Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia
Phase: NA
Conditions: Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
Sponsor: LimFlow, Inc.

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 1 of 38 
A PILOT STUDY TO INVESTIGATE THE SAFETY, EFFECTIVENESS, AND 
FEASIBILITY OF THE LIMFLOW STENT GRAFT SYSTEM FOR CREATING AN AV 
FISTULA FOR THE TREATMENT OF CRITICAL LIMB ISCHEMIA 
NCT03124875 
27 June 2018 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 2 of 38 
Protocol No: ECO-02527-009 
Revision D 
27 June 2018 
Sponsor: 
LimFlow, Inc. 
2934 Scott Blvd. 
Santa Clara CA 95054 
United States 
www.Limflow.com 
The information contained in this protocol is the property of LimFlow, Inc. and is therefore provided in 
confidence to an investigator, potential investigator or consultant for review by a member of their staff or for 
submission to the members of an appropriate Institutional Review Board. It is understood that this document is 
confidential and should not be disclosed, submitted for publication or use for any purpose other than the 
contemplated herein without the sponsor’s prior written authorization. 
A PILOT STUDY TO INVESTIGATE THE SAFETY, EFFECTIVENESS, AND 
FEASIBILITY OF THE LIMFLOW STENT GRAFT SYSTEM FOR CREATING AN AV 
FISTULA FOR THE TREATMENT OF CRITICAL LIMB ISCHEMIA 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 3 of 38 
 
 
 
 
 
 
 
Protocol Signatures 
 
 
 
 
 
I have read and agree to the final version of the protocol ECO-02527-009: 
 
I am aware of my responsibilities as an Investigator under the guidelines of 21 CFR Parts 50, 56, and 
812, and local IRB requirements. 
I agree to perform and conduct the study as described in the protocol. In addition, when applicable, I 
agree to enlist sub-investigators who also agree to perform and conduct the study as described in the 
protocol. 
 
 
 
 
 
 
 
 
 
Investigator Name: 
Institution Name: 
 
 
 
Signature:  
 
Date: 
  
 
A PILOT STUDY TO INVESTIGATE THE SAFETY, EFFECTIVENESS, AND 
FEASIBILITY OF THE LIMFLOW STENT GRAFT SYSTEM FOR CREATING AN AV 
FISTULA FOR THE TREATMENT OF CRITICAL LIMB ISCHEMIA 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 4 of 38 
 
 
 
 
 
 
 
 
Primary Objective 
The objective of this pilot clinical investigation is to investigate the safety, 
effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV 
fistula in the Below The Knee (BTK) vascular system using an endovascular, 
minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in 
subjects ineligible for conventional endovascular or surgical limb salvage 
procedures. 
Test Device 
The LimFlow Stent Graft System 
Indication 
for Use 
The LimFlow Stent Graft System is intended to treat critical limb ischemia by 
creating an AV fistula in the below-the-knee vasculature for treatment of CLI. 
Study Design 
A prospective, multi-center pilot study consisting of up to 35 subjects designed to 
confirm the safety, effectiveness and feasibility of the LimFlow Stent Graft System 
Number of Subjects Up to 35 consecutively enrolled subjects 
Principal 
Investigator 
Dr. Jihad Mustapha, MD 
Metro  Health Hospital 
5900 Byron Center Ave, SW 
Wyoming, MI 49519 
Number of Sites 
Up to 7 U.S. sites 
Duration of Study 
Each enrolled subject will be followed for up to 2 years (± 4 weeks) post- 
procedure. The primary endpoint assessment will be completed by 30 (+/- 7) days, 
and secondary endpoint assessments will be completed by 12 (+/- 1 month) post- 
procedure. 
Primary Safety 
Endpoint 
Amputation-Free Survival at 30 days, defined as the percentage of subjects with: 
• 
Limb Salvage: Freedom from above-ankle amputation of the index limb AND 
• 
Survival: Freedom from all-cause mortality 
Secondary Safety 
Endpoint 
Amputation-Free Survival Survival at 6 months, defined as the percentage of 
subjects with: 
• 
Limb Salvage: Freedom from above-ankle amputation of the index limb AND 
• 
Survival: Freedom from all-cause mortality 
PROTOCOL SYNOPSIS: 
A PILOT STUDY TO INVESTIGATE THE SAFETY, EFFECTIVENESS, AND 
FEASIBILITY OF THE LIMFLOW STENT GRAFT SYSTEM FOR CREATING AN AV 
FISTULA FOR THE TREATMENT OF CRITICAL LIMB ISCHEMIA 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 5 of 38 
 
 
 
Secondary 
Effectiveness 
Endpoints 
• 
Primary Patency at 30 days: Defined as the absence of occlusion of the stent 
graft1 without prior clinically-driven major re-intervention2 of the stent graft 
at 30 days. 
• 
Primary Patency at 6 months: Defined as the absence of occlusion of the 
stent graft1 without prior clinically-driven major re-intervention2 of the stent 
graft at 6 months. 
• 
Secondary Patency at 6 months: Defined as the absence of occlusion of the 
stent graft1 with or without prior clinically-driven major re-intervention2 of 
the stent graft at 6 months. Occlusion is determined by duplex ultrasound 
data. 
• 
Limb Salvage at 3, 6, 9 and 12 months: Defined as percentage of subjects 
with freedom from above-ankle amputation of the index limb. 
• 
Wound Healing at 3, 6, 9, and 12 months: Defined as percentage of subjects 
with completed index wound healing 
• 
Deterioration in Renal Function at 6 months: Defined as a > 25% increase in 
serum creatinine after using iodine contrast agents, without another clear 
cause for kidney injury. 
• 
Technical Success: Defined as percentage of subjects with technical success, 
defined as completion of the endovascular procedure and immediate 
morphological success with successful placement of the arterial and venous 
catheters in the desired location in the limb, and ability to place the stent 
graft. 
• 
Procedural Success: Defined as percentage of subjects with a procedural 
success, defined as combination of technical success, and absence of all-cause 
death, above-ankle amputation or clinically driven major re-intervention2 of 
the stent graft at 30 days. 
1 Occlusion is defined as absence of flow on color Doppler, and/or absence of flow 
on angiographic images (conventional or CT). 
2  Clinically-driven major re-intervention is defined as the creation of a new 
surgical bypass, the use of thrombectomy or thrombolysis (i.e., procedures done 
in the setting of lost primary-assisted patency), or major surgical revision such as a 
jump graft or an interposition graft performed for occlusion of the stent graft. 
Follow-Up 
Schedule 
Measures of safety and effectiveness will be assessed through hospital discharge, 
at 30 and 60 (+/- 7) days, at 3, 6, and 9 months (+/- 2 weeks), and at one year (+/- 
4 weeks) and 2 years (+/- 4 weeks) post-procedure. The study will be completed 
and closed after all subjects have either met a primary endpoint, or completed 
the 2 year follow-up requirements. 
Primary Patient 
Population 
In this first pilot study, the patients selected will be the “no hope” CLI patients, 
those that have been determined to be ineligible for conventional surgical or 
endovascular options due to severe vascular disease. 

ECO-02527-009 Rev D 
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Pilot Study 
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Page 6 of 38 
 
 
 
Pre-Operative 
Inclusion Criteria 
1. Subject must be > 21 and < 95 years of age 
2. Clinical diagnosis of symptomatic critical limb ischemia, defined as any of 
the following clinical assessments coupled with hemodynamic evidence of 
severely diminished arterial inflow of the index limb (e.g., absent pulse(s), 
TcPO2 < 30 mm Hg): 
a. Rutherford Classification 5, ischemic ulceration 
b. Rutherford Classification 6, severe ischemic ulcers or frank 
gangrene 
3. Subject has been assessed by the principal investigator, and reviewed by 
the Independent Safety Committee (ISC), and it was determined that no 
conventional distal bypass surgical or endovascular therapy for limb 
salvage is feasible due to the absence of a suitable distal target artery. 
4. Proximally, the Target In-flow Artery at the cross-over point must be 
treatable with a 3.5 – 4.0 mm stent after pre-treatment (by visual 
estimate), and be <50% stenosed. 
5. Prior stent(s) to the Target In-flow Artery are allowed. 
6. Planned minor amputation of target extremity within 30 days after the 
index procedure is allowed. 
7. Subject is willing and able to sign the informed consent form. 
8. Subject has an adequate support network to ensure that subject is 
compliant with medication regimen and follow-up study visits. 
Pre-Operative 
Exclusion Criteria 
Subjects will be excluded from participating in this study if they meet any of the 
following criteria prior to initiation of the endovascular procedure: 
1. Concomitant hepatic insufficiency, thrombophlebitis, deep venous 
thrombus, or coagulation disorder. 
2. Pre-existing immunodeficiency disorder or receiving immunosuppressant 
therapy. 
3. Prior peripheral arterial bypass procedure above or below the knee which 
could inhibit proximal inflow to the stent graft. 
4. Previous major amputation of the target limb. 
5. Life expectancy less than 12 months. 
6. Documented myocardial infarction or stroke within previous 90 days. 
7. Known or suspected active infection at the time of the index procedure 
that may preclude insertion of a prosthesis. 
8. Known or suspected allergies or contraindications to aspirin / dual 
antiplatelet therapy, heparin, stainless steel, nitinol or contrast agent that 
cannot be adequately pre-treated. 
9. Subject is currently taking warfarin, which in the opinion of the 
investigator interferes with the subject’s ability to participate in the study 
(i.e., intermittent interruption of therapy for procedure may compromise 
subject’s safety). 
10. Lower extremity venous disease with significant edema in the target limb 
that may inhibit the procedure and/or jeopardize wound healing, in the 
investigator’s opinion. 
11. Significant acute or chronic kidney disease with a serum creatinine of > 
2.5 mg/dl, and/or requiring dialysis. 
12. Severe heart failure, which in the opinion of the investigator may 
compromise subject’s ability to safely undergo a percutaneous procedure 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 7 of 38 
 
 
 
(e.g.,  known ejection fraction of < 40%, NYHA Classification III-IV). 
13. Any significant concurrent medical, psychological, or social condition, 
which may significantly interfere with the subject’s optimal participation 
in the study, in the opinion of the investigator. 
14. The subject is currently participating in another investigational drug or 
device study that has not completed the primary endpoint or that 
clinically interferes with the endpoints of this study. 
15. Subject is unwilling or unable to comply with any of the protocol or 
follow-up requirements. 
16. Prior to enrollment, women of childbearing potential must have a 
negative urine pregnancy test. 
Study Administration 
Study Sponsor 
LimFlow, Inc. 
Contact:  Thomas Engels 
2934 Scott Blvd. 
Vice President Clinical Affairs 
Santa Clara CA 95054 
LimFlow, Inc. 
United States 
Phone: (888) 478-7705, ext. 101 
Fax: (408) 898-1459 
e-mail: tengels@limflow.com 
CRO, 
Chellew Clinical Outsourcing, LLC 
United States 
7844 E. Riverdale St. 
(Clinical) 
Mesa, AZ 85207 
Marlys Chellew, BSN 
Mobile: 916-303-0879 
mchellew@chellewclinical.com 
Independent Safety 
Committee (ISC) 
Management 
Syntactx 
4 World Trade Center; 44th Floor 
150 Greenwich St. 
New York, NY 10006 
Phone: 212-228-9000 
Fax: 646-375-3183 
Data Management 
TBD 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 8 of 38 
 
 
 
 
 
