Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins
Phase: NA
Conditions: Chronic Venous Insufficiency
Sponsor: Angiodynamics, Inc.

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AngioDynamics, Inc. 
26 Forest Street 
Marlborough, MA 01752 
A Prospective Safety and Effectiveness Study: 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of 
Incompetent Perforator Veins  
CIP Number: PV-VC300 
Version: 1.3 
11-January-2017 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 2 of 55 
SYNOPSIS 
SPONSOR: AngioDynamics, Inc. 
26 Forest St 
Marlborough, MA 01752 
USA 
SPONSOR CONTACT: Kate Pietrovito 
Director, Medical Affairs and Clinical Operations 
P: 508-658-7806 
kpietrovito@angiodynamics.com  
 
INVESTIGATIONAL DEVICE: VenaCure EVLT 400 Micron (µm) Fiber Procedure Kit 
CIP TITLE: A Prospective Safety and Effectiveness Study:  
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of 
Incompetent Perforator Veins 
CIP NUMBER: PV-VC300 Version 1.2 
PRIMARY OBJECTIVE: The primary objective of this study is to evaluate the safety and 
effectiveness of the VenaCure EVLT 400 µm Fiber Procedure Kit when 
used to treat Incompetent Perforator Veins (IPVs).  
The 10 day (± 3 days) acute primary ablation success rate associated with 
the VenaCure EVLT 400 µm Fiber Procedure Kit will be compared to an IPV 
ablation success rate performance goal (PG) of 70% (based on published 
experience with endovascular radiofrequency ablation).  
SECONDARY OBJECTIVES: The secondary objectives of this study are to investigate post-procedural 
clinical outcomes associated with safety and effectiveness as 
evaluated/measured through the following: 
 
Procedural technical success rate 
 
1, 3, 6, 9, and 12 month primary ablation closure rates 
 
Primary assisted ablation rates 
 
Secondary (retreatment) ablation rates  
 
Changes in Venous Clinical Severity Score (rVCSS) 
 
Changes in clinical, etiologic, anatomic, and pathophysiologic 
(CEAP) symptoms 
 
Changes in Quality of Life from Baseline QoL (VEINES QoL) 
 
Pain assessment as related to the patient’s venous disease 
measured by the Visual Analog Scale (VAS) 
 
Ulcer Healing (when applicable) 
 
Incidence of procedure related adverse events (AEs)  

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 3 of 55 
DESIGN: This is a single-arm, prospective, multi-center, non-blinded clinical trial. 
Study data will be summarized and submitted to FDA in a premarket 
notification once all treated subjects have completed the 3-Month visit. 
Longer-term follow-up is being performed for publication purposes. 
STUDY POPULATION: Patients diagnosed with Incompetent Perforators Veins (IPVs) and 
meeting all inclusion and none of the exclusion criteria will be eligible for 
this study. Diagnosis and definition of perforating vein insufficiency will be 
consistent with the SVS/AVF Clinical Practice Guidelines for the Care of 
Patients with Varicose Veins and Associated Chronic Venous Disease 
(Gloviczki, et al, 2011). A perforator will be considered to be incompetent 
when outward flow is >0.5 sec in duration immediately after manual 
release of manual compression. IPVs that measure ≥3.5mm (measured at 
the level of the fascia) located superior to the foot and distal ankle will be 
eligible for treatment. Only one limb per patient may be treated in this 
study, although, multiple IPVs within the study limb may be treated. 
SAMPLE SIZE: For purposes of assessing safety and effectiveness, a minimum of 86 
patients and a minimum of 119 IPVs will be treated and included in the 
primary effectiveness endpoint. In addition, up to 3 lead-in cases will be 
allowed per Investigator. The maximum number of IPVs allowed to be 
treated under this CIP will be 182, which accounts for a 15% possible 
drop-out rate and 3 lead-in cases across 7 sites assuming 2 investigators 
per site. Patients will be treated until the minimum number of IPV’s 
required for primary endpoint analysis have been reached. Once the 
minimum number of patients/IPV’s has been reached, patients that have 
started the screening process can still be treated under this protocol.  
PATIENT SCHEDULE: 
SCREENING: Patients that appear to meet the eligibility criteria will be consented for 
participation in the trial. Following consent, patients will be screened to 
confirm that they meet all eligibility criteria. Screening will include a 
complete medical and surgical history assessment complemented by 
duplex ultrasonography (DUS) scanning of the entire study limb. 
BASELINE: Following Screening, all patients will undergo evaluation and 
documentation of Baseline assessments including a full physical 
examination and vital signs measurement, pain assessment as related to 
the patient’s venous disease, quality of life assessment, and ulcer 
measurement(s) when applicable. Following completion of Baseline 
assessments, patients will be scheduled for the study procedure. 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 4 of 55 
PROCEDURE: The study procedure will be conducted according to the Directions for Use 
(DFU) included with the VenaCure EVLT 400 µm Fiber Procedure Kit. 
Patients may only have one limb treated in this study; however, multiple 
IPVs in the study limb may be treated. All IPVs treated will be counted 
towards the primary endpoint, with the exception of lead-in cases. 
Concomitant venous procedures will be prohibited to avoid confounding 
results. 
FOLLOW-UP: Following the study procedure, patients will be clinically evaluated 
between 7 and 13 days post-procedure for the primary effectiveness 
endpoint and followed for a minimum of 3-months for the regulatory 
analysis. In addition, patients will be evaluated 6, 9, and 12 months post-
procedure to collect longer-term outcome data for publication.  
STATISTICS AND ASSESSMENTS: 
STATISTICAL 
METHODS: 
Standard statistical methods will be employed to analyze all data. All data 
collected in this study will be documented using summary tables and 
patient data listings. Continuous variables will be summarized using 
descriptive statistics, including counts, mean, median, standard deviation 
(SD), minimum and maximum. Where appropriate, 95% two-sided 
confidence intervals for the means will be presented. Categorical 
variables will be summarized by frequencies and percentages. Unless 
explicitly stated otherwise, percentages will utilize a denominator 
corresponding to the number of unique patients. 
SAFETY ASSESSMENTS: Procedure related adverse events (AE), serious adverse events (SAE), 
adverse device effects (ADE), serious adverse device effects (SADE), and 
unanticipated adverse device effects (UADE) will be followed. Device 
malfunctions will be reported by the investigator and reviewed by the 
Sponsor in compliance with applicable regulations 
PRIMARY ENDPOINT 
EFFECTIVENESS 
ASSESSMENT: 
The primary effectiveness endpoint is “Acute Primary Ablation Success” 
defined as complete lack of flow or IPV disappearance in the entire 
treated segment. Success will be measured via DUS imaging performed 10 
days (± 3 days) post procedure. Primary ablation success must be 
measured by a physician other than the physician that performed the 
study procedure. 
SECONDARY 
ENDPOINT TECHNICAL 
SUCCESS ASSESSMENT: 
Technical Success, defined as successful access and entry into the IPV to 
be ablated and the ability to deliver the intended laser energy, will be 
evaluated as a secondary endpoint for inclusion in device labeling. 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 5 of 55 
TABLE OF CONTENTS 
SYNOPSIS ................................................................................................................................................ 2 
TABLE OF CONTENTS .............................................................................................................................. 5 
LIST OF APPENDICES ............................................................................................................................... 8 
LIST OF ABBREVIATIONS ......................................................................................................................... 9 
1 
INTRODUCTION AND RATIONALE ................................................................................................ 11 
2 
INVESTIGATIONAL DEVICE ........................................................................................................... 13 
2.1 
VenaCure EVLT 400 µm Fiber Procedure Kit..................................................................... 13 
2.2 
Current Indications ........................................................................................................... 13 
3 
RISKS AND BENEFITS OF EVLT ...................................................................................................... 13 
4 
OBJECTIVES OF THE CLINICAL INVESTIGATION ............................................................................ 14 
4.1 
Study Objectives ............................................................................................................... 14 
4.1.1 
Primary Objective................................................................................................... 14 
4.1.2 
Secondary Objectives ............................................................................................. 14 
5 
DESIGN OF THE CLINICAL INVESTIGATION .................................................................................. 15 
5.1 
Patients ............................................................................................................................. 15 
5.1.1 
Inclusion Criteria .................................................................................................... 15 
5.1.2 
Exclusion Criteria .................................................................................................... 15 
5.1.3 
Informed Consent .................................................................................................. 16 
5.1.4 
Criteria and Procedures for Withdrawal or Discontinuation ................................. 16 
5.1.5 
Point of Enrollment ................................................................................................ 16 
5.1.6 
Number of Patients Required ................................................................................ 16 
5.2 
Screening Visit ................................................................................................................... 16 
5.3 
Baseline Visit ..................................................................................................................... 17 
5.4 
Procedure .......................................................................................................................... 18 
5.4.1 
Procedure Assessments ......................................................................................... 18 
 
Pre-procedure ............................................................................................. 18 
 
Procedure .................................................................................................... 18 
 
Post-procedure............................................................................................ 19 
5.5 
Follow-up Visits ................................................................................................................. 19 
5.5.1 
10 Day Follow-up (Day 10 ± 3 Days)....................................................................... 19 
5.5.2 
1, 3, 6, 9 and 12 Month Follow-up ......................................................................... 19 
5.6 
Primary Assisted Ablation ................................................................................................. 20 
5.7 
Secondary (Retreatment) Ablation ................................................................................... 20 
5.8 
Unscheduled Visits ............................................................................................................ 20 
5.9 
Lost to Follow-up Prevention ............................................................................................ 21 
5.10 
Discontinuation / End of Study ......................................................................................... 21 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 6 of 55 
6 
STATISTICAL CONSIDERATIONS ................................................................................................... 21 
6.1 
General Considerations .................................................................................................... 21 
6.2 
Determination of Sample Size .......................................................................................... 21 
6.3 
Baseline and Demographics Characteristics ..................................................................... 22 
6.4 
Analysis Populations ......................................................................................................... 22 
6.4.1 
ITT Population (Intention to Treat) ........................................................................ 22 
6.4.2 
PCIP Population (Per-Clinical Investigation Plan) ................................................... 22 
6.4.3 
Safety Population ................................................................................................... 23 
6.5 
Study Endpoint Analyses ................................................................................................... 23 
6.5.1 
Primary Endpoint Effectiveness Analysis ............................................................... 23 
6.5.2 
Secondary Technical Success Analysis ................................................................... 23 
6.5.3 
Additional Treatment Outcomes ........................................................................... 24 
 
