A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Phase: NA
Conditions: Kidney Failure, Chronic, Renal Dialysis
Sponsor: W.L.Gore & Associates

A Study to Evaluate the Safety and Effectiveness of 
the InnAVasc Arteriovenous Graft for 
Hemodialysis Access in Patients with End-Stage 
Renal Disease 
CSP-1001 
NCT03645681 
Protocol V3 Approval Date: 22 May 2019 
Amendment A Approval Date: 18 May 2020 
Amendment B Approval Date: 18 December 2020 
Informed Consent Approval Date: 02 March 2021 

A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for 
Hemodialysis Access in Patients with End-Stage Renal Disease 
 
 
 
 
Investigational Device: InnAVasc Vascular Access Graft 
Protocol Number: CSP-1001 
Version: 3.0, May 22, 2019 
 
IDE Number: G180188 
 
 
 
 
Sponsor 
InnAVasc Medical, Inc. 
110 Swift Avenue 
Durham, NC 27705 USA 
 
 
 
 
 
 
 
CONFIDENTIALITY STATEMENT 
 
This protocol and all attachments are considered confidential information. The contents must 
not be disclosed, unless authorized in writing by InnAVasc Medical, Inc., except that this 
document may be disclosed to the appropriate Institutional Review Board (IRB) or duly 
authorized representatives of the competent authorities with similar requests for 
maintenance of confidentiality. All data and study results are similarly subjected to the same 
disclosure restrictions as the investigational plan, as stated above. All copies of this 
investigational device exemption remain the property of InnAVasc Medical, Inc. 
 
 
 
Revision History 
 
Version 1.0 – 08 August 2018 
Version 2.0 – 16 August 2018

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Table of Contents 
LISTING OF TABLES ......................................................................................................... 6 
LISTING OF FIGURES ........................................................................................................ 6 
STUDY PERSONNEL ......................................................................................................... 7 
STATEMENT OF COMPLIANCE ......................................................................................... 8 
PROTOCOL AGREEMENT ................................................................................................. 9 
PROTOCOL APPROVAL .................................................................................................. 10 
SYNOPSIS ..................................................................................................................... 11 
ABBREVIATIONS ........................................................................................................... 17 
1 
INTRODUCTION AND BACKGROUND ...................................................................... 19 
1.1 Scientific Rationale .................................................................................................... 21 
1.2 Potential Risks and Benefits ...................................................................................... 21 
1.2.1 
Potential Risks ........................................................................................................................ 21 
1.2.2 
Potential Benefits ................................................................................................................... 22 
1.2.3 
Risk-Benefit Rationale ............................................................................................................ 22 
2 
INVESTIGATIONAL DEVICE ...................................................................................... 23 
2.1 Overview .................................................................................................................... 23 
2.2 Manufacturer ............................................................................................................. 23 
2.3 Model Numbers ......................................................................................................... 23 
2.4 Device Traceability ..................................................................................................... 23 
2.5 Intended Purpose of the Investigational Device in the Clinical Investigation ........... 23 
2.6 Indications for Use ..................................................................................................... 24 
2.7 Device Description ..................................................................................................... 24 
2.8 Implantation of the InnAVasc AVG ............................................................................ 26 
2.9 Use of the InnAVasc AVG for Hemodialysis ............................................................... 26 
3 
SUMMARY OF PRE-CLINICAL STUDIES AND PRIOR CLINICAL INVESTIGATIONS ......... 28 
4 
STUDY OBJECTIVE .................................................................................................. 29 
5 
STUDY DESIGN ....................................................................................................... 30 
5.1 Study Design .............................................................................................................. 30 

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5.2 Informed Consent ...................................................................................................... 30 
5.3 Inclusion Criteria ........................................................................................................ 30 
5.4 Exclusion Criteria ....................................................................................................... 31 
6 
STATISTICS AND DATA ANALYSIS ............................................................................ 33 
6.1 Statistical Methodology ............................................................................................. 33 
6.2 Primary Effectiveness Endpoint ................................................................................. 34 
6.3 Primary Safety Endpoint ............................................................................................ 34 
6.4 Success Criteria .......................................................................................................... 34 
6.5 Secondary Endpoints ................................................................................................. 34 
6.6 Exploratory Endpoints ............................................................................................... 35 
6.7 Trial Population.......................................................................................................... 35 
6.8 Missing Data .............................................................................................................. 35 
6.9 Primary Safety Endpoint Sample Size ........................................................................ 35 
6.9.1 
Table 2:  Incidence of Device Related Adverse Events in ePTFE Grafts ................................. 36 
6.10 Primary Effectiveness Endpoint Sample Size ............................................................. 36 
6.11 Changes to Planned Analyses .................................................................................... 37 
6.12 Assessment of Data Poolability ................................................................................. 37 
6.13 Enrollment ................................................................................................................. 37 
7 
ASSESSMENTS AND FOLLOW-UP SCHEDULE ........................................................... 38 
7.1 Screening/Baseline Visit (Day -45 to Day 0) .............................................................. 38 
7.2 Treatment (Day 0) ...................................................................................................... 39 
7.3 Follow-Up Assessment .............................................................................................. 40 
7.3.1 
Day 14 (± 5 days) .................................................................................................................... 41 
7.3.2 
Month 1 (M1) – Telephone (± 7 days) ................................................................................... 41 
7.3.3 
Day 45 (D45) - (± 7 days) ........................................................................................................ 41 
7.3.4 
Month 3 (M3) - Telephone (± 7  days) ................................................................................... 41 
7.3.5 
Month 4 (M4) - Telephone (± 7 days) .................................................................................... 42 
7.3.6 
Month 5 (M5) - Telephone (± 7 days) .................................................................................... 42 
7.3.7 
Month 6 (M6) (± 14 days) ...................................................................................................... 42 
7.3.8 
Month 9 (M9) - Telephone (± 7 days) .................................................................................... 42 
7.3.9 
Month 12 (M12) (± 30 days) .................................................................................................. 42 
7.3.10 
Month 18 (M18) - Telephone (± 7 days) ............................................................................. 43 

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7.3.11 
Month 24 (M24) / Early Termination (ET) (± 30 days) ........................................................ 43 
7.4 Assessment of Patency .............................................................................................. 43 
7.5 Dialysis Procedures .................................................................................................... 44 
7.6 Patient Reported Outcomes Survey .......................................................................... 44 
7.7 Secondary Interventions ............................................................................................ 44 
7.8 Early Termination Visit .............................................................................................. 45 
7.9 Unscheduled Post Treatment Follow-up Visits ......................................................... 45 
7.10 Withdrawals and Loss to Follow-up .......................................................................... 45 
7.11 Study Duration ........................................................................................................... 46 
7.12 Histological Examination of Resected InnAVasc AVG Material ................................. 46 
8 
STUDY MANAGEMENT CONSIDERATIONS ............................................................... 47 
8.1 Protocol Modifications .............................................................................................. 47 
8.2 Protocol Deviations ................................................................................................... 47 
8.3 Information to Study Personnel ................................................................................ 47 
9 
ASSESSMENTS OF SAFETY ....................................................................................... 48 
9.1 Definitions .................................................................................................................. 48 
9.1.1 
Adverse Event ........................................................................................................................ 48 
9.1.2 
Serious Adverse Event ........................................................................................................... 48 
9.1.3 
Adverse Event of Special Interest .......................................................................................... 49 
9.1.4 
Device Deficiency ................................................................................................................... 49 
9.1.5 
Adverse Device Effect ............................................................................................................ 49 
9.1.6 
Serious Adverse Device Effect ................................................................................................ 49 
9.1.7 
Unanticipated Serious Adverse Device Effect ........................................................................ 49 
9.2 Reporting of Adverse Events and Device Deficiencies .............................................. 49 
9.3 Data Safety Monitoring Board ................................................................................... 50 
10 DEVICE ACCOUNTABILITY ....................................................................................... 52 
10.1 Accountability and Procedures .................................................................................. 52 
11 STUDY ADMINISTRATION ....................................................................................... 53 
11.1 Site Initiation.............................................................................................................. 53 
11.2 Training and Oversight of Dialysis Units .................................................................... 53 
11.3 Study Monitoring ....................................................................................................... 54 

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11.4 Study Termination ..................................................................................................... 54 
11.5 Data Handling and Recordkeeping ............................................................................ 54 
11.5.1 
Completing, Signing and Archiving Case Report Forms ...................................................... 54 
11.5.2 
Data Management and Archiving ....................................................................................... 55 
11.5.3 
Direct Access to Source Data/Documentation ................................................................... 56 
12 ETHICS ................................................................................................................... 57 
12.1 Informed Consent ...................................................................................................... 57 
12.2 Institutional Review Board ........................................................................................ 57 
12.3 Confidentiality Regarding Study Subjects .................................................................. 58 
12.4 Participating Institutions and Investigators ............................................................... 58 
12.5 Agreements ............................................................................................................... 58 
12.6 Responsibilities .......................................................................................................... 58 
13 DATA SECURITY AND SCIENTIFIC INTEGRITY ........................................................... 60 
13.1 Access to Data ............................................................................................................ 60 
13.2 Security and Confidentiality ...................................................................................... 60 
13.3 Electronic Data ........................................................................................................... 60 
14 RISK ANALYSIS ....................................................................................................... 61 
14.1 Risks to the Subjects .................................................................................................. 61 
14.2 Risk Mitigation ........................................................................................................... 64 
14.3 Benefit to Subjects ..................................................................................................... 64 
14.4 Study Justification ...................................................................................................... 64 
15 PUBLICATION POLICY AND PUBLIC DISCLOSURE ..................................................... 65 
16 REFERENCES ........................................................................................................... 66 
17 Table 4:  Schedule of Assessments .......................................................................... 69 
 
 

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LISTING OF TABLES 
Table 1: Patency, Sustained Use, and Technical Success Definitions ........................................... 33 
Table 2: Incidence of Device Related Adverse Events in ePTFE Grafts ........................................ 36 
Table 3: Known Risks of Arteriovenous Graft Implantation ......................................................... 61 
Table 4: Schedule of Assessments ................................................................................................ 69 
 
LISTING OF FIGURES 
Figure 1: InnAVasc Arteriovenous Graft (Looped Configuration shown) ..................................... 25 
Figure 2: Cross section of InnAVasc Arteriovenous Graft. ........................................................... 25 
 

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STUDY PERSONNEL  
 
CRO: 
SCOPE International USA, Inc. 
3000 Sidney Street, 
Suite 200,  
Pittsburgh, PA 15203  
Scope_Innavasc@scope-international.com 
+1 412-618-3370 
 
 
Sponsor Medical Representative: 
Shawn M. Gage, PA-C,  
Founder, Director of Clinical Operations 
InnAVasc Medical, Inc.  
110 Swift Ave. 
Durham, NC 27705  
shawn.gage@innavasc.com 
+1 919-452-4686 
 
 
Sponsor Regulatory Representative: 
Caroline Rhim, PhD  
Executive Director 
NSF Medical Device, Regulatory Consulting  
2001 Pennsylvania Avenue, Suite 950 
Washington, DC 20006 
crhim@nsf.org 
+1 734-478-2775 
 
 
Medical Monitor US: 
Roger E. Morgan, MD, FACS  
Vice President Medical Affairs  
MedSurgPI, LLC 
3700 Lark Farm Rd.  
Franklinton, NC 27525  
rmorgan@medsurgpi.com 
+1 919-931-9799 
 
The sponsor or designee will maintain an updated list of principal investigators, investigation 
sites and institutions. 

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STATEMENT OF COMPLIANCE 
 
This trial will be conducted in compliance with the protocol and the following regulatory 
requirements: 
 
 
• International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH), E6 Good Clinical Practice: 
Consolidated Guidance (ICH E6(R2)) 
 
• ICH E2A Clinical Safety Data Management:  Definitions and Standards for Expedited 
Reporting 
 
• ICH E8 Guidance on General Considerations for Clinical Trials 
 
• ISO14155:2011 Clinical Investigation of Medical Devices for Human Subjects – Good 
Clinical Practice 
 
• Applicable sections of United States Food and Drug Administration (FDA) Code of 
Federal Regulations (CFR), including: 
o 21 CFR Part 50, Protection of Human Subjects 
 
o 21 CFR Part 54, Financial Disclosure by Clinical Investigators 
 
o 21 CFR Part 56, Institutional Review Boards 
 
o 21 CFR Part 812, Investigational Device Exemption Application 
 
• Any other regional or national regulations, as applicable 
 
Appropriate levels of clinical trial insurance will be obtained by InnAVasc Medical Inc. 

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PROTOCOL AGREEMENT 
 
Investigator Name 
Title 
Site Name 
Site Number 
 
I have read the protocol and agree that it contains all necessary details for carrying out this 
study. I will conduct the study as outlined therein. 
 
I will provide copies of the protocol and all information on the device relating to past non-
clinical and clinical experience, which were furnished to me by the Sponsor, to all physicians 
and other study personnel responsible to me who participate in this study and will discuss 
this material with them to ensure that they are fully informed regarding the device and the 
conduct of the study. I agree: 
• To assume responsibility for the proper conduct of the study at this site, and to 
conduct the study in compliance with this protocol, any future amendments, and with 
any other study conduct procedures provided by the sponsor, InnAVasc Medical, 
Incorporated (InnAVasc), or their authorized representatives. 
• Not to implement any deviations from or changes to the protocol (including protocol 
amendments) without agreement from the sponsor and prior review and written 
approval from the Institutional Review Board (and FDA, if applicable) except where 
necessary to eliminate an immediate hazard to the subject(s), or for administrative 
aspects of the study (where permitted by all applicable regulatory requirements). 
• That I am familiar with the appropriate use of the investigational product, as 
described in this protocol and any other information provided by the sponsor 
including, but not limited to the current Investigator’s Brochure or equivalent 
document provided by InnAVasc. 
• To ensure that all persons assisting me with the study are adequately informed about 
the investigational product and of their study-related duties and functions. 
• That I have been informed that certain regulatory authorities require the sponsor to 
obtain and supply details about the investigator’s ownership interest in the sponsor 
or the Investigational Product, and more generally about his/her financial ties with the 
sponsor. InnAVasc will use and disclose the information solely for the purpose of 
complying with regulatory requirements. 
 
 
 
Investigator’s Signature 
Date 

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PROTOCOL APPROVAL 
 
 
 
 
Sponsor Medical Approval:  ____Shawn M. Gage, PA-C    ___  _______  
___  
_   
 
 
 
 
 
___Clinical Operations, Founder, InnAVasc Medical, Inc.______ 
 
 
 
 
Signed:  
_  
Date:  22 May 2019_ 
 
 
 
 
 
 
 
 
                                                              
Medical Monitor Approval: ____ Roger E. Morgan, MD, FACS ____________________ 
 
___Vice President of Medical Affairs, MedSurgPI, LLC___ 
 
 
Signed: 
 
_  
Date: 22 May 2019_ 

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SYNOPSIS 
 
Protocol Number: 
CSP-1001 
Investigational Device: 
InnAVasc Arteriovenous Graft (InnAVasc AVG) 
Study Title 
A Study to Evaluate the Safety and Effectiveness of the 
InnAVasc Arteriovenous Graft for Hemodialysis Access in 
Patients with End-Stage Renal Disease 
Sponsor 
InnAVasc Medical, Inc. 110 Swift Avenue 
Durham, NC 27705 USA 
Study Objective 
To evaluate the safety and effectiveness of the InnAVasc 
Arteriovenous Graft for hemodialysis access in patients 
with end-stage renal disease (ESRD). 
Intervention Description 
Patients will be implanted with an InnAVasc AVG in the 
forearm or upper arm using standard vascular surgical 
techniques. The graft will be placed in a “straight” (soft 
“C”) configuration in the upper arm, or looped 
configuration in the forearm (forearm loop) or upper 
arm (axillary loop). Placing the graft across the elbow 
will be prohibited. 
Subject Population 
Patients with ESRD who require hemodialysis and are 
suitable for an AVG for hemodialysis access will be 
eligible for inclusion in the study. 
Subject Sample size 
60 subjects will be treated in the study 
Number of Sites 
Up to 10 investigational sites in the United States 
Study Design 
Prospective, multi-center, single arm, non-randomized 
study 
Expected Enrollment Start Q4 2018 
Estimated Accrual Period 
Approximately 9 months 
Study Duration and 
Consent 
Regulatory trial duration 
The primary endpoint of secondary patency will be 
assessed at 6 months, but follow up will continue out to 
2 years. The 510(k) will be submitted when the final 
subject completes their 6-month follow-up. 
Overall trial duration 
Subjects will be followed up for 24 months. 
The total expected duration of the clinical investigation 
for each subject is 25.5 months. 

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Primary Effectiveness 
Endpoint 
Secondary patency at 6 months. 
• Secondary patency is defined as the time from 
placement of the AVG to abandonment, including 
surgical or endovascular interventions designed to 
reestablish AVG patency. 
Primary Safety Endpoint 
Incidence of adverse events of special interest (AESIs) 
through 6 months, defined as: 
1. Infection of the study device; 
2. Pseudoaneurysm formation at any point along the 
access circuit requiring surgical/endovascular 
intervention, including thrombin injection and 
compression (pseudoaneurysms that occur at 
sites of needle cannulation, but which are small 
enough to be observed without intervention, do 
not trigger this element of the AESI endpoint); 
3. Bleeding from the access circuit requiring 
surgical/endovascular intervention or ≥2-unit 
blood transfusion; 
4. Hematoma from the study device requiring 
intervention; 
5. Seroma of the study device requiring 
intervention. 
6. Thrombosis of the study device. 
Secondary Endpoints 
1. Functional patency at 3, 6, 12, 18 and 24 months; 
2. Time to successful cannulation, defined as the 
time from the index procedure to the first 2- 
needle dialysis session through the study device; 
3. Proportion achieving sustained use of 3 months, 
6, months, 12 months, 18 months, and 24 
months. Sustained use is a period of time in 
which the study graft is used for consecutive 
dialysis sessions without the requirement for 
alternative hemodialysis vascular access to allow 
for renal replacement therapy. A sustained use 
period can be achieved at any time throughout 
the study period of 24 months. 
Exploratory Endpoints 
Unless otherwise specified, all exploratory endpoints will 
be assessed at 3, 6, 12, 18 and 24 months 
1. Primary patency rate; 
2. Assisted primary patency rate; 
3. Days of central venous catheter in situ; 
4. Incidence of individual adverse events; 

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5. Change from baseline Patient Reported 
Outcomes Measures/Patient Reported 
Experience Measures (PROM/PREM) survey; 
6. Health economics derived from collected study 
data, e.g. 
a. Overall cost to create and maintain 
arteriovenous (AV) access 
b. Catheter related costs 
c. Cost of AV access related complications 
Inclusion Criteria 
Patients must meet the following criteria to be included 
in the study: 
1. Patients with ESRD who are not, or who are no 
longer, candidates for creation of an autologous 
AV fistula and therefore need placement of an AV 
graft to start or maintain hemodialysis therapy; 
2. Age 18 to 80 years old, inclusive; 
3. Suitable anatomy for implantation of upper arm 
“straight” or looped graft, or forearm looped graft 
(graft not to cross the bend of the elbow); 
4. For patients NOT on Coumadin / warfarin, 
international normalized ratio (INR) ≤1.5; 
5. Able and willing to give informed consent; 
6. Anticipated life expectancy of at least 1 year.  
 