Contents 
1.0. Introduction .................................................................................................................................... 10 
1.1 Background and Rationale ..................................................................................................10 
1.2 Summary of Findings from Previous Studies ........................................................................11 
1.2.1. Pre-clinical studies: .............................................................................................................. 11 
1.2.2. Clinical studies ..................................................................................................................... 11 
1.3 Risks and Benefits ..............................................................................................................12 
1.3.1. Risks ..................................................................................................................................... 12 
1.3.2. Benefits ................................................................................................................................ 13 
2.0 Device Description ........................................................................................................................... 13 
2.1. Intended Use ....................................................................................................................13 
2.2 Device Labeling ..................................................................................................................13 
3.0 Study Objectives .............................................................................................................................. 14 
4.0 Study Design .................................................................................................................................... 14 
4.1 Overview ...........................................................................................................................14 
4.2 Sample Size ........................................................................................................................14 
4.3 Investigational Sites ...........................................................................................................14 
5.0 Study Population ............................................................................................................................. 14 
5.1 Selection Criteria ................................................................................................................14 
5.1.1. Pre-operative Inclusion Criteria........................................................................................... 14 
5.1.2. Exclusion Criteria ................................................................................................................. 15 
6.0 Study Procedures and Enrollment ................................................................................................... 15 
6.1. Duration of Subject Participation .......................................................................................15 
6.2. Screening, Written Informed Consent and Independent Safety Committee Review .............15 
6.3. Visit Schedule ...................................................................................................................16 
6.4 Study Procedures ...............................................................................................................17 
6.4.1 Enrollment ............................................................................................................................ 17 
6.4.2. Intra-operative .................................................................................................................... 17 
6.4.3. Post-operative ..................................................................................................................... 18 
6.5 Follow-up ..........................................................................................................................18 
6.6 Study Exit ...........................................................................................................................19 
7.0 Assessment of Safety and Effectiveness ......................................................................................... 19 

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document requires prior approval from LimFlow. 
Page 9 of 38 
 
 
7.1 Primary Safety Endpoint .....................................................................................................19 
7.2 Secondary Safety Endpoint .................................................................................................19 
7.3 Secondary Effectiveness Endpoints .....................................................................................19 
8.0 Statistical Considerations ................................................................................................................ 20 
8.1 Analysis Populations and Data Handling Conventions ..........................................................20 
8.1.1. Safety ................................................................................................................................... 20 
8.1.2. Effectiveness ........................................................................................................................ 20 
8.1.3. Missing Data ........................................................................................................................ 20 
8.2 Data Analysis .....................................................................................................................20 
8.2.1. Baseline Subject Characteristics .......................................................................................... 20 
8.2.2. Safety ................................................................................................................................... 20 
8.2.3. Effectiveness ........................................................................................................................ 21 
8.3 Sample Size Justification .....................................................................................................21 
9.0 Data Management and Monitoring ................................................................................................. 21 
9.1. Study Data Collection ........................................................................................................21 
9.2. Site Data Monitoring and Quality Control ..........................................................................21 
10.0 Safety Oversight ............................................................................................................................ 22 
10.1. Safety: Complication Analysis and Acceptance .................................................................22 
10.1.1 Procedural Complications .................................................................................................. 22 
10.1.2 Post-Procedural Complications .......................................................................................... 22 
10.2. Independent Safety Committee (ISC) ...............................................................................22 
10.3 Study Termination ............................................................................................................23 
11.0 Adverse Event Reporting ............................................................................................................... 23 
11.1. General Definitions .........................................................................................................23 
11.2. 
Reporting of Serious and Non-Serious Adverse Events ...................................................25 
11.2.1. 
General Reporting Requirements (Serious & Non-Serious Adverse Events) ................. 25 
11.2.2. Reporting to Sponsor ......................................................................................................... 26 
11.3. 
Device Failures and Malfunctions .................................................................................26 
12.0 Quality Control and Quality Assurance ......................................................................................... 27 
12.1. Site Training ....................................................................................................................27 
12.2. Physician Training ...........................................................................................................27 
12.3. Audits and Inspections ....................................................................................................27 
12.4. Independent Safety Committee (ISC) Member Training ....................................................27 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 10 of 38 
 
 
13.0 Ethical Considerations ................................................................................................................... 27 
13.1. Trial Conduct & the Declaration of Helsinki ......................................................................27 
13.2. Institutional Review Board (IRB) ......................................................................................28 
13.3. Provisions for Maintaining Confidentiality .......................................................................28 
13.4. Provisions for Compensation in Case of Injury ..................................................................28 
13.5. Emergency Actions ..........................................................................................................28 
13.6. Informed Consent Form ...................................................................................................29 
14.0. Study Administration .................................................................................................................... 29 
14.1. Pre-Study Documentation Requirements .........................................................................29 
14.2. Source Documentation ....................................................................................................29 
14.3. Record Retention ............................................................................................................30 
14.4. Criteria for Terminating Study..........................................................................................30 
14.5. Criteria for Suspending/Terminating a Study Center .........................................................30 
14.6. Amending the Protocol ....................................................................................................30 
14.7 Publication Policy .............................................................................................................31 
15.0 Regulatory Considerations ............................................................................................................ 31 
15.1. Sponsor’s Responsibilities................................................................................................31 
15.1.1 General ............................................................................................................................... 31 
15.1.2. Investigational Device Distribution ................................................................................... 32 
15.2 
Investigator Responsibilities ..........................................................................................32 
15.2.1. Investigator Agreement ..................................................................................................... 32 
15.2.2. Required Reports ............................................................................................................... 32 
15.2.3 Investigational Device Accountability ................................................................................ 33 
16.0 Glossary of Terms .......................................................................................................................... 33 
17.0 Informed Consent Template ......................................................................................................... 37 
18.0 Revision History ............................................................................................................................. 38 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 10 of 38 
 
 
 
1.0. Introduction 
1.1 Background and Rationale 
In the absence of treatment, Peripheral Vascular Disease (PVD) may progress to critical limb ischemia 
(CLI), which is characterized by profound chronic pain, and extensive tissue loss that restricts 
revascularization options and frequently leads to amputation. CLI is estimated to have an incidence 
of approximately 50 to 100 per 100,000 per year and is associated with mortality rates as high as 20% 
at 6 months after onset. 
 
Interventional radiologists have been aggressively trying to treat CLI by attempting to open up 
Chronic Total Occlusions (CTO’s) or bypassing them in the sub-intimal space using such products as 
the Medtronic Pioneer catheter which tunnels a wire into the sub-intimal space at the CTO and then 
attempts to re-enter the vessel after the occlusion. Once a wire is in place, one can place a stent to 
provide a bypass conduit passed the occlusion. More conventional approaches to treating PAD are 
also used in CLI treatment once (if) a wire gets across the occlusion. These conventional methods 
include PTA, Stenting and more recently drug eluting balloons and stents. 
 
From the amputee-coalition.org website, the following are some statistics regarding the CLI problem: 
 
• 
There are nearly 2 million people living with limb loss in the United States 
• 
The main causes of limb loss are dysvascular disease – including diabetes (54%), trauma 
(45%), and cancer (less than 2%). 
• 
Approximately 185,000 amputations occur in the United States each year. 
• 
Hospital costs associated with having a limb amputated totaled more than $6.5 billion in 
2007 
• 
Survival rates after an amputation vary based on a variety of factors. Those who have 
amputations due to vascular disease (including peripheral arterial disease and diabetes) face 
a 30-day mortality rate reported to be between 9 -15% and a long-term survival rate of 60% 
at 1 year, 42% at 3 years, and 35-45% at 5 years. 
• 
Nearly half of the people who lose a limb to dysvascular disease will die within 5 years. This is 
higher than the 5-year mortality rate experienced by people with colorectal, breast, and 
prostate cancer. 
Of people with diabetes who have a lower-limb amputation, up to 55% will require amputation of 
the second leg within 2 to 3 years. 
 
The LimFlow approach to treating CLI involves the concept of venous arterialization and this 
procedure has been performed surgically for many years and the first clinical surgical cases were 
reported in the early 1900’s. Numerous small series of clinical trials have been published over the 
year using a surgical approach and a recent meta-analysis article summarized this work. The 2006 
Meta Analysis article from the European Journal of Vascular and Endovascular Surgery titled: 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
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Pilot Study 
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document requires prior approval from LimFlow. 
Page 11 of 38 
 
 
 
“Meta-analysis of the clinical effectiveness of venous arterialization for salvage of critically 
ischemic limbs.” 
Had the following results and conclusions: 
 
Results: A total of 56 studies were selected for comprehensive review. No 
RCTs were identified. Seven patient series, comprising 228 patients, matched the 
selection criteria. Overall 1-year foot preservation was 71% (95% CI: 64-77%) and 
1-year secondary patency was 46% (95% CI: 39-53%). The large majority of 
patients in whom major amputation was avoided experienced successful wound 
healing, disappearance of rest pain and absence of serious complications. 
 
Conclusions: On the basis of limited evidence, venous arterialization may be 
considered as a viable alternative before major amputation is undertaken in 
patients with 'inoperable' chronic critical leg ischemia. 
 
The purpose of this first pilot clinical study is to test the LimFlow concept for creating an Arterio- 
Venous (AV) fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally 
invasive approach. 
1.2 Summary of Findings from Previous Studies 
1.2.1. Pre-clinical studies: 
Extensive in vitro bench, in vivo animal, and cadaver studies have been successfully performed with 
the LimFlow System and verification testing for the catheter has been completed. Testing on the 
device included comprehensive design verification and validation testing. The following testing was 
completed on the LimFlow devices: 
• 
Biocompatibility testing 
• 
Mechanical testing 
• 
Packaging testing 
• 
Shelf-life testing 
• 
Sterilization validation 
• 
Preclinical animal studies 
These tests were successfully completed and are described in more detail in the Investigator 
Brochure. 
1.2.2. Clinical studies: 
A non-randomized prospective pilot study and a CE Mark study have been conducted with the 
LimFlow System, see Report of Prior Investigations in the Investigator Brochure for details on the 
study and patient outcomes. These studies supported the CE Mark approval of the device on 
October 17, 2016. The subjects continue to be followed through 2 years post-procedure, and the 
results continue to be encouraging. 

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Page 12 of 38 
 
 
 
1.3 Risks and Benefits 
The associated risks proposed in this study are similar to risks posed by other interventional and 
vascular surgery procedures. The benefit to the subjects enrolled in this study is the potential for 
improved blood flow to the foot reducing or eliminating the need for major amputation. 
The potential benefit of reduced or no amputation of the foot greatly outweighs the standard 
endovascular/surgical risks associated with this procedure in this “no-hope” patient population who 
will have a major amputation if the LimFlow procedure is not attempted. 
 