Primary Ablation, Primary Assisted Ablation, and Secondary (retreatment) 
Ablation ....................................................................................................... 24 
 
Change from Baseline in rVCSS ................................................................... 24 
 
Change from Baseline in CEAP .................................................................... 24 
 
Quality of Life Assessments ........................................................................ 24 
 
Ulcer Healing ............................................................................................... 24 
6.5.4 
Safety Outcomes .................................................................................................... 24 
 
Evaluation of Procedure Related Adverse Events ....................................... 24 
 
Evaluation of Vital Signs .............................................................................. 25 
 
Evaluation of Device Malfunctions ............................................................. 25 
6.6 
Missing Data...................................................................................................................... 25 
7 
AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN ............................................................. 26 
8 
DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN ............................................................ 26 
9 
DEVICE ACCOUNTABILITY ............................................................................................................ 27 
10 
STATEMENTS OF COMPLIANCE ................................................................................................... 27 
10.1 
Role of the Sponsor ........................................................................................................... 27 
10.2 
Ethical Conduct of the Study ............................................................................................. 27 
10.3 
Institutional Review Board ................................................................................................ 27 
11 
INFORMED CONSENT PROCESS ................................................................................................... 28 
12 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND PROCEDURE-RELATED COMPLICATIONS .... 28 
12.1 
Definitions ......................................................................................................................... 28 
12.1.1 
Adverse event ........................................................................................................ 28 
12.1.2 
Serious Adverse Events .......................................................................................... 29 
12.1.3 
Adverse Device Effects ........................................................................................... 29 
12.1.4 
Serious Adverse Device Effects .............................................................................. 29 
12.1.5 
Unanticipated Adverse Device Effect..................................................................... 29 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 7 of 55 
12.1.6 
Device Complaints.................................................................................................. 29 
 
Procedure-Related Complications-Event Severity ...................................... 30 
 
Recording Procedure-Related Complications ............................................. 30 
12.1.7 
Device Malfunctions .............................................................................................. 30 
12.2 
Adverse Event Reporting .................................................................................................. 31 
12.2.1 
Serious Adverse Event Reporting ........................................................................... 31 
12.2.2 
United States Reporting Obligations ...................................................................... 32 
12.3 
Adverse Event Relatedness ............................................................................................... 32 
12.4 
Adverse Event Severity ..................................................................................................... 32 
12.5 
Adverse Event Coding ....................................................................................................... 32 
13 
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION ...................... 33 
14 
QUALITY CONTROL AND ASSURANCE (STUDY MONITORING) .................................................... 33 
14.1 
Quality Control .................................................................................................................. 33 
14.2 
Monitoring ........................................................................................................................ 33 
14.3 
Access to Source Documentation ..................................................................................... 34 
15 
ADMINISTRATIVE AND DATA MANAGEMENT ............................................................................. 34 
15.1 
Patient Confidentiality ...................................................................................................... 34 
15.2 
Case Report Forms and Clinical Investigation Records ..................................................... 35 
15.2.1 
Electronic Case Report Forms (CRFs) ..................................................................... 35 
15.3 
Retention of Data .............................................................................................................. 35 
15.4 
Study Reporting Requirements ......................................................................................... 35 
15.5 
Selection of Investigators.................................................................................................. 36 
15.6 
Financial Disclosure........................................................................................................... 36 
15.7 
Investigator Documentation ............................................................................................. 36 
15.8 
Site Training ...................................................................................................................... 36 
15.9 
Device Returns .................................................................................................................. 36 
16 
PUBLICATION POLICY ................................................................................................................... 36 
17 
BIBLIOGRAPHY ............................................................................................................................. 38 
18 
APPENDICES ................................................................................................................................. 40 
PROTOCOL REVISION HISTORY .......................................................................................................... 54 
PROTOCOL CHANGE LOG .................................................................................................................... 55 
 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 8 of 55 
LIST OF APPENDICES 
Appendix 1 
Schedule of Events ...................................................................................... 41 
Appendix 2 
Sponsor / Principal Study Investigator Approval ........................................ 42 
Appendix 3 
Investigator’s Signature .............................................................................. 43 
Appendix 4 
Lower Extremity Venous Mapping.............................................................. 44 
Appendix 5 
CEAP Classification ...................................................................................... 45 
Appendix 6 
Revised Venous Clinical Severity Score (rVCSS) .......................................... 46 
Appendix 7 
Visual Analog Scale ..................................................................................... 47 
Appendix 8 
VEINES QoL.................................................................................................. 49 
Appendix 9 
Ulcer Measurement .................................................................................... 53 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 9 of 55 
LIST OF ABBREVIATIONS 
Abbreviation 
Meaning 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AVF 
American Venous Forum 
CCC 
Complaint Call Center 
CFR 
Code of Federal Regulations 
CEAP 
Clinical, Etiologic, Anatomic, and Pathophysiologic 
CIP 
Clinical Investigation Plan 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CS 
Clinically Significant 
CTMF 
Clinical Trial Master Files 
CV 
Curricula Vitae 
CVD 
Chronic Venous Disease 
CVI 
Chronic Venous Insufficiency 
DUS 
Duplex Ultrasonography 
DVT 
Deep Vein Thrombosis 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EVLA 
Endovenous Laser Ablation 
EVRF 
Endovascular Radiofrequency 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GSV 
Great Saphenous Vein  
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IPV 
Incompetent Perforator Veins 
IR 
Interventional Radiologist 
IRB 
Institutional Review Board 
ISF 
Investigator Site File 
ISO 
International Organization for Standardization 
ITT 
Intention to Treat 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRU 
Medical Resource Utilization 
NCS 
Not Clinically Significant 
OR 
Operating Room 
PAPS 
Percutaneous ablation of perforators 
PE 
Pulmonary Embolism 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 10 of 55 
Abbreviation 
Meaning 
PG 
Performance Goal 
PI 
Principal Investigator 
PSI 
Pounds per Square Inch 
PCIP 
Per Clinical Investigation Plan 
PT 
Preferred Term 
RFA 
Radiofrequency Ablation  
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SEPS 
Subfascial Endoscopic Perforator 
SIR 
Society of Interventional Radiology 
SVS/AVF 
Society of Vascular Surgery/American Venous Forum 
SVT 
Supraventricular tachycardia 
TEAE 
Treatment Emergent Adverse Event 
UADE 
Unanticipated Adverse Device Effects 
US 
Ultrasound 
rVCSS 
Revised Venous Clinical Severity Score 
VEINES 
Venous Insufficiency Epidemiological and Economic Study  
WHO DDE 
World Health Organization Drug Dictionary Enhanced 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 11 of 55 
1 INTRODUCTION AND RATIONALE 
Varicose veins affect up to 25% of men and 40% of women in the United States. While many 
people seek treatment for varicose veins because they are unsightly, many also experience 
symptoms such as aching pain, night cramps, fatigue, heaviness or restlessness. If left 
untreated, nearly 50% of patients with significant superficial venous insufficiency will 
eventually experience chronic venous insufficiency characterized by lower extremity 
swelling, eczema, pigmentation, hemorrhage and ulceration (Homans, 1917). 
The importance of incompetent perforator veins (IPVs) in the pathogenesis of chronic 
venous insufficiency has been recognized since the early 1900s first by Homans and later by 
Linton (Homans, 1917 and Linton, 1938). It is theorized that as perforating veins become 
incompetent, blood refluxes into the superficial venous system, worsening venous 
hypertension which results in relevant clinical manifestations. In two successive landmark 
studies over 90 years ago, Homans emphasized the value of interrupting IPVs as a 
component of reducing superficial venous hypertension for treating venous ulcerations; 
20 years later, Linton developed the open surgical approach to ligate IPVs through a 
subfascial medial calf incision. Outcomes from numerous observational studies with high 
ulcer recurrence rates combined with a significant morbidity led to a decreased use of the 
procedure in the 1980s. 
To avoid the complications associated with open surgery, German surgeon GH Hauer 
(Hauer, 1985) employed endoscopic techniques to gain access to the subfascial space; this 
led to future development of a laparoscopic modality, known as subfascial endoscopic 
ligation of incompetent perforators (Gloviczki, et al, 1996). In spite of this, the risk of 
complication associated with the procedure prevented its universal adaptation. 
Newer methods for treating venous disease, including, endovenous laser and 
radiofrequency ablation as well as foam sclerotherapy now have positive clinical evidence 
available and have gained widespread support (Coleridge-Smith, 2009). Endovenous 
treatments are less invasive than conventional surgery, which may be advantageous in 
more elderly patients who are affected by leg ulcers (Coleridge-Smith, 2009). 
Recent clinical practice guidelines of the Society for Vascular Surgery and the American 
Venous Forum suggest treatment of pathologic perforating veins (outward flow duration 
≥500 ms, vein diameter ≥3.5 mm) located underneath healed or active ulcers (CEAP class 
C5-C6; GRADE 2B) (Gloviczki, et. al., 2011). 
This study seeks to establish the safety and effectiveness of the VenaCure EVLT 400 µm 
Fiber Procedure Kit when used to ablate IPVs. A 2013 study Abdul-Haqq and colleagues 
demonstrated that patients who have IPVs treated along with the Great Saphenous Vein 
(GSV) fare better in a retrospective review of 95 C6 patients. Ulcer healing was 
accomplished to a significantly greater degree using Endovenous Laser Ablation (EVLA) of 
the GSV and IPV compared to GSV ablation alone. 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 12 of 55 
A 2012 study of EVLA treatment of varicose perforating veins with 1470 nm diode found the 
procedure effective and safe. After one month, 95.6% of the treated veins were still 
occluded (67/69). During follow-up, researchers did not diagnose any DVT, PE or SVT in the 
area related to the treated perforating vein (Zerweck, et. al., 2012). 
There are much existing data highlighting the safety and effectiveness of perforator vein 
ablation, as well as the important contributions of perforator vein treatment to reducing 
disease recurrence and improvements in venous ulcer healing. 
There is a wide basis of literature establishing the effectiveness and safety of thermal 
ablation of perforator veins, as well as a sound argument within the historical literature for 
improving overall treatment effectiveness with ablation of IPVs. The concept of treating 
perforator veins is not new; liquid sclerotherapy was used to treat IPVs as early as 1974 
(Hobbs, 1974). The term PAPS (percutaneous ablation of perforators) was coined in 2005 
and collectively refers to IPV treatment (comprising laser, RF, and sclerotherapy). 
While historical literature based on older interventions found questionable benefit from 
perforator vein treatment alone, recent data demonstrate incompetent perforator veins 
contribute to Chronic Venous Insufficiency (CVI) and indicate treatment of IPVs is beneficial 
to overall Chronic Venous Disease (CVD) improvement. A cross-sectional study 
demonstrated the contributions of IPVs to CVI, finding that the extent of venous 
insufficiency “correlated with an increase in the number and the diameter of perforators” 
and that clinical status worsened perforator insufficiency (Krnic, et. al., 2005). In an 
ultrasound study, perforator vein insufficiency was “common in limbs with complications” 
(Myers, et. al., 1995). Iafrati and colleagues (2002) demonstrated that aggressive treatment 
of both superficial and perforating vein reflux resulted in rapid ulcer healing and low 5-year 
recurrence rates in patients with C5 and C6 disease.  
With more aggressive disease (CEAP class C5-C6), recent literature has shown that treating 
the superficial venous system alone is not enough. Among 64 limbs with pre-op IPVs, IPVs 
persist in 40% of limbs 2 years after superficial venous surgery alone (Blomgren, et. al., 
2005). Rueda and colleagues 2013 article echoed this, their retrospective cohort analysis of 
64 patients (C5 and C6) who underwent adjunctive IPV treatment from a prospective 
venous database collected over 6 years (64% Subfascial Endoscopic Perforator Surgery 
[SEPS], 36% Radiofrequency Ablation [RFA]-IPV). Over a mean patient follow-up of 37 
months, 88% of SEPS-treated patients and 100% of RFA-IPV patients with C6 disease went 
on to completely heal their venous ulcers. The authors concluded that they support an 
“aggressive approach to patients with C5/C6 disease” which would include treatment of 
incompetent perforating veins when appropriate. 
In a prospective evaluation, Oscar and colleagues evaluated outcomes following EVLA of 
302 perforator veins predominantly in the internal part of the leg. Acute closure success 
was achieved for 97.6% of treated perforators and with recurrence observed in 15 
perforators within 6 months (93% closure rate). The authors reported improved cosmetic 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 13 of 55 
and symptomatic improvement. There was no incidence of deep venous thrombosis, no 
infections and no skin necrosis during the follow-up period. 
Given the basis of the published literature, AngioDynamics believes there is a clinical basis 
for the proposed study of the VenaCure EVLT 400 µm Fiber Procedure Kit for the treatment 
of incompetent perforator vein ablation.  
2 INVESTIGATIONAL DEVICE 
2.1 
VENACURE EVLT 400 µM FIBER PROCEDURE KIT 
The VenaCure EVLT 400 µm Fiber Procedure Kit contains a 400 µm Optical Fiber with 
SiteMark and compression clamp, 21G Venous Access Needle, a 10cm x 4F Introducer 
Sheath and a .018 inch guidewire. All components contained in the Procedure Kit are single 
use, disposable devices, for use with a laser in the treatment of varicose veins. 
2.2 
CURRENT INDICATIONS 
The VenaCure EVLT 400 µm Fiber Procedure Kit is indicated for use in the treatment of 
varicose veins and varicosities associated with superficial vein reflux of the Great Saphenous 
vein, and with veins in the lower limbs with superficial reflux. 
3 RISKS AND BENEFITS OF EVLT  
Potential complications associated with EVLT are listed below; 
 Vessel Perforation 
 Thrombosis 
 Pulmonary Embolism 
 Deep Venous Thrombosis 
 Phlebitis 
 Hematoma 
 Infection 
 Skin Pigmentation Alteration 
 Neovascularization 
 Paresthesia due to thermal damage of adjacent sensory nerves 
 Complications associated with anesthetic tumescence 
 Non-Target Irradiation 
 Hemorrhage 
 Necrosis 
 DEHP Exposure 
 Skin Burns and Pain 
 Dysesthesia 
 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 14 of 55 
The risks described above will be minimized via the selection of physicians that have 
experience performing interventional vascular procedures, specifically with the use of laser 
ablation. Patients will be selected and enrolled using clearly defined inclusion and exclusion 
criteria to ensure that patients with conditions and/or comorbidities that put them at a 
higher risk for procedural complications are excluded. Patient treatment and follow-up will 
be performed consistent with current medical best practices. Furthermore, risks will be 
minimized by requiring participants to report for routine clinic visits allowing for prospective 
diagnosis of potential procedure related complications. Participants will be given 
instructions on whom to contact in the event that they have questions regarding their 
medical care or experience health related problems. 
Appropriate therapeutic intervention following medical best-practices will be used in the 
event of medical complications. 
4 OBJECTIVES OF THE CLINICAL INVESTIGATION 
4.1 
STUDY OBJECTIVES  
4.1.1 
PRIMARY OBJECTIVE 
The primary objective of this study is to evaluate the VenaCure EVLT 400 µm Fiber 
Procedure Kit when used to treat Incompetent Perforator Veins (IPVs). The 10 day (± 3 days) 
acute primary ablation success rate associated with the VenaCure EVLT 400 µm Fiber 
Procedure Kit will be compared to an IPV ablation success rate performance goal (PG) of 
70% (based on published experience with endovascular radiofrequency ablation). 
4.1.2 
SECONDARY OBJECTIVES 
The secondary objectives of this study are to investigate post-procedural clinical outcomes 
associated with safety and effectiveness as evaluated/measured through the following: 
 Procedural technical success rate 
 1, 3, 6, 9, and 12 month primary ablation closure rates 
 Primary assisted ablation rates 
 Secondary (retreatment) ablation rates  
 Changes in Venous Clinical Severity Score (rVCSS) 
 Changes in clinical, etiologic, anatomic, and pathophysiologic (CEAP) symptoms 
 Changes in quality of life from Baseline QoL (VEINES QoL) 
 Pain assessment as related to the patient’s venous disease measured by the Visual 
Analog Scale (VAS) 
 Ulcer Healing (when applicable) 
 Incidence of procedure related adverse events (AEs)  
 