Additional inclusion criteria on Day 0 
(intraoperative): 
7. Both vessels have been exposed and are deemed 
appropriate for implantation (i.e. based on the 
surgeon’s opinion, artery is of adequate size, has 
adequate pulse to support AV access flow and is 
safely clampable (i.e. artery has lack of significant 
calcification); and the vein is of adequate size, 
free of localized sclerosis, and is free of 
immediate outflow obstruction). 
Exclusion Criteria: 
Patients will be excluded from the study for: 
1. History or evidence of severe cardiac disease 
(New York Heart Association [NYHA] Functional 
Class III or IV), myocardial infarction within 6 
months prior to enrollment, ventricular 
tachyarrhythmias requiring continuing treatment, 
or unstable angina; 
2. Diabetes with a hemoglobin A1c (HbA1c) > 10% 
3. For upper arm straight configuration, antecubital 

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fossa crease to axillary crease distance < 18 cm. 
4. History or evidence of severe peripheral arterial 
disease in the extremity selected for implant (i.e. 
arterial inflow insufficient to support hemodialysis 
access); 
5. Known or suspected central vein stenosis or 
obstruction on the side of planned graft 
implantation; 
6. In the opinion of the investigator, baseline 
hypotension, or history of frequent hypotensive 
episodes during dialysis that puts the patient at 
increased risk of graft thrombosis; 
7. In the opinion of the investigator, uncontrolled 
hypertension; 
8. Baseline hemoglobin <8 g/dL; 
9. Baseline platelet count <100,000 or >500,000 
cells/mm3; 
10. Documented history of stroke within 6 months 
prior to enrollment; 
11. Treatment with any investigational drug or device 
within 30 days prior to enrollment; 
12. Female patients who are pregnant, intending to 
become pregnant, nursing or intending to 
breastfeed during the study (pregnancy test may 
only be omitted, if patient is post-menopausal or 
has a documented history of hysterectomy); 
13. History of cancer with active disease or treatment 
within the previous year, except for non-invasive 
basal or squamous cell carcinoma of the skin; 
14. Immunodeficiency, including documented history 
of human immunodeficiency virus (HIV) or 
acquired immunodeficiency syndrome (AIDS) or 
patients receiving immunosuppressive therapy 
for treatment of an acute inflammatory event or 
autoimmune flare.  Chronic immunosuppressive 
therapy is acceptable; 
15. Documented or suspected hypercoagulable  
state; 
16. Bleeding diathesis, other than that associated 
with ESRD; 
17. Documented history of heparin-induced 
thrombocytopenia (HIT); 
18. Active local or systemic infection as documented 

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from the medical history or bloodwork / blood 
culture data. If the infection resolves, the subject 
must be at least one-week post resolution of that 
infection before implantation; 
19. Scheduled renal transplant within 6 months; 
20. Any other condition which in the judgment of the 
investigator would preclude adequate evaluation 
of the safety and effectiveness of the InnAVasc 
AVG. 
Primary Analysis 
Population 
The primary analysis population is the intention to treat 
(ITT) cohort which is defined as the subjects in whom the 
host vessels have been deemed appropriate by the 
investigator for placement of an AVG and the 
investigator has made the decision to proceed with 
implantation of the investigational device. 
Statistical Analyses 
Primary safety and effectiveness endpoints will be 
summarized via standard descriptive statistics, including 
exact binomial 95% lower confidence intervals for 
dichotomous variables. No hypothesis tests are planned 
and there are no a priori study success criteria specified. 
Sample Size Calculation 
A sample size of 60 subjects will provide: 
• A sufficiently precise 95% lower bound on the 
secondary patency rate at 6 months, and 
• Working cohort to enable capture of the adverse 
event profile associated with the use of the 
InnAVasc Vascular Access Graft. 
Baseline Testing 
Medical history, physical examination with vital signs, 
laboratory assessment, and mapping of vessels to ensure 
suitability of the implantation site and to exclude 
suspected central vein stenosis on the side of graft 
implantation. 

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Follow-Up Schedule 
Subjects will have required in-person follow-up 
evaluations at the following time points post index 
procedure: 
1. 14 days; 
2. 45 days; 
3. 6 months; 
4. 12 months; 
5. 24 months 
Subjects will have required telephone check-up/dialysis 
clinic contact evaluations at the following time points 
post index procedure: 
1. 1 month; 
2. 3 months; 
3. 4 months; 
4. 5 months 
5. 9 months 
6. 18 months 
Timing 
The data will be analyzed and submitted for 510(k) 
clearance when the last subject completes their 6-
month follow-up. Additional 24-month data will be 
analyzed for safety. 
Data Safety Monitoring 
Board (DSMB) 
An independent DSMB will review safety data from the 
study at predetermined time points and as deemed 
necessary by the Sponsor or the DSMB Chair. The DSMB 
will make recommendations on protocol modifications 
and continuation of the study. 
Protocol Version and 
Date 
Version 3.0; 22 May 2019 

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ABBREVIATIONS 
 
ADE 
Adverse device effect 
AE 
Adverse event 
AESI 
Adverse event of special interest 
AIDS 
Acquired Immunodeficiency Syndrome 
AV 
Arteriovenous 
AVF 
Arteriovenous fistula 
AVG 
Arteriovenous graft 
CBC 
Complete blood count 
CDC 
US Centers for Disease Control and Prevention 
CKD 
Chronic kidney disease 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CVC 
Central venous catheter 
DSMB 
Data and Safety Monitoring Board 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EPPY 
Events per patient year 
ePTFE 
Expanded polytetrafluoroethylene 
ESRD 
End stage renal disease 
ET 
Early termination 
FDA 
US Food and Drug Administration 
HbA1c 
Hemoglobin A1c 
HD 
Hemodialysis 
HIV 
Human Immunodeficiency Virus 
HIT 
Heparin induced thrombocytopenia 
IB 
Investigator brochure 
ID 
Individual identification 

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IFU 
Instructions for Use 
InnAVasc AVG 
InnAVasc arteriovenous graft 
INR 
International normalized ratio 
IRB 
Institutional Review Board 
ITT 
Intention to Treat 
LSR 
Liquid silicone rubber 
NYHA 
New York Heart Association 
PA 
Pseudoaneurysm 
PASS 
Power analysis and sample size 
PREM 
Patient reported experience measures 
PROM 
Patient reported outcome measures 
SADE 
Serious Adverse Device Effect 
SAF 
Safety Analysis Set 
SIV 
Site initiation visit 
SOP 
Standard Operating Procedure 
TMF 
Trial master file 
USADE 
Unanticipated Severe Adverse Device Effect 
USRDS 
United States Renal Data System 

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1 
INTRODUCTION AND BACKGROUND 
 
Chronic kidney disease (CKD) is a worldwide health problem, with a global prevalence of 
between 11-13% of the adult population.1 A recent report from the United States Renal Data 
System (USRDS) estimates the prevalence of CKD to be 14.8% in the U.S. alone.2 The 
prevalence of CKD is rising in tandem with the increased prevalence of its risk factors, such 
as older age, diabetes mellitus, hypertension, cardiovascular disease, and obesity.1,3 Patients 
with CKD can progress to end stage renal disease (ESRD) and require long-term hemodialysis 
(HD) or kidney transplantation. Patients with diabetes mellitus or hypertension tend to 
progress to ESRD faster than patients with other comorbid conditions,4 therefore, as these 
conditions are increasing in prevalence, the number of patients with ESRD is also expected 
to increase. Worldwide projections show the number of patients with ESRD is increasing, 
especially in developing countries.5 A recent report shows that there are nearly 700,000 
cases of ESRD in the U.S., a number that has increased by approximately 100,000 since 
2012.2,6 An increase in the number of patients with CKD and ESRD signifies an increasing 
financial burden. The total Medicare spending on both CKD and ESRD was over $50 billion 
for people aged over 65 years, or approximately 20% of the overall Medicare spending in 
that age group in 2015,2 and these costs are projected to rise. 
 
For patients with ESRD, HD is a vital therapy. Needle access to a surgically created, high flow, 
vascular shunt or arteriovenous (AV) access is required 3-5 times a week. It is imperative that 
the AV access is efficient and well performing for HD therapy to be effective. Complications 
relating to AV access, such as infections and thrombosis, are the main reason for morbidity 
among HD patients.7 The ideal AV access should be easy to place, available for immediate 
use, low cost, able to provide proper blood flow, long-lasting, and without complications.8,9 
There are 3 main types of AV accesses available for HD: a central venous catheter (CVC), an 
AV fistula (AVF), or an arteriovenous graft (AVG). However, new innovations in AV access 
technology are necessary, as none of the current AV access modalities are ideal and there 
are advantages and disadvantages with each of these forms of AV access. 
 
Of the three types of AV access, CVCs are not recommended for long-term AV access.9,10 
However, as other forms of AV access need time to mature, HD is often initiated with a CVC.11 
When another AV access site fails, or in an emergency situation, CVCs provide immediate 
vascular access, often via the right internal jugular vein.12,13 However, CVCs are not 
recommended for long term use as they are associated with an increased risk of infection, 
poor blood flow, and shorter HD duration.7,11,14,15 Therefore, other forms of AV access are 
required to maintain HD long-term. 
 
The AVF is the most common form of vascular access and is usually the first choice for 
treatment.11,16 An AVF is created by surgically joining an artery to a vein, usually the brachial 
or radial artery to the cephalic or basilic vein.9 The AVF results in arterial blood flowing 
directly into the vein, causing engorgement and thickening of the vein. The AVF can be used 
when it is considered mature, which can take weeks for the adequate dilatation and 
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require patients to rely on the use of CVCs for HD access. Overall, the AVF is generally 
considered to be highly effective, with a low rate of complications and a lower cost compared 
to other forms of AV access.9,10,16,17 Patients with AVFs have better outcomes compared to 
those with other forms of vascular access.11 Old age, peripheral vascular disease, diabetes 
mellitus and hypertension are the main risk factors for AVF failure.18 These comorbidities can 
affect the quality of the vascular bed, leading to endothelial dysfunction, and impaired 
dilation which can increase the likelihood of neointimal hyperplasia and stenosis.18-20 
However, not all patients are suitable for treatment with an AVF. Early thrombosis (< 6 weeks 
after placement) and inadequate maturation are the main reasons for failure of AVFs.9,10,18 
In these cases, an open surgical or, more often, an endovascular intervention is required to 
rescue the AVF. In some cases, a new vascular access may be required. These reinterventions 
and reoperations add significantly to the cost of AVF and the lower the chances of 
maintaining vascular access over the long-term. 
 
In situations where the construction of an AVF is not suitable or cannot be used, AVGs often 
provide a viable alternative.11 AVGs may be appropriate in high-risk patients, late referred 
patients, elderly patients, patients with severe comorbidity burden or patients with a history 
of recurrent AVF failure. The use of expanded polytetrafluoroethylene (ePTFE) was 
introduced as a suitable prosthetic graft for vascular access in the 1970s,21 and it is now 
commonly used for connecting arteries and veins. The AVG is often placed between the 
brachial artery to the axillary vein in a straight configuration in the upper arm or a looped 
configuration between the brachial artery and cephalic or brachial/basilic vein in the 
forearm.9  Grafts constructed from ePTFE require prolonged periods of healing until the time 
of safe cannulation, to allow tissue incorporation. This period can take 2 to 5 weeks8, 
requiring patients to rely on the use of an external dialysis catheter for HD access. These 
catheters, which serve as a direct line from the outside of the body to the blood stream, 
place the patient at significant risk for a blood stream infection, sepsis, and death. 7,11,14,15  
This period is shorter than the maturation time for AVF, but still not ideal. However, there 
are some newer AVGs that allow for faster cannulation.22,23 Unlike AVFs, blood flow through 
an AVG is dependent on the size of the graft, and not the maturation of vessel. Therefore 
with a prosthetic graft there is a better chance of achieving adequate blood flow.10,24 Also, 
AVGs, are easier to cannulate, with a larger area for cannulation, they offer more cannulation 
sites.24 
 
However, AVGs have disadvantages and many complications can occur. AVGs are associated 
with a risk of infection, aneurysm formation, stenosis, thrombosis, and degradation of the 
graft material.19,25-27 Some of these complications result from improper graft puncture 
technique and repeated trauma due to needle cannulation. Needle punctures of the graft 
wall can damage the graft material lead and to the formation of hematomas and 
pseudoaneurysms (PAs).28,29 Graft degradation can be significantly accelerated by 
inadvertent puncture of the posterior or sidewall of the graft. The growth of hematomas can 
result in thinning and erosion of the skin, leading to a risk of bleeding, thrombosis and 
ultimately surgical intervention.27 Overly aggressive graft compression, in an attempt to 
provide hemostasis following needle withdrawal, can also result in graft thrombosis and 

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failure. Infections are another major complication associated with AVGs, often as a result of 
frequent cannulations, which can introduce an infection around the access site.27,28  These 
complications have serious side effects, resulting in bleeding, pain, disability and ultimately 
surgical interventions, which if unsuccessful can lead to abandonment and explantation of 
the graft.27,29 Largely due to these complications, AVGs generally have a shorter lifespan than 
AVFs (< 2 years compared to < 5 years).30,31 
 
The devices and equipment used in AV access have improved in the last decade, however, 
there is still room for improvement as many complications persist. Surgical and endovascular 
interventions to manage these complications can lead to huge healthcare expenditures 
annually. Therefore, innovations that can prolong the survival of the AVG and reduce or 
prevent complications associated with AVGs are a necessity. 
 
1.1 
Scientific Rationale 
Currently, no available grafts offer protection from needle access injury, and no United 
States Food and Drug Administration (FDA)- approved HD grafts offer immediate 
cannulation. Only 2 grafts are FDA cleared for early access (24-72 hours post implant [Vectra, 
CR Bard, and Acuseal, W.L. Gore]), but outcomes data for these devices are lacking. To 
mitigate dialysis access graft cannulation complications, InnAVasc has developed an AVG 
modification that incorporates two multilayer cannulation chambers with potentially 
improved low bleed technology that are resistant to posterior and sidewall needle 
penetration/injury; the InnAVasc arteriovenous graft (InnAVasc AVG). This device has the 
potential to eliminate many of the current complications and costs associated with AVG 
failure and infection, and thus could relieve patient-associated pain and suffering, as would 
potentially lead to a significant reduction in health care costs related to chronic dialysis graft 
injury. 
 
1.2 
Potential Risks and Benefits 
1.2.1 Potential Risks 
It is anticipated that subjects participating in the study will be exposed to the same risks 
as those associated with other AV grafts. Risks associated with the study device may 
include but are not limited to: 
 
• Bleeding and hematoma formation at the surgical site or the dialysis puncture sites 
• Thrombosis/occlusion of the graft or host vessels 
• Infection of the graft, at the surgical site or systemically 
• Skin erosion 
• Steal syndrome 
• Stenosis of the graft or its anastomoses 

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• Swelling of the limb 
Regular clinical examination of the graft site and assessment of the graft patency and blood 
flow using ultrasound during the study should allow early detection of graft complications 
and permit appropriate intervention including graft explantation if necessary. 
 
1.2.2 Potential Benefits 
Subjects who undergo implantation of the InnAVasc AVG may benefit from immediate and 
improved reliable hemodialysis access versus the challenges posed by a conventional ePTFE 
graft. In addition, the risks listed in Section 1.2.1, most importantly bleeding and hematoma 
formation, typically encountered with conventional ePTFE grafts may be decreased with the 
InnAVasc AVG. Finally, the longevity of the InnAVasc AVG may be greater than that of 
conventional ePTFE grafts. 
 
1.2.3 Risk-Benefit Rationale 
As mentioned above, subjects who undergo implantation of the InnAVasc AVG may benefit 
from immediate and improved reliable hemodialysis access versus a conventional ePTFE 
graft. The risks anticipated in this study are similar to those associated with currently 
marketed prosthetic grafts used for dialysis access. The superficial site of implantation of the 
InnAVasc AVG, when used for dialysis access, facilitates clinical and regular ultrasound 
monitoring of the graft, allowing any such complication to be recognized and treated 
promptly, thus minimizing potential risk to the patient. The potential advantages of the 
InnAVasc AVG compared to currently marketed grafts may lead to a lower complication rate 
and reduced need for surgical intervention. 
To summarize, unique potential benefits of the investigational device include, early use 
(same day as implant), reduced dialysis catheter contact time for the patient, reduced 
infections, significantly reduced bleeding following needle removal (self-sealing potential) 
[patient safety], less dialysis chair time [patient/technician convenience], easy identification 
of the cannulation area [enhancement for dialysis technicians/patient safety], reduced 
pain/suffering for patient, and protection from commonly suffered graft back and side wall 
needle injuries during the cannulation process [enhanced safety for the patient, reduced 
hospitalizations and interventions]. Furthermore, this device is intended for use in patients 
with end stage renal disease who require hemodialysis. By definition, ALL patients who 
receive this device will be Medicare beneficiaries as long as they have required renal 
replacement therapy for greater than 90 days, and therefore ALL patients who benefit from 
the enhanced features of this investigational device will be Medicare beneficiaries. 

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2 
INVESTIGATIONAL DEVICE 
 
2.1 
Overview 
The Sponsor, InnAVasc, (Durham, NC), has developed the study device known as the 
InnAVasc AVG. The InnAVasc AVG is a hemodialysis vascular access graft, intended for 
implantation in the lower or upper arm using standard vascular techniques, in patients 
requiring hemodialysis. 
 
2.2 
Manufacturer  
Manufactured by: 
Medical Murray 
4508 Westinghouse Blvd. Suite B 
Charlotte, NC 28273 USA 
Ph: +1 847.620.7990 
Fax: +1 847.620.7995 
ncinfo@medicalmurray.com 
 
For: 
InnAVasc Medical, Inc.  
110 Swift Avenue 
Durham, NC 27705 USA 
 
2.3 
Model Numbers 
The InnAVasc AVG will be made available in two models for the clinical study (Straight, 
model #017717 and Looped, model #023000). 
 
2.4 
Device Traceability 
Lot numbers will be used to trace devices used in the study. A unique lot number will be 
assigned to each device. 
 
2.5 
Intended Purpose of the Investigational Device in the Clinical Investigation 
The investigational device is a sterilized, single-use implant intended for use as a vascular 
prosthesis (blood access for hemodialysis) as an implanted vascular access conduit for 
hemodialysis. It will be surgically implanted in the forearm or upper arm. The first end of 
the graft is connected to an artery and the second end is connected to a vein, such that 
blood flows through the conduit from artery to vein. Implantation of the graft will occur 
once and the graft will be accessed by needle cannulation, on average, 3 to 5 times per 
week. 
 

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2.6 
Indications for Use 
The InnAVasc AVG is intended for use in hemodialysis patients who are not candidates for 
the creation of an autologous AV fistula. 
 
2.7 
Device Description 
The InnAVasc AVG is a modified graft technology, aimed at improving AVG safety and 
access, in patients with ESRD requiring hemodialysis. As currently designed, the InnAVasc 
AVG makes no changes to the construction of a standard 6 mm ePTFE vascular graft, but 
rather incorporates added safety features such as semi-rigid, penetration-resistant 
cannulation chambers that have been externally molded and bonded to one contiguous 
segment of vascular graft tubing. The modified design of the InnAVasc AVG allows for 
continuous flow, and immediate, durable and easier cannulation. The looped and straight 
configurations undergo the same manufacturing process. The only difference between the 
two models is the distance between the two chambers (closer for straight, further apart 
for looped) to allow the necessary differences in tunneling geometry. 
The InnAVasc AVG is constructed of biocompatible material and has one continuous 
lumen that is designed to allow for uninterrupted blood flow, as there are no transition 
points. The device has a semi-rigid design, which reduces graft compression and 
expansion, thereby minimizing disruptions in blood flow. A thin (0.15 mm) ePTFE veneer 
covers the cannulation chamber to create a graft surface with continuous ePTFE 
coverage. This external finish is crucial to promote tissue ingrowth and incorporation 
across the entire graft for purposes of stability. 
Another advantage of the InnAVasc AVG is that it should be able to be used immediately 
post implantation. The device contains two specialized cannulation zones. The liquid 
silicone rubber (LSR) material used in these zones is self-sealing, allowing for early 
cannulation. The LSR material is on the external surface of the graft, so as not to interrupt 
blood flow. The back plate of the cannulation zone is constructed of medical grade 
polysulfone, which is a strong, stable, biocompatible material, that is resistant to 
inadvertent needle puncture. Due to the specialized cannulation area, the AVG has the 
potential to be easily cannulated even by inexperienced users. 
Overall, this device has the potential to reduce many of the complications associated with 
AV grafts, such as, graft injury due to improper cannulation, graft compression and low 
blood flow. In addition, a major advantage of this AVG is that we postulate that it can be 
cannulated immediately after implantation, therefore the implantation of temporary a 
CVC is not necessary, reducing the risk of infections and CVC- associated complications. 

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A cross section of the InnAVasc Graft is provided in Figure 2 (clear area consists of silicone).  
 
Figure 1: InnAVasc Arteriovenous Graft (Looped Configuration shown) 
Figure 2: Cross section of InnAVasc Arteriovenous 
Graft.  InnAVasc components are labeled in Figure 2 
above: a) base graft (CR Bard Impra AVG, K830543), 
b) polysulfone back plate, c) silicon molding, d) ePTFE 
sleeve, e) ePTFE tape. 