1.3.1. Risks 
The associated risks proposed in this study are similar to risks posed by other interventional and 
vascular surgery procedures. 
Adverse events that may possibly be caused by or associated with the use of the investigational 
device or the related procedures, and which may or may not require endovascular or surgical 
treatment in this clinical trial include: 
• 
Allergic response 
• 
Arterial occlusion 
• 
Arterial thrombus 
• 
Arterio-venous fistula (unplanned) 
• 
Bleeding/oozing from the puncture site 
• 
Bruising at wound site 
• 
Contrast-induced nephropathy and renal failure 
• 
Compartment syndrome 
• 
Congestive cardiac failure 
• 
Death 
• 
Device failure / malfunction 
• 
Edema 
• 
Embolization (air, tissue, device) 
• 
Hematoma 
• 
Infection 
• 
Inflammatory response 
• 
Intimal tear / dissection 
• 
Lower extremity ischemia 
• 
Occlusion of the Stent Graft 
• 
Peripheral nerve injury 
• 
Perforation of the vessel wall 
• 
Pseudoaneurysm 
• 
Retroperitoneal bleeding 
• 
Venous thrombus formation 
• 
Vasovagal response 
• 
Vasospasm 
• 
Vascular injury 
• 
Wound dehiscence 
• 
Wound site pain 
• 
Systemic infection, sepsis 

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LimFlow Stent Graft System 
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Pilot Study 
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document requires prior approval from LimFlow. 
Page 13 of 38 
 
 
 
• 
Requirement for major amputation of index limb 
 
1.3.2. Benefits 
The benefit to the subjects enrolled in this study is the potential for improved blood flow to the foot 
reducing, but not necessarily eliminating the need for major amputation. The potential benefit of 
improved wound healing greatly outweighs the standard endovascular/surgical risks associated with 
this procedure in this “no-hope” patient population who will have a major amputation if the LimFlow 
procedure is not attempted. 
 
Specifically, risks to the patient are minimized due to: 
 
- The use of standard medical grade materials that have been thoroughly characterized and tested 
to assure biocompatibility 
- Extensive pre-clinical evaluation including in vitro bench testing, animal and cadaver study 
- The well established, standard nature of the endovascular procedures and techniques to be used 
- The ability to quickly and safely remove the LimFlow System from the procedure; the physician 
may elect to discontinue the use of the device at any time in favor of alternate devices. 
- Frequent follow-up visits are conducted in the first year post-operatively to allow for systematic 
monitoring and surveillance of the index limb, allowing for early detection of hemodynamically 
significant stenoses in the graft that may occur in the absence of obvious symptoms. 
- Potential subjects will be screened by the Independent Safety Committee to ensure that all 
subjects meet defined inclusion/exclusion criteria. 
- Investigators will receive device training and will be proctored for their first case, and then for as 
many cases as they deem necessary to perform the procedure proficiently. 
 
 
2.0 Device Description 
2.1. Intended Use 
The LimFlow Stent Graft System is intended to treat the critical limb ischemia by creating an arterio- 
venous fistula in the below-the-knee vasculature. 
The LimFlow Stent Graft System consists of: 
 
• 
Arterial Ultrasound Catheter w/needle 
• 
Venous Ultrasound Catheter 
• 
Covered Nitinol Stent in 7 Fr delivery system 
• 
Valvulotome 
• 
Ultrasound system with laptop computer 
 
For the initial procedures, commercially available GORE VIABAHN stents will also be used as 
extension stents. 
2.2 Device Labeling 
A copy of the Instructions for Use (IFU) will be included with the devices. The LimFlow Stent Graft 
System labels contain the following information: 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 14 of 38 
 
 
 
• 
LimFlow Stent Graft System Model Number 
• 
Lot or Serial number 
• 
Expiration (use before) date 
• 
For Investigational Use Only 
 
 
3.0 Study Objectives 
The objective of this study is to evaluate the feasibility, safety and effectiveness of the LimFlow Stent 
Graft System in creating a below-the-knee AV-fistula for venous arterialization in subjects with 
critical limb ischemia. 
 
 
4.0 Study Design 
4.1 Overview 
This study represents a prospective, non-randomized, single arm, multi-center pilot study to evaluate 
the feasibility, safety and effectiveness of the LimFlow Stent Graft System. Measures of safety and 
efficacy will be assessed through hospital discharge, at 30 +/- 7 days, at 3, 6, and 9 months +/- 2 
weeks post-procedure, and then annually (+/- 4 weeks) for up to 2 years post-procedure. 
 
4.2 Sample Size 
Up to 35 subjects will be enrolled in this study. 
 
4.3 Investigational Sites 
The study will be conducted at up to 6 clinical sites in the United States. 
 
 
5.0 Study Population 
5.1 Selection Criteria 
The following section outlines the specific inclusion and exclusion criteria for the study. Before 
enrollment, a patient must meet all of the inclusion and exclusion criteria. 
5.1.1. Pre-operative Inclusion Criteria 
1. Subject must be > 21 and < 95 years of age 
2. Clinical diagnosis of symptomatic critical limb ischemia, defined as any of the following 
clinical assessments coupled with hemodynamic evidence of severely diminished arterial 
inflow of the index limb (e.g., absent pulse(s), TcPO2 < 30 mm Hg): 
a. Rutherford Classification 5, ischemic ulceration 
b. Rutherford Classification 6, severe ischemic ulcers or frank gangrene 
3. Subject has been assessed by the principal investigator, and reviewed by the Independent 
Safety Committee (ISC), and it was determined that no conventional distal bypass surgical or 
endovascular therapy for limb salvage is feasible due to the absence of a suitable distal 
target artery. 
4. Proximally, the Target In-flow Artery at the cross-over point must be treatable with a 3.5 – 
4.0 mm stent after pre-treatment (by visual estimate), and be <50% stenosed 
5. Prior stent(s) to the Target In-flow Artery are allowed 

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6. Planned minor amputation of target extremity within 30 days after the index procedure is 
allowed 
7. Subject is willing and able to sign the informed consent form 
8. Subject has an adequate support network to ensure that subject is compliant with 
medication regimen and follow-up study visits 
 
5.1.2. Exclusion Criteria 
1. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, or coagulation 
disorder 
2. Pre-existing immunodeficiency disorder or receiving immunosuppressant therapy 
3. Prior peripheral arterial bypass procedure above or below the knee which could inhibit 
proximal inflow to the stent graft. 
4. Previous major amputation of target limb 
5. Life expectancy less than 12 months 
6. Documented myocardial infarction or stroke within previous 90 days 
7. Known or suspected active infection at the time of the index procedure that may preclude 
insertion of a prosthesis 
8. Known or suspected allergies or contraindications to aspirin / dual antiplatelet therapy, 
heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated 
9. Subject is currently taking warfarin, which in the opinion of the investigator interferes with 
the subject’s ability to participate in the study (i.e., intermittent interruption of therapy for 
procedure may compromise subject’s safety) 
10. Lower extremity venous disease with significant edema in the target limb that may inhibit 
the procedure and/or jeopardize wound healing, in the investigator’s opinion. 
11. Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl, and/or 
requiring dialysis. 
12. Severe heart failure, which in the opinion of the investigator may compromise subject’s 
ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of < 40%, 
NYHA Classification III-IV) 
13. Any significant concurrent medical, psychological, or social condition, which may significantly 
interfere with the subject’s optimal participation in the study, in the opinion of the 
investigator 
14. The subject is currently participating in another investigational drug or device study that has 
not completed the primary endpoint or that clinically interferes with the endpoints of this 
study 
15. Subject is unwilling or unable to comply with any of the protocol or follow-up requirements 
16. Prior to enrollment, women of childbearing potential must have a negative urine pregnancy 
test 
 
 
6.0 Study Procedures and Enrollment 
6.1. Duration of Subject Participation 
Subjects enrolled in the study will participate for up to 2 years (+/- 4 weeks). 
 
6.2. Screening, Written Informed Consent and Independent Safety Committee Review 
All subjects considered for the treatment of the critical limb ischemia by creating an arterio-venous 
fistula in the below-the-knee vasculature, and eligible for treatment as determined by the study 
investigator should have the study explained to them, be given the IRB-approved informed consent 
form and allowed adequate time to consider whether or not they wish to take part in the study. The 

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Page 16 of 38 
 
 
 
investigator or a member of his/her staff should inform the patient about the study’s purpose and 
risks/benefits. 
Written informed consent must be obtained for all patients who are potential study candidates 
before any study-specific tests or procedures are performed. The wound shall be photographed, to 
include a metric ruler for adequate evaluation of the index wound/limb. 
Once the principal investigator concludes that all inclusion criteria and no exclusion criteria are met, 
the patients will be reviewed by an Independent Safety Committee (ISC) consisting of at least 2 
independent physicians with expertise in treatment of CLI patients. Once the ISC determines that a 
subject is not a candidate for conventional surgical or endovascular procedures for limb salvage, they 
may be enrolled in the study. See Section 10.2 Screening Responsibilities. 
Patients who give consent to take part in the study and subsequently do not meet the eligibility 
criteria will not be enrolled. 
6.3. Visit Schedule 
The study coordinator at the site should schedule the 30-day follow-up visit before the subject is 
discharged post-procedure. Obtain contact information for subject’s significant other or caretaker(s) 
to ensure that subject will be able to comply with follow-up study visits. Study assessments to be 
performed at each visit are summarized in Table 1. 
 
TABLE 1: Study Assessment 
Schedule 
Visit 1 
Day -1 
-21 to -2 
(Screen- 
ing & 
Baseline) 
Visit 
2 
Day 0 
(Treat- 
ment- dis 
charge) 
Visit 3 
30 (+/- 
7) Days 
Visit 4 
60 (+/- 
7) Days 
Visit 5 (3 
mo. +/- 2 
wks) & 
Visit 7 (9 
mo. +/- 2 
wks) 
Visit 6 
6 
months 
(+/- 2 
weeks) 
Visit 8 
1 Year 
(+/- 4 
weeks) 
Visit 95 
2 Year 
(+/- 4 
weeks) 
Written Informed Consent 
√ 
Baseline angiogram/images for screening 
√ 
Inclusion / Exclusion criteria assessment, 
including enrollment concurrence by an 
Independent Safety Committee that subject 
is not a candidate for conventional surgical 
or endovascular limb salvage procedures 
√ 
Demographic data, medical history, 
medication review, & physical exam 
√ 
Review of medications / dual anti-platelet 
regimen1 
√ 
√ 
√ 
 
√ 
√ 
√ 
√ 
Rutherford Classification (RCC) 
√ 
√ 
 
√ 
√ 
√ 
√ 
Wound healing assessment (completed or 
not), and photographs2 
√ 
√ 
 
√ 
√ 
√ 
√ 
Index limb oxygenation measurement – 
TcPO23 
√ 
√ 
 
√ 
√ 
√ 
Pulse evaluation via continuous wave 
doppler assessment of grafted area 
(proximal, graft, and distal to outflow 
vessels)4 
√ 
(target 
location) 
√8 
√ 
 
√ 
√ 
√ 
√ 

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TABLE 1: Study Assessment 
Schedule (cont) 
Visit 1 
Day -1 
-21 to -2 
(Screen- 
ing & 
Baseline) 
Visit 
2 
Day 0 
(Treat- 
ment- 
discharge
) 
Visit 3 
30 (+/- 
7) Days 
Visit 4 
60 (+/- 
7) Days 
Visit 5 (3 
mo. +/- 2 
wks) & 
Visit 7 (9 
mo. +/- 2 
wks) 
Visit 6 
6 
months 
(+/- 2 
weeks) 
Visit 8 
1 Year 
(+/- 4 
weeks) 
Visit 95 
2 Year 
(+/- 4 
weeks) 
Serum Creatinine 
√ 
√ 
√ 
Numeric Pain Scale Rating (1-10)5 
√ 
√ 
 
√ 
√ 
√ 
√ 
Procedural angiogram and device 
performance data 
√ 
Technical Success 
√ 
Procedural Success 
√ 
√ 
Procedure time, defined from sheath 
insertion to final catheter removal 
√ 
Fluoroscopy time and Contrast Load for the 
index procedure 
√ 
Device- or procedure-related AE/SAE‘s6 
√ 
√ 
 
√ 
√ 
√ 
√ 
Assessment of amputation and/or major re- 
intervention of the Stent Graft 
√ 
 