 

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5 DESIGN OF THE CLINICAL INVESTIGATION 
5.1 
PATIENTS 
5.1.1 
INCLUSION CRITERIA 
Patients are required to fulfill all the following criteria to be included in the study: 
1. Is ≥ 18 years of age  
2. IPV(s) to be treated have an outward flow duration of ≥ 0.5 sec immediately after 
manual release of manual compression 
3. IPV(s) to be treated have a diameter of > 3.5 mm (measured at the level of the 
fascia) located superior to foot and distal ankle 
4. Has been diagnosed with refractory symptomatic disease (CEAP Class 4b to Class 6) 
attributable to the IPV to be treated  
5. Has palpable pedal pulses in the study limb 
6. Any pathologic superficial saphenous veins have been previously eliminated and 
were done so at least more than 30 days prior to the study procedure 
7. Is able to ambulate 
8. Is able to comprehend and have signed the Informed Consent Form (ICF) to 
participate in the study 
9. Is willing and able to comply with the CIP and follow-up schedule 
5.1.2 
EXCLUSION CRITERIA 
Patients will be excluded from participation in the study if they meet any of the following: 
1. Has venous insufficiency secondary to venous obstruction proximal to the intended 
treatment site 
2. Has thrombus in the vein segment to be treated 
3. Has known peripheral arterial disease 
4. Has a BMI calculation (BMI = W / H2 ) >40kg/m2 
5. Is undergoing active anticoagulant therapy for DVT or other conditions (e.g., 
warfarin, Q10 inhibitors or low molecular weight heparin) or has a history of DVT 
within the last 6 months or hypercoagulable state.  
6. Has had prior venous procedures in the study limb within the last 30 days (including 
but not limited to, thrombolysis / thrombectomy / stenting / ablation / phlebectomy 
/ sclerotherapy) 
7. Has undergone or is expected to undergo any major surgery within 30 days prior to 
or within 90 days following the study procedure 
8. Has a condition, judged by the treating physician, that may jeopardize the patient’s 
well-being and/or confound the results or the soundness of the study 
9. Is pregnant or lactating at the time of the study procedure or is intending on 
becoming pregnant within 90 days following the study procedure  
10. Is participating in another clinical study that is contraindicative to the treatment or 
outcomes of this investigation 