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2.8 
Implantation of the InnAVasc AVG 
The InnAVasc AVG is implanted using standard vascular surgical techniques similar to 
placement of predicate peripheral vascular prostheses. Implantation of the InnAVasc AVG 
will be undertaken by qualified vascular surgeons experienced in dialysis access surgery. The 
InnAVasc AVG is tunneled in the subcutaneous space using a standard Kelly-Wick tunneler 
using a 10 mm tunneling tip for the initial tunnel. The graft is attached to the tunneling rod 
using a 6 mm tunneling tip to be pulled back through the subcutaneous tissue. For straight 
configurations, ensure that the natural curvature of the graft is positioned such that the arc 
is lateral on the extremity. For looped configurations, ensure that the natural curvature of 
the chambers and graft conform to a loop (arc of lateral chamber points lateral, arc of medial 
chamber points medial). The blue stripe on the graft and the palpable cannulation ovals must 
be oriented anteriorly. For straight configurations, it is recommended to pull the graft from 
the arterial exposure site towards the venous exposure site when possible to avoid 
stretching the arterial limb of the graft. Stretching the arterial limb of the ePTFE can increase 
the risk of graft ultrafiltration syndrome (“weeping syndrome”). For looped configurations, 
it is recommended to pull each limb, separately, through the counter incision, toward the 
vascular exposure site. The anastomoses are fashioned using 5-0 or 6-0 polypropylene suture 
with a running or interrupted technique. Intraoperative anticoagulation is used at the 
investigators’ discretion. 
2.9 
Use of the InnAVasc AVG for Hemodialysis 
The InnAVasc AVG is accessed for hemodialysis in the same fashion as standard dialysis 
grafts, using two hemodialysis needles; one for arterial draw to the dialysis machine, and the 
other for venous return to the subject. The InnAVasc AVG has two cannulation chambers 
(one arterial, one venous) in which one standard dialysis needle (15, 16, or17 gauge) is placed 
in each chamber to commence HD. It is recommended to use the smallest bore needle to 
provide the prescribed hemodialysis over the prescribed time. Each cannulation chamber 
can be easily identified by the palpable cannulation oval on the anterior chamber. The needle 
should penetrate the chamber on or within the cannulation oval at a 45-degree angle for 
best results. It is recommended to keep the needle tip within the lumen of the graft, but if 
the tip advances beyond, the safety backplate will prevent the needle from penetrating the 
posterior or side walls of the graft. Due to the firmness of the chamber, it may be best to 
stabilize the needle at the cannulation angle and secure rather than securing the needle flat 
to the subject’s arm. At the conclusion of HD, mild to moderate digital pressure should be 
applied to the puncture site for 30-60 seconds before applying a small bandage. Pressure 
dressings are not required for the InnAVasc AVG. The design of the InnAVasc AVG is such 
that it can be cannulated and used for HD on the same day as surgical implant. The self-
sealing technology, combined with the safety backplate will prevent backwall injuries and/or 
bleeding of the puncture site into the peri-graft space, which can lead to graft thrombosis, 
subject hemorrhage, and infection. Subjects will be asked to wear a study ID band for 
purposes of identification for the study, but also to provide cannulation instructions via a 
linked QR code printed on the band.  This is in addition to education provided first hand from 
the dialysis organizations directly to the dialysis units and additional education provided 

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directly from the Sponsor.  For purposes of this clinical investigation, the expectation is that 
the first use of the InnAVasc AVG for two needle HD will occur on the same day as implant, 
or the next day, but not beyond 7 days post implant as long as medically appropriate. 

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3 
SUMMARY OF PRE-CLINICAL STUDIES AND PRIOR CLINICAL INVESTIGATIONS 
 
The non-clinical testing program was designed to evaluate the InnAVasc AVG’s ability to 
function in vivo as intended as a hemodialysis graft and to address post cannulation time to 
hemostasis, hematoma formation, prevention of posterior wall penetration, ease of access, 
and graft patency. Overall, the results of these studies indicated that the InnAVasc AVG was 
substantially equivalent or superior to the control (standard ePTFE) in all addressed aspects. 
Generally, the grafts functioned as intended and maintained patency, or assisted patency 
during the study period. A detailed description of these studies, including bench testing, are 
outlined in the Investigator Brochure (IB). 
 
This clinical investigation will be the first evaluation of the InnAVasc AVG in humans and will 
allow the Sponsor to collect safety and effectiveness data regarding its device. 

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4 
STUDY OBJECTIVE 
 
The objective of this study is to evaluate the safety and effectiveness of the InnAVasc AVG 
for hemodialysis access in patients with ESRD. The safety and the effectiveness of the device 
and the procedure will be assessed using separate primary endpoints through 6 months. 

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5 
STUDY DESIGN 
 
The study population will include up to 60 subjects, male and female, who are appropriate 
candidates for implantation of an InnAVasc AVG and require hemodialysis treatment for 
ESRD. 
 
5.1 
Study Design 
This clinical trial is a prospective, multi-center, single-arm, non-randomized, premarket 
study designed to assess the safety and effectiveness of the InnAVasc AVG device in 
subjects with ERSD who require HD. The safety and effectiveness of the device will be 
evaluated with primary safety and effectiveness endpoints that will be summarized via 
standard descriptive statistics, including exact binomial 95% lower confidence intervals. 
No hypothesis tests are planned and there are no a priori study success criteria specified. 
 
Data will be collected through 24 months. 
 
5.2 
Informed Consent 
Written, study-specific informed consent will be obtained from each subject prior to the 
first study-specific procedure. The investigator will keep the original informed consent 
form and a copy will be given to the subject. It will also be explained to the subjects that 
they are free to take part in the study and free to withdraw from the study at any time 
without prejudice to future treatment. A subject is considered enrolled after informed 
consent has been completed. 
 
5.3 
Inclusion Criteria 
Patients must meet the following criteria to be included in the study: 
 
1. Patients with ESRD who are not, or who are no longer, candidates for creation of an 
autologous AV fistula and therefore need placement of an AV graft to start or maintain 
hemodialysis therapy; 
2. Age 18 to 80 years old, inclusive; 
3. Suitable anatomy for implantation of upper arm “straight” or looped graft, or 
forearm looped graft (graft not to cross the bend of the elbow); 
4. For patients NOT on Coumadin / warfarin, international normalized ratio (INR) 
≤1.5; 
5. Able and willing to give informed consent; 
6. Anticipated life expectancy of at least 1 year.  
Additional inclusion criteria on Day 0 (intraoperative): 
7. Both vessels have been exposed and are deemed appropriate for implantation (i.e. 

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based on the surgeon’s opinion, artery is of adequate size, has adequate pulse to 
support AV access flow and is safely clampable (i.e. artery has lack of significant 
calcification); and the vein is of adequate size, free of localized sclerosis, and is free 
of immediate outflow obstruction). 
5.4 
Exclusion Criteria 
Patients will be excluded from the study for: 
 
1. History or evidence of severe cardiac disease (New York Heart Association [NYHA] 
Functional Class III or IV), myocardial infarction within 6 months prior to enrollment, 
ventricular tachyarrhythmias requiring continuing treatment, or unstable angina; 
2. Diabetes with hemoglobin A1c (HbA1c) > 10%; 
3. For upper arm straight configuration, antecubital fossa crease to axillary crease 
distance < 18 cm; 
4. History or evidence of severe peripheral arterial disease in the extremity selected for 
implant (i.e. arterial inflow insufficient to support hemodialysis access); 
5. Known or suspected central vein stenosis or obstruction on the side of planned graft 
implantation; 
6. In the opinion of the investigator, baseline hypotension, or history of frequent 
hypotensive episodes during dialysis that puts the patient at increased risk of graft 
thrombosis; 
7. In the opinion of the investigator, uncontrolled hypertension; 
8. Baseline hemoglobin <8 g/dL; 
9. Baseline platelet count <100,000 or >500,000 cells/mm3; 
10. Documented history of stroke within 6 months prior to  enrollment; 
11. Treatment with any investigational drug or device within 30 days prior to enrollment; 
12. Female patients who are pregnant, intending to become pregnant, nursing or 
intending to breastfeed during the study (pregnancy test may only be omitted, if 
patient is post-menopausal or has a documented history of hysterectomy); 
13. History of cancer with active disease or treatment within the previous year, except for 
non-invasive basal or squamous cell carcinoma of the skin; 
14. Immunodeficiency including documented history of human immunodeficiency virus 
(HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving 
immunosuppressive therapy for treatment of an acute inflammatory event or 
autoimmune flare.  Chronic immunosuppressive therapy is acceptable; 
15. Documented or suspected hypercoagulable state; 
16. Bleeding diathesis, other than that associated with ESRD; 
17. Documented history of heparin-induced thrombocytopenia (HIT); 
18. Active local or systemic infection as documented from the medical history or 
bloodwork / blood culture data. If the infection resolves, the subject must be at least 
one-week post resolution of that infection before implantation; 

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19. Scheduled renal transplant within 6 months; 
20. Any other condition which in the judgment of the investigator would preclude 
adequate evaluation of the safety and effectiveness of the InnAVasc AVG. 

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6 
STATISTICS AND DATA ANALYSIS 
6.1 
Statistical Methodology 
Summary statistics will be provided for primary and secondary study endpoints and other 
variables of interest as appropriate. Continuous data will be summarized via means, 
medians, standard deviations, ranges, and confidence intervals. Dichotomous variables will 
be summarized via counts, percentages, and 95% lower exact binomial confidence 
intervals. 
 
Categorical variables will be summarized via counts and percentages. Graphical 
presentations may be provided for select study outcomes. No hypothesis testing is 
defined for any of the study endpoints. 
 
The following definitions will be applied: 
 
Table 1: Patency, Sustained Use, and Technical Success Definitions 
 
Technical success 
Procedure conclusion by successful implantation of 
the study device with a patent graft 
Successful cannulation 
Two-needle dialysis session through the study device 
Functional patency 
AV access that can be cannulated with two dialysis 
needles for at least 75% of dialysis sessions within a 4- 
week period to achieve the prescribed dialysis 
Primary patency 
Interval from the time of access placement until any 
intervention designed to maintain or reestablish 
patency, access thrombosis, or the time of 
measurement of patency 
Assisted primary patency 
Interval from the time of access placement until 
access thrombosis or the time of measurement of 
patency, including intervening manipulations (surgical 
or endovascular interventions) designed to maintain 
the functionality of a patent access 
Secondary patency 
Time from placement of the AVG to abandonment, 
including surgical or endovascular interventions 
designed to reestablish AVG patency 
Sustained use 
Period of time in which the study graft is used for 
consecutive dialysis sessions without the requirement 
for alternative hemodialysis vascular access to allow 
for renal replacement therapy 
 

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6.2 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint for this study is defined as secondary patency at 
6 months. 
 
• Secondary patency is defined as the time from placement of the AVG to 
abandonment, including surgical or endovascular interventions designed to 
reestablish AVG patency.32 
 
6.3 
Primary Safety Endpoint 
The primary safety endpoint is the incidence of adverse events of special interest (AESIs) 
through 6 months, defined as: 
 
1. Infection of the study device; 
2. Pseudoaneurysm formation at any point along the access circuit requiring surgical/ 
endovascular intervention, including thrombin injection and compression 
(pseudoaneurysms that occur at sites of needle cannulation, but which are small 
enough to be observed without intervention, do not trigger this element of the AESI 
endpoint); 
3. Bleeding from the access circuit requiring surgical/ endovascular intervention or ≥2-
unit blood transfusion; 
4. Hematoma from the study device requiring intervention; 
5. Seroma from the study device requiring intervention 
6. Thrombosis of the study device. 
6.4 
Success Criteria 
There are no prespecified study success criteria as neither primary endpoint will undergo 
hypothesis testing.  However, device safety and efficacy will be compared to the relevant 
literature for early cannulation grafts considering patency rates at 6, 12, 18, and 24 
months as well as complication rates over 2 years. 
 
6.5 
Secondary Endpoints 
The following secondary endpoints will be collected and assessed via summary statistics: 
1. Functional patency at 3, 6, 12, 18 and 24 months; 
2. Time to successful cannulation, defined as the time from the index procedure to the 
first 2-needle dialysis session through the study device; 
3. Proportion achieving sustained use of 3 months, 6, months, 12 months , 18 months 
and 24 months. Sustained use is a period of time in which the study graft is used for 
consecutive dialysis sessions without the requirement for alternative hemodialysis 
vascular access to allow for renal replacement therapy. A sustained use period can be 
achieved at any time throughout the study period of 24 months. 

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6.6 
Exploratory Endpoints 
Unless otherwise specified, all exploratory endpoints will be assessed at 3, 6, 12, 18 and 
24 months. 
The following exploratory endpoints will be collected and assessed via summary statistics: 
1. Primary patency rate; 
2. Assisted primary patency rate; 
3. Days of central venous catheter in situ; 
4. Incidence of individual adverse events; 
5. Change from baseline patient reported outcomes measures (PROM) / patient 
reported experience measures (PREM) survey; 
6. Health Economics based on collected study data, e.g. 
a. Overall cost to create and maintain AV access 
b. Catheter related costs 
c. Cost of AV access related complications. 
6.7 
Trial Population 
The Intention-to-Treat Population (ITT) includes all subjects in whom the host vessels 
have been deemed appropriate by the investigator for placement of an AVG and the 
investigator has made the decision to proceed with implantation of the investigational 
device. Subjects with technical failures will not be excluded from the ITT. 
 
6.8 
Missing Data 
Every effort will be made to minimize the amount of missing data. The amount of and 
reasons for missing endpoint data will be provided in the final report. The primary 
analyses in the clinical study report will be based on available data; however, a number 
of sensitivity analyses will be performed including best- and worst- case analyses to help 
assess the potential impact of missing data. 
 
6.9 
Primary Safety Endpoint Sample Size 
A literature review was conducted to estimate the incidence of AESIs associated with 
other ePTFE grafts through 6-months. The results provided in Table 1 show that the 
adverse event (AE) profile associated with ePTFE grafts in general is well-understood and 
that individual AEs of special interest would be expected to occur at incidence levels 
ranging from 5%-12%. 
A sample size of 60 treated subjects provides a high likelihood identifying unique AEs 
associated with the use of the InnAVasc graft, thereby properly characterizing its risk 
profile. In particular, 60 treated subjects study will mean a greater than 95% chance to 
detect an AE that would occur at an underlying rate of 5% and a greater than 99% chance 
to detect an AE that would occur at an underlying rate of 8%. 

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6.9.1 Table 2:  Incidence of Device Related Adverse Events in ePTFE Grafts 
Adverse 
Event 
6-month 
incidence 
estimate for 
ePTFE 
grafts 
 
 
 
 
Literature Support and Estimate Calculation 
Infection 
5% - 20% 
• 4% - 20% per year for prosthetic AV access with 7 sources 
cited, survey from Centers for Disease Control [CDC] - 
average of 3.2% of patients per month at dialysis 
centers27 
 
• 11% @ 1 year (138 pts)33 
Pseudo- 
aneurysm 
5 - 10% 
• range from 2-10% in ePTFE grafts with 3 sources cited, 
0.049 to 0.1 per patient-year from two randomized 
trials27 
 
Note: (0.1 events per patient year [EPPY] * 30 patient 
years = 3 events, 3 events / 60 = 5%) 
Hematomas 4-10% 
• Incidence ranges from 0.073 – 0.2 per patient year with 
2 sources cited27 
 
• 4% @ 1 year (138 pts)33 
 
Note: 0.2 EPPY * 30 patient years = 6 events, 6 events / 60 
=10% 
Bleeding 
12% 
• 0.24 EPPY34  
 
Note: 0.24 EPPY * 30 patient years = 7.2 events, 7.2 events 
/ 60 = 12% 
 
6.10 Primary Effectiveness Endpoint Sample Size 
The primary endpoint of secondary patency at 6 months post-procedure was assessed 
from a literature review of secondary patency rates, where a meta-analysis on the basis 
of 34 relevant studies found the cumulative patency rate to be 76% at 6 months for 
arteriovenous grafts.35 
 
Secondary patency in this study is defined as the time from placement of the AVG to 
abandonment, including surgical or endovascular interventions designed to reestablish 
AVG patency.32 
 
Utilizing a simple asymptotic one-sided calculation in Power Analysis and Sample Size 

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(PASS) 2013 software to provide a lower, one-sided 95% confidence bound shows that a 
primary effectiveness success rate of 76% would have a lower confidence bound of 
65.29%, or a distance of just over 10% from the estimate to the bound limit. In the event 
the study realized a 5% subject loss, there would be minimal impact to the confidence 
bound calculation as a sample size of 57 subjects with a 76% success rate would elicit a 
lower bound of 64.9%.  Sample size calculations were performed in PASS 2013 utilizing an 
exact Clopper-Pearson calculation method and a one-sided, lower 95% confidence bound. 
 
Therefore, the proposed sample size of 60 subjects will provide a highly confident 
understanding of where the true secondary patency rate at six months associated with use 
of the InnAVasc graft lies. 
 
6.11 Changes to Planned Analyses 
Any changes to the planned analyses will be documented in the study report. 
 
6.12 Assessment of Data Poolability 
Poolability of data across clinical study sites is justified on a clinical basis (i.e. all study sites 
use the same protocol, the sponsor monitors the site for protocol compliance, and the 
data gathering instruments are identical). 
 
Poolability will also be assessed visually via presentation of primary and secondary study 
endpoints, as well as key baseline variables by study center.  No statistical method is 
proposed to assess poolability due to the lack of hypothesis testing associated with the 
primary study endpoints.  Differences between study sites will be investigated and 
elucidated in the study report.   
 
6.13 Enrollment 
Enrollment is competitive, but in order to reduce instance of a significant center effect, 
there will be an enrollment cap of 32% (19 subjects) per center. 

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7 
ASSESSMENTS AND FOLLOW-UP SCHEDULE 
 
Subjects will undergo the assessments outlined below. 
 
7.1 
Screening/Baseline Visit (Day -45 to Day 0) 
An initial evaluation will be used to determine if a subject may be considered for 
treatment. This evaluation includes an assessment of diagnostic testing that would have 
been done as part of a subject’s routine care. 
 
The data captured for the Screening Visit may be gathered over the course of more than 
one office visit; however, the data must have been obtained within 45 days of the 
scheduled procedure date. 
 
The following procedures will be performed at the Screening Visit prior to the procedure. 
All data must be recorded in the subject’s case report form (CRF): 
 
• Informed consent 
- The subject’s informed consent must be obtained prior to commencement of 
any study-related procedures/activities, using the site’s Institutional Review 
Board (IRB) approved consent form.  Standard of care procedures such as 
vitals or laboratory evaluations conducted prior to Screening may be used to 
fulfill screening requirements rather than repeating the test providing they 
are within the Screening period time window and all required data are 
available.  The informed consent will cover each of the following: 
• Agreement to participate in the study for the full 2 years; 
• Agreement to wear the study ID band and/or carry the cannulation 
template which provides the QR code link to the cannulation instruction 
animation video. 
• Willingness to have study-specific medical information collected if the 
subject desires to stop coming for study visits.  It should be noted that 
consent for this information collected is not a requirement for 
participating in the study; 
• Willingness to have part of the InnAVasc AVG collected for histology (if 
explanted for clinical reasons). It should be noted that consent for 
collection of histology is not a requirement for participation in the 
study. 
• Demographic information 
• Medical history including risk factors 
• Laboratory tests (within 45 days of index procedure) 
• Prior and concomitant medications 

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• Physical examination 
• Vessel mapping (if not done within 8 weeks; to ensure suitability of the 
implantation site and to exclude central vein stenosis on the side of graft 
implantation (if there is a suspicion for central venous obstruction)) 
 
• Review inclusion/exclusion criteria 
• Adverse events (occurring from a research only procedure) 
• Patient-reported outcomes questionnaire 
• Clinical laboratory tests  
- Clinical laboratory tests will be performed at this visit to establish baseline 
levels. It is recognized that specific panels may vary between institutions. 
Laboratory data will not be specially analyzed but will be used only to support 
AE evaluations. The following must be collected: 
• Complete blood count (CBC) [platelets and hemoglobin] 
• HbA1c 
• INR 
• Pregnancy test (unless no childbearing potential) 
 
7.2 
Treatment (Day 0) 
Implantation of the InnAVasc AVG is considered the treatment phase of the study. Refer 
to Section 2.8  above and/or to the Instructions for Use (IFU) for techniques and methods 
for device deployment. 
 
Subjects who require interventions to salvage the AVG, explantation of the AVG or the 
insertion of a central venous catheter due to treatment failure with the device will be 
followed at each of the follow-up visits specified in Table 2. 
 
The following data are to be recorded on the subject’s CRF. 
 
• Concomitant medication 
• Confirmation of inclusion/exclusion criteria 
• Device placement location and configuration (looped or straight) 

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• Required adjunctive therapy and additional procedures prior, post and/or during 
procedure 
 
• Confirmation of patency while the subject is in the operating room/ recovery 
room using physical exam (palpation or auscultation), or Doppler exam; 
• InnAVasc Graft first use; 
• Documentation of InnAVasc Graft use and patency beyond D0; 
• AE observation, evaluation, and treatment. 
 
 
Prior to discharge the subject will be instructed to contact the study staff promptly if he/she 
develops new or worsening pain, redness, local swelling or bruising around the surgical site 
or the graft or any generalized swelling of the operative arm.  If such symptoms occur and 
the investigator considers that they might be clinically significant an additional unscheduled 
visit should be scheduled. (As a minimum, AEs and concomitant medication should be 
recorded at an unscheduled visit.) Each subject will be provided with contact information for 
use in such circumstances.  These instructions will be repeated at every study visit. The 
dialysis unit treating the subject will be notified that the subject is participating in the study 
and will be asked to contact the study staff urgently if they have any concerns about the 
graft.  The subjects will be provided with the study ID band and cannulation template which 
are both equipped with the QR code link the “how to” cannulation animation video. 
 
7.3 
Follow-Up Assessment 
Formal, in person follow-up evaluation will be scheduled for 14 days (+/- 5 days) 45 days (+/- 
7 days), 6 months (+/- 14 days), 12 months (+/- 30 days), and 24 months (+/- 30 days) post-
procedure.  
 