√ 
√ 
√ 
√ 
Duplex Ultrasound Exam to assess Stent 
Graft patency7 
√ 
√ 
√9 
√ 
All-cause mortality 
√ 
 
√ 
√ 
√ 
√ 
1 Dual antiplatelet therapy is required for 3 months post-procedure. At a minimum, all subjects must be started on 
DAPT at least 1 week before procedure or adequately pre-loaded with DAPT as per institution practice. 
2 Prior to any re-intervention of the stent graft, an angiogram/image and wound photograph should be 
obtained for adjudication purposes. 
3 TcPO2 will be measured at 2 constant points on the dorsum of the midfoot through the 12 month follow-up. 
4 Per ACC/AHA 2006 Peripheral Arterial Disease Guidelines 
5 McCaffery, M., Beebe, A., et al.  (1989). Pain: Clinical manual for nursing practice, Mosby: St. Louis, MO. 
6 Review of any hospitalizations or procedures involving the index limb, and/or potentially related to the 
device or procedure; all SAEs through 6 months. For patients out of area or who refuse to come in for this 
visit, a telephone 
assessment should be conducted to capture as much information as possible at this time point. 
7 May be performed at any visit as standard of care, as indicated by clinical symptoms. 
8 Continuous wave doppler must be performed between 4 and 30 hours post-procedure to assess for acute thrombosis; any 
findings of acute thrombosis must be reported to the Sponsor within 24 hours of the exam. The sponsor must notify 
the FDA via email of any cases of acute stent graft thrombosis within 5 days of the event. 
9 3 Month visit only 
 
6.4 Study Procedures 
6.4.1 Enrollment 
Once any component of the LimFlow Stent Graft System is introduced into the body, the subject 
will be considered to be enrolled in the study and subject to all follow-up requirements. If the 
device is introduced but implantation is either not attempted or unsuccessful, subjects will be 
followed through 30 days for safety only, or through resolution or stabilization of any device- or 
procedure- related adverse events, whichever is longer. Those subjects will then be exited from 
the study and will not be replaced. 

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6.4.2. Intra-operative 
At a minimum, all subjects must be started on dual anti-platelet therapy (DAPT) at least 1 week 
before the procedure or adequately pre-loaded with DAPT according to the institution’s practice. 
For consented subjects that meet the pre-operative eligibility criteria, record the relevant data 
regarding their endovascular procedure. Record the following information: 
 
• 
Target In-Flow Artery (cross-over point), including proximal reference vessel diameter (RVD) 
and assessment of calcification or any other abnormalities 
• 
Target Out-Flow Vein (cross-over point) characteristics 
• 
Intra-operative anticoagulants administered, and corresponding ACT levels 
• 
Pre- and post-procedural angiographic images showing flow to the foot 
• 
Procedure start and finish times 
• 
Total contrast amount given 
• 
Total fluoroscopy time for the procedure 
• 
Documentation of any device- or procedure-related adverse events 
• 
Technical Success 
 
At the end of the endovascular procedure, with the procedural sheath in place and under 
fluoroscopic visualization, an injection of contrast will be made to assess the anatomy, placement 
and patency of the proximal, body and distal ends of the Stent Graft. 
6.4.3. Post-operative 
After the LimFlow Stent Graft System is successfully placed, the access site and peripheral extremity 
should be closely monitored. Dual anti-platelet therapy should be prescribed for a minimum of 3 
months post-procedure. 
All subjects will undergo a continuous wave doppler exam of the stent graft between 4 and 30 hours 
post-procedure. The exam is intended to verify the patency of the LimFlow stent graft and assess for 
acute stent graft thrombosis. Any findings of acute stent graft thrombosis must be reported to 
Sponsor within 24 hours of the exam and reported as an adverse event. The sponsor must notify the 
FDA by email of any cases of acute stent graft thrombosis within 5 days of the event. 
 
6.5 Follow-up 
Subjects should return to the clinic at 30 and 60 days (+/- 7 days), at 3, 6, and 9 months (+/- 2 
weeks), and then annually for up to 2 years following their endovascular procedure and the 
peripheral limb/wound should be assessed. 
 
Routine surveillance of the wound and index limb will be performed during each follow-up visit, in 
accordance with ACC/AHA 2006 Peripheral Disease Guidelines. Examinations will include 
assessments of pulse, pain, Rutherford Classification, TCP02, wound healing status, medication 
regimen and any procedures or complications related to the index limb occurring since the last visit. 
The limb/wound will be photographed, displaying a metric ruler in the frames, and in enough detail 
to capture any change in wound status. Photographs are to include Anterior-Posterior (AP) photos of 
the dorsum of the foot including toes, medial and lateral projections and plantar. 
Duplex Ultrasound Exam Guidelines: A duplex ultrasound exam will be performed at 1, 2, 3, and 6 
month visits to assess the following: 

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• 
Presence of any significant stenotic or occlusive lesions proximal to the AV fistula that may 
compromise in-flow 
 
• 
Diameter of the stent graft proximal to the crossing point, just distal to the crossing point, 
proximal upper tibial, mid tibial and lower tibial 
• 
Flow volume measurements based on Diameter and Time Averaged Mean Velocity (TAMV) at the 
identical points stated above where diameter measurements were made 
• 
Presence of flow in the outflow veins of the foot and flow volume measurements if possible 
• 
Standard duplex ultrasound of the tibial arteries with particular reference to the presence of 
reverse flow. 
Subjects should be instructed to promptly notify the investigator regarding any outside surgical 
referrals initiated by referring physicians caring for the subject’s wounds. 
NOTE: In the event that an index limb is determined to need a re-intervention or major amputation, a 
photograph of the wound and angiogram/images should be collected prior to the procedure for 
event adjudication by the ISC. 
 
6.6 Study Exit 
Once the subject has a) completed the follow-up visits; b) has withdrawn consent to participate in 
the study; c) has met a primary study endpoint, or d) was enrolled but not able to have the device 
implanted, they will be exited from the study provided they do not have any conditions that require 
continued follow-up. The date of exit, reason, and subject status should be recorded. 
 
 
7.0 Assessment of Safety and Effectiveness 
7.1 Primary Safety Endpoint 
Amputation-Free Survival at 30 days, defined as the percentage of subjects with: 
• 
Limb Salvage: Freedom from above-ankle amputation of the index limb AND 
• 
Survival: Freedom from all-cause mortality 
 
7.2 Secondary Safety Endpoint 
Amputation-Free Survival at 6 months, defined as the percentage of subjects with: 
• 
Limb Salvage: Freedom from above-ankle amputation of the index limb AND 
• 
Survival: Freedom from all-cause mortality 
 
7.3 Secondary Effectiveness Endpoints 
There are multiple secondary effectiveness endpoints to be evaluated in the study: 
 
• 
Primary Patency at 30 days: Defined as the absence of total occlusion1 of the stent graft 
without prior clinically driven major re-intervention2 of the stent graft at 30 days. 
• 
Primary Patency at 6 months: Defined as the absence of total occlusion1 of the stent graft 
without prior clinically driven major re-intervention2  of the stent graft at 6 months. 
• 
Secondary Patency at 6 months: Defined as the absence of total occlusion1 of the stent graft 
with or without prior clinically-driven major re-intervention2  of the stent graft at 6 months. 

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• 
Deterioration in Renal Function at 6 months: Defined as a 25% increase in serum creatinine 
after using iodine contrast agent without another clear cause for kidney injury. 
 
• 
Limb Salvage at 3, 6, 9, and 12 months: Defined as percentage of subjects with freedom 
from above-ankle amputation of the index limb. 
• 
Wound Healing at 3, 6, 9, and 12 months: Defined as percentage of subjects with completed 
index wound healing. 
• 
Technical Success: Percentage of technical success, defined as completion of the 
endovascular procedure and immediate morphological success with successful placement of the 
arterial and venous catheters in the desired location in the limb, and ability to place the stent 
graft. 
• 
Procedural Success: Percentage of subjects with a procedural success, defined as 
combination of technical success, and absence of all-cause mortality, above-ankle amputation or 
clinically-driven major re-intervention of the stent graft through 30 days. 
 
1 Occlusion is defined as absence of flow on color Doppler, and/or absence of flow on angiographic 
images (conventional or CT). 
2 Clinically-driven major re-intervention is defined as the creation of a new surgical bypass, the use of 
thrombectomy or thrombolysis (i.e., procedures done in the setting of lost primary-assisted patency), 
or major surgical revision such as a jump graft or an interposition graft performed for critical 
occlusion of the stent graft. 
 
 
8.0 Statistical Considerations 
8.1 Analysis Populations and Data Handling Conventions 
8.1.1. Safety 
All subjects who receive any portion of the LimFlow Stent Graft System will be included in safety 
analysis, as Intent to Treat population (ITT). 
8.1.2. Effectiveness 
All enrolled subjects meeting all inclusion and exclusion criteria that receive the LimFlow Stent Graft 
System (e.g., implanted) will be included in the effectiveness analyses, as Per Protocol population 
(PP). 
8.1.3. Missing Data 
Missing data will not be imputed by any method. All subject data will be collected on standardized 
case report forms. 
8.2 Data Analysis 
8.2.1. Baseline Subject Characteristics 
Subject demographics, baseline characteristics and medical history will be summarized descriptively. 
Mean and standard deviation will generally be reported for continuous variables; median and range 
may be reported instead if the data distribution is skewed. Frequencies and proportions will be 
reported for categorical variables. 
8.2.2. Safety 
 
8.2.2.1. Primary Safety Analysis 

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The primary safety analyses will be based on the 30-day incidence rate of Amputation-Free Survival 
for the safety study sample per 8.1.1. Survival rates, 95% confidence intervals, and Kaplan-Meier 
analyses will be reported. 
8.2.2.2. Secondary Safety Endpoints Analyses 
 
The secondary safety endpoint will be similarly summarized as described in 8.2.2.1. 
 
Additionally, all serious and non-serious adverse events that are potentially device- and/or 
procedure-related, and/or related to the index limb will be summarized by type of event, severity, 
relationship to the device and/or procedure, and timing of event relative to the procedure date. 
 
8.2.3. Effectiveness 
 
8.2.3.1. Secondary Effectiveness Analysis 
 
The secondary effectiveness endpoints will be summarized for the effectiveness study sample per 
8.1.2. Summary statistics for the Composite (rate and 95% confidence interval) will be reported. The 
proportion of LimFlow Stent Graft subjects who are converted to other treatment means due to 
technical failure will also be reported. 
 
8.3 Sample Size Justification 
It is generally recognized that a minimum of 10 completed subjects is sufficient to satisfy the goals of 
pilot studies such as the study described herein. Subjects will be carefully screened and followed to 
ensure all efforts are made to secure follow-up compliance in this frail subject population. 
 
 
9.0 Data Management and Monitoring 
9.1. Study Data Collection 
Electronic Case Report Forms (eCRF) will be used to capture data for the safety and performance 
analysis. Sites will be required to maintain source documentation, in accordance with GCP guidelines 
and 21 CFR 812 to substantiate all data collected. 
9.2. Site Data Monitoring and Quality Control 
Primary data collection based on source-documented hospital chart reviews will be performed by the 
clinical research team, which may include sponsor or sponsor’s designees. CRFs will be completed 
and forwarded to the sponsor within 14 days of the procedure or scheduled visit. The sponsor will 
provide adequate source document worksheets for capture of study-specific data during the 
procedure and follow-up visits that may not normally be collected during routine procedures. 
The clinical site will be monitored periodically by the sponsor’s personnel, or sponsor’s designee, for 
protocol adherence, accuracy of CRFs, and compliance to applicable regulations. Any observations of 
non-compliance will be reviewed with the principal investigator. Any evident pattern of ongoing non- 
compliance may result in corrective actions by the sponsor, including potential study suspension, as 
deemed appropriate by the sponsor. 