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5.1.3 
INFORMED CONSENT 
Patients that appear to meet the eligibility criteria will be consented for participation in the 
trial. The patient will be asked to sign an Informed Consent Form (ICF) prior to performance 
of any study-specific procedures. The ICF must have prior approval from each respective 
Institutional Review Board (IRB). Failure to provide informed consent renders the patient 
ineligible for the study. A progress note indicating that the patient was consented for 
participation in the study should be included in the patient’s medical record. 
Participants enrolled at sites in the United States must also sign a Health Insurance 
Portability and Accountability Act (HIPAA) release of protected health information. 
5.1.4 
CRITERIA AND PROCEDURES FOR WITHDRAWAL OR DISCONTINUATION 
Any patient may withdraw his or her consent at any time for any reason during the study. 
The investigator will also withdraw a patient if the Sponsor or local regulatory agency (e.g., 
FDA) terminates the study. 
The investigator may withdraw a patient from the study for any of the following reasons: 
 The investigator determines that it is not in the patient’s best interest to continue in 
the study, or 
 The sponsor or investigator terminates the study, or 
 The patient requests to be discontinued from the study. 
If a patient is withdrawn or discontinued from the study for any reason, the reason(s) for 
withdrawal or discontinuation will be recorded on the eCRF. 
5.1.5 
POINT OF ENROLLMENT 
A patient is considered enrolled at the time of informed consent.  
5.1.6 
NUMBER OF PATIENTS REQUIRED 
For purposes of assessing safety and effectiveness, a minimum of 86 patients and a 
minimum of 119 IPVs will be treated and included in the primary effectiveness endpoint 
analysis. In addition, up to 3 lead-in cases will be allowed per Investigator. The maximum 
number of patients allowed to be treated under this CIP will be 182, which accounts for a 
15% possible drop-out rate and 3 lead-in cases across 7 sites assuming 2 investigators per 
site. Patients will be treated until the minimum number of IPV’s required for primary 
endpoint analysis have been reached. Patients that are in the screening process when the 
minimum number of IPVs required has been reached will be treated. 
5.2 
SCREENING VISIT 
Patients that appear to meet the eligibility criteria will be consented for participation. All 
patients must complete the Informed Consent process prior to starting any Screening 
assessments. A Screening visit will be conducted for all patients. All Screening assessments 
must be performed on or before the date of Baseline assessments and no more than 14 
days prior to the date of the study procedure (except where noted below). Screening 

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assessments are not required to be performed on the same day. A full schedule of events 
can be found in Appendix 1. 
Diagnosis and definition of perforating vein insufficiency will be consistent with the SVS/AVF 
Clinical Practice Guidelines for the Care of Patients with Varicose Veins and Associated 
Chronic Venous Disease (Gloviczki, et al, 2011). A perforator will be considered to be 
incompetent when outward flow is >0.5 sec in duration immediately after manual release of 
manual compression. IPVs that measure ≥3.5mm (measured at the level of the fascia) 
located superior to the foot and distal ankle will be eligible for treatment. A Patient that 
does not meet the eligibility criteria will be considered a Screen Failure. Reason(s) for 
Screen Failure will be documented in the eCRF. 
The following Screening assessments will be performed and documented in the eCRF: 
 Demographics 
 Inclusion/exclusion criteria assessment 
 Medical and surgical history, including current medical conditions 
 Medications taken, current and prior 14 days  
 DUS of entire study limb with assessment of superficial and deep system, including 
diameter (mm) of each perforator and duration of reflux (seconds) according to DUS 
Screening Protocol 
 Venous Mapping, including anatomic location of each IPV to be treated (Appendix 4) 
 Ipsilateral and contralateral standardized limb girth measurement 
 CEAP Classification (Appendix 5) 
 rVCSS Classification (Appendix 6) 
5.3 
BASELINE VISIT 
Patients must have completed all Screening assessments prior to beginning any Baseline 
assessments, although both Screening and Baseline may occur on the same day. All Baseline 
assessments must be performed no more than 14 days prior to the date of the study 
procedure. Baseline assessments are not required to be performed on the same day. The 
following Baseline assessments will be performed and documented in the eCRF: 
 Vital Signs (height, weight, blood pressure, pulse) 
 Pain assessment as related to patients venous disease measured by the Visual 
Analog Scale (Appendix 7) 
 Physical Examination 
 Quality of Life score as measured by the VEINES QoL (Appendix 1) 
 Ulcer Measurement (if applicable) (Appendix 9) 
 
 

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5.4 
PROCEDURE 
5.4.1 
PROCEDURE ASSESSMENTS 
All Screening and Baseline assessments must be completed prior to performing the study 
procedure, although Screening and Baseline may occur on the same day as the study 
procedure. Pre-procedure, Procedure and Post-procedure details will be captured. 
 
Pre-procedure 
The following pre-procedure assessments will be performed and documented in the eCRF: 
 Confirmation of negative pregnancy test within 2 days of the study procedure (for 
women of child-bearing potential) or per IRB policy* 
 Review of new or recurring medical conditions not documented during Screening 
and/or Baseline* 
 Review of new medications or changes to current medications since Screening 
and/or Baseline* 
 Vital Signs (weight, blood pressure, pulse)* 
 Physical Examination (Abbreviated)* 
*If the Screening/Baseline visit occurs on the same day as the study procedure, these 
assessments do not need to be repeated. 
 
Procedure 
Only one limb can be treated and included in this study; however, multiple IPVs within the 
study limb may be treated. All IPV’s treated will be followed according to this CIP schedule. 
The study procedure should be followed according to the VenaCure EVLT 400 µm Fiber 
Procedure KIT Directions for Use (DFU) included with the product. 
The following procedure details will be collected and documented in the eCRF: 
 Method and location of vein access for each IPV to be treated 
 Anatomic location of each IPV to be treated 
 Laser Details: Wavelength, Settings, etc. 
 Energy Delivery (watts, duration, etc.) 
 Total procedure duration 
 Anesthesia details 
 Concomitant Procedure(s)* 
 Adverse event assessment 
*Concomitant procedures are not allowed under this CIP and must be documented as a 
protocol deviation. 
 
 

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Post-procedure 
The following post-procedure assessments will be performed and documented in the eCRF: 
 Vital Signs (blood pressure, pulse) 
 Adverse event assessment 
 Post procedure medications 
 Additional interventions performed 
Following the study procedure, the treated limb should be dressed and wrapped per 
standard practice assuring direct pressure over the treated vein(s). The use of graduated 
compression garments is recommended. Immediately following the study procedure, the 
patient should ambulate for 15 – 20 minutes. Instruct the patient to avoid hot baths and 
vigorous activity for 7 days following the study procedure.  
5.5 
FOLLOW-UP VISITS 
5.5.1 
10 DAY FOLLOW-UP (DAY 10 ± 3 DAYS) 
All patients will be seen 10 (+/- 3) days following the study procedure. The following 
assessments will be performed and documented in the eCRF: 
 DUS for the primary effectiveness endpoint 
o DUS findings must be read and interpreted by a physician that has been 
trained according to the standardized DUS Post Procedure protocol 
o DUS findings must be read and interpreted by an independent physician that 
did not perform the study procedure  
 Vital Signs (weight, blood pressure, pulse) 
 Physical Examination (Abbreviated) 
 Review of new medications or changes to current medications 
 Interventions and/or procedures performed since the study procedure 
 Ipsilateral and contralateral standardized limb girth measurement 
 CEAP Classification 
 rVCSS Classification 
 
Adverse event assessment 
5.5.2 
1, 3, 6, 9 AND 12 MONTH FOLLOW-UP 
All patients will be seen at 1, 3, 6, 9 and 12 month post procedure. The following windows 
are acceptable for follow up visits: 
 1 month follow-up must be performed within 30 – 45 days post procedure 
 3 month follow-up must be performed within 90 (+/- 15) days post procedure 
 6 month follow-up must be performed within 180 (+/- 15) days post procedure 
 9 month follow-up must be performed within 270 (+/-15) days post-procedure 
 12 month follow-up must be performed within 365 (+/- 15) days post procedure  

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The following assessments will be performed at each follow-up visit and documented in the 
eCRF: 
 DUS for evaluation of primary ablation, primary assisted ablation and secondary 
(retreatment) ablation closure according to standardized DUS Post Procedure 
Protocol 
 Vital Signs (weight, blood pressure, pulse) 
 Physical Examination (Abbreviated) 
 Review of new medications or changes to current medications 
 Interventions and/or procedures performed since the study procedure 
 Ipsilateral and contralateral standardized limb girth measurement 
 Ulcer Measurement (if applicable) (Appendix 9) 
 CEAP Classification (Appendix 5) 
 rVCSS Classification (Appendix 6) 
 Pain assessment as related to the patient’s venous disease measured by the Visual 
Analog Scale (Appendix 7) 
 Quality of Life score as measured by the VEINES QoL (Appendix 8) 
 Adverse Event(s) Assessment 
 
Study Exit (Only at 1 Year Follow-up or Early Withdrawal) 
5.6 
PRIMARY ASSISTED ABLATION 
Any primary assisted ablation(s) will be documented in the eCRF. Primary assisted ablation 
is defined as successful retreatment of anatomic recanalization before clinical failure has 
occurred. 
5.7 
SECONDARY (RETREATMENT) ABLATION 
Any secondary (retreatment) ablation(s) will be documented in the eCRF. Secondary 
(retreatment) ablation is defined as successful retreatment of patients with anatomic and 
clinical failure. 
5.8 
UNSCHEDULED VISITS 
Unscheduled visits, as a result of the study procedure, may occur as deemed necessary by 
the treating Physician or the Patient. The following assessments should be performed and 
documented in the eCRF: 
 Vital Signs 
 Physical Examination (Abbreviated) 
 Adverse Event Assessment 
 Review of new medications or changes to current medications 
 Interventions and/or procedures performed since the study procedure 
 
 