During months 1, 3, 4, 5, 9 and 18 (+/- 7 days), telephone contact will be made with the 
dialysis unit to check on the status of the subject. At ALL study assessment time points, the 
dialysis records will be obtained to conduct an accurate assessment of the interval history 
with the recorded study graft related AEs, cannulation related events, known interventions, 
and graft function/patency information.  An additional step to ensure that all the AEs have 
been captured with these time intervals, will consist of direct contact of the subject by the 
study coordinator to capture any safety or intervention information that might have been 
missed by the dialysis unit.  The following assessments and procedures will be performed at 
the scheduled follow-up visits/assessments: 
 

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7.3.1 Day 14 (± 5 days) 
• Concomitant medication 
• Adverse events 
• InnAVasc graft use for HD 
• Documentation of InnAVasc Graft patency 
• Examination of access site 
• Documentation of InnAVasc graft interventions 
• Directed PE to evaluate AEs 
• Patient reported outcomes questionnaire 
 
7.3.2 Month 1 (M1) – Telephone (± 7 days) 
• Adverse events 
• Dialysis access use/patency 
• Documentation of graft interventions 
 
7.3.3 Day 45 (D45) - (± 7 days) 
• Documentation of InnAVasc Graft patency 
• Concomitant medication 
• Adverse events 
• InnAVasc graft use for HD 
• Examination of access site 
• Documentation of InnAVasc graft interventions 
• Patient-reported outcomes questionnaire 
 
7.3.4 Month 3 (M3) - Telephone (± 7  days) 
• Adverse events 
• Documentation of InnAVasc Graft patency 
• InnAVasc graft use for HD 
• Documentation of InnAVasc graft interventions 
 

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7.3.5 Month 4 (M4) - Telephone (± 7 days) 
• Adverse events 
• Documentation of InnAVasc Graft patency 
• InnAVasc graft use for HD 
• Documentation of InnAVasc graft interventions 
 
7.3.6 Month 5 (M5) - Telephone (± 7 days) 
 
• Adverse events 
• Documentation of InnAVasc Graft patency 
• InnAVasc graft use for HD 
• Documentation of InnAVasc graft interventions 
 
7.3.7 Month 6 (M6) (± 14 days) 
• Concomitant medication 
• Adverse events 
• Documentation of InnAVasc Graft patency 
• InnAVasc graft use for HD 
• Examination of access site 
• Documentation of InnAVasc graft interventions 
• Duplex ultrasound examination (patency, flow, and monitoring of entire graft 
length for aneurysm development) 
• Patient-reported outcomes questionnaire 
 
7.3.8 Month 9 (M9) - Telephone (± 7 days) 
• Adverse events 
• Documentation of InnAVasc Graft patency 
• InnAVasc graft use for HD 
• Documentation of InnAVasc graft interventions 
 
7.3.9 Month 12 (M12) (± 30 days) 
• Concomitant medication 

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• Adverse events 
• Documentation of InnAVasc Graft patency 
• InnAVasc graft use for HD 
• Examination of access site 
• Documentation of InnAVasc graft interventions 
• Patient-reported outcomes questionnaire 
 
7.3.10 Month 18 (M18) - Telephone (± 7 days) 
• Adverse events 
• Documentation of InnAVasc Graft patency 
• InnAVasc graft use for HD 
• Documentation of InnAVasc graft interventions 
 
7.3.11 Month 24 (M24) / Early Termination (ET) (± 30 days) 
• Concomitant medication 
• Physical examination 
• Adverse events 
• Dialysis access use 
• Examination of access site 
• Documentation of InnAVasc graft interventions 
• Patient-reported outcomes questionnaire 
 
7.4 
Assessment of Patency 
Patency and dialysis access use will be assessed at all visits (except Screening). For in 
person visits, patency will be assessed by investigator preference, by one of four 
methods: Palpation, auscultation, Doppler, or ultrasound. 
For telephone visits, patency will be assessed by dialysis unit treatment sheets.  The 
InnAVasc graft will be considered patent if any of the following is documented: 
• Palpation of thrill;  
• Auscultation of bruit; 
• Successful dialysis with one or two needles via the InnAVasc graft 
 

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7.5 
Dialysis Procedures 
 
Hemodialysis via the InnAVasc Graft is allowed as early as the same day as implant. For 
purposes of this clinical investigation, the expectation is that the first use of the 
InnAVasc AVG for two needle HD will occur on the same day as implant, or the next 
day, but not beyond 7 days post implant as long as medically appropriate.  Dialysis 
should be initiated using small needles (17G or 16G). This needle size should be used for 
at least the first 2 weeks of dialysis using the InnAVasc AVG. After 2 weeks the needle 
size may be increased and standard needles (no greater than 14G) may be used. Needle 
placement sites should be rotated using a rope - ladder technique to allow for healing of 
the skin, and to reduce graft material degradation secondary to area cannulation, and 
thus minimize the possibility of aneurysm formation or complication. A cannulation 
template will be provided for each subject participating in the study to ensure that 
proper needle site rotation is heeded during the study. The provided cannulation 
template and study ID bands are both equipped with the QR code link the “how to” 
cannulation animation video, which is in addition to education provided to the dialysis 
units and technicians from the dialysis organization education team and additional 
training direct from the Sponsor. Since the InnAVasc graft is an immediate use dialysis 
access graft, we will require proper skin preparations and sterile technique (including 
sterile glove use) prior to each cannulation occurring within the first 30 days post 
implant.  The InnAVasc graft features self-sealing properties, but gentle pressure should 
still be applied to needle puncture sites post needle withdrawal for at least 60 seconds 
(or until bleeding stops) to prevent skin capillary bleeding.  There is no need for 
application of a pressure dressing to needle puncture sites. 
 
7.6 
Patient Reported Outcomes Survey 
All subjects will be asked to respond to a short questionnaire with a focus on patient 
reported outcome measures (PROMs) and patient reported experience measures 
(PREMs) specific to hemodialysis access. The survey features approximately 12 questions 
(approximately 5-10 minutes to complete) that focus on technical aspects of vascular 
access, emotional concerns, pain and anxiety around vascular access, and logistical 
issues. The survey is administered in the study site clinic, during specified study visits at: 
Screening, D14, D45, M6, M12, and M24. 
7.7 
Secondary Interventions 
Subsequent to treatment, conditions warranting additional treatment (e.g., thrombosis, 
stenosis, etc.) may present. Any intervention taken to treat a condition involving the 
InnAVasc AVG shall be documented on the Additional Treatment CRF. Additional 
InnAVasc AVG devices may be provided for conditions involving the initially-treated 
lesion. Since such procedures would be secondary interventions, repeating the 
determination of eligibility and consenting are not required unless mandated by 
institutional policies. 
 

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Additional InnAVasc AVG devices may not be used for other conditions without prior 
written approval from the Sponsor. Such procedures must be presented in advance to the 
competent authorities and Institutional Review Board (IRB) unless deemed emergent. In 
either case, the use of the InnAVasc AVG device for other lesions/conditions shall be 
treated as a protocol deviation. 
 
7.8 
Early Termination Visit 
The subject may withdraw from the study at any time at their own or their physician’s 
discretion. If withdrawal occurs before the M24 visit, the subject will be asked to 
complete an early termination visit at which all assessments normally performed at M24 
will be completed. The reasons for early termination should be recorded in the CRF. 
 
7.9 
Unscheduled Post Treatment Follow-up Visits 
If a subject returns to the institution between scheduled follow-up visits for matters 
related to the study procedure, the visit will be treated as an unscheduled visit and the 
assessments completed at this visit will be done at the discretion of the Investigator. CRF 
pages are provided for unscheduled visits and contain the same information as all the 
follow-up visits, in addition to the reason for the visit.  Dialysis units are instructed to refer 
study subjects back to the investigator immediately if any adverse event, cannulation 
related issues, or safety concerns are identified in or around dialysis treatments. 
 
7.10 Withdrawals and Loss to Follow-up 
Participation is completely voluntary, and each subject is free to withdraw from the study 
at any time. An investigator also has the right to withdraw the subject from the study in 
the event of reasons concerning the health or well-being of the subject, or in the case of 
lack of cooperation. Should a subject decide to withdraw for any reason, or should the 
investigator decide to withdraw the subject, all efforts will be made to complete and 
report the observations up to the time of withdrawal as thoroughly as possible. A 
complete final evaluation at the time of the subject’s withdrawal must be made and an 
explanation given of why the subject is withdrawing or being withdrawn from the study. 
 
The reason for and date of withdrawal must be recorded on the subject’s End of Study CRF. 
If the reason for the withdrawal is a device-related or procedure-related AE, the event 
must be reported to the Sponsor and recorded in the CRF. 
If the index surgical implant procedure is aborted, the subject does not need to complete 
the follow-up assessments. In that circumstance, an Early Termination (ET) visit should be 
performed. 
 
If a subject dies during the course of the study, the Sponsor will request an autopsy 
provided the subject authorized an autopsy in the event of death during the course of the 
study. Autopsy observations should include documentation of condition of body organs 
and determination of device and/or procedure relationship to death. 

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All efforts will be made to retain subjects in order to collect data at all the follow-up visits 
(14 days through 24 months). Due diligence in reaching the subject must be made by: 
 
• Two documented telephone contact attempts, emails, or regular postal mail 
letters; and 
 
• Certified letter 
After the above attempts were made, if no response is obtained, the final evaluation of a 
given subject will be the last visit at which study-related procedures were performed on 
that subject. The End of Study CRF page will need to be completed and communication 
attempts will need to be documented. 
 
7.11 Study Duration 
The total study duration (first subject enrolled to the last subject’s final study visit) is 
expected to be approximately 34 months. The total duration for each subject’s 
participation is expected to be 25.5 months. 
 
7.12 Histological Examination of Resected InnAVasc AVG Material 
If all or part of the InnAVasc AVG is resected it should, wherever possible, be retained for 
future histological examination. Instructions for preservation, storage and shipping of this 
material will be provided separately in a procedures manual. If a subject dies with an 
InnAVasc AVG in situ and it is feasible to obtain a fresh post mortem sample of the graft 
this should be attempted in accordance with local regulations. 

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8 
STUDY MANAGEMENT CONSIDERATIONS 
 
8.1 
Protocol Modifications 
No changes from the final approved (signed) protocol will be initiated without the IRB’s 
prior written approval or favorable opinion of a written amendment, except when 
necessary to eliminate immediate hazards to the subjects or when the change involves 
only logistics or administration. The Principal Investigator will acknowledge the 
amendment by signing the Protocol Agreement. 
 
8.2 
Protocol Deviations 
A protocol deviation is the non-adherence to or divergence from the protocol-specific 
study procedures. For example, violations of the inclusion and exclusion criteria, 
deviations from the schedule of required follow-up assessments, improper or lack of 
consent, and lack of IRB approval, would all be considered protocol deviations. A protocol 
deviation undertaken to protect the life or physical well-being of the subject in an 
emergency is a special circumstance that must be reported to the Sponsor and the 
reviewing IRB within 5 working days. The Sponsor must report the deviation to the FDA 
within 5 working days after the Sponsor learns of the deviation. No other type of 
prospective protocol deviation is permitted without prior approval. A record of all protocol 
deviations will be maintained and reviewed throughout the conduct of the study. The 
Sponsor will address deviations and take appropriate corresponding action. Continued 
non-compliance with the study protocol may lead to termination of the 
Investigator’s participation in the study. 
 
8.3 
Information to Study Personnel 
The Investigator is responsible for giving information about the study to all staff members 
involved in the study or in any element of subject management, both before starting the 
study procedures and during the course of the study (e.g., when new staff become 
involved). The Investigator must ensure that all study staff members are qualified by 
education, experience, and training to perform their specific responsibilities. 
 
The sites will be trained on the protocol and device by the sponsor or designee. 

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9 
ASSESSMENTS OF SAFETY 
 
9.1 
Definitions 
9.1.1 Adverse Event 
An adverse event (AE) is an untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device. 
• This definition includes events related to the procedures  involved. 
Adverse events are rated in several ways: 
• 
Severity (mild, moderate, severe) 
- Mild: No limitation of usual activities, no therapy or only symptomatic therapy 
required to treat the injury or illness. 
- Moderate: Some limitation of usual activities or specific therapy is required. 
- Severe: Inability to carry out usual activities, hospitalization, emergency 
treatment, life threatening events, or death. 
• Anticipated (anticipated, not anticipated) 
• Device and procedure relationships (unrelated, possibly related, or definitely 
related) 
- Unrelated: The clinical event is completely independent of study 
procedure/study device and/or evidence exists that the event is definitely 
related to another etiology. 
- Possibly related: The clinical event occurs within a reasonable time sequence to 
study procedure/study device and there is some evidence to “possibly” 
suggest a causal relationship. However, the influence of other factors such as 
underlying disease, concomitant medications, or concurrent treatment may 
have contributed to the event. 
- Definitely related: The clinical event occurs in a plausible time relationship to 
study procedure/study device and cannot be explained by any concurrent 
disease or other devices, drugs or chemicals. 
9.1.2 Serious Adverse Event 
A Serious Adverse Event (SAE) is an adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) 
a life-threatening illness or injury, or 
2) 
a permanent impairment of a body structure or a body function, or 
3) 
in-patient or prolonged hospitalization, or 
4) 
medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or a body function, 

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c) led to fetal distress, fetal death or a congenital abnormality or birth defect 
Planned hospitalization for a pre-existing condition, or a procedure required by the 
clinical investigation plan (i.e., protocol), without serious deterioration in health, is not 
considered a serious adverse event. 
9.1.3 Adverse Event of Special Interest 
An adverse event of special interest (AESI) is a subcategory of adverse events that include 
any of the primary safety endpoints. 
 
9.1.4 Device Deficiency 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. Device deficiencies include malfunctions, use 
errors, and inadequate labelling. 
 
9.1.5 Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of an investigational medical 
device. 
• This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
• This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device. 
9.1.6 Serious Adverse Device Effect 
A serious adverse device effect (SADE) is an adverse device effect that has resulted in any 
of the consequences characteristic of a serious AE. 
 
9.1.7 Unanticipated Serious Adverse Device Effect 
An unanticipated serious adverse device effect (USADE) is defined as serious adverse 
device effect which by its nature, incidence, severity or outcome has not been identified 
in the current version of the risk analysis report. 
 
Section 14.1 includes a list of possible adverse events associated with AVG implantation 
and use, including those events considered AESIs.  
 
9.2 
Reporting of Adverse Events and Device Deficiencies 
All adverse events and device deficiencies must be via the Adverse Event Case Report 
Form. The report should include, whenever possible, severity, duration, outcome, and the 
Investigator’s medical judgment as to the relationship of the adverse event to the study 
device, procedure, or underlying disease (i.e., not related, possibly related, or definitely 

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related). 
 
All SAEs and device deficiencies that could have led to a SADE  must be reported to the 
Sponsor or its Contract Research Organization (CRO) within 1 business day of the 
Investigator’s knowledge of the event using the SAE report form. IRB notification of the 
AE may also be required, depending on the conditions of approval or requirements of the 
respective committee.  
 
Emergency contact details for reporting SAEs and device deficiencies that could lead to 
SADEs are specified below: 
 
Study initiation to 6 months: 
SCOPE International Pharmacovigilance  
E-Mail:  safety@scope-international.com  
Fax:  +370 52 327 903 
Tel:  +370 52 360 349 
 
Beyond 6 months (for each patient), safety reporting transitions to: 
TAB Clinical Pharmacovigilance 
E-Mail:  dbuckley@tabclinical.com 
Fax:  919 882 1451 
Tel:  919 694 5454 
Following notification by the Investigator, the Sponsor will immediately conduct an 
evaluation of the event(s) and SCOPE Pharmacovigilance or the Sponsor will report 
USADEs and device deficiencies that could have led to a SADE to all participating IRBs, 
Investigators, and FDA on expedited basis, as required by the FDA within 10 working days 
after the Sponsor first receives notice of the adverse effect. 
 
Certain 
reportable 
events 
may 
require 
adjudication; 
therefore, 
supporting 
documentation must be sent to the Sponsor/CRO, as requested. 
 
9.3 
Data Safety Monitoring Board 
The Data Safety Monitoring Board (DSMB) will be responsible to assure the study is being 
conducted ethically and to adjudicate all possibly and definitely device and/or procedure-
related serious adverse events. The DSMB membership is represented from the key 
medical disciplines involved with the care of ESRD patients and the creation and 
management AV access, and includes a biostatistician. None of the members is directly 

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involved with the clinical trial and all possess experience with clinical trial participation or 
management in the ESRD or AV access space. The Sponsor has contracted a third party to 
organize, facilitate, and document meetings for the DSMB for this trial. The DSMB will 
meet regularly and as necessary, guided by a DSMB charter. 
 
Since this study has been designed to sufficiently characterize effectiveness and safety 
outcomes, the study does not contain hypothesis testing to statistically assess study 
success.  As such, the DSMB will make recommendations on protocol modifications and 
continuation of the study based on what the relevant literature provides as expected 
ranges for success in both primary effectiveness and safety.  This will provide a 
mechanism to visually assess the comparability of the study results relative to prior, 
relevant research.  These metrics are explained and defined within the DSMB charter. 

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10 DEVICE ACCOUNTABILITY 
 
10.1 Accountability and Procedures 
a.) Each device shipment must be documented on the Device Accountability Log and 
include the receipt, dispensing, and return of investigational devices. 
b.) When a shipment is received, the Investigator (or designee) must record on the 
Device Accountability Log the date received and the Catalog and Lot Number of 
each device. It is recommended that the Packing List also be signed and dated. 
c.) Investigational devices must be kept in a secure, limited access storage area under 
recommended storage conditions (room temperature). 
d.) During the course of the study, the following information must also be noted on 
the Device Accountability Log: 
• Identification number of the subject for whom the device was intended 
• Procedure date 
e.) The Device Accountability Log must be readily available for inspection by 
representatives from the Sponsor, the IRB, and/or other relevant regulatory 
authorities at any time. 
f.) The Device Accountability Log and device storage locations will be reviewed during 
monitoring visits. 
g.) All unused investigational devices must be returned to InnAVasc Medical, Inc. once 
it is determined they will not be used. Upon completion of the study, all unused 
investigational devices must be returned to InnAVasc Medical, Inc., if any remain 
at the site. The monitor is to verify return. 

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11 STUDY ADMINISTRATION 
 
11.1 Site Initiation 
A Site Initiation Visit (SIV) will be conducted by the Sponsor or other appropriate 
designee, for example, its contract research organization (CRO), to ensure that all study 
supplies are present, to ensure proper training of the Investigator and study staff 
members in study-specific procedures, to ensure regulatory requirements are fulfilled 
prior to enrollment of the first study subject at a site, and to verify the site facilities and 
equipment are appropriate for conduct of the study. 
11.2 Training and Oversight of Dialysis Units 
Although neither the dialysis organizations nor the individual dialysis units are study sites, 
the dialysis units and staff will play an integral role in documenting safety and 
effectiveness information required for the study or reporting safety concerns to the 
investigator sites.  The information required for the clinical study is part of the standard 
medical record and will be requested from the dialysis units by the investigator at each 
study visit/communication date listed in the Schedule of Assessments table (Table 4).  This 
will ensure that all pertinent safety and effectiveness information is collected throughout 
the duration of the clinical trial. 
In advance of first access, the Sponsor will ensure that the dialysis staff accessing the graft 
is trained via a platform agreeable to the dialysis center.  Training documentation will be 
collected by the sponsor and will be filed in the trial master file (TMF).  The sponsor will 
be available for questions from the dialysis centers during usual dialysis center business 
hours. In addition, the provided cannulation template and study ID bands are both 
equipped with the QR code link the “how to” cannulation animation video. This will help 
to serve as an adjunct to initial training, but will also serve as cannulation training in the 
event that a subject is admitted to another dialysis unit or hospital without the primary 
dialysis unit, the subject’s PI, or study Sponsor being notified. 
 
Specific attention should be paid to needle cannulation related AEs in and around the 
InnAVasc graft cannulation sites.  Information essential to document should include (but 
not limited to) what is provided in the list below: 
a. Missed graft puncture attempt 
b. Hematoma formation (during HD, or post needle withdraw) 
c. Identification of Pseudoaneurysm development 
d. Bleeding from graft (> 10 min) 
e. Infection present at access site 
f. Ulcers or eschar development 
g. Skin erosion 

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h. Suspected backwall puncture 
i. Elevated pressures in graft circuit 
j. Needle displacement during dialysis. 
k. Wounds or complications at the access site 
 
11.3 Study Monitoring 
Interim monitoring visits will be conducted by InnAVasc Medical, Inc., personnel or other 
appropriate designees (e.g., a CRO) to ensure compliance with standard operating 
procedures (SOPs), the protocol, and other written instructions and regulatory guidelines. 
 
The study monitor will contact and visit the Investigator at regular intervals throughout 
the study (refer to Monitoring Plan for details). The monitor will be allowed to check and 
verify the various records (CRFs and other pertinent source data records) relating to the 
study to verify adherence to the protocol and to ensure the completeness, consistency, 
and accuracy of the data being recorded. 
 
As part of the supervision of the study progress, other Sponsor personnel may accompany 
the study monitor on visits to the study center. The Investigator and assisting staff must 
agree to cooperate with the study monitor to resolve any problems, errors, or possible 
misunderstandings concerning the findings detected in the course of these monitoring 
visits. 
 
