designee must provide 
the Sponsor with written documentation of IRB / EC approval identifying the documents 
and amendments (if applicable) on which the opinion was based. The IRB / EC must give 
written renewal of the original approval at least annually to continue the clinical 
investigation. A copy of each written renewal must be provided to the Sponsor.  
The PI or authorized designee is also responsible for fulfilling any conditions of approval 
imposed by the IRB / EC, such as regular safety reporting (SAEs), reporting of and / or 
requests for major CIP deviation(s), reporting of clinical investigation progress / timing, 
approval of resumption of a suspended clinical investigation, etc.  The PI or authorized 
designee will provide the Sponsor with copies of associated reports, communications and 
/ or approvals. 
The IRB / EC will be notified of any amendments to the CIP, as well as possible associated 
information and consent form changes, where applicable, and written favorable opinion / 
approval will be obtained prior to implementation, as applicable and evidence thereof is to 
be supplied to the Sponsor. For non-substantial changes (e.g. minor logistical or 
administrative changes, change of telephone numbers, etc.) not affecting the rights, safety 
and well-being of human participants or not related to the clinical investigation objectives 
or endpoints, a simple notification to the IRB / EC and, where appropriate, regulatory 
authorities can be sufficient. 
13.3 
Informed Consent and National Privacy Laws 
Prior to any non-SOC clinical investigation related procedure, the PI (or authorized 
designee) must explain to each prospective participant in layman’s terms, the nature of the 
clinical investigation, its purpose, its expected duration, as well as the risks and benefits of 
clinical investigation participation.  The informed consent process must avoid any coercion 
or undue improper influence on, or inducement of, the patient to participate and must not 

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waive (or appear to waive) the legal rights of the patient in any way. Also, prospective 
participants 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., General Data Protection Regulation (GDPR) in the EU) will be 
followed in this clinical investigation. The prospective participants must be informed of 
their right to withdraw from the clinical investigation 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 clinical investigation will not jeopardize their future medical care.  
Prospective participants will be informed of their right to new information and / or findings 
relating to the clinical investigation, and the process by which this information is made 
available.  
 
After this explanation, given sufficient time to review the informed consent and decide 
whether to participate, before any clinical investigation procedure is conducted, and before 
entering the clinical investigation, the prospective participant must voluntarily provide 
consent in accordance with ISO 14155:2020(E) (see Section 13.3.1 for special 
circumstances). The PI (or authorized designee) must ensure that the ICF receives a 
personally dated signature from the participant (see Section 13.3.1 for special 
circumstances) after agreeing to participate in this clinical investigation. The PI or 
authorized designee that conducted the informed consent must also provide a personally 
dated signature on the form. Documentation of the informed consent process shall be 
captured in the participant’s source documentation and the original signed ICF maintained 
with the essential clinical investigation files. The participant will receive a copy of his / her 
signed ICF.  
 
Part of the IRB / EC approval must include approval of an ICF that is specific to this 
investigation. The PI or authorized designee must administer this approved ICF to each 
prospective clinical investigation participant and obtain the participant’s signature (see 
Section 13.3.1 for special circumstances) on the ICF prior to any non SOC clinical 
investigation related procedure. The ICF may be modified to suit the requirements of the 
individual site. The PI or authorized designee will provide the Sponsor or authorized 
designee with a copy of the approved ICF for his / her site. The ICF templates are 
standalone documents to facilitate revision(s) as necessary, without requiring a CIP 
amendment.  
 
New information that arises throughout the course of the investigation which may relate to 
the participant’s willingness to continue participation in the clinical investigation will be 
evaluated for the appropriate methods of disseminating and disclosure (if deemed 
applicable) to participants by the Sponsor and the PI. 

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13.3.1 Special Circumstances for Informed Consent 
Note that the process described in this section is subject to local IRB / EC approval and 
national regulations. PIs must follow the allowable procedures for their investigational 
sites with respect to special circumstances for informed consent. 
 
Informed consent may be given by the LAR only if a prospective participant is unable 
to make the decision to participate in a clinical investigation (e.g. patient with a mental, 
intellectual disability). In such cases, the prospective participant shall also be informed 
about the clinical investigation within his / her ability to understand. Note that this is 
subject to national regulations.  
 
Informed consent shall be obtained through a supervised oral process if a prospective 
participant or LAR is unable to read or write. An independent and impartial witness 
shall be present throughout the process. The written ICF and any other information 
shall be read aloud and explained to the prospective participant or his / her LAR. And, 
whenever possible, either the participant or his / her LAR shall sign and personally date 
the ICF. The witness shall sign and personally date the ICF attesting that the 
information was accurately explained, and that informed consent was freely given. 
 
The nature of this clinical investigation does not involve emergency treatments consent 
must always be obtained prior to the completion of any clinical investigation related 
procedure that is not SOC. 
13.3.2 Confidentiality 
Participant confidentiality and confidentiality of data shall always be observed by all 
parties involved throughout the clinical investigation. All information and data sent to 
the Sponsor or its designees concerning participants or their participation in the clinical 
investigation will be considered confidential.  All data used in the analysis and 
reporting of this clinical investigation will be used in a manner without identifiable 
reference to the participant.   
 
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 PI consents to visits and inspections by personnel of the Sponsor and its affiliates 
or designees, as well as Regulatory and Health Authority (e.g. FDA) representatives 
and shall provide direct access to all source data during and after the clinical 
investigation for monitoring, audits, IRB / EC reviews and regulatory inspections. As 
required, the PI or institution shall obtain permission for direct access to source 

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documents from the participant, hospital administration and regulatory authorities 
before starting the clinical investigation. 
13.4 
Statement of Compliance 
This clinical investigation will be conducted in compliance with this CIP and the following 
regulatory requirements: 
• 
ISO 14155:2020(E) and GCP; 
• 
Ethical principles of the Declaration of Helsinki adopted by the 18th World Medical 
Assembly in Helsinki, Finland, in 1964, in its current revision; and 
• 
Applicable sections of the national laws and regulations. 
 
The clinical investigation will not commence at a clinical site until favorable opinion(s) 
from the respective IRB / EC has been received and provided to the Sponsor. All additional 
requirements imposed by the IRB / EC(s) must be followed. Involvement of the national 
competent authorities (e.g. by notification, seeking authorization, etc.), will be 
accomplished as required by national laws and regulations. 

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14 REFERENCES 
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the vascular access society, Berlin, Germany, 2005. www.vascularaccesssociety.com  
 
2. United States Renal Data System (USRDS) 2008 Annual Report. 
 
3. GBD chronic kidney disease collaboration. Global, regional, and national burden of 
chronic kidney disease, 1990–2017: A systematic analysis for the global burden of 
disease study 2017. Lancet. 2020;395:709–33. 
 
4. Kramer A, et al. The European renal association – European dialysis and transplant 
association (ERA-EDTA) registry annual report 2016: A summary. Clinical Kidney 
Journal. 2019:1-19. 
 
5. Sidawy AN, et al. Recommended standards for reports dealing with arteriovenous 
hemodialysis access. J. Vasc. Surgery. 2002;35(3):603-10.  
 
6. Xue JL, et al. The association of initial hemodialysis type with mortality outcomes in 
elderly Medicare ESRD patients. Am J Kidney Disease. 2003;42(5):1013-9. 
 
7. Dhingra RK. Type of vascular access and mortality in U.S. hemodialysis patients. Kid 
Int. 2001;60:1443-51. 
 
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WAVELINQ™ ENDOAVF SYSTEM  
BDPI-19-005, Version 1.0 
 
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