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5.9 
LOST TO FOLLOW-UP PREVENTION 
Follow-up visit expectations will be discussed with each patient before they are consented 
into the study. Prior to each follow-up visit, patients will be contacted via telephone to 
confirm the scheduled visit date and time. If a patient does not appear for their scheduled 
visit, a minimum of 2 telephone contact attempts will be made. If contact is not made via 
telephone after at least 2 attempts, a certified letter will be issued and sent to the patient’s 
residence. All attempts to contact the patient will be documented in the eCRF. If patient 
contact was still unsuccessful after sending the certified letter, then the date the certified 
letter was mailed will be used as the date of study exit. 
5.10 DISCONTINUATION / END OF STUDY 
Patients will not be followed beyond 12 months except in the event that a procedure 
related AE or SAE extends beyond 12 months. Procedure related AEs/SAEs will be followed 
until resolved or stabilized. Once a patient completes their 12 month visit, they are 
considered to have completed the study. The patient’s 12 month visit date will serve as the 
patient’s date of study exit. 
6 STATISTICAL CONSIDERATIONS 
6.1 
GENERAL CONSIDERATIONS 
All data collected in this study will be documented using summary tables and patient data 
listings. Summary tables will be presented. Continuous variables will be summarized using 
descriptive statistics, including counts, mean, median, standard deviation (SD), minimum 
and maximum. Where appropriate, 95% two-sided confidence intervals for the means will 
be presented. Categorical variables will be summarized by frequencies and percentages. 
Unless explicitly stated otherwise, percentages will utilize a denominator corresponding to 
the number of unique patients. 
A detailed Statistical Analysis Plan (SAP) will be developed and finalized prior to the locking 
of the database for this study. 
6.2 
DETERMINATION OF SAMPLE SIZE 
In a review of the literature, the cumulative success rate observed for EVRF ablation is 
between 70.6% and 80.5% [95% CI]. In all studies, acute ablation success was based on 
follow-up duplex ultrasound scan. 
Based on the lower 95% confidence interval for the cumulative success rate for EVRF 
ablation, A PG of 70% will be used for hypothesis testing. Assuming an EVLT primary 
ablation success rate of 80%, 119 IPVs must be treated in the study (sample size is based on 
an Exact test for a single proportion assuming a one-sided α of 0.05 and a power of 80%). 
For safety, it was determined that there is greater than an 80% chance to detect at least 
one medically significant adverse event if the true event rate is at least 2.2% with a sample 
size of 75 patients. Assuming a 15% drop-out rate, a minimum of 86 patients would be 

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treated to obtain the appropriate number of veins for the effectiveness endpoint and meet 
the minimum number of patients needed to detect at least one medically significant 
adverse event.  
In addition, each investigator will be allowed to treat up to 3 patients as “lead-in” cases. 
Lead-in cases will be analyzed separately for safety and effectiveness and will not be 
included in any of the analysis populations. 
Assuming an expected 15% drop-out rate and assuming 2 investigators across 7 sites 
performing 3 “lead-in” cases, the maximum number of veins that may be treated under this 
protocol is 182 as calculated using this formula:  
182 veins = ((119 veins /0.85)) + (7 sites * 2 investigators * 3 lead-in cases) 
6.3 
BASELINE AND DEMOGRAPHICS CHARACTERISTICS 
Descriptive statistics will be used to summarize the baseline and demographic 
characteristics as well as vessel, lesion and procedural characteristics. For continuous 
variables, the variables will be summarized using frequencies and percentages. 95% 
confidence intervals will be utilized as appropriate.  
6.4 
ANALYSIS POPULATIONS  
The following analysis populations are planned for the study: 
6.4.1 
ITT POPULATION (INTENTION TO TREAT) 
The ITT Population will consist of all enrolled patients where vein access was attempted and 
energy was delivered with the VenaCure EVLT 400 µm Fiber Procedure Kit. The ITT 
population will be used as the primary analysis for the effectiveness endpoints, secondary 
technical success endpoint and other clinical outcome data. Lead-in patients are not 
included in the ITT population. 
6.4.2 
PCIP POPULATION (PER-CLINICAL INVESTIGATION PLAN) 
The Per-Clinical Investigation Plan (PCIP) population is a subset of the ITT population. 
Patients will be included in the PCIP population if they have had a technically successful 
procedure and completed the study without major CIP deviations. The PCIP population will 
be used as the secondary or supportive analysis for the effectiveness endpoints and other 
clinical outcome data. Lead-in patients are not included in the PCIP. 
The following will be considered major CIP deviations: 
 Major inclusion/exclusion criterion deviation 
 Major procedural deviation 
 Missing primary endpoint data (no US performed) 
 Significant CIP non-compliance that may confound the incidence of adverse events  
 
 

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6.4.3 
SAFETY POPULATION 
The safety population will include all enrolled patients where vein access was attempted 
with the VenaCure EVLT 400 µm Fiber Procedure Kit. Lead-in patients are included in the 
safety population. 
6.5 
STUDY ENDPOINT ANALYSES 
6.5.1 
PRIMARY ENDPOINT EFFECTIVENESS ANALYSIS 
The primary endpoint effectiveness analysis will be based on the 10 day follow-up visit (± 3 
days) and will include the ITT and PCIP populations with the ITT population being of primary 
interest. Primary ablation success will be determined via DUS and must be measured by a 
physician other than the physician that performed the study procedure. 
Primary ablation success will be compared to an objective Performance Goal (PG) of 70%. 
The PG has been established based on the acute closure success rate associated with EVRF 
published within the historical literature but also with input/concurrence of experienced 
endovascular interventionalists. The hypothesis of the study is as follows: 
H0: PVenaCureEVLT < 0.70 
HA: PVenaCureEVLT ≥ 0.70 
Where PVenaCureEVLT is the proportion of treated IPVs demonstrating acute primary ablation 
success. 
The proportion of IPVs in the treatment group being classified as “Acute Primary Ablation 
Successes” will be compared to the performance goal of 70% using a one sample proportion 
test with a significance level of 0.05. In conjunction with the proportion test, a 95% 
one-sided lower confidence bound for the treatment success rate will be constructed. 
6.5.2 
SECONDARY TECHNICAL SUCCESS ANALYSIS 
Assuming the primary endpoint has been met, the secondary analysis for labeling will be 
evaluated.  The secondary endpoint technical success analysis will be based on procedural 
technical success defined as successful access and entry into the IPV to be ablated and the 
ability to deliver the intended laser energy and will include the ITT and PCIP populations. 
The hypothesis for the secondary technical success analysis is as follows: 
H0: TSVenaCureEVLT < 0.75 
HA: TSVenaCureEVLT ≥ 0.75 
Where TSVenaCureEVLT is the proportion of treated IPVs demonstrating technical success. For 
this analysis, IPVs will be summarized by count and percentage for technical success with 
the rate of technical successes compared to the performance goal of 75% using a one 
sample proportion test with a significance level of 0.05. In conjunction with the proportion 
test, a 95% one-sided lower confidence bound for the treatment success rate will be 
constructed. With a sample size of 119 IPVs, assuming a one one-sided α of 0.05 and a 
power of 80%, the null hypothesis will be rejected if TSVenaCureEVLT is equal to or greater than 
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6.5.3 
ADDITIONAL TREATMENT OUTCOMES 
 
Primary Ablation, Primary Assisted Ablation, and Secondary (retreatment) 
Ablation  
Treated IPVs will be summarized by time-point, count and percentage for primary, primary 
assisted and secondary (retreatment) closure rates.  
 
Change from Baseline in rVCSS 
Descriptive statistics (i.e., N, mean, median, standard deviation, 25th percentile, 75th 
percentile, min, and max), will be presented and for the changes from baseline at each time 
point where collected. A signed-rank test will be performed to evaluate the change from 
baseline values at each time point to see if they are significantly different from their 
respective baseline values. 
 
Change from Baseline in CEAP 
Descriptive statistics (i.e., N, mean, median, standard deviation, 25th percentile, 75th 
percentile, min, and max), will be presented and for the changes from baseline at each time 
point where collected. A signed-rank test will be performed to evaluate the change from 
baseline values at each time point to see if they are significantly different from their 
respective baseline values. 
 
Quality of Life Assessments 
The VEINES-QOL/VEINES-SYM survey will be given to patients to assess their quality of life. 
Both the VEINES-QOL and VEINES-SYM scores will be computed for patients. Descriptive 
statistics (i.e., N, mean, median, standard deviation, 25th percentile, 75th percentile, min, 
and max), will be presented for these scores and for their changes from baseline at each 
time point where collected. A signed-rank test will be performed to evaluate the change 
from baseline values at each time point to see if they are significantly different from their 
respective baseline values. 
 
Ulcer Healing  
Patients will be summarized by count and percentage for ulcer healing. The denominator 
for this calculation will be the count of patients who had an ulcer.  
6.5.4 
SAFETY OUTCOMES 
 
Evaluation of Procedure Related Adverse Events  
Standard adverse event rate tables based on MedDRA will be created and presented. 
Tabulations include the following: 
 Tables presenting adverse event rates by {body system X preferred term} overall 
 Tables presenting adverse event rates by {body system X preferred term X strongest 
relationship to therapy} overall  
 Tables presenting adverse event rates by {body system X preferred term X maximum 
severity} overall 

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Adverse events leading to death or to discontinuation from the study, serious adverse 
events, and UADEs will be listed separately. 
 
Evaluation of Vital Signs 
Descriptive statistics of vital signs will be calculated at each scheduled time point and will 
include the change from baseline (e.g., value at daily assessment minus value at baseline). 
The summary of descriptive statistics at each time point will be displayed by visit and the 
change from baseline within treatment group tested using the signed rank test. 
 
Evaluation of Device Malfunctions  
Device malfunctions will be tabulated and listing in a manner similar to methods described 
for the adverse events. Device malfunctions will not be coded but will be categorized into 
like events. Any device malfunction leading to an AE or to study termination will be listed 
separately. 
6.6 
MISSING DATA 
All practical monitoring and follow-up steps will be taken to ensure complete and accurate 
data collection. While the primary endpoint is evaluated at 10 days, it is not anticipated that 
there will be much missing data. However, missing observations will be described in detail 
and evaluated for assessment of possible bias. It is assumed that data will be missing at 
random. However, to examine this assumption, an analysis will be performed to compare 
baseline characteristics and symptomatic status (at earlier time points) between those 
participants with missing data and those who completed the study. A sensitivity analysis of 
missing data will be performed. Methods of imputation such as: 
1) “last observation carry forward (LOCF)”, 
2) “missing-equals-failure”, and 
3) multiple imputation methods (e.g., SAS PROC MI) will be considered for handling of missing 
data provided statistical assumptions of these methods are satisfied. In addition, a tipping 
point analysis could be performed for the primary study endpoint which will allow 
assessment of sensitivity without need for postulating any missing data mechanism. For this 
analysis, all possible combinations of missing data will be considered, and the point at 
which significance is no longer achieved will be identified. Missing data techniques 
will be described more fully in the Statistical Analysis Plan (SAP). 
All data collected on safety or adverse events will be reported to the extent it is available, 
regardless of the active/withdrawn status of patients.. 
 