11.4 Study Termination 
InnAVasc Medical, Inc. and applicable regulatory authorities have the right to terminate 
the entire study or a study site at any time. Situations that could warrant study termination 
include, but are not limited to: 
 
a) Increased incidence of adverse experiences and/or the severity of such, suggestive 
of a potential, device-related health hazard 
b) Insufficient subject enrollment 
c) Recurrent protocol non-compliance, violations or deviations 
d) Inaccurate, incomplete, and/or untimely data recording (>2 business days) on a 
recurrent basis 
e) Lack of cooperation with monitoring visits (e.g., failure to adequately prepare for 
visits, address action items from one visit to the next, or provide access to medical 
records) 
11.5 Data Handling and Recordkeeping 
11.5.1 Completing, Signing and Archiving Case Report Forms 
The investigator must keep a separate subject identification list showing enrollment 

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numbers, names, and dates of birth to allow unambiguous identification of each 
subject included in the study. It is recommended a note be made in the medical record 
that the subject is participating in a clinical research study. 
 
The required data will be recorded on CRFs. Clinical study data will be collected using 
electronic case report forms (eCRFs). A web-based electronic data capture (EDC) 
database will be used to record and manage study data. eCRF completion guidelines, 
the instructions for electronic data-entry, will be developed in conjunction with the 
sponsor, the CRO, and/or the EDC vendor. The CRFs will be completed electronically 
or legibly in black or blue ink, with reasons documented for missing data. All eCRFs 
must be kept in good order and updated so they always reflect the latest observations 
on the subjects participating in the study. 
 
The Investigator will sign the appropriate pages of the CRF and source documentation. 
eCRF corrections will be made electronically and signed electronically by the 
Investigator. An embedded audit trail will capture the date, time and user making 
updates and changes to the electronic data. 
 
Because it is important to have proper data collection in a timely manner, within 2 
business days, the Investigator/Study Coordinator shall complete the eCRFs and 
provide them to the monitor upon request. When the monitor requests additional 
data or clarification of data for the eCRF, the request must be answered satisfactorily 
before the next monitoring visit. 
 
11.5.2 Data Management and Archiving 
The Sponsor will be responsible for the processing and quality control of the data. 
Source data for safety will be retained for at least 2 years after the 
termination/completion of the study or after the approval/withdrawal of the 
marketing application, whichever occurs later. All other source data, eCRFs, copies of 
protocols and protocol amendments, device accountability forms, correspondence, 
subject identification lists, informed consent forms, and other essential documents 
must be retained for a period of at least 2 years after the last approval of the marketing 
application and until there are no pending or contemplated marketing applications, or 
at least 2 years have elapsed since the formal discontinuation of clinical development 
of the investigational device. 
InnAVasc Medical, Inc. will inform the Investigator/institution when these documents 
are no longer required to be retained. 
 
No study document or image will be destroyed without prior written agreement 
between the Sponsor and the Investigator. Should the Investigator wish to assign the 
study records to another party or move them to another location, advance written 
notice must be given to the Sponsor. 
 

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11.5.3 Direct Access to Source Data/Documentation 
The Sponsor, auditors, and health authority inspectors (or their agents) will be given 
direct access to source data and documentation (e.g., medical charts/records, 
laboratory test results, printouts, videotapes) for source data verification, provided 
that subject confidentiality is maintained in accordance with local requirements. 
 
The Investigator must maintain, at all times, the primary records, (i.e., source 
documents) of each subject’s data. Examples of source documents are hospital 
records, office visit records, examining physician’s findings or progress notes, 
consultant’s written opinion or notes, laboratory reports, device inventory, device 
label records, and CRFs that are used as the source. 
 
The Investigator will maintain a confidential subject identification list that allows the 
unambiguous identification of each subject. All study-related documents must be kept 
until notification by InnAVasc Medical, Inc. 

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12 ETHICS 
 
12.1 Informed Consent 
Written informed consent must be obtained for each subject before any study-specific 
procedures or assessments are done and, specifically, prior to the subject being treated 
with the InnAVasc AVG. Written informed consent will be obtained after the aims, 
methods, anticipated benefits, and potential hazards are explained. 
 
The subject’s willingness to participate in the study will be documented in writing in a 
study-specific informed consent form, which will be signed and dated by the subject. The 
investigator will keep the original consent form and a copy will be given to the subject. It 
will be explained to the subjects that this is a voluntary study and they are free to 
withdraw from the study at any time without prejudice to future treatment. 
 
12.2 Institutional Review Board 
This study must be approved by an appropriate IRB respectively at each investigational 
site. The Investigator will ensure that IRB approval is obtained prior to starting the study, 
as defined by regulations (21 CFR §56.103 and 21 CFR §812.110(a)). 
 
The Sponsor must receive a copy of the IRB approval letter (or equivalent documentation) 
for the study protocol and informed consent form before the study can be started at that 
site or devices shipped to that Investigator. 
 
The IRB and Sponsor must approve any significant changes to the protocol as well as a 
change of Principal Investigator. Documentation of the IRB approval must be provided to 
the Sponsor. Records of all study review and approval documents must be maintained by 
the Investigator in the Regulatory Binder and are subject to inspection by the Sponsor or 
regulatory authority during or after completion of the study. 
Unexpected Serious Adverse Events, unanticipated problems adding risk to subjects, and 
deaths must also be reported to the IRB and Sponsor (reference Section 10.2 for reporting 
instructions). 
 
The Investigator must notify the IRB, as per their reporting guidelines, and the Sponsor 
when he or she deviates from the protocol. The Sponsor must be notified of all relevant 
action taken by the IRB and must receive a copy of all study-related correspondence 
between the Investigator and the IRB. 
 
The IRB must receive notification of the completion of the study and final report within 3 
months of study completion or termination. The Investigator must maintain an accurate 
and complete record of all submissions made to the IRB, including a list of all reports and 
documents submitted. 
 

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12.3 Confidentiality Regarding Study Subjects 
The Investigator must ensure that the privacy of all subjects, including their personal 
identity and all personal medical information, will be maintained at all times. In CRFs and 
other documents or image material submitted to the Sponsor, subjects will not be 
identified by their names, but by an individual identification (ID) code (i.e., institutional 
ID and subject identification number). 
 
Personal medical information may be reviewed for the purpose of verifying data recorded 
in the CRFs. The monitor may conduct source-document verification on behalf of the 
Sponsor, the quality assurance unit, or regulatory authorities. Personal medical 
information will always be treated as confidential. 
 
12.4 Participating Institutions and Investigators 
Study sites and Investigators will be selected based on a variety of factors including, but 
not limited to, experience with the surgical implantation of AV access sites, access to 
required facilities and equipment, sufficient and adequately trained personnel including 
in human clinical research, and availability of potential subjects. The criteria used for 
determination will be documented. No other centers/institutions are intended to 
participate in this study without permission from the relevant regulatory authority. 
 
12.5 Agreements 
All Principal Investigators and their Sub-Investigators or Co-Investigators must sign an 
Investigator Agreement. InnAVasc Medical Inc., (or the authorized CRO) must receive a 
copy of the signed Investigator Agreements before the study may be started at that 
institution or devices shipped. Any Investigators joining the study after the site has been 
initiated may not receive devices or participate until an agreement is signed and received 
by the Sponsor. 
 
12.6 Responsibilities 
Investigator responsibilities include, but are not limited to, the following: 
a.) Conducting the study in accordance with this investigational plan, signed 
agreement, and applicable regulations protecting the rights and safety of study 
subjects 
b.) Informing all subjects that the device being utilized is for investigational purposes 
only, and ensuring that the requirements relating to obtaining informed consent 
and IRB approval are met 
c.) Ensuring that informed consent is obtained for each study subject in accordance 
with applicable regulations (e.g., ISO 14155-2011, ICH GCP, 21 CFR Part 50) 
d.) Ensuring that IRB approval is secured prior to starting the study and ensuring 
continuing review and approval as required throughout the investigation 

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e.) Ensuring all associates, colleagues, and employees assisting in the conduct of the 
study are informed about their obligations, are adequately qualified and trained, 
and meet their commitments 
f.) Maintaining adequate and accurate records and ensuring those records are 
available for inspection at any time 
g.) Ensuring that conducting the study does not give rise to conflict of interest 
(financial disclosure is required) 
h.) Controlling of all investigational devices under investigation. 

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13 DATA SECURITY AND SCIENTIFIC INTEGRITY 
 
13.1 Access to Data 
The Sponsor, auditors, and health authority inspectors (or their agents) will be given 
access to source data and documentation (e.g., medical charts/records, laboratory test 
results, printouts, videotapes, etc.) for source data verification, provided that subject 
confidentiality is maintained in accordance with local requirements. 
 
The Investigator must maintain, at all times, the primary records (source documentations) 
of each subject’s data. Examples of source documents are hospital records, office visit 
records, examining physician’s finding or notes, consultant’s written opinion or notes, 
laboratory reports, device inventory, device label records, and CRFs that are used as the 
source. 
 
The Investigator will maintain a confidential subject identification list that allows the 
unambiguous identification of each subject. 
 
13.2 Security and Confidentiality 
The Investigator must ensure that the privacy of all subjects, including their personal 
identity and all personal medical information, will be maintained at all times. In CRFs and 
other documents or image material submitted to the Sponsor, subjects will not be 
identified by their names, but by an identification code (i.e., subject number). 
 
Personal medical information may be reviewed for the purpose of verifying data recorded 
in the CRFs. The monitor may perform source data verification on behalf of the Sponsor 
or regulatory authorities. Personal medical information will always be treated as 
confidential. 
 
13.3 Electronic Data 
Electronic data will only be accessible to authorized personnel through the use of a 
unique user identifier and password. Passwords are set to expire periodically. Access to 
electronic study data will be provided to research personnel upon completion of training. 
Read and write access will be provided to investigational sites but only for information 
and subject data at their own site. The CRO will have read-only access and can post 
queries for potential data-related discrepancies. 

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14 RISK ANALYSIS 
 
14.1 Risks to the Subjects 
Treatment with the InnAVasc AVG is a procedure that poses significant risks to the 
subject, although these risks are not expected to be greater than with the current 
standard of care AVGs presently available. A summary of some of the known risks are 
identified in Table 3; however, there may be risks that are not known or are unforeseen 
at this time. The risks include those related to the device and to the procedure, including 
those related to concomitant medications used periprocedurally and during follow-up. 
 
Table 3: Known Risks of Arteriovenous Graft Implantation 
Event Category 
Event 
Bleeding 
Early, postoperative 
Prolonged bleeding from needle puncture 
site 
Infection 
Early infection, during procedure 
Late infection, due to cannulation 
Noninfectious fluid collections 
Hematoma 
Seroma 
Lymphocele 
Anastomotic complications 
Hemorrhage 
Pseudoaneurysm 
Stenosis with intimal hyperplasia 
Mid-AV 
access/runoff 
vein 
complications 
Dilation/aneurysm 
Pseudoaneurysm at needle stick site 
Mid-AV access stenosis 
AV access malfunction 
Insufficient inflow 
Insufficient runoff 
Inability to puncture 
Ischemia 
Steal syndrome 
Cardiac 
Myocardial infarction 

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Table 3. Known Risks of Arteriovenous Graft Implantation 
Event Category 
Event 
Congestive heart failure 
Arrhythmia 
Valve disorders; stenosis and insufficiency 
Hypertension 
Hypotension 
Wound 
Wound infection 
Wound pain 
Wound dehiscence 
Serous wound drainage 
Lymphorrhea 
Hematoma 
Ecchymosis 
Venous 
Deep venous thrombosis 
Pulmonary embolism 
Paradoxical embolization 
Venous hypertension 
Local 
Arm edema 
Arm pain 
Back pain 
Cerebrovascular 
Transient ischemic attack 
Stroke 
Intracranial hemorrhage 
Genitourinary 
Urinary retention 
Urinary tract infection 
Renal stones 
Renal insufficiency, failure 
Hematuria 

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Table 3. Known Risks of Arteriovenous Graft Implantation 
Event Category 
Event 
Impotence and other disorders of sexual 
function 
Pulmonary 
Exacerbation of chronic lung disease 
Pneumonia 
Pulmonary embolism 
Respiratory failure 
Bronchitis 
Bronchospasm 
Gastrointestinal 
Peptic ulcer disease 
Reflux esophagitis 
Nausea and vomiting 
Diarrhea 
Constipation 
Hepatitis 
Hepatic insufficiency 
Cholelithiasis / cholecystitis 
Metabolic/systemic disorders 
Electrolyte imbalances 
Hyperglycemia 
Hypoglycemia 
Fluid overload 
Dehydration 
Thrombocytopenia 
Leukopenia 
Anemia 
with 
or 
without 
need 
for 
transfusion 
Miscellaneous 
Sepsis 
Skin erosion 
Table 3. Known Risks of Arteriovenous Graft Implantation 

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Event Category 
Event 
Compartment syndromes 
Psychiatric disorders including depression 
Mental status changes 
Insomnia 
Allergic reactions to device components 
Allergic 
reactions 
to 
concomitant 
medications 
 
There are other health risks and discomforts associated with the testing that the subjects 
will undergo before and after their procedure, including, but not limited to, bruising 
during blood collection, pain and bruising at the access site and radiation exposure during 
imaging procedures. 
 
14.2 Risk Mitigation 
The Sponsor designed the InnAVasc AVG and the clinical investigational protocol to 
minimize risks to the study participants. Study eligibility criteria were formulated to limit 
use of the study device to subjects that fit the device specifications. Evaluation of safety 
data by an independent DSMB will provide an ongoing assessment of safety- related 
events, both individually and in aggregate. 
 
14.3 Benefit to Subjects 
It is hoped that the InnAVasc AVG will provide an additional improved treatment option 
for patients with ESRD requiring hemodialysis. The InnAVasc AVG has several advantages 
over many of the AVGs that are currently available. The InnAVasc device may reduce the 
number of complications associated with the implantation and use of AVGs. For example, 
the InnAVasc AVG can be cannulated immediately, reducing the need for the insertion of 
a temporary CVC and thereby eliminating exposure of the patient to CVC associated 
infections and complications. In addition, the design of the InnAVasc AVG aims to reduce 
graft injury due to improper cannulation and allows for easier cannulation. Lastly, this 
device is designed to reduce graft compression and the resulting interruptions in blood 
flow. 
 
14.4 Study Justification 
This study is justified considering previous work showing positive outcomes obtained 
through use of the InnAVasc AVG. This study will attempt to build on past results and, 
potentially, identify additional benefits of AV access grafts in patients with ESRD. 

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15 PUBLICATION POLICY AND PUBLIC DISCLOSURE 
 
The information generated by this trial is the property of InnAVasc Medical, Inc. InnAVasc 
Medical, Inc. will appropriately publish the results of this clinical trial in accordance with all 
applicable regulations. 
 
This study will be listed in the www.clinicaltrials.gov database, and results will be posted 
following the end of the study. 

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16 REFERENCES 
 
1. Hill NR, Fatoba ST, Oke JL, et al. Global Prevalence of Chronic Kidney Disease – A 
Systematic Review and Meta-Analysis. PLoS ONE 2016;11:e0158765. 
 
2. Saran R, Robinson B, Abbott KC, et al. US renal data system 2016 annual data report: 
epidemiology of kidney disease in the United States. Am J Kidney Dis 2017;69:A7-A8. 
 
3. Fraser SDS, Roderick PJ, May CR, et al. The burden of comorbidity in people with 
chronic kidney disease stage 3: a cohort study. BMC Nephrol 2015;16:193. 
 
4. Anderson S, Halter JB, Hazzard WR, et al. Prediction, progression, and outcomes of 
chronic kidney disease in older adults. J Am Soc Nephrol 2009;20:1199-209. 
 
5. Wetmore JB, Collins AJ. Global challenges posed by the growth of end-stage renal 
disease. Ren Replace Ther 2016;2:15. 
 
6. Collins AJ, Foley RN, Herzog C, et al. US renal data system 2012 annual data report. Am J 
Kidney Dis 2013;61:A7. 
 
7. Feldman HI, Kobrin S, Wasserstein A. Hemodialysis vascular access morbidity. J Am Soc 
Nephrol 1996;7:523-35. 
 
8. Maya ID, Allon M. Vascular Access: Core Curriculum 2008. Am J Kidney Dis 2008;51:702-
8. 
 
9. Torreggiani M, Scaramuzzi ML, Manini A, et al. Hemodialysis vascular access: everything 
you always wanted to know about it (but were afraid to ask). J Nephrol 2013;26:836-47. 
 
10. Murphy F. The ongoing challenges with renal vascular access. Br J Nurs 2011;20:S6- 
S14. 
 
11. Ethier J, Mendelssohn DC, Elder SJ, et al. Vascular access use and outcomes: an 
international perspective from the dialysis outcomes and practice patterns study. Nephrol 
Dial Transplant 2008;23:3219-26. 
 
12. Mickley V. Central venous catheters: many questions, few answers. Nephrol Dial 
Transplant 2002;17:1368-73. 
 
13. Macdonald S, Watt AJB, McNally D, Edwards RD, Moss JG. Comparison of technical 
success and outcome of tunneled catheters inserted via the jugular and subclavian 

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approaches. J Vasc Interv Radiol 2000;11:225-31. 
 
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Access. Semin Dial 2011;24:515-24. 
 
16. Lynch JR, Wasse H, Armistead NC, McClellan WM. Achieving the Goal of the Fistula First 
Breakthrough Initiative for Prevalent Maintenance Hemodialysis Patients. Am J Kidney Dis 
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18. Lok CE, Allon M, Moist L, Oliver MJ, Shah H, Zimmerman D. Risk Equation Determining 
Unsuccessful Cannulation Events and Failure to Maturation in Arteriovenous Fistulas 
(REDUCE FTM I). J Am Soc Nephrol 2006;17:3204-12. 
 
19. Lee T, Roy-Chaudhury P. Advances and New Frontiers in the Pathophysiology of Venous 
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38. 
 
20. Jacek JP, Alan D. Arterial Wall Shear Stress: Observations from the Bench to the 
Bedside. Vasc Endovascular Surg 2003;37:47-57. 
 
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2005;20:2629-35. 
 
22. Chiang N, Hulme KR, Haggart PC, Vasudevan T. Comparison of FLIXENE™ and standard 
PTFE arteriovenous graft for early haemodialysis. J Vasc Access 2014;15:116- 22. 
 
23. Berard X, Ottaviani N, Brizzi V, et al. Use of the Flixene vascular access graft as an early 
cannulation solution. J Vasc Surg 2015;62:128-34. 
 
24. Schild AF. Maintaining vascular access: the management of hemodialysis arteriovenous 
grafts. J Vasc Access 2010;11:92-9. 
 
25. Roy-Chaudhury P, Kelly BS, Miller MA, et al. Venous neointimal hyperplasia in 
polytetrafluoroethylene dialysis grafts. Kidney Int 2001;59:2325-34. 
 

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26. Li L, Terry CM, Shiu Y-TE, Cheung AK. Neointimal hyperplasia associated with synthetic 
hemodialysis grafts. Kidney Int 2008;74:1247-61. 
 
27. Padberg FT, Jr., Calligaro KD, Sidawy AN. Complications of arteriovenous hemodialysis 
access: Recognition and management. J Vasc Surg 2008;48:S55-S80. 
 
28. Galanopoulos G, Lambidis C. Infectious complications of prosthetic arteriovenous grafts 
for hemodialysis: prevention is better than cure. Ren Fail 2014;36:658-60. 
 
29. Raju S. PTFE grafts for hemodialysis access. Techniques for insertion and management 
of complications. Ann Surg 1987;206:666-73. 
 
30. Rodriguez JA, Armadans L, Ferrer E, et al. The function of permanent vascular access. 
Nephrol Dial Transplant 2000;15:402-8. 
 
31. Huber TS, Carter JW, Carter RL, Seeger JM. Patency of autogenous and 
polytetrafluoroethylene upper extremity arteriovenous hemodialysis accesses: a systematic 
review. J Vasc Surg 2003;38:1005-11. 
 
32. Sidawy AN, Gray R, Besarab A, et al. Recommended standards for reports dealing with 
arteriovenous hemodialysis accesses. J Vasc Surg 2002;35:603-10. 
 
33. Glickman MH, Burgess J, Cull D, Roy-Chaudhury P, Schanzer H. Prospective multicenter 
study with a 1-year analysis of a new vascular graft used for early cannulation in patients 
undergoing hemodialysis. J Vasc Surg 2015;62:434-41. 
 
34. Dixon BS, Beck GJ, Vazquez MA, Greenberg A, Delmez JA, Allon M, Dember LM, 
Himmelfarb J, Gassman JJ, Greene T, Radeva MK. Effect of dipyridamole plus aspirin on 
hemodialysis graft patency. New England Journal of Medicine. 2009 May 21;360(21):2191-
201. 
 
35. Beathard GA, Lok CE, Glickman MH, Al-Jaishi AA, Bednarski D, Cull DL, Lawson JH, Lee 
TC, Niyyar VD, Syracuse D, Trerotola SO. Definitions and end points for interventional 
studies for arteriovenous dialysis access. Clinical Journal of the American Society of 
Nephrology. 2018 Mar 7;13(3):501-12. 
 