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The sponsor will review significant new information, including unanticipated serious adverse events 
and ensure that such information is provided to the appropriate regulatory agencies, the 
investigators and to all reviewing IRBs as required by applicable regulations. 
 
 
10.0 Safety Oversight 
10.1. Safety: Complication Analysis and Acceptance 
Revascularization catheter procedures are known to have inherent risks of complications. No new or 
additional complications or adverse events are expected due to the LimFlow portion of the 
procedure. 
10.1.1 Procedural Complications 
If serious procedural complications or adverse events are observed, the events will be individually 
analyzed for root cause relative to the complete treatment procedure and then evaluated by the 
Independent Safety Committee and the Principal Investigator. The sponsor will assess these events 
for expedited reporting requirements. 
10.1.2 Post-Procedural Complications 
If serious complications or adverse events related to the procedure or device are observed during 
and through the 6 month follow-up, the events will be individually analyzed for root cause relative to 
the complete treatment procedure and then evaluated by the Independent Safety Committee and 
Principal Investigator. The sponsor will assess these events for expedited reporting requirements. 
 
10.2. Independent Safety Committee (ISC) 
 
An Independent Safety Committee will act as the medical monitor for this early Pilot Study. The ISC 
will consist of at least two (2) physicians with experience in surgical and/or endovascular treatment 
of CLI patients, who are independent from the Sponsor and are not investigators in the study. 
Whenever possible, the ISC will review data in a blinded fashion (i.e., blinded to site and subject ID, 
follow-up period, etc.) to minimize any potential bias. Specific roles, responsibilities and processes 
will be described in a Safety Charter, which will be agreed upon by ISC members and published prior 
to commencement of the study. 
 
Screening Responsibilities: 
 
The ISC will review potential study candidates to evaluate their eligibility for the study, specifically to 
determine that no conventional distal bypass surgical or endovascular therapy for limb salvage is 
feasible due to the absence of a suitable distal target artery. Specific criteria to be evaluated by the 
ISC in this determination include, but may not be limited to: 
• 
Baseline angiograms/images to evaluate the status and patency of the distal arterial bed (i.e., 
tibial and peritoneal arteries, dorsalis pedis artery, and plantar arteries) 
• 
Wound photographs 
• 
Medical history, including Rutherford Classification 
• 
Clinical evidence of severe hemodynamic compromise in the index limb (e.g., TcPO2, pulse 
assessments) 

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Endpoint Assessment/Adjudication: 
 
Technical Success: The ISC will review the procedural angiograms to assess stent graft/limb 
patency post-procedure to determine Technical Success. 
Outcomes Adjudication: Reports of endpoint events will be reviewed and adjudicated, 
including but not limited to: 
• 
Major amputation of the index limb 
• 
Stent graft occlusion and/or acute stent thrombosis (via DUS and/or angiographic 
documentation) 
• 
Death 
• 
Major and minor re-interventions of the index limb 
• 
Contrast-induced nephropathy 
• 
Wound healing (progression, completion, confirmation). 
 
 
Ongoing Safety Overview: 
 
The ISC will also review safety data while the study is in progress, including reports of any serious 
device- or procedure-related adverse events and/or any reports of device malfunction or failure. 
During the study, the ISC will be asked to ensure that the rights and welfare of the subjects are 
protected by providing recommendations concerning the continuation, modification, or termination 
of the study based on review of safety data. 
 
10.3 Study Termination 
 
If LimFlow and/or the ISC and/or principal investigator determine that an event, or event rate 
presents an unreasonable risk to subjects, then the investigation or parts of the investigation 
presenting that risk shall be immediately revised or terminated. Termination shall occur not later 
than 5 working days after the sponsor makes this determination and not later than 15 working days 
after the sponsor first received notice of the event. LimFlow will notify all participating investigators, 
and IRBs and the FDA of the termination of the investigation. 
 
 
11.0 Adverse Event Reporting 
11.1. General Definitions 
An AE is defined as any undesirable clinical occurrence in a subject whether or not it is considered to 
be device related. In addition, the definition of AE applies to any event with an onset post study 
procedure or to any underlying diseases, present at baseline that exacerbate in severity post study 
procedure. Therefore, an underlying disease that was present at the time of enrollment is not 
reported as an AE, but any increase in the severity of the underlying disease is to be reported as an 
AE. 
 
The following definitions for rating severity of adverse events will be used: 

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Mild: 
Awareness of  signs or  symptoms,  but  easily  tolerated;  are  of minor irritant 
type; causing no loss of time from normal activities; symptoms would not 
require medication or a medical evaluation; signs or symptoms are transient. 
 
Moderate: 
Interferes   with   the   subject’s   usual   activity   and/or requires  symptomatic 
treatment. 
 
Severe: 
Symptom(s) causing severe  discomfort and significant  impact of  the subject’s 
usual activity and requires treatment. 
 
A serious adverse event (SAE) is defined as an event which leads to: 
 
• 
Death due to any cause 
• 
Life-threatening condition 
• 
Results in persistent or significant disability/incapacity 
• 
Requires in-patient hospitalization or prolonged hospitalization 
• 
Necessitates an intervention to prevent a permanent impairment of a body function or 
permanent damage to a body structure 
• 
Results in congenital abnormality 
All SAE’s will be reported. 
Device-Related Adverse Event: an adverse event is considered to be device-related when, in the 
judgment of the investigator, the clinical event has a reasonable time sequence associated with use of 
the investigational device and is unlikely to be attributed to concurrent disease or other procedures or 
medications. It is reasonable to believe that the device directly caused or contributed to the adverse 
event. 
Procedure-Related Adverse Event: an adverse event is considered to be procedure-related when, in 
the judgment of the investigator; it is reasonable to believe that the event is associated with the 
assigned study procedure and is not specific to the investigational device used. Other products, 
surgical techniques, or medications required specifically for the procedure are likely to have 
contributed to the occurrence of the event. 
Concomitant Medication-Related Adverse Event: an adverse event is considered to be concomitant 
medication related when, in the judgment of the investigator, it is reasonable to believe that the event 
is associated with concomitant medications used in conjunction with the investigational device and is 
not otherwise specific to the investigational device (e.g. bleeding associated with anticoagulation 
medication). 
Pre-Existing Condition-Related Adverse Event: an adverse event is considered to be related to a pre- 
existing condition when, in the judgment of the investigator, it is reasonable to believe that the event is 
associated with the subject’s pre-existing condition and is not specific to the investigational device or 
procedure. Pre-existing conditions that are aggravated or become more severe during or after the 
procedure should be evaluated on a case-by-case basis to determine if the event may be more 
appropriately classified as device-related or procedure-related. 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 25 of 38 
 
 
 
Unanticipated Adverse Device Effect (UADE): Any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or associated with the study device, if that effect, 
problem or death was not previously identified in nature, severity, or degree of incidence in the 
Investigational Plan or any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects. 
 
LimFlow, or its designee, in cooperation with the investigator, will assess all adverse events considered 
to be serious and device-related for potential reportability to the FDA and other regulatory authorities 
as an Unanticipated Adverse Device Effect (UADE). 
 
The investigator should follow all unresolved serious adverse events until the events are resolved, the 
subject is lost to follow-up, the subject has withdrawn consent, or the adverse event is otherwise 
explained. 
For purposes of this study, the following events are not considered adverse events, because they are 
normally expected to occur in conjunction with endovascular procedures / post-procedure, or are 
associated with customary, standard care of subjects undergoing these procedures: 
• Early post-operative pain (within 24 hours post-index procedure) at the access site  
and/or related to position on procedure table 
• Post-anesthesia/conscious sedation emesis, nausea, or headache (within 24 hours post- 
index procedure) 
• Chest pain without associated ECG changes 
• Hematocrit decrease from baseline not associated with hemodynamic changes, 
remaining above 30% and not requiring transfusion 
• Electrolyte imbalance without clinical sequelae following endovascular procedure, even if 
requiring correction 
• Low grade temperature increase (≤38.3°C/≤101°F) 
• Sinus bradycardia/tachycardia that does not require treatment or intervention 
• Systolic or diastolic blood pressure changes that do not require treatment or intervention 
This listing of events is intended to provide guidance to the investigational sites for purposes of adverse 
event reporting. The investigator at the investigational site should utilize his/her own clinical judgment in 
evaluating adverse experiences, and may decide that the above events should be reported as adverse 
events. 
 
11.2. Reporting of Serious and Non-Serious Adverse Events 
 
11.2.1. General Reporting Requirements (Serious & Non-Serious Adverse Events) 
All potentially device- and/or procedure-related adverse events (AE) and all serious adverse events 
(SAE) will be reported and monitored from the time of treatment through the 6 month follow-up  
visit. Any SAEs related to the index limb will be reported and monitored throughout the 2 year 
follow-up visit. The report  should include:  severity, duration, action taken, treatment  outcome  and 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 26 of 38 
 
 
 
relationship of the adverse experience to the study device, procedure, concomitant medications, pre- 
existing condition, etc. (i.e., unrelated, related or relationship unknown). 
In the case of serious adverse events, procedure and/or device observations and malfunctions, 
medical record documentation (e.g. procedure notes, operative notes, discharge summary, relevant 
progress notes, imaging or lab studies) must be provided to sponsor or its designee. 
The following criteria must also be adhered to by the investigator in the case of serious adverse 
events: 
• 
The Adverse Event eCRF must be signed by the investigator. 
• 
It is the responsibility of the investigator to inform their IRB of serious adverse events as 
required by their IRB procedures and in conformance with FDA and local regulatory 
requirements. 
 
11.2.2. Reporting to Sponsor 
All serious device- and/or procedure-related adverse events and any device malfunctions or failures 
should be reported by the investigator (or designee) to the sponsor, within 24 hours of learning of 
the adverse event or failure via phone or email contact. The LimFlow contact information for reports 
and questions is: 
Sponsor Contact: 
LimFlow, Inc. 
Contact:   Thomas  Engels 
Vice President Clinical Affairs 
Phone: (888) 478-7705, ext. 101 
Fax: (408) 898-1459 
e-mail: tengels@limflow.com 
Monitor Contact: 
Marlys Chellew, BSN, RAC 
Mobile: 916-303-0879 
mchellew@chellewclinical.com 
 
11.3. Device Failures and Malfunctions 
Device performance will be evaluated by the treating physician. All performance data will be 
captured on the electronic case report forms. 
Device Failure: A device has failed if it does not perform according to labeling and negatively impacts 
the treatment while used according to the labeling. 
Device Malfunction: A device malfunction is an unexpected change to the device that is 
contradictory to the labeling and may or may not affect device performance. 
All reported device malfunctions or failures of the LimFlow Stent Graft System are required to be 
documented in the eCRF. In the event of a suspected observation or device problem, refer to the 
Manual of Operations for further instructions. Device failures and malfunctions should also be 
documented in the subject’s medical record. 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 27 of 38 
 
 
 
NOTE: Device failures or malfunctions are NOT to be reported as adverse events. However, if there is 
an adverse event that results from a device failure or malfunction, that specific event would be 
recorded in the CRF. 
 