 

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7 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
Any changes in this research activity, except those necessary to remove an apparent 
immediate hazard to the patient, must be reviewed and approved by the Sponsor. The CIP 
amendment(s) must be signed by the investigator and approved by the IRB before 
implementation. The CIP amendment(s) will be filed with the appropriate regulatory 
agency(s) having jurisdiction over the conduct of the study. 
Substantial changes will require approval from the Sponsor, FDA, and IRB prior to 
implementation. 
8 DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
The investigator will not deviate from the CIP except in medical emergencies or in 
unforeseen, isolated instances where minor changes are made that will not increase the 
patient’s risk or affect the validity of the trial. In medical emergencies the Sponsor must be 
notified within 2 working days of the incident. Periodic monitoring of CIP compliance will be 
performed for each site. The Sponsor has the right to suspend enrollment at sites deemed 
to have excessive CIP compliance issues. 
All deviations related to study inclusion or exclusion criteria, conduct of the trial, patient 
management or patient assessment must be appropriately documented and reported. 
Other CIP deviations to be considered include non-adherence to the CIP that results in a 
significant additional risk to the patient, or non-adherence to FDA regulations and/or 
ISO 14155.  
The investigator must document and explain any CIP deviation in the patient’s source 
documentation. CIP deviations should be reported to the IRB according to their 
requirements. Deviations will also be documented by the monitor during site visits and 
those observations will be reviewed with the investigator. 
If the investigator believes that any exception to the CIP is justified for an individual patient 
or if the investigator has a question concerning a patient who may not meet an eligibility 
criterion, they should contact their Clinical Research Associate (CRA). The Sponsor will 
evaluate circumstances where the investigator deviates from the study CIP and will retain 
the right to remove either the investigator or the investigational site from the study. 
 
 

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9 DEVICE ACCOUNTABILITY 
Investigators or qualified, trained designees will be responsible for maintaining device 
accountability from the time of receipt of product at the clinical site through use or return 
of product to AngioDynamics. All investigational devices must be accounted for using the 
Device Accountability Logs designed to keep track of investigational devices in this study. 
The investigator is responsible for maintaining accurate records of the three transactions 
key to material transfer in this study: 
 Device received (Sponsor to investigator) 
 Device used (investigator to patient) 
 Device returned (investigator to Sponsor), or discarded 
The necessary documents can be found in the Investigator Site File (ISF) binder. 
The site monitor will verify accountability of the study devices during routine monitoring 
visits to the site. 
Investigational devices must be stored according to the conditions set forth for the device 
on the label in a controlled, locked area. All device shipment records (packing lists, etc.) 
must be maintained at the site. 
10 STATEMENTS OF COMPLIANCE 
10.1 ROLE OF THE SPONSOR 
As the study Sponsor of this clinical trial, AngioDynamics has the overall responsibility for 
the conduct of the study, including assurance that the study meets the requirements of the 
appropriate regulatory bodies. In this study, the Sponsor will have certain direct 
responsibilities and may delegate other responsibilities to the CRO. 
10.2 ETHICAL CONDUCT OF THE STUDY 
The investigator agrees that the study will be conducted according to the applicable FDA 
regulations (21CFR). The investigator will conduct all aspects of this study in accordance 
with all national, state, and local laws or regulations. 
10.3 INSTITUTIONAL REVIEW BOARD 
Federal regulations and 21CFR require that approval be obtained from an IRB prior to 
participation of patients in research studies. Prior to patient enrollment, a signed copy of 
the IRB approval letter must be submitted to AngioDynamics. In addition, the CIP, informed 
consent, advertisements to be used for patient recruitment, and any other written 
information regarding this study to be provided to the patient and/or the patient’s legal 
authorized representative, must be approved by the IRB. Documentation of all IRB 
approvals will be maintained by the site and will be available for review by the Sponsor or 
its designee. 

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All IRB approvals should be signed by the IRB chairperson or designee and must identify the 
IRB by name and address, the clinical CIP by title and/or CIP number, and the date approval 
was granted. 
The Investigator is responsible for submitting and obtaining initial and continuing review of 
the trial at intervals not exceeding 1 year or as otherwise directed by the IRB. The 
investigator must supply the Sponsor or its designee written documentation of continued 
review of the study. 
11 INFORMED CONSENT PROCESS 
A written informed consent in compliance with Title 21 of the Code of Federal Regulations 
(CFR) Part 50 shall be obtained from each patient prior to participating in the study or 
performing any unusual or non-routine procedure that involves risk to the patient. An 
informed consent form (ICF) template will be provided by the Sponsor or designee to 
investigative sites. If any institution-specific modifications to study-related procedures are 
proposed or made by the site, the consent must be reviewed by the Sponsor prior to IRB 
submission. Once reviewed, the consent will be submitted by the investigator to their IRB 
for review and approval prior to the start of the study. If the ICF is revised during the course 
of the study, all active participating patients must sign the revised form. 
Before recruitment and enrollment, each prospective patient and/or patient’s legal 
authorized representative will be given a full explanation of the study and be allowed to 
read the approved ICF. Once the investigator is assured that the patient/legal 
representative understands the implications of participating in the study, the patient/legal 
representative will be asked to give consent to participate in the study by signing the ICF. 
The investigator shall provide a copy of the signed ICF to the patient/legal representative. 
The original form shall be maintained in the patient binder at the site.ADVERSE EVENTS, 
ADVERSE DEVICE EFFECTS AND PROCEDURE-RELATED COMPLICATIONS 
12.1 DEFINITIONS 
12.1.1 
ADVERSE EVENT 
An adverse event (AE) is defined as any untoward medical occurrence in a patient. This 
definition does not imply a relationship between the adverse event and the study 
procedure. 
 
 

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12.1.2 
SERIOUS ADVERSE EVENTS 
A serious adverse event (SAE) is defined as any event that: 
 
Leads to death 
 
Leads to serious deterioration in the health of a patient that: 
o results in a life threatening illness or injury 
o results in a permanent impairment of a body structure or a body function 
o requires in-patient hospitalization 
o results in medical or surgical intervention to prevent permanent impairment 
to a body structure or a body function 
12.1.3 
ADVERSE DEVICE EFFECTS 
An adverse device effect (ADE) is defined as any untoward and unintended response to a 
medical device. This definition includes any event resulting from insufficiencies or 
inadequacies in instructions for use or deployment of the device. This definition also 
includes any event that is a result of user error. 
12.1.4 
SERIOUS ADVERSE DEVICE EFFECTS 
A serious adverse device effect (SADE) is defined as an ADE that results in any of the 
consequences characteristic of an SAE or that may lead to any of these consequences if 
suitable action is not taken or intervention is not made. 
12.1.5 
UNANTICIPATED ADVERSE DEVICE EFFECT 
An unanticipated adverse device effect (UADE) is defined as any SADE on health or safety or 
any life threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death has not been previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of patients. 
12.1.6 
DEVICE COMPLAINTS 
Should a problem be encountered with the study device at any time during the course of 
this trial, it should be reported to AngioDynamics following the usual complaint process, as 
well as documented in the eCRF if applicable 
Device kit contents are supplied sterilized and should not be used if the sterile barrier is 
damaged. If damage is found, or any other issues with the device or kit components are 
identified, the following number should be called to report the issue: 
Complaint Call Center (CCC) 
Phone:  
1-800-772-6446 (select option #2 for Customer Service) 
E-mail:  
Complaints@angiodynamics.com  

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All device kits should be inspected prior to use to verify that no damage has occurred during 
shipping. 
These complaints will be reported following 21 CFR Part 803.53. 
 
Procedure-Related Complications-Event Severity 
Complications will be classified using the Society of Interventional Radiology (SIR) 
classification system for grading minor or major complications (Kundu, et al, 2009): 
Minor Complication: 
 No therapy, no consequence 
 Nominal therapy, no consequence; includes overnight admission for observation 
only 
Major Complication: 
 Require therapy, minor hospitalization (<48 hours) 
 Require major therapy, unplanned increase in level of care, prolonged 
hospitalization (>48 hours) 
 Permanent adverse sequelae 
 Death 
 
Recording Procedure-Related Complications 
All procedure-related complications observed during the study procedure and during the 
course of follow-up, regardless of severity, will be recorded on the Adverse Event eCRF. To 
the extent possible, the event to be recorded and reported is the event diagnosis as 
opposed to event symptoms, e.g., thrombophlebitis vs swelling. Medical interventions 
administered to address procedure-related complications will be documented within the 
eCRF. 
The Investigator shall notify the reviewing IRB of all major procedure-related complications 
occurring in the study according to the IRB’s requirements for serious adverse event 
reporting.  
Device failures or problems not associated with procedure-related complications will be 
documented separately on the Device Malfunction eCRF. 
12.1.7 
DEVICE MALFUNCTIONS 
All device malfunctions involving the study device will be documented on the Device 
Malfunction eCRF and reported to AngioDynamics within 24 hours. The product involved 
should be retained if feasible. AngioDynamics will advise whether the device(s) should be 
returned for analysis. 
 