 
 

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17 Table 4:  Schedule of Assessments 
Assessment 
Screening/ 
Baseline 
(Day -45 to 
Day 0) 
Treatment 
(Day 0) 
Day 
14 
± 5 
days 
M1 
± 7 
days 
D 45 
± 7 
days 
M3 
± 7 
days 
M4 / 
M5 
± 7 
days 
M6 
± 14 
days 
M9 
± 7 
days 
M12 
± 30 
days 
M18 
± 7 
days 
M24 
± 30 
days / 
ET Visit 
On-site visit  / telephone contact 
(1) 
 
 
 
 
 
 
 
 
  
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographic information (2) 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical history (3) 
X 
 
 
 
 
 
 
 
 
 
 
 
Laboratory tests (4) 
X 
 
 
 
 
 
 
 
 
 
 
 
Prior and concomitant medications 
X 
X 
X 
 
X 
 
 
X 
 
X 
 
X 
Directed physical examination 
X 
 
X 
 
 
 
 
 
 
 
 
X 
Vessel mapping 
(if not done within 8 weeks) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
Surgical placement of InnAVasc AVG 
 
X 
 
 
 
 
 
 
 
 
 
 
Documentation of adjunctive 
procedures and any complications 
during surgery 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Adverse events (5) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
InnAVasc Graft first use (6) 
 
X 
 
 
 
 
 
 
 
 
 
 
Documentation of graft use and 
patency 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

22 May 2019 
 
 
 
Page 70 of 70 
 
Examination of access site 
 
 
X 
 
X 
 
 
X 
 
X 
 
X 
Documentation of graft interventions 
 
 
X 
 
X 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Duplex ultrasound examination or 
angiography 
 
 
 
 
 
 
 
 
X 
 
 
 
 
Patient-reported outcome 
questionnaires (7) 
 
X 
 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
X 
(1) Assessment Days and Months are relative to Day 0. 
(2) Demographic data will also include smoking history. 
(3) Medical history will include relevant prior and ongoing diseases, in particular: etiology of kidney disease and kidney transplant 
history, and risk factors. 
(4) The following must be collected: CBC (platelets and hemoglobin), HbA1c, INR, pregnancy test (unless no childbearing potential). 
 
(5) For screening, only AEs related to study specific procedures should be recorded. 
 
(6) First use to be captured on D0.  Reason for first use beyond 7 days will be documented in eCRF. 
 
(7) In the event a patient early terminates due to no AVG placement or prior to first cannulation, this questionnaire is not required. 
 

Page 1 of 8 
 
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for 
Hemodialysis Access in Patients with End-Stage Renal Disease 
 
 
 
 
Investigational Device: InnAVasc Vascular Access Graft 
Protocol Number: CSP-1001 
IDE Number: G180188 
Addendum A: May 18, 2020 
 
 
 
 
Sponsor 
InnAVasc Medical, Inc. 
110 Swift Avenue 
Durham, NC 27705 USA 
 
 
 
 
 
 
 
CONFIDENTIALITY STATEMENT 
 
This protocol and all attachments are considered confidential information. The contents must 
not be disclosed, unless authorized in writing by InnAVasc Medical, Inc., except that this 
document may be disclosed to the appropriate Institutional Review Board (IRB) or duly 
authorized representatives of the competent authorities with similar requests for 
maintenance of confidentiality. All data and study results are similarly subjected to the same 
disclosure restrictions as the investigational plan, as stated above. All copies of this 
investigational device exemption remain the property of InnAVasc Medical, Inc. 
 
 
 
 

Page 2 of 8 
 
Table of Contents 
1. 
BACKGROUND ................................................................................................................................... 3 
2. 
STUDY OBJECTIVES AND DESIGN ............................................................................................... 3 
3. 
NUMBER OF SUBJECTS AFFECTED ............................................................................................ 3 
4. 
NUMBER OF SITES AFFECTED ..................................................................................................... 3 
5. 
STUDY DURATION ............................................................................................................................ 4 
6. 
STUDY PROCEDURES AND EVALUATIONS OF EXISTING SUBJECTS............................... 4 
6.1. 
18 MONTH FOLLOW-UP VISIT ....................................................................................................................... 4 
6.2. 
24 MONTH FOLLOW-UP VISIT ....................................................................................................................... 4 
6.3. 
ADDITIONAL DATA COLLECTION INSTRUCTIONS .......................................................................................... 5 
6.3.1. 
Collection of HD session data from Dialysis Centers ............................................................................. 5 
6.3.2. 
Collection of HD Data from Homecare Sessions (if applicable) ............................................................. 5 
6.3.3. 
Adverse Events ......................................................................................................................................... 5 
6.3.4. 
Concomitant Medications ........................................................................................................................ 6 
6.3.5. 
Questionnaires ......................................................................................................................................... 6 
6.3.6. 
Missed Visits ............................................................................................................................................ 6 
6.3.7. 
Study Discontinuations ............................................................................................................................ 6 
7. 
DATA MONITORING AND ANALYSIS .......................................................................................... 6 
8. 
APPENDIX 1: SCHEDULE OF ASSESSMENTS ............................................................................ 7 
 
 
 

Page 3 of 8 
 
1. Background 
The current study received IDE approval on September 7, 2018. A total of 26 subjects were 
enrolled in the study between January 2, 2019 and May 3, 2019, at which time enrollment in the 
study was concluded.  As of the date of this addendum, 5 of the 26 treated subjects remain 
implanted with a functioning InnAVasc arteriovenous (IAVG).  All of these subjects have 
completed follow-up through the one-year timepoint and are pending the 18-month follow-up 
timepoint. 
The intent of this protocol addendum is to provide guidance to the investigators and research 
staff involved in this clinical investigation during the period of time clinical studies are being 
limited due to the national and international response to the COVID-19 pandemic.  It is being 
implemented to ensure the safety of study subjects, maintain compliance with good clinical 
practice (GCP), and minimize risks to trial integrity during the COVID-19 public health 
emergency. This addendum is not intended to replace the policies and procedures specified by 
national, state, local or institutional authorities, but rather, to provide specific guidance on how to 
conduct this particular investigation in compliance with those requirements. This addendum is 
intended to remain in effect only for the duration of the public health emergency. 
2. Study Objectives and Design 
The study objectives and design of the original protocol will not be modified by this addendum. 
The objective of this study is to evaluate the safety and effectiveness of the InnAVasc AVG for 
hemodialysis access in patients with ESRD. The safety and the effectiveness of the device and 
the procedure will be assessed using separate primary endpoints through 6 months. 
This clinical trial is a prospective, multi-center, single-arm, non-randomized, premarket study 
designed to assess the safety and effectiveness of the InnAVasc AVG device in subjects with 
ERSD who require HD. The safety and effectiveness of the device will be evaluated with 
primary safety and effectiveness endpoints that will be summarized via standard descriptive 
statistics, including exact binomial 95% lower confidence intervals. No hypothesis tests are 
planned and there are no a priori study success criteria specified. 
Data will be collected through 24 months. 
3. Number of Subjects Affected 
As of the date of this addendum, 5 of the 26 treated subjects remain implanted with a functioning 
IAVG.  All other subjects with an abandoned IAVG have withdrawn from the study. 
4. Number of Sites Affected 
The five IAVG implanted subjects remaining in follow-up are enrolled at 3 of the original 5 
study sites.  The following sites are potentially impacted by this addendum: 
• Site 14 (DIA) – 2 subjects 
• Site 20 (Greenwood) – 2 subjects 
• Site 19 (CTVS) – 1 subject 

Page 4 of 8 
 
5. Study Duration 
The original protocol defines that each subject will be followed for 24 months following 
implantation of the IAVG.  As of the date of this addendum, the 5 remaining treated subjects 
have completed follow-up through the one-year timepoint, and are pending the 18-month follow-
up timepoint. 
Refer to Appendix 1 for the study visit schedule. 
6. Study Procedures and Evaluations of Existing Subjects 
All of the protocol-specified follow-up examinations require an in person visit by the subjects to 
the study site or a dialysis center.  As such, if the study hospitals/clinics implement general 
restrictions on all patient visits, it is expected that these restrictions will also apply to the study-
related follow-up visits.  Nevertheless, it is still important to monitor the safety of the patients 
that have already been treated with the investigational device and to obtain as much of the 
protocol-defined efficacy data as possible. 
For this reason, if hospital/clinic access restrictions are implemented due to the COVID-19 
pandemic, the protocol-specified follow-up assessments are being reduced to include only those 
items that can be performed via a telephone call, and those requiring an in person visit by the 
patient are being temporarily suspended until such time as regular patient visits can be resumed.  
The details indicating which assessments are still required and which may be temporarily 
suspended for the remaining scheduled follow-up visits are described further below.  
Importantly, InnAVasc and its clinical monitors will not require these temporarily 
suspended assessments or missing data (as prospectively specified in this addendum) to be 
reported as protocol deviations for GCP purposes.  Rather, applicable follow-up written 
source documentation and case report forms (CRFs) should have a notation added 
indicating “certain assessments were not performed due to limitations imposed on in-
person visits during the COVID-19 pandemic”. 
Specific instructions as to how to conduct study follow-up visits and data collection in the event 
of hospital/clinic access restrictions are as follows: 
6.1.  18 Month Follow-up Visit 
The 18M follow-up visit evaluations are already scheduled to be performed via telephone.  
The required evaluations are as follows: 
• Adverse events 
• Documentation of InnAVasc Graft patency 
• InnAVasc graft use for HD 
• Documentation of InnAVasc graft interventions 
 
6.2. 24 Month Follow-up Visit 
If hospital/clinic restrictions are implemented, the 24M follow-up visit evaluations should be 

Page 5 of 8 
 
performed via telephone.  The required evaluations are as follows: 
• Concomitant medication 
• Adverse events 
• InnAVasc graft use for HD 
• Documentation of InnAVasc graft interventions 
• Patient-reported outcomes questionnaire 
The following assessments will be temporarily suspended (unless these examinations are able 
to be performed at the dialysis center, and this this case, data will be collected as available): 
• Physical examination 
• Examination of access site 
 
6.3. Additional Data Collection Instructions 
6.3.1. Collection of HD session data from Dialysis Centers 
Current practice for collection of HD session data from the Dialysis Centers is as follows: 
o The Study Coordinator calls the Dialysis Center directly at regular intervals and 
verbally asks for the subject information needed. The information is recorded onto 
the appropriate source documents for data entry into the EDC.   
6.3.2. Collection of HD Data from Homecare Sessions (if applicable) 
In the event hospital/clinic restrictions are implemented and subjects begin undergoing 
remote HD sessions at home, the same data assessments pertaining to dialysis access use 
and performance of the IAVG will be performed.  Study Coordinators will be expected to 
collect data via phone to the extent possible from the homecare personnel and record this 
onto the appropriate source documents.   
6.3.3. Adverse Events 
During the 18M or 24M follow-up visit phone call, the site’s Study Coordinator should 
ask the subject directly whether they have experienced any adverse events since the prior 
follow-up, and if so, obtain sufficient information to allow the AE CRF to be completed.  
The questioning should include whether the most common expected adverse events (such 
as study graft thrombosis, infection, poor graft flow (stenosis), bleeding, hematoma, 
pseudoaneurysm, abandonment) have occurred or worsened.  If a subject has a previous 
adverse event still ongoing since the last contact or that has resolved prior to the call, the 
Study Coordinator should obtain the necessary information to complete an updated AE 
CRF for those adverse event(s) as well. 

Page 6 of 8 
 
6.3.4. Concomitant Medications 
During the follow-up visit phone call, the Site Coordinator should ask the subject about 
current medications they are taking or have ceased taking and update the Conmed Log 
accordingly. 
6.3.5. Questionnaires 
The Patient Survey questionnaire (only one) can be conducted over the phone and 
transcribed by the site’s Study Coordinator on the respective forms or mailed to the 
subject to complete and return.  If transcribed, a notation should be written on the forms 
indicating this was done (“Transcribed by [initials and date]”).  If the questionnaires are 
mailed to the patient, they should be sent just prior to the scheduled follow-up and the 
Site Coordinator should ensure they are completed and returned by the patient in a timely 
fashion. 
6.3.6. Missed Visits 
If follow-up telephone visits cannot be performed, this should be considered a missed 
visit and documented accordingly on the Visit CRF.  If the missed visit is due to the 
patient contracting the COVID-19 virus, this should be specifically noted on the form. 
6.3.7. Study Discontinuations 
Any subjects that discontinue participation in the study due to COVID-19 should be 
clearly documented as a COVID-19 related discontinuation on the End of Study CRF. 
 
7. Data Monitoring and Analysis 
If planned on-site monitoring visits are no longer possible, InnAVasc will implement remote 
monitoring to the fullest extent possible to maintain oversight of the clinical sites and study data. 
Prior to locking the database and InnAVasc will address in the statistical analysis plan how any 
protocol deviations or missing data related to COVID-19 will be handled for the prespecified 
analyses. 
 

Page 7 of 8 
 
8. Appendix 1: Schedule of Assessments 
Assessment 
Screening/ 
Baseline (Day 
-45 to 
Day 0) 
Treatment 
(Day 0) 
Day 
14 
± 5 
days 
M1 
± 7 
days 
D 45 
± 7 
days 
M3 
± 7 
days 
M4 / 
M5 
± 7 
days 
M6 
± 14 
days 
M9 
± 7 
days 
M12 
± 30 
days 
M18 
± 7 
days 
M24 
± 30 
days / ET 
Visit 
On-site visit ⊗ / telephone contact  (1) 
⊗ 
⊗ 
⊗ 
 
⊗ 
 
 
⊗ 
 
⊗ 
 
⊗ 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographic information (2) 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical history (3) 
X 
 
 
 
 
 
 
 
 
 
 
 
Laboratory tests (4) 
X 
 
 
 
 
 
 
 
 
 
 
 
Prior and concomitant medications 
X 
X 
X 
 
X 
 
 
X 
 
X 
 
X 
Directed physical examination 
X 
 
X 
 
 
 
 
 
 
 
 
X 
Vessel mapping 
(if not done within 8 weeks) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
Surgical placement of InnAVasc AVG 
 
X 
 
 
 
 
 
 
 
 
 
 
Documentation of adjunctive procedures 
and any complications during surgery 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Adverse events (5) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
InnAVasc Graft first use (6) 
 
X 
 
 
 
 
 
 
 
 
 
 
Documentation of graft use and patency 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Examination of access site 
 
 
X 
 
X 
 
 
X 
 
X 
 
X 

Page 8 of 8 
 
Documentation of graft interventions 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Duplex ultrasound examination or 
angiography 
 
 
 
 
 
 
 
 
X 
 
 
 
 
Patient-reported outcome questionnaires (7) 
X 
 
X 
 
X 
 
 
X 
 
X 
 
X 
(1) Assessment Days and Months are relative to Day 0. 
(2) Demographic data will also include smoking history. 
(3) Medical history will include relevant prior and ongoing diseases, in particular: etiology of kidney disease and kidney transplant history, and risk factors. 
(4) The following must be collected: CBC (platelets and hemoglobin), HbA1c, INR, pregnancy test (unless no childbearing potential). 
(5) For screening, only AEs related to study specific procedures should be recorded. 
(6) First use to be captured on D0.  Reason for first use beyond 7 days will be documented in eCRF. 
(7) In the event a patient early terminates due to no AVG placement or prior to first cannulation, this questionnaire is not required. 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 1 
 
 
 
 
 
 
Investigational Plan 
Addendum B 
 
 
 
 
Title: 
A Study to Evaluate the Safety and Effectiveness of the InnAVasc 
Arteriovenous Graft for Hemodialysis Access in Patients with End-
Stage Renal Disease 
 
 
Protocol Number: 
CSP-1001, Rev. B    
IDE Number: 
 G180188 
Sponsor: 
InnAVasc Medical, Inc. 
110 Swift Avenue 
Durham, NC 27705 USA 
 
Primary Contact: 
Shawn M. Gage, PA-C,  
Founder, Director of Clinical Operations 
InnAVasc Medical, Inc.  
110 Swift Ave. 
Durham, NC 27705  
shawn.gage@innavasc.com 
+1 919-452-4686 
 
Date: 
December 18, 2020 
 
 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 2 
 
 
Table of Contents 
1 
BACKGROUND .................................................................................................................................... 3 
2 
OVERALL STUDY DESIGN AND PLAN ......................................................................................... 3 
2.1 
STUDY POPULATION AND INCLUSION-EXCLUSION CRITERIA .......................................................................... 3 
2.2 
NUMBER OF SITES ........................................................................................................................................... 3 
2.3 
NUMBER OF PATIENTS ..................................................................................................................................... 3 
2.4 
STUDY DURATION ........................................................................................................................................... 4 
2.4.1 
Original Protocol Study End Point Duration ......................................................................................... 4 
2.4.2 
Additional Long-Term Follow-up ........................................................................................................... 6 
2.4.2.1 
Long-Term Follow-up Duration .......................................................................................................................... 6 
2.4.2.2 
Long-Term Follow-up Assessments .................................................................................................................... 6 
2.4.2.3 
Long-Term Follow-up Adverse Event Reporting ................................................................................................ 9 
 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 3 
 
1 
BACKGROUND 
The InnAVasc CSP-1001 study originally received IDE approval in November 2018.  The Sponsor 
would now like to add a plan for longer-term follow-up of implanted subjects beyond the 24-
month time point in the original protocol.  This addendum describes the planned assessments, 
duration of follow-up, and safety reporting that will be performed for the longer-term follow-up 
(Section 2.4.2). 
2 
OVERALL STUDY DESIGN AND PLAN 
The objective of this study is to evaluate the safety and effectiveness of the InnAVasc AVG for 
hemodialysis access in patients with ESRD. The safety and the effectiveness of the device and the 
procedure will be assessed using separate primary endpoints through 6 months.   
This clinical trial is a prospective, multi-center, single-arm study designed to assess the safety and 
effectiveness of the InnAVasc AVG device in subjects with ESRD who require HD. The study 
population included 26 enrolled subjects, male and female, who are appropriate candidates for 
implantation of an InnAVasc AVG and require hemodialysis treatment for ESRD. The safety and 
effectiveness of the device will be evaluated with primary safety and effectiveness endpoints that 
will be summarized via standard summary statistics, including 95% two-sided confidence 
intervals. No hypothesis tests are planned for the primary study endpoints and there are no a 
priori study success criteria specified.   
The total follow-up for the original protocol included up to 24 months. The long-term follow up 
described in this addendum will continue to 5 years (60 months). 
2.1 
Study Population and Inclusion-Exclusion Criteria 
The study population intended for enrollment and the Inclusion/Exclusion criteria for 
subjects will remain the same as defined in the original protocol.   
2.2 
Number of Sites 
Up to 10 investigational sites in the United States. 
2.3 
Number of Patients 
26 subjects were enrolled in the study. 
 