 
12.0 Quality Control and Quality Assurance 
12.1. Site Training 
To ensure accurate, complete, and reliable data, the Sponsor or its representative will provide 
instructional material to the study site, as appropriate: 
• 
Instruct the investigators and study personnel on the protocol, the completion of the CRFs, 
and study procedures 
• 
Communicate regularly with site personnel via mail, email, telephone, and/or fax 
• 
Make periodic visits to the study site. 
12.2. Physician Training 
All investigators participating in this clinical trial are skilled in vascular interventional procedures and 
the use of the competitors’ endovascular catheters. The Site Initiation will include procedural 
relevant workflow and instruction for the LimFlow System. All treating physicians will have 
experience with the LimFlow system in cadaver and animal labs prior to treating the first subject, or 
LimFlow will provide a trained physician or clinical specialist to proctor the investigator’s first cases, 
until the investigator is comfortable with the procedure. 
 
12.3. Audits and Inspections 
The principal investigator for the site will also allow representatives of the governing IRB, the United 
States Food and Drug Administration (FDA), and other applicable regulatory agencies to inspect all 
study records, CRFs, and corresponding portions of the subject’s office and/or hospital medical 
records at regular intervals throughout the study. These inspections are for the purpose of verifying 
adherence to the protocol, completeness and exactness of the data being transcribed onto the CRF, 
and compliance with FDA or other regulatory agency regulations. 
The principal investigator for the site will inform the sponsor or sponsor’s designee in advance if they 
are to be audited or inspected by any regulatory agencies. The sponsor will also inform the site if 
they are made aware of a pending audit or inspection by a regulatory agency. 
 
12.4. Independent Safety Committee (ISC) Member Training 
All ISC members will be trained to the protocol, the procedure/device, the Safety Charter, and the 
documentation requirements prior to commencement of duties for this trial. 
 
 
13.0 Ethical Considerations 
13.1. Trial Conduct & the Declaration of Helsinki 
The study will be performed in accordance with the relevant parts of Title 21 CFR Parts 812, 50, 54, 
and 56, and the ICH Guidelines for Good Clinical Practices (E6). 

ECO-02527-009 Rev D 
LimFlow Stent Graft System 
LimFlow, Inc. 
Pilot Study 
CONFIDENTIAL: The contents of this document are proprietary and confidential. This protocol contains valuable engineering, 
clinical and commercial information which must not be disclosed to potential competitors. Duplication and distribution of this 
document requires prior approval from LimFlow. 
Page 28 of 38 
 
 
 
13.2. Institutional Review Board (IRB) 
A copy of the protocol, proposed Informed Consent form, other written patient information and any 
proposed advertising material must be submitted to the Institutional Review Board (IRB) for written 
approval prior to use. A copy of the written IRB approval of the protocol and Informed Consent form 
must be received by the sponsor, before recruitment of patients into the study and shipment of 
investigational product. 
The investigator must submit and, where necessary, obtain approval from the IRB as well as any 
required regulatory agencies, for all subsequent significant protocol amendments and significant 
changes to the Informed Consent form. The investigator should notify the IRB of deviations from the 
protocol or SAEs and UADEs occurring at the site and other SAE/UADE reports received from the 
sponsor in accordance with local procedures. 
The investigator will be responsible for obtaining annual IRB approval and renewal throughout the 
duration of the study. Copies of the investigator’s reports and the IRB continuance of approval must 
be sent to the sponsor. 
 
13.3. Provisions for Maintaining Confidentiality 
Confidentiality of subjects will be maintained throughout the study. A unique identification code will 
be assigned to each subject participating in this study. Any data that may be published in abstracts, 
scientific journals, or presented at medical meetings will reference a unique subject code and will not 
reveal the subject’s identity. The Sponsor and their CRO representative will make every reasonable 
effort to protect the confidentiality of the subjects participating in the study. 
 
13.4. Provisions for Compensation in Case of Injury 
On the conditions that a subject follows the directions of the study investigators in charge of this 
study, and in a case a subject is physically injured due to the trial procedure given under the plan for 
this study, the sponsor will pay the medical expenses for the treatment of that injury. 
The sponsor will not provide payment for management of the normally expected consequences of 
the treatment of a subject. Subjects will not be reimbursed or compensated for participating in the 
study, except for modest reimbursement for travel costs related to attendance of follow-up visits. 
By signing the Informed Consent Form, a subject will not waive any of his/her legal rights or release 
the parties involved in this study from liability for negligence. 
13.5. Emergency Actions 
The sponsor accepts the right of the investigator to deviate from the protocol in an emergency when 
necessary to safeguard the life or the physical well being of a study subject. The investigator must 
give notice of any emergency deviations and justification for the deviation to the sponsor and the IRB 
as quickly as possible after the episode, in any event no later than 24 hours after the emergency. 

E C O -0 2 5 2 7 -0 0 9 R e v D  
Li m Fl o w St e nt Gr aft Syst e m 
Li m Fl o w, I nc. 
Pil ot St u dy  
C O N FI D E N TI A L: T h e c o nt e nt s of t hi s d o c u m e nt ar e pr o pri et ar y a n d c o nfi d e nti al. T hi s pr ot o c ol c o nt ai n s v al u a bl e e n gi n e eri n g, 
cli ni c al a n d c o m m er ci al i nf or m ati o n w hi c h m u st n ot b e di s cl o s e d t o p ot e nti al c o m p etit or s. D u pli c ati o n a n d di stri b uti o n of t hi s 
d o c u m e nt r e q uir e s pri or a p pr o v al fr o m Li m Fl o w.  
P a g e 2 9  of 3 8  
 
 
 
1 3. 6.  I nf or m e d C o ns e nt F or m 
A s a m pl e I nf or m e d C o ns e nt f or m is pr o vi d e d i n Att ac h m e nt 1 f or t h e i nv esti g at or t o pr e p ar e f or us e 
at  his/ h er  sit e.  T h e  writt e n  I nf or m e d  C o ns e nt  d oc u m e nts  s h o ul d  b e  pr e p ar e d  i n  t h e  l a n g u a g e(s) of 
t h e p ot e nti al p ati e nt p o p ul ati o n at a r e a di n g l e v el t h at t h e s u bj ects c a n u n d erst a n d.  
T h e r evi e wi n g I R B a n d t h e s p o ns or m ust first a p pr ov e t h e I nf or m e d C o ns e nt f or ms t h at ar e us e d. T h e 
I nf or m e d  C o ns e nt f or ms  t h at  ar e  us e d  s h o ul d  b e  i n  acc or d a nc e  wit h  t h e  c urr e nt  g ui d eli n es  as 
o utli n e d by t h e r el ev a nt p arts of Titl e 2 1 C F R P arts 8 1 2, 5 0, 5 4, a n d 5 6, a n d t h e I C H G ui d eli n es f or 
G o o d Cli nic al Pr actic es ( E 6).  
Pri or t o p artici p ati o n i n t h e cli nic al st u dy, e ac h p ati e nt m ust giv e writt e n I nf or m e d C o ns e nt aft er t h e 
c o nt ext of t h e st u dy h as b e e n f ull y ex pl ai n e d t o t h e p ati e nt i n l a n g u a g e t h at is e asil y u n d erst o o d by 
t h e  p ati e nt.  T h e  p ati e nts  m ust  als o  b e  gi v e n  t h e  o p p ort u nity  t o  ask  q u esti o ns  a n d  h a v e  t h os e 
q u esti o ns a ns w er e d t o t h eir s atisf acti o n.  
Writt e n  I nf or m e d  C o ns e nt  m ust  b e  r ec or d e d  a p pr o pri at ely  by  m e a ns  of  t h e  p ati e nt’s  d at e d  
si g n at ur e. T h e p ati e nt will r ec eiv e a c o py of t h e I nf or m e d C o ns e nt f or m. 
 
 
1 4. 0.  St u d y A d mi nistr ati o n  
T h e s p o ns or will m a k e n ec ess ar y eff orts t o e ns ur e t h at t his st u dy is c o n d uct e d i n c o m pli a nc e wit h 
G C Ps a n d all a p plic a bl e r e g ul at or y r e q uir e m e nts.  
1 4. 1.  Pr e -St u d y D oc u m e nt ati o n  R e q uir e m e nts  
Pri or  t o  s hi p m e nt  of  i nv esti g ati o n al  pr o d uct,  t h e  f oll o wi n g  d oc u m e nts  m ust  b e  pr ovi d e d  t o  t h e 
s p o ns or: 
 
Si g n e d a n d d at e d I nv esti g at or A gr e e m e nt, c o ntr act a n d  b u d g et  
 
C o m pl et e d Fi n a nci al Discl os ur e f or m(s) f or all  I nv esti g at ors 
 
A c o py of t h e writt e n I R B a p pr o v al of t h e  pr ot oc ol  
 
A c o py of t h e writt e n I R B a p pr o v al of t h e I nf or m e d C o ns e nt  F or m  
 
A c o py of t h e c urric ul u m vit a e of t h e Pri nci p al I nv esti g at or a n d C o -I nv esti g at or (if a p plic a bl e).  
 
 
1 4. 2.  S o urc e  D oc u m e nt ati o n  
T h e  pri nci p al  i nv esti g at or  m ust  m ai nt ai n  d et ail e d  s o urc e  d oc u m e nts  o n  all  st u dy  s u bj ects  w h o  ar e 
e nr oll e d i n t h e st u dy or w h o u n d er g o scr e e ni n g. S o urc e d oc u m e nts i ncl u d e s u bj ect m e dic al r ec or ds, 
h os pit al c h arts, cli nic c h arts, i nv esti g at or’s s u bj ect st u dy fil es, as w ell as t h e r es ults of di a g n ostic t ests 
( e. g., l a b or at ory t ests). 
T h e f oll o wi n g mi ni m u m i nf or m ati o n s h o ul d b e r ec or d e d i n t h e s u bj ect’s m e dic al r ec o r ds: 
 
T h e d at e t h e s u bj ect e nt er e d t h e st u dy a n d t h e s u bj ect  n u m b er  
 
T h e st u dy pr ot oc ol n u m b er a n d t h e n a m e of t h e  S p o ns or  
 
T h e d at e t h at i nf or m e d c o ns e nt w as o bt ai n e d a n d a st at e m e nt of i nf or m e d c o ns e nt  pr oc ess  

E C O -0 2 5 2 7 -0 0 9 R e v D  
Li m Fl o w St e nt Gr aft Syst e m 
Li m Fl o w, I nc. 
Pil ot St u dy  
C O N FI D E N TI A L: T h e c o nt e nt s of t hi s d o c u m e nt ar e pr o pri et ar y a n d c o nfi d e nti al. T hi s pr ot o c ol c o nt ai n s v al u a bl e e n gi n e eri n g, 
cli ni c al a n d c o m m er ci al i nf or m ati o n w hi c h m u st n ot b e di s cl o s e d t o p ot e nti al c o m p etit or s. D u pli c ati o n a n d di stri b uti o n of t h i s 
d o c u m e nt r e q uir e s pri or a p pr o v al fr o m Li m Fl o w.  
P a g e 3 0 of 3 8  
 
 
 
 
E vi d e nc e t h at t h e s u bj ect m e ets st u dy eli gi bi lit y r e q uir e m e nts ( e. g., m e dic al hist or y, st u dy 
pr oc e d ur es a n d/ or  ev al u ati o ns)  
 
T h e d at es of all st u dy r el at e d s u bj ect  visits  
 
E vi d e nc e t h at r e q uir e d pr oc e d ur es a n d/ or e v al u ati o ns w er e c o m pl et e d, i ncl u di n g r e q uir e d 
p h ot o gr a p hs, a n gi o gr a p hic i m a g es, a n d D U S  im a g es  
 
Us e of a ny c o nc urr e nt  m e dic ati o ns  
 
D oc u m e nt ati o n of s p ecific d e vic e us e d, if  a ny  
 
Occ urr e nc e a n d st at us of a ny A dv ers e  E v e nts  
 
T h e d at e t h e s u bj ect exit e d t h e st u dy, a n d a n ot ati o n as t o w h et h er t h e s u bj ect c o m pl et e d 
t h e st u dy or w as disc o nti n u e d, i ncl u di n g t h e r e as o n f or disc o nti n u ati o n.  
1 4. 3.  R ec or d  R et e nti o n  
T h e i nv esti g at or will m ai nt ai n all ess e nti al st u dy d oc u m e nts a n d s o urc e d oc u m e nt ati o n, i n ori gi n al 
f or m at, t h at s u p p ort t h e d at a c oll ect e d o n t h e st u dy s u bj ects i n c o m pli a nc e wit h t h e I C H/ G C P 
g ui d eli n es . D oc u m e nts m ust b e r et ai n e d f or at l e ast 2 y e ars aft er t h e l ast a p pr o v al of m ark eti n g 
a p plic ati o n or u ntil at l e ast 2 y e ars h av e el a ps e d si nc e t h e f or m al disc o nti n u ati o n of t h e cli nic al 
i nv esti g ati o n of t h e pr o d uct. 
 