 

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12.2 ADVERSE EVENT REPORTING 
Only procedure related AEs will be collected. AEs will be reported by the investigator and 
reviewed by the Sponsor in compliance with applicable regulations. AEs may be volunteered 
by patients, elicited by the investigator or designee, or collected via observation by the 
investigator. 
AEs will be assessed by the investigator who will determine whether or not the event is 
related to the study procedure or related to the study device, and whether or not the event 
meets serious criteria. If it is determined that an AE has occurred, the investigator should 
obtain all the information required to complete the AE eCRF. Source documents must be 
submitted to the Sponsor within a timely manner to ensure timely assessment of the event 
as appropriate.  
In addition, patients will be instructed to contact the investigator or a member of their care 
team if any significant AEs occur between study visits. 
An AE assessment will be performed at each visit. AEs are reported starting from the day of 
study procedure until patient participation has ended (i.e. completion of study or 
withdrawal of consent). All AEs must be followed until resolution, AE has stabilized, or the 
study has been completed.  
Pre-existing medical conditions or symptoms observed prior to the study procedure date 
will not be recorded as an AE and should be collected in the patient’s medical history. In the 
event there is a change (i.e. worsening) in the pre-existing medical condition or symptoms 
after the study procedure, then an AE must be reported. Whenever possible, the adverse 
event diagnosis (and not the signs or symptoms) should be recorded on the CRF (i.e. leg 
edema with leg pain associated with a DVT should be recorded as a DVT).  
12.2.1 
SERIOUS ADVERSE EVENT REPORTING 
A completed SAE eCRF must be entered in the clinical study database (EDC system) for all 
SAEs within 24 hours of knowledge of the event. The site will also be responsible for 
submitting relevant source documentation for the SAE. If the patient is hospitalized because 
of or during the course of an SAE, then a copy of the hospital discharge summary must also 
be included with the SAE source documentation. In case of death, the investigator must 
make every effort to obtain a copy of the death certificate to submit to the Sponsor. When 
submitting copies of source documentation, all patient identifying information must be 
redacted and only the unique patient number will be used to label the forms for 
identification purposes. 
Withdrawal from the study and all therapeutic measures will be at the discretion of the 
investigator. All SAEs will be followed until resolution, SAE has stabilized, or the study has 
been completed. All device or procedure related SAEs will be followed until resolution. 
AngioDynamics will notify the regulatory agency of any unexpected, fatal, or life-
threatening experience (expedited report) associated with the study as soon as possible in 

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accordance with regulatory requirements in each country after becoming aware of the 
event. 
Copies of any reports to regulatory agencies regarding serious and unexpected AEs will be 
provided to the investigators for review and submission to the IRB. The investigator is 
responsible for informing the IRB of any SAEs and/or UADEs. Copies of SAE/UADE 
correspondence with the investigators, regulatory authorities, and Sponsor must be 
retained with study records. 
12.2.2 
UNITED STATES REPORTING OBLIGATIONS 
All UADEs must be reported to the FDA and governing IRB within 10 working days after the 
Sponsor is first made aware of the event. Reporting to the FDA will be consistent with 
21 CFR Part 803.53 and 21 CFR Part 812.150. 
12.3 ADVERSE EVENT RELATEDNESS 
The investigator will be responsible for making a determination on the causal relationship of 
the AE. Specifically, the investigator will report whether the AE was related to the study 
procedure. 
The causal relationship for each adverse event will be rated as follows:  
 
Unrelated: The event is not related to the procedure or the study device.  
 
Possibly Related: The temporal sequence is such that the relationship is not unlikely 
or there is no contradicting evidence that can reasonably explain the patient’s 
condition. There is a possibility of any relation between the event and the procedure 
or the study device.  
 
Related: The temporal sequence is relevant or the event abates upon completion of 
the procedure/study device, or the event cannot be reasonably explained by the 
patient’s condition or comorbidities. The event is related or most likely associated 
with the procedure or the study device. 
12.4 ADVERSE EVENT SEVERITY 
The severity of the AE will be rated based upon the following grades: 
 Mild: an experience that is usually transient, & requires no special treatment or 
intervention  
 Moderate: an experience that is alleviated with simple therapeutic treatments 
 Severe: an experience that requires therapeutic intervention 
12.5 ADVERSE EVENT CODING 
Adverse events will be coded using the most recent version of the Medical Dictionary for 
Regulatory Activities (MedDRA). 
 
 

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13 SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION 
Although AngioDynamics, Inc. intends to complete the study, they reserve the right to 
discontinue the study at any time for clinical or administrative reasons, or if required by the 
local regulatory authority, with suitable written notice to the investigators and regulatory 
authorities as appropriate. 
Similarly, investigators may withdraw from the study providing written notification to 
AngioDynamics, Inc. within 30 days of their intent to withdraw. However, AngioDynamics, 
Inc. and investigators will be bound by their obligation to complete the follow-up of 
patients already enrolled into the trial. Patients must be followed according to the clinical 
CIP and information obtained during patient follow-up shall be reported on the eCRF. 
14 QUALITY CONTROL AND ASSURANCE (STUDY MONITORING) 
14.1 QUALITY CONTROL  
In accordance with applicable regulations, GCP, and AngioDynamics procedures, 
AngioDynamics monitors (or their designees) will contact the site prior to the start of the 
study to review with the site staff the CIP, study requirements, and their responsibilities to 
satisfy regulatory, ethical, and AngioDynamics requirements. When reviewing data 
collection procedures, the discussion will include identification, agreement and 
documentation of data items for which the eCRF will serve as the source document. 
AngioDynamics, or their designees, will monitor the study to ensure that the: 
 
data are authentic, accurate, and complete. 
 
the safety and rights of patients are being protected. 
 
the study is conducted in accordance with the currently approved CIP and any other 
study agreements, GCP, and all applicable regulatory requirements. 
14.2 MONITORING 
This study will be monitored in accordance with applicable regulatory requirements and 
guidance by AngioDynamics to ensure compliance with the study CIP. Site monitoring will 
be conducted by the qualified monitor (CRA) on behalf of the Sponsor. This will include 
conducting study initiation visits, interim monitoring visits, and study closure visits, as well 
as device reconciliation procedures for each participating clinical site. 
The monitor will ensure that the applicable data points on the eCRFs match the source 
documents, and resolve differences. Records of each visit will be documented in the 
appropriate monitoring report format and will include a statement of findings, conclusions, 
and any actions taken to correct any deficiencies noted during the visit.  
The monitor will report to the Sponsor any non-compliance with the signed Investigator 
Statement, the study CIP, applicable GCP requirements, or any conditions imposed by the 

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IRB or local regulatory authority. If compliance cannot be secured, device shipments to the 
Investigator may be discontinued and the Investigator’s participation in the investigation 
terminated. 
The frequency of monitoring visits will be determined by the Sponsor, but should not be 
less than one site visit annually. 
Investigators and site coordinators are expected to make source files and other records and 
reports available to the CRAs as required. 
14.3 ACCESS TO SOURCE DOCUMENTATION 
The Sponsor or its designee may perform periodic site and study file audits to evaluate 
compliance with its own clinical standard operating procedures (SOP) and Good Clinical 
Practice (GCP) standards. Investigators and institutions involved in the study will permit 
trial-related monitoring, audits, IRB review, and regulatory inspection by providing direct 
access to all study records. In the event of an audit, the investigator agrees to allow the 
Sponsor, representatives of the Sponsor, the FDA, or other regulatory authorities access to 
all study records. 
The investigator should promptly notify the Sponsor of any audits scheduled by the 
regulatory authorities and promptly forward copies of any audit reports received to the 
Sponsor. 
15 ADMINISTRATIVE AND DATA MANAGEMENT 
15.1 PATIENT CONFIDENTIALITY 
All data used in the analysis and reporting of the study will be without identifiable reference 
to the patient. Only the unique patient number will be used to identify patient data 
submitted to the Sponsor, and only the investigating site will be able to link the unique 
patient ID to the patient’s name. 
Collecting and analyzing data is considered processing of personal data under the law. All 
information and data sent to the Sponsor concerning study patients or their participation in 
this trial will be considered confidential. Only authorized personnel will have access to these 
confidential files. All records will be kept in secure storage areas and on password-
protected computers. Patient identification and confidentiality will be ensured according to 
the terms and definitions in ISO 14155.  
This includes, but is not limited to the following: 
 Patients will be identified on all eCRFs by a unique patient ID 
 eCRFs are confidential documents and will only be available to the Sponsor 
(including delegates, such as CRAs), the investigator, the biostatistician, and if 
requested, to regulatory authorities. The investigator will maintain, as part of the 
investigation file, a list identifying all patients entered into the trial. 

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All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain patient confidentiality. Clinical information will not be 
released without the written permission of the patient and/or the patient’s legal authorized 
representative, except as necessary for monitoring and auditing by the Sponsor, its 
designee, the FDA, or the IRB. 
The investigator and all site staff involved in this study may not disclose (or use for any 
purpose other than performance of the study), any data, record, or other unpublished 
confidential information disclosed to those individuals for the purpose of the study. Prior 
written agreement from the Sponsor or its designee must be obtained for the disclosure of 
any said confidential information to other parties. 
Participants enrolled at sites in the United States must also sign a HIPAA (Health Insurance 
Portability and Accountability Act) release of protected health information. 
15.2 CASE REPORT FORMS AND CLINICAL INVESTIGATION RECORDS 
15.2.1 
ELECTRONIC CASE REPORT FORMS (CRFS) 
This trial will utilize Electronic Data Capture (EDC) to collect patient data. Data will be 
recorded on electronic CRFs (eCRFs) during the course of the trial. The EDC database will 
reside on a central server accessible via the Internet. Paper copies may be printed off the 
EDC website. 
The investigator is responsible for the accuracy and completeness of data reported on the 
eCRFs. Each set of patient eCRFs must be reviewed and signed by the investigator in the 
EDC system. The investigator also agrees to maintain accurate source documentation as 
part of the patient’s medical records. These source documents may include chart notes, 
laboratory reports, images, etc. 
15.3 RETENTION OF DATA 
Investigators shall maintain all study-related documentation for a period of two (2) years 
following completion of the study, or as per the local regulatory authority’s guidelines and 
practices. 
15.4 STUDY REPORTING REQUIREMENTS 
By participating in this study, the investigator agrees to submit safety reports according to 
the timeline and method outlined in this CIP. In addition, the investigator agrees to submit 
annual reports to his/her IRB as appropriate. 
Upon completion or termination of the study, the principal investigator (PI) must submit a 
final written report to the Sponsor and IRB. The report must be submitted within 3 months 
(90 days) of completion or termination of the trial. 
The Sponsor will submit all reports required by the appropriate regulatory authorities, 
including unanticipated adverse device effects, withdrawal of IRB approval, list of current 
investigators, annual progress reports, recall information, final reports and CIP deviations. 