 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 4 
 
2.4 
Study Duration 
2.4.1 
Original Protocol Study End Point Duration 
The original protocol defines that each subject will be followed for 24 months following the 
index surgical implant procedure, or until lost to follow up or study device abandonment. The 
primary analysis will occur when all subjects reach the month 6 follow up assessment.  
All procedures, evaluations, and collection and documentation of clinical data will remain the 
same as defined by the original protocol and are designed to provide the data necessary to 
assess the study time points and document any adverse effects related to device use.  
Definitions of expected adverse events reported during the original protocol study duration 
will remain the same as defined in the original protocol. 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 5 
 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 6 
 
2.4.2 
Additional Long-Term Follow-up 
2.4.2.1 
Long-Term Follow-up Duration 
This addendum is defining longer term subject follow-up as an addition to the original 
protocol. These additional visits are intended to provide for subject follow-up through a total 
of 5 years (60 months) following the procedure.   
Subjects will be followed at an additional eight (8) study time points: 27, 30, 33, 36, 42, 48, 
54, and 60 months following the procedure.  Months 27, 30, 33, 42, and 54 will be subject 
phone contact assessments and Months 36, 48, and 60 will be in-person clinic assessments 
by the study PI/research staff. 
2.4.2.2 
Long-Term Follow-up Assessments 
Evaluations, and collection and documentation of clinical data for the additional long-term 
follow-up visits will be performed as described below.  The phone assessments will include 
study graft patency and use, cannulation-related issues, anticoagulant/antiplatelet 
medications and device or HD-related adverse events. The in-person clinic assessments will 
capture access site exam and duplex ultrasound of the study graft site, and a patient reported 
outcomes survey, in addition to those assessments captured in the phone assessments. 
Phone Assessments (Months 27, 30, 33, 42 and 54) 
• 
Assessment of InnAVasc graft patency and function for hemodialysis; 
• 
Assessment of and documentation of study graft related AEs since the last 
call/assessment; 
- HD procedure or study graft-related AEs, as well as any interventions performed 
on the study graft.  
- Study graft abandonment and/or explantation. 
• 
InnAVasc graft cannulation-related issues; 
• 
Antiplatelet and anticoagulant medications will be documented. 
In-person Clinic Visits (Months 36, 48, 60) 
• 
Assessment of InnAVasc graft patency and function for hemodialysis; 
• 
Assessment of and documentation of study graft related AEs since the last 
call/assessment; 
- HD procedure or study graft-related AEs, as well as any interventions performed 
on the study graft.  
- Study graft abandonment and/or explantation. 
• 
InnAVasc graft cannulation-related issues; 
• 
Antiplatelet and anticoagulant medications will be documented. 
• 
Examination of InnAVasc graft access site; 
• 
Duplex ultrasound examination (confirmation of study graft function and patency, 
flow, and monitoring of entire graft length for aneurysm development); 
• 
Patient reported outcomes questionnaire (SF-VAQ). 
 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 7 
 
Table 1 below describes the additional long –term visits as described above that will occur 
during years 3-5 of patient follow-up in the study for each visit timepoint. 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 8 
 
 
 Table 1: Extended Follow-Up Schedule of Assessments 
 
 
Year 3 
Year 4 
Year 5 
 
M27 
± 14 days 
M30 
± 14 days 
M33 
± 14 days 
M36 
± 14 days 
M42 
± 21 days 
M48 
± 30 days 
M54 
± 21 days 
M60 
± 30 days 
Assessments 
Phone 
Phone 
Phone 
Clinic 
Phone 
Clinic 
Phone 
Clinic 
Assessment of Study Graft Patency & 
Function 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events (device & HD specific) 
X 
X 
X 
X 
X 
X 
X 
X 
Study Graft Cannulation Issues 
X 
X 
X 
X 
X 
X 
X 
X 
Antiplatelet/Anticoagulant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
Examination of Study Graft Access Site 
 
 
 
X 
 
X 
 
X 
Duplex Ultrasound Examination 
 
 
 
X 
 
X 
 
X 
Patient-Reported Outcome 
Questionnaire 
 
 
 
X 
 
X 
 
X 
 
 
 
 
 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 9 
 
2.4.2.3 
Long-Term Follow-up Adverse Event Reporting 
Adverse events that will be collected at the additional long-term follow-up visits will 
be limited to just those events that are related to the InnAVasc AVG, or are related 
to HD procedures in general.  Examples of such events are further defined as follows: 
 
Device Related AE 
An adverse event that is deemed a device related event or hemodialysis therapy related 
event (procedure of placing the dialysis needles into the study graft) may be defined as 
follows (note: these definitions are the same as defined in the original protocol): 
• 
Missed graft puncture attempt 
• 
Hematoma formation (during HD, or post needle withdraw) 
• 
Infiltration of access site (ecchymosis, or swelling) 
• 
Identification of Pseudoaneurysm development 
• 
Bleeding from graft (> 10 min) 
• 
Uncontrollable bleeding 
• 
Localized Infection present at access site 
• 
Systemic Infection (suspected to be related to the study device) 
• 
Ulcers of the skin or eschar development overlying the study device 
• 
Skin erosion over the study device 
• 
Suspected backwall puncture 
• 
Elevated pressures in graft circuit 
• 
Stenosis of the study graft (includes a. and v. anastomoses and intragraft, but 
NOT inflow or outflow lesions) 
• 
Kinking or twisting of the study device 
• 
Needle displacement during dialysis 
• 
Wounds or complications at the access site 
• 
Seroma or fluid collection around the study device 
• 
Thrombosis of the study graft 
 
 

InnAVasc Medical, Inc. 
CSP-1001 Addendum B 
 
 
18-December-2020 
 
 
Confidential 
Page 10 
 
 
HD Procedure Related AE 
An adverse event that is related to the HD procedure in general will also be reported, 
regardless of whether the event is considered to be device or therapy-related or not.  An 
adverse event that is deemed a HD therapy-related event may be defined as follows: 
• 
Missed graft puncture attempt 
• 
Hematoma formation (during HD, or post needle withdraw) 
• 
Infiltration of access site (ecchymosis, or swelling) 
• 
Bleeding from graft (> 10 min) 
• 
Uncontrollable bleeding 
• 
Localized Infection present at access site 
• 
Ulcers of the skin or eschar development overlying the study device 
• 
Skin erosion over the study device 
• 
Suspected backwall puncture 
• 
Elevated pressures in graft circuit 
• 
Needle displacement during dialysis 
• 
Wounds or complications at the access site 
• 
Seroma or fluid collection around the study device 
• 
Thrombosis of the study graft 
 
Serious adverse event (SAE) and unanticipated and serious adverse device effect (USADE) 
reporting and adjudication will continue to be performed as defined in the original 
protocol. 
 
All other aspects of the clinical trial and protocol not addressed by this addendum will 
remain the same as defined in the original study protocol. 
 

IRB Approved Template 
MUST BE APPROVED  
FOR SITES BEFORE USE  
AS MODIFIED 
Mar 02, 2021 
 
CSP-1001 
ICF Final Version 3.0, 18-Feb-21 
Page 1 of 24 
 
RESEARCH SUBJECT CONSENT FORM AND HIPAA AUTHORIZATION 
 
TITLE: 
A Study to Evaluate the Safety and Effectiveness of the 
InnAVasc Arteriovenous Graft for Hemodialysis Access in 
Patients with End-Stage Renal Disease 
 
PROTOCOL NO.: 
CSP-1001 
 
IRB Protocol#: 420180414 
 
SPONSOR: 
InnAVasc Medical, Inc. 
 
110 Swift Ave. 
 
Durham, NC 27705 
 
<<CF-Main Header Block - Investigator>> 
STUDY RELATED 
PHONE NUMBER(S): 
<<CF-Main User Defined #1>> 
 

IRB Approved Template 
MUST BE APPROVED  
FOR SITES BEFORE USE  
AS MODIFIED 
Mar 02, 2021 
 
CSP-1001 
ICF Final Version 3.0, 18-Feb-21 
Page 2 of 24 
 
You are being invited to take part in this research study because you have kidney failure 
and are currently undergoing hemodialysis (a process to filter your blood) or are 
expected to require hemodialysis within 60 days. To continue with long-term 
hemodialysis, it is generally considered best practice to create a permanent route to 
connect your blood stream to the dialysis machine. There are several ways to do this 
including surgically implanting an arteriovenous graft (AVG), a short piece of plastic-like 
tubing, to connect an artery to a vein, or by surgically making a direct connection 
between your artery and vein (this connection is called an autologous arteriovenous 
fistula or AVF). Your doctor will have already explained why he or she thinks that a graft 
or an AVF is the right approach for you. If you are being considered for this study, it has 
been determined that an AVG is your best option and that you are not, or you are no 
longer, an AVF candidate. A person who takes part in a research study is called a 
research subject, or research participant.  
 
WHAT SHOULD I KNOW ABOUT THIS RESEARCH? 
Someone will explain this research to you. 
 
• This form sums up that explanation. Please read this consent form carefully and 
take your time making your decision as to whether to participate. 
• Taking part in this research is voluntary. Whether you take part is up to you. 
• You can choose not to take part. There will be no penalty or loss of benefits to 
which you are otherwise entitled. 
• You can agree to take part and later change your mind. There will be no penalty 
or loss of benefits to which you are otherwise entitled. 
• If you don’t understand something, ask questions. 
• Ask all the questions you want and be sure they are answered before you 
decide. 
• Before you decide, we encourage you to talk to anyone you feel comfortable 
with. If you would like, you may take this consent form home with you to discuss 
with your friends and family before you decide whether to participate in this 
study. 
 
This study is sponsored by InnAVasc which is paying the study doctor, the hospital, or 
the clinic, to conduct the study. If applicable, the study doctor will tell you about any 
financial interests he or she may have in InnAVasc. <<CF-Main Financial Disclosure>> 
 
WHY IS THIS RESEARCH BEING DONE? 
The purpose of this research is to assess the safety and effectiveness of a new 
investigational dialysis graft developed by InnAVasc. 
 
The InnAVasc Graft is made from the same materials as standard grafts, but with added 
medically safe materials that may make the graft easier to identify, safer to stick for 
dialysis, more durable, and less likely to bleed after your dialysis session when 

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compared to standard grafts. The InnAVasc graft is an investigational product, which 
means that this is not yet approved by government agencies like the FDA, but 
preliminary tests in the laboratory and in animals have proven safe enough to be 
allowed to be used in human clinical studies such as this. 
 
At least 60 subjects will take part in this research at approximately 6 different medical 
facilities/hospitals in the United States. This will be the first time the InnAVasc graft will 
be used in human subjects. 
 
HOW LONG WILL I BE IN THIS RESEARCH? 
The total length of your involvement in the study will be up to 5 years (60 months). You 
will continue in the study as long as your graft is still open and flowing, or working for 
dialysis. Follow up assessments will become fewer and further apart as the study goes 
on.  After 2 years, five of the follow-up assessments will be by telephone, three will be at 
your study doctor’s office. 
 
WHAT HAPPENS TO ME IF I AGREE TO TAKE PART IN THIS RESEARCH? 
If you agree to take part in the study, you will be asked to sign and date this consent 
form. You will then have several tests and procedures done to ensure you are eligible 
for the study (this is called screening). You will be asked to complete a short survey 
regarding your current and previous dialysis access. 
 
After completing the screening visit, your study doctor, physician assistant (PA), or other 
authorized study personnel will review your test results and talk with you. If you are 
eligible for the study, you will be scheduled for surgery. 
 
During the study you will be asked to come to the study doctor’s office for regular study 
visits. As a part of these visits, the study doctor will obtain information about you and 
your InnAVasc graft from other healthcare personnel and people from dialysis centers 
looking after you. During months that an in-person study visit is not scheduled, you will 
have telephone contact with your study coordinator to answer a few simple questions 
about your study graft. Study visits will become less frequent over time.  
 
During the visits, you will have several tests; some of these would have been done as a 
part of your regular care and some are done as part of this investigational study. 
 
The Day of Surgery 
If you qualify to take part in the research study, surgery will be scheduled within 45 days 
of your screening visit.  
 
All participants will be treated the same: all subjects will receive the InnAVasc Graft and 
the surgery for implementation of the graft will be similar for all subjects. 
 

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On the day of surgery, you will have an InnAVasc graft surgically implanted in your 
upper arm or forearm just under the skin and attached to your own artery and vein (just 
like a standard-of-care graft). This treatment will provide an intended permanent route to 
receive hemodialysis in the same fashion as a standard of care graft.  Within 7 days 
after surgery, needles used for your dialysis access will then be inserted into the 
InnAVasc graft through your skin, as long as your doctor agrees that it is appropriate. 
 
The surgery may be carried out under general or local anesthesia. During or 
immediately after surgery your study doctor will check that the graft is working properly, 
and that blood is flowing through the access.  
 
Follow-up Visits 
You will be asked to come to the study doctor’s office for eight study visits following your 
surgery so that your InnAVasc Graft can be checked, and an additional five follow up 
assessment telephone calls over the final 3 years of the study. The first study visit will 
be approximately 2 weeks after the implant surgery, which should correlate with the 
standard post-operative visit that your doctor will schedule. Additional in person visits 
will occur at approximately 45 days, and 6, 12, 24, 36, 48, and 60 months after surgery. 
At these study visits, you will be asked to complete a short, 12 question survey about 
your dialysis access. This will be the same survey completed at the screening visit. If 
needed, a physical exam will be performed. Telephone contact will be made with you 
and your dialysis unit charge nurse during the months listed below when you do not 
have an in-person study visit to check on you and the status of the graft. Formal 
telephone contact will be made with you at approximately 27, 30, 33, 42, and 54 months 
after surgery to ask about InnAVasc graft function and any potential problems with 
dialysis. 
 
At all visits, in your doctor’s office or by phone, it is very important that you tell your 
study doctor (or other study personnel) about any problems you experience or about 
any change in medications.  It is especially important to mention any procedures that 
have been done to your InnAVasc Graft. 
 
The table below lists what tests and procedures will be performed at each of your study 
visits. 
 
Visit 
Description of Study-related Tests/Procedures 
Performed During Study Visits 
Screening Visit 
• Your study doctor will collect your medical history 
and ask you about any medications you are 
currently taking.  
• A physical exam will be conducted. 
• A small amount of blood (approximately 2 
tablespoons or 30 mL) may be collected to do 

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several tests.  
• An ultrasound may be done to check that you have 
suitable blood vessels for the surgery, if it hasn’t 
been done within 8 weeks previously. An 
ultrasound is a test that uses sound waves to make 
an image of the inside of your body. This is typical 
before most AV access surgeries. 
• Completion of dialysis access survey.  
Day of Surgery 
• InnAVasc Graft implant surgery (no different than 
surgery to implant a standard dialysis graft). 
• During or immediately after the surgery, your study 
doctor will check that your InnAVasc AVG is 
working properly.  
In Office Follow-Up 
Visits  
• You will be asked to come into the office for 
assessments on the following days after surgery: 
14 days, 45 days, 3 months, 6 months, 12 months, 
24 months, 36 months, 48 months, and 60 months. 
 
The following assessments and procedures will be 
performed at the scheduled follow-up 
visits/assessments: 
 
• Your study doctor will ask you questions about how 
you and your InnAVasc AVG are doing.  
• He/she will look at your InnAVasc AVG and will ask 
about any problems you might be having.  
• During these study visits you may have a physical 
exam.  
• At the 6-month, 36-month, 48-month, and 60-
month visits, an ultrasound (takes a picture with 
sound waves) will be done on the InnAVasc AVG 
to check that it is working properly.  
• At each visit, your study doctor will ask if your 
InnAVasc AVG is being used for hemodialysis.  
• Completion of dialysis access survey. 
• Study personnel will contact your dialysis unit to 
check to see if you have had any problems with 
your InnAVasc AVG or if you have had any 
procedures performed on your graft up to month 24 
only.. 
Telephone Follow 
up 
• At months 1, 3, 4, 5, 9, and 18, study personnel will 
contact you and your dialysis unit to check to see if 

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you have had any problems with your InnAVasc 
AVG or if you have had any procedures performed 
on your graft. 
 
You will be asked to participate in additional 
assessments by phone after the first 24 months at the 
following time points: 27, 30, 33, 42, and 54 months 
after surgery. 
 
The following assessments will be performed at the 
scheduled follow-up visits/assessments: 
• You will be asked about new medications or 
changes in current medications you are taking.  
• You will be asked if your InnAVasc Arteriovenous 
Graft is still working, if you are using it for 
hemodialysis and if you have had any problems or 
had any procedures performed on it.  You will also 
be asked about your general health overall. 
 
Dialysis using the InnAVasc AVG 
Your study doctor will decide when the InnAVasc AVG is ready to be used for dialysis 
for the first time. Since the InnAVasc AVG is an immediate use graft, it may be used for 
the first time as early as the day of implant depending on the opinion of your study 
doctor. The graft may be able to be used for hemodialysis much sooner than standard 
grafts due to the materials used and unique construction of the graft. The procedures for 
dialysis with the InnAVasc Graft are the same as for a standard graft, but we anticipate 
easier cannulation and less bleeding after dialysis. Your usual dialysis unit will be 
educated on the use of InnAVasc AVG prior to your first session, but we will also give 
you a reminder bracelet and informational card that will provide instructions for use in 
case you go to a different hemodialysis unit. Information from your dialysis center will be 
collected for study purposes. The data collected from your dialysis center will be part of 
your routine care and include laboratory data drawn at the dialysis center, data about 
any procedures/interventions done at your dialysis center and data from your dialysis 
machine. 
 
Keeping Discarded Parts of the InnAVasc AVG 
In some cases, during a possible surgery to revise the InnAVasc AVG if necessary, a 
small part of it may have to be removed and would normally be discarded. InnAVasc 
would like to use that discarded piece of the InnAVasc AVG to conduct special tests that 
would tell us how your tissue reacts to the InnAVasc AVG and how the graft looks 
following several dialysis needle cannulations. You do not need to agree to this to be 
part of the study; we ask that you indicate your choice about this separately from the 
main agreement to join the study at the end of this form. 

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WHAT ARE MY RESPONSIBILITIES IF I TAKE PART IN THIS RESEARCH? 
If you take part in this research, you will be responsible to:  
 
• Follow the instructions you are given by the study doctor, PA or other study staff; 
in particular, follow your surgeon’s instructions for the maintenance of wound 
dressings and any medications that the surgeon may prescribe. 
• Provide the cannulation instructions for use to anyone new to cannulation of your 
InnAVasc graft.  The instructions can be viewed by scanning a QR code link on 
the reminder band and information card provided to you.  You must carry one of 
these items with you at all times to ensure proper use of your InnAVasc graft at 
each dialysis session. 
• Report to your surgeon/the study doctor or other study staff after discharge and 
at every study visit, immediately any changes in your health such as sudden 
increase in pain, redness, wound drainage or excessive local swelling or bruising 
around the operative site, or any generalized swelling of the operative arm.  Note 
that all wounds, however created, share some risk of infection, bleeding and poor 
wound healing.  
• Follow your surgeon’s instructions regarding what types and degrees of activity 
are to be avoided at various times postoperatively. 
• Return to your surgeon’s office/research study center as scheduled for your 
postoperative visits. 
• Tell the study doctor or staff if you want to stop being in the research study. 
 
COULD BEING IN THIS RESEARCH HURT ME? 
In general, the type of risks associated with having the InnAVasc AVG implanted are 
expected to be like the risks of having a standard dialysis graft surgery. You will be 
asked to sign a separate consent form at the place of your surgery for the actual 
surgical procedure. 
 
Known Risks of Arteriovenous Graft Implantation: 
 
Event Category  
Event (Medical) 
Event (Lay) 
Bleeding  
Early, postoperative  
 
 
Prolonged bleeding from 
needle puncture site  
 
Infection  
Early infection, during 
procedure  
Infection related to surgery 
 
Late infection, due to 
cannulation  
Needle stick site infection 
Noninfectious fluid 
collections  
Hematoma  
Collection of blood under skin 

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Seroma  
Fluid collection 
 
Lymphocele  
Lymphatic fluid collection 
Anastomotic 
complications  
Hemorrhage  
Bleeding  
 
Pseudoaneurysm  
Outpouching (sac) of contained 
blood 
 
Stenosis with intimal 
hyperplasia  
Narrowing of the area where the 
graft is sewn to blood vessel 
Mid-AV access/runoff 
vein complications  
Dilation/aneurysm  
 
 
Pseudoaneurysm at 
needle stick site  
Outpouching (sac) of contained 
blood at the needle stick site 
 
Mid-AV access stenosis  
Narrowing in the middle of the 
graft (at needle stick sites) 
AV access malfunction  
Insufficient inflow  
Poor flow into the graft 
 
Insufficient runoff  
Poor flow out of the graft 
 
Inability to puncture  
Not able to stick graft 
Ischemia  
Steal syndrome  
Too much blood flow into the graft 
and not enough to the hand 
Cardiac  
Myocardial infarction  
Heart attack 
 
Congestive heart failure  
Heart can’t pump very well and 
gets overloaded with blood 
 
Arrhythmia  
Abnormal heart rhythm 
 
Valve disorders; stenosis 
and insufficiency  
Heart valve malfunction 
 
Hypertension  
High blood pressure 
 
Hypotension  
Low blood pressure 
Wound  
Wound infection  
 
 
Wound pain  
 
 
Wound dehiscence  
Wound separates 
 
Serous wound drainage  
Fluid drainage 
 
Lymphorrhea  
Draining lymphatic fluid 
 
Hematoma  
Collection of blood in the wound 
 
Ecchymosis  
Bruising 
Venous  
Deep venous thrombosis  Clot in a large vein (typically the 
leg) 
 
Pulmonary embolism  
Clot (from a vein) that travels to 
the lung 
 
Paradoxical embolization  Multiple clots 
 
Venous hypertension  
High pressure in the vein 
Local  
Arm edema  
Swelling of the whole arm 
 
Arm pain  
 

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Back pain  
 
Cerebrovascular  
Transient ischemic attack  “mini” (temporary) stroke 
 
Stroke  
Lack of blood flow to a portion of 
the brain “brain attack” 
 
Intracranial hemorrhage  
Bleeding into the brain 
Genitourinary  
Urinary retention  
Unable to pee 
 
Urinary tract infection  
Infection of the bladder 
 
Renal stones  
Small mineral based stones in the 
kidneys 
 
Renal insufficiency, 
failure  
Kidney failure 
 
Hematuria  
Blood in the urine 
 
Impotence and other 
disorders of sexual 
function  
Unable to get an erection 
Pulmonary  
Exacerbation of chronic 
lung disease  
Making a lung disease worse 
 
Pneumonia  
Infection of the lungs 
 
Pulmonary embolism  
Clot (from a vein) that travels to 
the lung 
 
Respiratory failure  
Lung failure (unable to breath) 
 
Bronchitis  
Inflammation of the small tubes of 
the lungs 
 
Bronchospasm  
Spasm/constriction of the tubes in 
the lungs 
Gastrointestinal  
Peptic ulcer disease  
Stomach ulcer 
 
Reflux esophagitis  
Inflammation of the tube that food 
passes through 
 
Nausea and vomiting  
 
 
Diarrhea  
 
 
Constipation  
Unable to have a bowel 
movement for more than 3 days 
 
Hepatitis  
Infection/inflammation of the liver 
 
Hepatic insufficiency  
Poor liver function 
 
Cholelithiasis / 
cholecystitis  
Stones in the or inflammation of 
the gall bladder  
Metabolic/systemic 
disorders  
Electrolyte imbalances  
 
 
Hyperglycemia 
High blood sugar 
 
Hypoglycemia  
Low blood sugar 
 
Fluid overload  
 
 
Dehydration  
Not enough fluid or water in the 

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body 
 
Thrombocytopenia  
Low platelet count 
 
Leukopenia  
Low white blood cell count 
 
Anemia with or without 
need for transfusion  
Low red blood cell 
count/concentration 
Miscellaneous  
Sepsis  
Blood infection that can lead to 
organ failure and/or death 
 
Skin erosion  
 
 
Compartment syndromes  Increased pressure in a muscle 
compartment 
 
Psychiatric disorders 
including depression  
 
 
Mental status changes  
 
 
Insomnia  
Not able to sleep 
 
Allergic reactions to 
device components  
Allergic reaction to the graft 
 
Allergic reactions to 
concomitant medications  
Allergic reactions to medicines 
you may be taking or have been 
administered 
 
Careful and frequent monitoring of the InnAVasc AVG by physical assessment and 
telephone contact is expected to detect problems that may occur. The risks with any 
dialysis access include the following typical events, most of which can be reversed by 
careful medical care or an operation:  
 
• Dilation (pseudoaneurysm) or weakening of the access; rarely a dilation may 
burst 
• Bleeding after surgery or from the graft after dialysis; possible hematoma 
formation (collection of blood under the skin) 
• Blockage (clotting) of the access  
• Narrowing (stenosis) of the access 
• Infection around or in the access  
• Skin ulcers (skin erosion) Fluid collection (seroma) 
• Discomfort or swelling in the arm or hand 
• Steal syndrome (blood flow in the wrong direction caused by unnatural 
connection of blood vessels) 
 
Any of these problems may require additional tests, such as ultrasound or blood tests, 
to help identify the cause. Sometimes further surgery is needed. If you or the nurses at 
the dialysis center believe the InnAVasc AVG has become blocked, you should make 
sure that your study doctor (or nurse) is told about this urgently. 
 