1 4. 4.  Crit eri a f or T er mi n ati n g  St u d y  
T h e s p o ns or r es erv es t h e ri g ht t o t er mi n at e t h e st u dy b ut i nt e n ds o nly t o ex ercis e t his ri g ht f or v ali d 
sci e ntific or a d mi nistr ati v e r e as o ns a n d r e as o ns r el at e d t o pr ot ecti o n of s u bj ects. I nv esti g at ors a n d 
ass oci at e d I R Bs will b e n otifi e d i n writi n g i n t h e ev e nt of t er mi n ati o n.  
 
P ossi bl e r e as o ns f or st u dy t er mi n ati o n i ncl u d e:  
 
 
T h e disc o v er y of a n u n ex p ect e d, si g nific a nt, or u n acc e pt a bl e ris k t o t h e s u bj ects e nr oll e d i n 
t h e st u dy. 
 
A d ecisi o n o n t h e p art of t h e s p o ns or t o s us p e n d or disc o nti n u e d e v el o p m e nt of t h e  d e vic e. 
1 4. 5.  Crit eri a f or S us p e n di n g/ T er mi n ati n g a St u d y  C e nt er  
T h e s p o ns or r es erv es t h e ri g ht t o st o p t h e e nr oll m e nt of s u bj ects at a st u dy c e nt er at a ny ti m e aft er 
t h e st u dy i niti ati o n visit if n o s u bj ects h av e b e e n e nr oll e d or if t h e c e nt er h as m ulti pl e or s ever e 
pr ot oc ol vi ol ati o ns wit h o ut j ustific ati o n or f ails t o f oll o w r e m e di al acti o ns.  
P ossi bl e r e as o ns f or s us p e n di n g/t er mi n ati n g a st u dy c e nt er i ncl u d e:  
 
 
R e p e at e d f ail ur e t o c o m pl et e c as e r e p ort f or ms pri or t o sc h e d ul e d m o nit ori n g  visits  
 
F ail ur e t o o bt ai n writt e n I nf or m e d C o ns e nt pri or t o  tr e at m e nt 
 
F ail ur e t o r e p ort S A E/ U A D E t o s p o ns or wit hi n 2 4 h o urs of  k n o wl e d g e  
 
L oss of ( or u n acc o u nt e d f or) i nv esti g ati o n al pr o d uct  i nv e nt or y 
1 4. 6.  A m e n di n g t h e  Pr ot oc ol  
A n i nv esti g at or m a y n ot m a k e pr ot oc ol c h a n g es wit h o ut pri or a p pr o v al by t h e s p o ns or. All si g nific a nt 
pr ot oc ol c h a n g es t h at m ay aff ect t h e f oll o wi n g m ust b e s u b mitt e d a n d a p pr o v e d by t h e I R B b ef or e 
i niti ati n g t h e c h a n g e: 

E C O -0 2 5 2 7 -0 0 9 R e v D  
Li m Fl o w St e nt Gr aft Syst e m 
Li m Fl o w, I nc. 
Pil ot St u dy  
C O N FI D E N TI A L: T h e c o nt e nt s of t hi s d o c u m e nt ar e pr o pri et ar y a n d c o nfi d e nti al. T hi s pr ot o c ol c o nt ai n s v al u a bl e e n gi n e eri n g, 
cli ni c al a n d c o m m er ci al i nf or m ati o n w hi c h m u st n ot b e di s cl o s e d t o p ot e nti al c o m p etit or s. D u pli c ati o n a n d di stri b uti o n of t hi s 
d o c u m e nt r e q uir e s pri or a p pr o v al fr o m Li m Fl o w.  
P a g e 3 1  of 3 8  
 
 
 
 
v ali dit y of t h e d at a or i nf or m ati o n r es ulti n g fr o m t h e c o m pl eti o n of t h e a p pr o v e d  pr ot oc ol;  
 
r el ati o ns hi p of t h e li k el y s u bj ect risk t o b e n efit r eli e d u p o n t o a p pr ov e t h e pr ot oc ol;  
 
sci e ntific s o u n d n ess of t h e i nv esti g ati o n al pl a n, or;  
 
ri g hts, s af ety, or w elf ar e of t h e h u m a n s u bj ects i nv olv e d i n t h e i nv esti g ati o n. 
T h e  s p o ns or  will  s u b mit  a  c o py  of  a ny pr ot oc ol  a m e n d m e nt  t o  t h e  i nv esti g at ors  f or  t h eir  I R B  t o 
r e vi e w  a n d  e ns ur e  t h e  st u dy  c o nti n u es  t o  b e  c o n d uct e d  c o nsist e ntly  acr oss  all  sit es.    T h e  
i nv esti g ativ e sit e m ust s e n d s p o ns or a c o py of t h e I R B a p pr o v al l ett er f or t h e pr ot oc ol a m e n d m e nt.  
T h e s p o ns or m a y m ak e c ert ai n a d mi nistr ati v e c h a n g es t o t h e pr ot oc ol wit h o ut pri or a p pr ov al of t h e 
I R B,  a n d  will  n otif y  all  i nv esti g ati v e  sit es  of  s uc h  c h a n g es  t o  e ns ur e  t h e  st u dy  c o nti n u es  t o  b e 
c o n d uct e d acc or di n gl y. 
 
1 4. 7 P u blic ati o n P olic y  
T h e exist e nc e of t his cli nic al st u dy is c o nfi d e nti al, a n d it s h o ul d n ot b e disc uss e d wit h p ers o ns o utsi d e 
of t h e st u dy. A d diti o n all y, t h e i nf or m ati o n i n t his d oc u m e nt a n d r e g ar di n g t his st u dy c o nt ai ns tr a d e 
s ecr ets a n d c o m m erci ally s e nsiti v e i nf or m ati o n t h at is c o nfi d e nti al a n d m a y n ot b e discl os e d u nl ess 
s uc h discl os ur e is r e q uir e d by r e gi o n al or n ati o n al l a w or r e g ul ati o ns. S u bj ect t o t h e f or e g oi n g, t his 
i nf or m ati o n m ay b e discl os e d o nl y t o t h os e p ers o ns i nv olv e d i n t h e st u dy w h o h av e a n e e d t o k n o w, 
b ut all s uc h p ers o ns m ust b e i nstr uct e d n ot t o f urt h er diss e mi n at e t his i nf or m ati o n t o ot h ers. T h es e 
r estricti o ns of discl os ur e will a p pl y e q u all y t o all f ut ur e i nf or m ati o n pr ovi d e d t h at is i n dic at e d as 
c o nfi d e nti al. 
 
 
T h e d at a g e n er at e d by t his cli nic al st u dy ar e t h e pr o p ert y of t h e s p o ns or, a n d s h o ul d n ot b e discl os e d 
wit h o ut t h eir pri or writt e n p er missi o n.  T h es e d at a m ay b e us e d by t h e s p o ns or n o w a n d i n t h e 
f ut ur e f or pr es e nt ati o n or p u blic ati o n at s p o ns or’s discr eti o n or f or s u b missi o n t o g ov er n m e nt al 
r e g ul at ory a g e nci es. T h e pri nci p al i nv esti g at or m ay p u blis h or pr es e nt t h e st u dy r es ults wit h pri or 
c o ns e nt of t h e s p o ns or, b ut will n ot discl os e c o nfi d e nti al i nf or m ati o n. Pri or t o s u b missi o n by a 
pri nci p al i nv esti g at or f or p u blic ati o n or pr es e nt ati o n, t h e s p o ns or will b e pr ovi d e d  wit h t h e 
o p p ort u nity t o r e vi e w t h e s u b missi o n f or c o nfi d e nti al i nf or m ati o n a n d  acc ur acy.  
 
 
1 5. 0 R e g ul at or y C o nsi d er ati o ns  
1 5. 1. S p o ns or’s R es p o nsi biliti es  
1 5. 1. 1 G e n er al  
T h e s p o ns or of t his cli nic al st u dy h as t h e o v er all r es p o nsi bilit y f or t h e c o n d uct of t h e st u dy, i ncl u di n g 
ass ur a nc e t h at t h e st u dy m e ets t h e r e g ul at ory r e q uir e m e nts of t h e U nit e d St at es F o o d a n d Dr u g 
A d mi nistr ati o n ( U S F D A). T o g et h er, b ot h t h e s p o ns or a n d its d esi g n e es will e ns ur e a d h er e nc e t o t h e 
s p o ns or’s g e n er al d uti es, s el ecti o n of i nvesti g at ors, m o nit ori n g, s u p pl e m e nt al a p plic ati o ns, 
m ai nt ai ni n g r ec or ds, a n d s u b mitti n g r e p orts.  
T h e s p o ns or’s g e n er al d uti es c o nsist of o bt ai ni n g I R B a p pr o v al pri or t o s hi p pi n g t h e d e vic es, s el ecti n g 
q u alifi e d i nv esti g at ors a n d s hi p pi n g d e vic es o nl y t o t h os e q u alifi e d i nv esti g at ors. T h e s p o ns or is als o 
r e q uir e d t o o bt ai n si g n e d st u dy a gr e e m e nts, t o pr ovi d e t h e i nv esti g at ors wit h t h e i nf or m ati o n 

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document requires prior approval from LimFlow. 
Page 32 of 38 
 
 
 
necessary to conduct the study and adequate on-site training to conduct the study, to ensure proper 
clinical site monitoring, and to provide the required reports to the investigators, IRBs and 
appropriate regulatory agencies. 
The sponsor will be responsible for providing quality data that satisfies appropriate regulations and 
informing of serious unanticipated adverse events and deviations from the protocol. Written 
progress reports and a final report will be prepared. 
 
15.1.2. Investigational Device Distribution 
LimFlow will control the distribution of the investigational devices. The investigator is responsible for 
ensuring that the devices are ordered for shipment to arrive at the hospital before the procedure 
date. 
Devices will be shipped with an Investigational Device Shipment Record. This form is to be used by 
LimFlow and the investigational site to record any shipments of the investigational device. A copy is 
to be retained by the shipper and the recipient. 
 