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In this current study, we have seen a higher frequency of blockage (clotting) of the 
access and removal of the study graft as compared to the frequency of a standard 
dialysis graft.  For this reason, additional enrollment in the study has been halted until 
more information is known.  Subjects who are currently enrolled and have a working 
InnAVasc AVG may continue in the study and use the graft as usual.  
 
In addition, it is possible that there might be InnAVasc AVG risks that we do not know 
about. If new information becomes available that could affect your health or welfare or 
willingness to stay in this study, we will tell you about that as soon as possible. 
 
If your InnAVasc AVG stops working, another access for hemodialysis will need to be 
created or implanted/placed. Any surgery to do this is not a part of this study.  
 
Risks of Anesthesia 
The InnAVasc AVG will be placed/created surgically under either general anesthesia 
(you are given special drugs to make you sleep during your operation) or local 
anesthesia (you are given special drugs that numb the arm that the InnAVasc AVG is 
being placed in). Your doctor will decide which is best for you after talking with you. 
Anesthesia has some risks that may include: nausea (feeling sick), vomiting, heart 
attack, a reaction to the medicines given, stroke, and death. You will be asked to sign a 
separate consent form at the place of your surgery for the use of anesthesia during your 
surgery.  
 
Risks of Drawing Blood 
You may feel a sharp prick when the needle is pushed through the skin and there may 
be bruising around the puncture site. Infection, bleeding, or fainting are possible, 
although unlikely. In rare cases taking blood samples may cause nerve damage at the 
needle puncture site. 
 
Risks of Ultrasound Scan  
Ultrasound scanning is a non-invasive pain-free method use sound waves to make an 
image of the inside of your body. This examination is carried out by placing a small 
device on the skin surface and moving it along the blood vessels. To improve the 
contact with the skin special gel may be used. In rare cases this gel may cause skin 
irritation. During scanning, you must remain still. 
 
In addition to these risks, taking part in this research may harm you in unknown ways.  
 
Pregnancy 
If you are female and become pregnant during the study, please tell your study doctor 
who will discuss the situation with you and keep a careful watch over you. Currently, 
there has been no experience of women becoming pregnant while they are using the 
InnAVasc AVG. This study may involve risks to the fetus that are not yet known, 

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although it is unlikely, given these materials have all been used safely in humans 
before. 
 
If you are male, you do not need to tell the study doctors or nurses about any 
pregnancies of your partner. 
 
WILL IT COST ME MONEY TO TAKE PART IN THIS RESEARCH? 
There will be no additional costs to you because of being in this study. InnAVasc will 
provide the InnAVasc AVG free of charge and will pay for tests that are not a part of 
your routine medical care. Routine medical care (care you would have received if you 
were not in the study) will not be covered by InnAVasc. The surgical procedure to 
implant the InnAVasc AVG is considered routine medical care and will not be covered 
by InnAVasc. InnAVasc will cover additional costs for things that are not considered part 
of your routine medical care that occur because you participate in this study.  
 
You should also note that insurance or other reimbursement mechanisms might not 
fund the medical care you receive because you are participating in a clinical 
investigation even when the care is the standard care you would otherwise receive if not 
participating in a clinical investigation. You should discuss this with your study doctor (or 
nurse) or with anyone involved in paying for your medical care. 
 
WILL BEING IN THIS RESEARCH BENEFIT ME? 
The main reason for you to participate in this study is to add knowledge about the use of 
InnAVasc AVG for hemodialysis rather than to improve your current state of healthcare 
delivery. 
 
We cannot promise any benefits to you or others from your taking part in this research. 
However, the InnAVasc Graft was developed with the goal to make it easier to identify 
and stick your graft, to protect patients from needle related injuries (for example, back 
wall or side wall injuries that cause excessive bleeding), and to reduce bleeding after 
dialysis.  
 
It is possible that the InnAVasc AVG may provide better outcomes compared to a 
standard AVG, but that is not yet known or confirmed. However, the information 
collected in this study may help other patients in the future.  
 
WHAT OTHER CHOICES DO I HAVE BESIDES TAKING PART IN THIS 
RESEARCH? 
If you do not want to join the study, your doctor will discuss with you the best dialysis 
access for you and how your dialysis will be managed in the future. The types of risks 
associated with alternative dialysis accesses are expected to be like those you might 
experience if you will join this trial. However, because the InnAVasc AVG is an 

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investigational product, it is not known how the risks of other dialysis accesses compare 
to the InnAVasc AVG. 
 
Alternative methods of renal replacement therapy include peritoneal dialysis (fluid 
exchange in your belly), or kidney transplant. It is always advisable to ask your 
nephrologist or surgeon if you are a candidate for these other forms of kidney 
replacement therapy. 
 
WHAT HAPPENS TO THE INFORMATION COLLECTED FOR THIS RESEARCH? 
Federal regulations give you certain rights related to your health information. These 
include the right to know who will receive the information and how it will be used. The 
study doctor must obtain your authorization (permission) to use or release any health 
information that might identify you. 
 
What information may be used and shared? 
The study doctor and study staff will use and share your health information as part of 
this research study. Except when required by law, you will not be identified by name, 
address, telephone number or other facts that could identify the health information as 
yours.   
 
Examples of the information that may be used are: 
 
• Medical records (from any doctor, hospital or other healthcare provider) 
• Information created or collected during the research. This could include your 
medical history, and dates or results from any physical exams, laboratory tests or 
other tests. 
 
Information about how you and your InnAVasc AVG are doing will be kept in special 
study records with security protections. If you choose to participate in the study, these 
records will be entered into a computerized, secure database. 
 
Who will receive information about me? 
The study doctor and study staff will share your personal health information with: 
 
• The research Sponsor 
• People who work with the research sponsor 
• The Institutional Review Board (IRB) that reviewed this research.  The IRB is a 
group of scientists and non-scientists who review the ethics of research. The goal 
of the IRB is to protect the rights and welfare of study subjects.<<CF-Main SMO 
Company 1>><<CF-Main Affiliated IN Language 1>> 
• Government agencies, such as the Food and Drug Administration (FDA) 
• Department of Health and Human Services (DHHS) agencies 
• Other regulatory agencies 

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Why will this information be used and/or given to others? 
The sponsor and the groups above will use your health information: 
 
• to complete this research 
• to evaluate the results of the study 
• to check that the study is being done properly 
• to obtain marketing approval for new products resulting from this research 
 
Is my health information protected after it has been given to others? 
Your health information may be further shared by the groups above. If shared by them, 
the information will no longer be covered by this Authorization. These groups are 
committed to keeping your health information confidential.  
 
What if I decide not to allow the use of my health information? 
You do not have to sign this form. If you do not sign this form, you cannot take part in 
this research study.  
 
May I withdraw or revoke (cancel) my permission? 
YES.  You may withdraw your permission to use and disclose your health information at 
any time. You can do this by sending written notice to the study doctor. If you withdraw 
your permission, you will not be able to continue being in the research study. 
 
What happens if I want to withdraw my authorization? 
Information that has already been gathered may still be used and given to others. If you 
withdraw your permission, no new health information will be gathered unless you have a 
side effect related to the study.  
 
If you withdraw from the study but do not withdraw your Authorization, new health 
information may be collected until this study ends.  
 
Will my authorization expire? 
If you do not withdraw this Authorization, it will remain in effect. 
 
If the research site is located in California, Delaware, Indiana, Washington, or 
Wisconsin this authorization will expire on 31Dec2060. 
 
There is no expiration of this authorization except for research conducted in the states 
listed above. 
 
May I review or copy the information obtained or created about me? 
YES. You have the right to review and copy your health information. However, your 
access to this information may be delayed until the study is complete. 

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We may publish the results of this research. However, we will keep your name and 
other identifying information confidential. 
 
During one or more of your visits, a representative from the Sponsor may be present to 
observe the surgery or other procedures and provide information to the study doctor. 
Your privacy will be protected if one or more of these individuals are present. 
 
We protect your information from disclosure to others to the extent required by law. We 
cannot promise complete confidentiality. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site 
at any time. 
 
Data or specimens collected in this research might be deidentified and used for future 
research or distributed to another investigator for future research without your consent. 
 
WHO CAN ANSWER MY QUESTIONS ABOUT THIS RESEARCH? 
If you have questions, concerns, or complaints, or think this research has hurt you or 
made you sick, talk to the research team at the phone number listed above on the first 
page. 
 
This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a 
group of people who perform independent review of research studies. You may talk to 
them at (888)-303-2224 or (800) 562-4789, irb@cgirb.com if: 
 
• You have questions, concerns, or complaints that are not being answered by the 
research team. 
• You are not getting answers from the research team. 
• You cannot reach the research team. 
• You want to talk to someone else about the research. 
• You have questions about your rights as a research subject. 
 
WHAT IF I AM INJURED BECAUSE OF TAKING PART IN THIS RESEARCH? 
If you are hurt or get sick in the study, you should call the study doctor.  The study 
doctor will make sure you get medical care for your injury or illness. If you experience 
any injury as a direct result of your participation in this research study, immediate 
treatment will be provided. InnAVasc will pay only for treatment related to problems that 
occur as a direct result of the study provided all aspects of the study protocol have been 
followed correctly.  

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The study doctor/site has no program for financial compensation for injuries which you 
may incur as a result of participation in this research. The costs of the treatment may be 
covered by the study site, InnAVasc, or billed to you or your insurer just like other 
medical costs, depending on several factors. However, you are not prohibited from 
seeking to collect compensation for injury related to malpractice, fault, or blame on the 
part of those involved in the research, including the study site. 
 
If InnAVasc covers these costs they will need to know some information about you like 
your name, date of birth, and Medicare Health Insurance Claim Number, or, if you do 
not have one, your Social Security Number. This information will be used to check to 
see if you receive Medicare, and, if you do, report the payment they make to Medicare. 
InnAVasc will not use this information for any other purpose.  
 
CAN I BE REMOVED FROM THIS RESEARCH WITHOUT MY APPROVAL? 
The person in charge of this research can remove you from this research without your 
approval. Possible reasons for removal include: 
 
• It is in your best interest regarding your health and well-being 
• You have serious problems 
• New information indicates that the InnAVasc AVG poses a significant risk to you 
• You become pregnant 
• The research is canceled by the FDA or the sponsor 
• You are unable to keep your scheduled appointments 
• You are unable or unwilling to fulfill the study requirements 
 
We will tell you about any new information that may affect your health, welfare, or 
choice to stay in this research. 
 
WHAT HAPPENS IF I AGREE TO BE IN THIS RESEARCH, BUT I CHANGE MY 
MIND LATER? 
Joining this study is completely voluntary; you may choose to join the study and then 
decide to stop coming for visits. If you choose to stop coming for visits or decide not to 
participate there will be no penalties or loss of other benefits you would otherwise be 
entitled to receive.  
 
If you agree to be in the study, even if your InnAVasc AVG stops working, you will be 
asked to attend the study visits during the first 6 months. You can choose to stop 
coming for study visits at any time without affecting the way you are looked after. Before 
you make that decision, please talk with your study doctors or nurses, so we can assure 
a safe and orderly withdrawal. If you do decide to stop coming for study visits, we would 
like to be able to contact your doctors or nurses to understand how you and your 

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InnAVasc AVG are doing; we will ask you to indicate your choice about this separately 
from agreeing to be in the main study at the end of this form. 
 
If you decide to stop coming for study visits, the InnAVasc AVG will stay in your arm and 
be used for dialysis as long as it continues to work. InnAVasc may retain and use any 
research results that have already been collected before you decide to stop coming to 
study visits. InnAVasc must do this to comply with its legal obligations and to maintain 
the quality of the study.  
 
If new information becomes available that could affect your health or welfare, or 
willingness to stay in the study, we will tell you about that as soon as possible. 
 
WILL I BE PAID FOR TAKING PART IN THIS RESEARCH? 
You will receive $XX per study visit that you attend in person to cover the costs related 
to you coming for a study visit; this will cover things like travel and parking, and $20 per 
phone follow up visit to cover your time. In addition, you should discuss with your study 
doctor (or nurse) whether arrangements can be made to make your visits to the office 
easier. 
 
<<CF-Main Payment for Part. Paragraph>> 
 
WHO HAS REVIEWED THIS STUDY? 
This study has been reviewed by an Independent Review Board (IRB) which is a 
committee whose task it is to protect patients from harm.  
 

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STATEMENT OF CONSENT: 
 
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft 
for Hemodialysis Access in Patients with End-Stage Renal Disease 
 
1. I confirm that I have read and understand the informed consent form for the 
above study. I have had the opportunity to consider the information, ask 
questions and have had these answered satisfactorily. 
2. I understand that my participation is voluntary and that I am free to withdraw 
at any time without giving any reason, without affecting my medical care or 
legal rights. 
3. I will be given a copy of this signed information sheet and consent form to 
keep for myself<<CF-Main User Defined #2>>. 
4. I understand that my medical notes and information collected during the study 
may be looked at by individuals from InnAVasc and its representatives, from 
government agencies (FDA) or from the hospital / clinic, where it is relevant to 
my taking part in this research. I give permission for these individuals to have 
access to my records. 
5. I consent to the transfer of my personal information to other countries, I  
understand that reasonable steps will be undertaken to ensure my 
confidentiality. 
 
By signing below (and also initialing tick boxes by statements above), I am agreeing to 
participate in this research study, but understand that I can change my mind at any 
time.  
 
Your signature documents your consent to take part in this research and to allow the 
use or disclosure of your health information. 
 
 
 
 
 
Printed Name of Adult Subject Capable of Consent 
 
 
 
 
 
 
 
Signature of Adult Subject Capable of Consent 
 
Date 
 

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I confirm that I have explained the study to  
 
____________________________________ and that he/she understands what his/her 
participation in the study entails and the risks involved. I further attest that all questions 
asked by the subject were answered to the best of my knowledge. 
 
 
 
 
 
Printed Name of Person Obtaining Informed Consent 
 
 
 
 
 
 
 
Signature of Person Obtaining Consent 
 
Date 
 

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CONSENT TO ALLOW THE STUDY DOCTOR TO FOLLOW-UP WITH MY HEALTH 
CARE PROVIDERS IN THE EVENT I DECIDE TO STOP ATTENDING STUDY VISITS 
 
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft 
for Hemodialysis Access in Patients with End-Stage Renal Disease   
 
By signing below, I am agreeing that if I choose to stop coming for visits to the study 
doctor’s office, the study doctor, or nurse can get information on how I am doing and 
whether my InnAVasc AVG is working properly. To do that, the study doctor may 
contact my doctor, or dialysis center.  
 
I understand that I do not have to agree to this to be part of the main research study. I 
am agreeing to participate in this part of this research study but understand that I can 
change my mind at any time. 
 
 
 
 
 
Printed Name of Adult Subject Capable of Consent 
 
 
 
 
 
 
 
Signature of Adult Subject Capable of Consent 
 
Date 
 
I confirm that I have explained this aspect of the study to  
 
_______________________________ and that he/she understands what his/her 
participation in the study entails and the risks involved. I further attest that all questions 
asked by the subject were answered to the best of my knowledge. 
 
 
 
 
 
Printed Name of Person Obtaining Informed Consent 
 
 
 
 
 
 
 
Signature of Person Obtaining Consent 
 
Date 
 

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CONSENT TO ALLOW FOR THE STUDY DOCTORS TO COLLECT ANY 
DISCARDED PARTS OF THE INNAVASC AVG 
 
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft 
for Hemodialysis Access in Patients with End-Stage Renal Disease   
 
I understand that any problems associated with the InnAVasc AVG may require extra 
surgery.  
 
I agree that any part of the InnAVasc AVG removed during surgery may be sent to 
InnAVasc or its designee for special testing. 
 
I understand that this sample will be stored and will not be returned to me.  
 
I understand that I do not have to agree to this to be part of the main research study. I 
am agreeing to participate in this part of this research study but understand that I can 
change my mind at any time. 
 
 
 
 
 
Printed Name of Adult Subject Capable of Consent 
 
 
 
 
 
 
 
Signature of Adult Subject Capable of Consent 
 
Date 
 
I confirm that I have explained this aspect of the study to  
 
_______________________________ and that he/she understands what his/her 
participation in the study entails and the risks involved. I further attest that all questions 
asked by the subject were answered to the best of my knowledge. 
 
 
 
 
 
Printed Name of Person Obtaining Informed Consent 
 
 
 
 
 
 
 
Signature of Person Obtaining Consent 
 
Date 
 
<<CF-Main User Defined #9>> 

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CALIFORNIA HIPAA AUTHORIZATION 
 
Federal regulations give you certain rights related to your health 
information.  These include the right to know who will receive the 
information and how it will be used.  The study doctor must obtain your 
authorization (permission) to use or release any health information that 
might identify you. 
 
What information may be used and shared? 
The study doctor and study staff will use and share your health information 
as part of this research study. Except when required by law, you will not be 
identified by name, address, telephone number or other facts that could 
identify the health information as yours.   
 
Examples of the information that may be used are: 
 
• Medical records (from any doctor, hospital or other healthcare 
provider) 
• Information created or collected during the research.  This could 
include your medical history, and dates or results from any physical 
exams, laboratory tests or other tests. 
 
Who will receive information about you? 
The study doctor and study staff will share your personal health information 
with: 
 
• the sponsor, including persons or companies working for or with the 
sponsor 
• Independent / Institutional Review Board  
• the U.S. Food and Drug Administration (FDA) 
• Department of Health and Human Services (DHHS) agencies 
• other regulatory agencies  
 
Why will this information be used and/or given to others? 
The sponsor and the groups above will use your health information: 
 

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• to complete this research 
• to evaluate the results of the study 
• to check that the study is being done properly 
• to obtain marketing approval for new products resulting from this 
research 
 
Is my health information protected after it has been given to others? 
Your health information may be further shared by the groups above. If 
shared by them, the information will no longer be covered by this 
Authorization.  These groups are committed to keeping your health 
information confidential.  
 
What if I decide not to allow the use of my health information? 
You do not have to sign this form.  If you do not sign this form, you cannot 
take part in this research study.  
 
May I withdraw or revoke (cancel) my permission? 
YES.  You may withdraw your permission to use and disclose your health 
information at any time.  You can do this by sending written notice to the 
study doctor.  If you withdraw your permission, you will not be able to 
continue being in the research study. 
 
What happens if I want to withdraw my authorization? 
Information that has already been gathered may still be used and given to 
others.  If you withdraw your permission, no new health information will be 
gathered unless you have a side effect related to the study.   
 
If you withdraw from the study but do not withdraw your Authorization, new 
health information may be collected until this study ends.   
 
Will my authorization expire? 
This Authorization will expire December 31, 2060, unless you withdraw it in 
writing before then. 
 

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May I review or copy the information obtained or created about me? 
YES. You have the right to review and copy your health information.  
However, your access to this information may be delayed until the study is 
complete. 
 
Your decision to withdraw your Authorization or not to participate will not 
involve any penalty or loss of access to treatment or other benefits to which 
you are entitled.   
 
AUTHORIZATION 
By signing this form, I allow the use or disclosure of my health information.  
I will receive a signed and dated copy of this Authorization. 
 
 
 
 
Printed Name of Subject 
 
 
 
 
Signature of Subject 
Date