15.2 
Investigator Responsibilities 
15.2.1. Investigator Agreement 
The investigator must: 
• 
Agree to sign and adhere to the Investigator Agreement 
• 
Be willing to provide required assessments for analysis 
• 
Be willing to perform and be capable of performing treatment procedures as outlined in 
this protocol 
• 
Comply with all required elements of this protocol (e.g., perform testing and follow-up as 
specified, especially during personnel transitions) and supply material suitable for 
quantitative analysis 
• 
Agree to obtain written Informed Consent before any study specific procedures are 
performed in accordance with GCP 
• 
Complete all case report forms prior to scheduled monitoring visits 
• 
Be willing to change hospital routine if required by protocol (as long as subject safety and 
well-being is not compromised). 
 
15.2.2. Required Reports 
Table 2 displays a list of the reports that are the principal investigator's responsibility to generate. 
The local IRB may have additional reporting requirements. 
 
Table 2: Reports Required From Clinical Investigators 
 
Type of Report 
Prepared By Investigator For: 
Time Constraints of Notification 
Acute stent thrombosis 
Sponsor 
Within 24 hours of knowledge of 
event; LimFlow will report to FDA 
within 5 working days 
Subject death during 
investigation 
Sponsor 
Within 24 hours of knowledge of 
event 
Unanticipated adverse device 
effect 
Sponsor 
If serious or life-threatening, 
within 2 calendar days; otherwise 

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within 10 working days 
Report of subject enrollment 
Sponsor 
Within 2 working days 
Subject withdrawal 
Sponsor 
Within 5 working days 
Withdrawal of IRB or Ethics 
Committee approval 
Sponsor 
Within 5 working days 
Deviations from 
investigational plan 
(emergent) 
Sponsor 
Within 5 working days 
Informed consent not 
obtained 
Sponsor 
Within 5 working days 
Final summary report 
Sponsor 
Within 3 months 
 
15.2.3 Investigational Device Accountability 
The investigator shall maintain adequate records of the receipt and disposition of all investigational 
devices. The investigator is responsible for ensuring that the investigational devices are used only 
under the investigator’s supervision and are only used according to this protocol and any approved 
amendments. The investigator will not supply an investigational device to any person not authorized 
to participate in the LimFlow study. The investigator shall document in the operative notes and CRF’s 
the lot number of the devices used during a case. In addition, the investigator shall keep complete 
and accurate records of all devices used or unused that have been returned to LimFlow in a Device 
Accountability Log provided by the sponsor. 
After the cases are completed, all unused devices must be accounted for and returned to LimFlow. 
Instructions for device return to LimFlow will be reviewed at the site initiation visit. 
 
 
16.0 Glossary of Terms 
ACUTE STENT THROMBOSIS REQUIRING IMMEDIATE REPORTING 
Identification of thrombus within the stent graft/segment, as assessed by duplex ultrasound (DUS) 
exam, continuous wave Doppler exam, or angiogram. Sponsor must be notified within 24 hours of 
findings, and Sponsor will subsequently report findings to the FDA via email within 5 working days of 
the event. 
 
 
ALL-CAUSE DEATH, divided into 2 categories: 
 
Cardiac death is defined as death due to any of the following: 
1. 
Acute myocardial infarction. 
2. 
Cardiac perforation/pericardial tamponade. 
3. 
Arrhythmia or conduction abnormality. 
4. 
Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected 
of being related to the procedure. 
5. 
Death due to complication of the procedure, including bleeding, vascular repair, transfusion 
reaction, or bypass surgery. 
6. 
Any death in which a cardiac cause cannot be excluded. 
 
Non-cardiac death is defined as a death not due to cardiac causes (as defined above). 

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document requires prior approval from LimFlow. 
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AMPUTATION 
Major amputation is defined as amputation of the index limb at the level above the ankle. 
 
Minor amputation is defined as amputation(s) of the index limb/metatarsals at the level below the 
ankle. Indication for minor amputations should be documented in the CRF. 
 
Pre-planned amputation is defined as minor amputation(s) that are prospectively anticipated as part 
of the overall procedure and care plan for a subject. These anticipated procedures should be 
documented in the medical record prior to the index procedure. 
 
AMPUTATION-FREE SURVIVAL 
Defined as the percentage of subjects with: 
• 
Limb Salvage: Freedom from above-ankle amputation of the index limb AND 
• 
Survival: Freedom from all-cause mortality 
 
ARTERIAL / VENOUS THROMBOSIS 
Formation or development of a blood clot or thrombus, specifically in the arterial or venous system 
of the ipsilateral distal extremity. 
 
ARTERIOVENOUS (AV) FISTULA 
An unplanned, anatomical connection between the access artery and the adjacent vein that is 
demonstrated by arteriography or ultrasound, most often characterized by a continuous bruit. 
 
CLINICALLY-DRIVEN MAJOR RE-INTERVENTION OF THE STENT GRAFT 
The creation of a new surgical bypass, the use of thrombectomy or thrombolysis (i.e., procedures 
done in the setting of lost primary-assisted patency), or major surgical revision such as a jump graft 
or an interposition graft performed for occlusion of the stent graft. 
 
CLINICALLY-DRIVEN MINOR RE-INTERVENTION OF THE STENT GRAFT 
Endovascular procedures (PTA, atherectomy, stenting) without thrombectomy / thrombolysis, and 
minor surgical revisions (patch angioplasty) performed to prevent occlusion of the stent graft. 
 
DETERIORATION IN RENAL FUNCTION / CONTRAST-INDUCED NEPHROPATHY 
An increase of > 25% in serum creatinine after using an iodine contrast agent, without another clear 
cause for kidney injury. 
 
EMBOLISM 
The sudden blocking of an artery by a clot or other material that has been brought to its site of 
lodgment by the blood current (embolus). Potential sources of emboli include blood clots, fat 
globules, air bubbles, tissue, clumps of bacteria, thrombus or foreign material. 
 
HEMATOMA 
A localized collection of extravasated blood in subcutaneous tissue, usually clotted. A metric ruler 
should be used to measure the widest portion of the hematoma. 

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INTIMAL TEAR / DISSECTION 
Disruption of an arterial wall resulting in splitting and separation of the intimal (subintimal) layers. 
 
IPSILATERAL DEEP VEIN THROMBOSIS 
Presence of a thrombus in the peripheral venous system of the ipsilateral limb. May be a 
complication of phlebitis or may result from injury to a vein or from prolonged bed rest. Symptoms 
include a feeling of heaviness, pain, warmth, or swelling in the affected part. 
 
IPSILATERAL LOWER EXTREMITY ARTERIAL EMBOLI 
Presence of emboli in the peripheral arterial system of the ipsilateral limb. 
 
LOCALIZED ACCESS SITE INFECTION 
Infection occurring at the access site requiring treatment with oral or intramuscular antibiotic 
therapy.  Does not include administration of prophylactic antibiotic regimens. 
 
MAJOR BLEEDING COMPLICATION 
Defined as blood loss resulting from the percutaneous revascularization procedure or adjunctive drug 
therapy requiring transfusions of blood products. 
NYHA HEART FAILURE CLASSIFICATIONS 
I: Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical 
activity does not cause undue fatigue, palpitation, dyspnea or angina pain. 
II: Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable 
at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or angina pain. 
III: Patients with cardiac disease resulting in marked limitation of physical activity. They are 
comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or angina pain. 
IV: Patients with cardiac disease resulting in inability to carry on physical activity without discomfort. 
Symptoms of heart failure or the angina syndrome may be present even at rest. If any physical 
activity is undertaken, discomfort increases. 
 
OCCLUSION OF THE STENT GRAFT 
Absence of flow on color Doppler, and/or absence of flow on angiographic images (conventional or 
CT). 
 
PERFORATION OF ARTERIAL VESSEL WALL 
A hole or break in the arterial wall (e.g., from insertion/advancement of a percutaneous device) as 
seen on angiography, which may or may not require intervention. 
 
PERFORATION OF VENOUS VESSEL WALL 
A hole or break in the venous wall (e.g., from insertion/advancement of a percutaneous device). 
 
PERI-OPERATIVE DEATH 
All-cause death that occurs within the peri-operative period of 30 days post-procedure. 
 
PERIPHERAL PULSE ASSESSMENT SCALE (IF PALPABLE) 

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0 = absent; not palpable; 1 = diminished; 2 = expected; 3 = full, increased; 4 = bounding. 
 
PSEUDOANEURYSM 
A blood vessel abnormality resembling an aneurysm (localized abnormal dilatation of a blood vessel) 
but consisting of a collection of blood with persistent flow outside an artery, contained by 
surrounding tissue and due to a leaking hole through all layers of the arterial wall. The leaking hole is 
due to injury of (e.g., rupture of or trauma to) the arterial wall. The pseudoaneurysm is usually 
identified by angiography or ultrasound. 
 
RETROPERITONEAL BLEEDING 
Bleeding from an injured vessel, with deposition of blood into the retroperitoneal space (between 
the peritoneum and the posterior abdominal wall). 
 
SERIOUS ADVERSE EVENT (SAE) 
Any untoward medical occurrence that results in death, is life threatening, requires subject 
hospitalization or prolongation of existing hospitalization, or results in persistent or significant 
disability/incapacity. 
 
STROKE 
A stroke is any sudden development of neurological deficits, such as vertigo, numbness, aphasia, or 
dysarthria due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or 
rupturing aneurysm. 
SUB-INVESTIGATOR / CO-INVESTIGATOR 
Any individual member of the clinical investigation team designated and supervised by the 
Investigator at an investigational site who performs critical investigation-related procedures and/or 
makes important investigation-related observations.  See also Investigator. 
 
SUBJECT 
An individual who participates in a clinical investigation. 
 
TRANSIENT ISCHEMIC ATTACK (TIA) 
Focal neurologic abnormalities of sudden onset and brief duration (i.e., lasting less than 24 hours) 
that reflect dysfunction in the distribution of the affected artery. TIAs include transient monocular 
blindness (e.g., amaurosis fugax defined as a transient episode of monocular blindness, or partial 
blindness, lasting ten minutes or less) and transient hemispheric attacks. 
VASCULAR INJURY REQUIRING REPAIR 
Injury to the access site, and/or target vessel arterial or venous vessel wall resulting in persistent 
bleeding and requiring repair (via surgery, angioplasty, ultrasound-guided compression, thrombin 
injection, or other means). 
 
VASOSPASM 
The sudden, but transitory constriction of a blood vessel, potentially causing discomfort and 
limitation of distal blood flow. 

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Page 37 of 38 
 
 
 
 
17.0 Informed Consent Template 

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document requires prior approval from LimFlow. 
Page 38 of 38 
 
 
 
 
 
18.0 Revision History 
 
Rev. Change 
Date 
01 
Original Issue of protocol for US Pilot study. 
30Jan2017 
02 
FDA-requested revision to acute stent thrombosis reporting requirements, and post- 
procedural continuous wave doppler evaluation. 
03Mar2017 
A 
US Sponsor information added; updated to Rev. A according to new Clinical Document 
Control procedures. 
28Mar2017 
B 
Increased number of subjects from 10 to 25. Increased number of sites from 3 to 6.  
27Dec2017 
C 
Increased number of sites from 6 to 7. Added Pulse evaluation of the target location via 
continuous wave doppler to the baseline assessment. Added Duplex Ultrasound Exam at 
2 months and 3 months. 
18May2018 
D 
Increased number of subjects from 25 to 35.  
27June2018 

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