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15.5 SELECTION OF INVESTIGATORS 
The Sponsor will select qualified investigators, ship devices only to participating 
investigators, obtain a signed Investigator’s Agreement and provide all investigators with 
the information necessary to conduct the study. 
15.6 FINANCIAL DISCLOSURE 
Investigators and sub-investigators are required to provide financial disclosure information 
to allow the Sponsor to submit the complete and accurate certification or disclosure 
statements required under Title 21 CFR 54. In addition, the investigator must notify the 
Sponsor promptly of any relevant changes that occur during the course of the study, at the 
completion of the study and 1 year following the completion of the study. 
15.7 INVESTIGATOR DOCUMENTATION 
Prior to beginning the study, the investigator will be asked to comply with ISO14155 and 
Title 21 CFR by providing the following essential documents, including but not limited to: 
 
An original investigator-signed Investigator Agreement page of the CIP  
 
An IRB-approved informed consent, samples of site advertisements for recruitment 
for this study, and any other written information regarding this study that is to be 
provided to the patient 
 
IRB approval of the investigator, CIP, and acknowledgement of the instruction 
manuals 
 
Curricula vitae (CV) for the PI and each investigator participating in the study. 
 
Financial disclosure information (as stated above) and a commitment to promptly 
update this information if any relevant changes occur 
 
Normal ranges for any local laboratories used by the site in accordance with Title 42 
CFR 493 
15.8 SITE TRAINING 
The training of appropriate clinical site personnel will be the responsibility of the Sponsor or 
its designee. To ensure proper device usage, uniform data collection, and CIP compliance, 
the Sponsor or designee will present formal training sessions to relevant study site 
personnel. The Sponsor reserves the right to enforce retraining for sites who have 
demonstrated study or procedure compliance issues. 
15.9 DEVICE RETURNS 
Any unused or damaged devices must be returned to the study Sponsor. To initiate the 
return, the site will contact the AngioDynamics clinical affairs representative. 
16 PUBLICATION POLICY 
All data and results and all intellectual property rights in the data and results derived from 
the study will be the property of AngioDynamics. The investigator must discuss any 

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publication or presentation with AngioDynamics prior to release and obtain written consent 
on the intended publication. 
AngioDynamics recognizes the right of the investigator to publish the results upon study 
completion. However, the investigator must send a draft manuscript of the publication or 
abstract to AngioDynamics thirty (30) days in advance of submission in order to obtain 
approval prior to submission of the final version for publication. This will be reviewed 
promptly and approval will not be withheld unreasonably. 
In case of a difference of opinion between AngioDynamics and the investigator(s), the 
contents of the publication will be discussed in order to find a solution which satisfies both 
parties. 
 
 

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32. Lumsden A, Chang D, Peden E, Ultrasound-guided Percutaneous Radiofrequency 
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http://scvs.org/Abstracts/2006/SCVS06_Abstract20.cgi accessed on March 24, 2014 
33. Medical Dictionary for Regulatory Activities (MedDRA). 
34. World Health organization Drug Dictionary Enhanced (WHO DDE). 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 40 of 55 
18 APPENDICES

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 41 of 55 
APPENDIX 1 SCHEDULE OF EVENTS 

AngioDynamics, Inc,
VenaCure Endovenous Laser Treatment (EVLT)
00 |im Fiber Procedure Kit for Treat ent of Incompetent Perforator  eins
CIP No,: PV-VC300  ersion 1.3
APPENDIX 2 SPONSOR / PRINCIPAL STUDY INVESTIGATOR APPROVAL
Clinical Investigation
Plan Title 
CIP Number:
Version;
A Prospective Clinical Study Evaluating the Safety and Effectiveness
of the VenaCure Endo enous Laser Treatment (EVLT) 400 pm Fiber
Kit for Ablation of Inco petent Perforator Veins
PV-VC300
1.3
This Clinical Investigation Plan was subject to critical review and has been approved by the
sponsor and the Principal Study Investigator. The followin  personnel contributed to writing
and/or approving this Clinical Investigation Plan:
Signed:.
Date:
Mark Adelman, MD, FACS - Chief, Division of
Vascular and Endovascular Surgery, Principal
Study Investigator
U-
Signed:  Date: 
Kate Pietrovito - Director, Medical Affairs and Clinical Operations,
AngioDynamics, Inc.
CONFIDENTIAL
Page 42 of 55
1/12/2017

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 43 of 55 
APPENDIX 3 INVESTIGATOR’S SIGNATURE 
Clinical Investigation Plan 
Title: 
A Prospective Clinical Study Evaluating the Safety and Effectiveness of the 
VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Kit for Ablation of 
Incompetent Perforator Veins 
CIP Number: 
PV-VC300 
Version: 
1.3 
Investigator Agreement and Certification 
SeCure Study: A Prospective Safety and Effectiveness Study: Treating Incompetent Perforator Veins with the 
VenaCure EVLT 400 µm Fiber Procedure Kit 
I hereby agree to participate in the SeCure Study, a clinical investigation of the VenaCure EVLT 400 µm Fiber 
Procedure Kit sponsored by AngioDynamics Inc. (hereinafter “Study Sponsor”). I agree to conduct this 
investigation in accordance with this agreement, the investigational plan, 21 CFR Part 812, other applicable 
FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA. I agree to supervise all use 
of the investigational device and to ensure appropriate informed consent is obtained from all subjects prior to 
inclusion in this study. The rights, safety, and well-being of clinical investigation subjects shall be protected 
consistent with the ethical principles laid down in the 21 CFR Part 50. This shall be understood, observed, and 
applied at every step of the investigation. 
I understand that this investigation will be monitored by the Study Sponsor and/or a designee employed by 
Study Sponsor. This monitoring will involve periodic inspection of my investigational site and ongoing review 
of the data that is submitted by me to the Study Sponsor. I am also aware that I may be inspected by a 
representative of the regulatory authorities/agencies to verify compliance with applicable requirements 
related to clinical research on human subjects.  
I am aware that Study Sponsor reserves the right to discontinue this investigation at any time. In the event 
that I decide to discontinue my participation as an Investigator in this study, I will notify AngioDynamics Inc. 30 
days prior of my intent to discontinue. I understand that I am obligated to complete the follow up of the 
subjects already participating in the investigation. 
I agree to provide to the Study Sponsor a current curriculum vitae along with the curriculum vitae of those 
physicians at this institution who will be using this investigational device or participating in this study as sub-
Investigators under my supervision. These CVs include the extent and type of our relevant experience with 
pertinent dates and locations. I certify that I have not been involved in an investigation that was terminated 
for noncompliance at the insistence of Study Sponsor, this institution’s IRB or FDA. 
I understand that this investigation, protocol, and trial results are confidential and I agree not to disclose any 
such information to any person other than a representative of Study Sponsor or a regulatory authority 
(IRB/FDA/ Office of Human Research Protections-OHRP) without the prior written consent of the Study 
Sponsor. 
I will provide financial information, as indicated in U.S. Code of Federal Regulations: 21 CFR Part 812.43 (c)(5) 
and 21 CFR Part 54. 
Accepted by: 
Signed: 
 
 
Date: 
 
 
Principal Site Investigator 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 44 of 55 
APPENDIX 4 LOWER EXTREMITY VENOUS MAPPING 
 
 
Please use the following legend for completing the venous map 
RED -Reflux 
BLUE-Thrombophlebitis 
BLACK – Previously Treated 
RF, Laser, Chemical 
Ablation, Ligation & 
Stripping 
----- Recanalization 
Neovascularization 
Deep VVs 
>5mm depth 
Superficial VVs 
<5mm depth 
Reticular Vein 
Telangiectasia 
Incompetent 
Perforator 
 Venous Ectasia 
SVT - Superficial Venous Thrombophlebitis 
DVT – Deep Venous Thrombosis 
SFJ - Sapheno-Femoral Junction 
SPJ - Sapheno-Popliteal Junction 
B – Bulging Varicose Vein 
NB – Non-bulging Varicose Vein 
Small Caliber Vein - 1-2mm diameter 
Medium Caliber- 2-3mm diameter 
Large Caliber - >3mm diameter 
DTA - Distal to access 
A - Aplastic 
H - Hypoplastic 
U – Active Ulcer 
HU – Healed Ulcer 
CP – Corona Phlebectasia 
PC – Pigment Changes 
NE - Not Evaluated 
NV - Not Visualized 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
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APPENDIX 5 CEAP CLASSIFICATION 
Clinical Classiﬁcation 
C0:  no visible or palpable signs of venous disease 
C1: 
telangiectases or reticular veins 
C2: 
varicose veins 
C3: 
edema 
C4a: 
pigmentation or eczema 
C4b: 
lipodermatosclerosis or atrophie blanche 
C5: 
healed venous ulcer 
C6: 
active venous ulcer 
S: 
symptomatic, including ache, pain, tightness, skin, irritation, heaviness, and muscle cramps, and other 
complaints attributable to venous dysfunction 
A: 
asymptomatic 
 
Etiologic Classiﬁcation 
Ec:  congenital 
Ep:  primary 
Es:  secondary (post thrombotic) 
En:  no venous cause identiﬁed 
 
Anatomic Classiﬁcation 
As: 
superﬁcial veins 
Ap: 
perforator veins 
Ad: 
deep veins 
An: 
no venous location identiﬁed 
 
Pathophysiologic Classiﬁcation 
Pr: 
Pr: reﬂux 
Po: 
Po: obstruction 
Pr,o: 
Pr,o: reﬂux and obstruction 
Pn: 
Pn: no venous pathophysiology identiﬁable 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
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APPENDIX 6 REVISED VENOUS CLINICAL SEVERITY SCORE (RVCSS) 
The revised Venous Clinical Severity Score (rVCSS) will be used as an assessment tool to 
evaluate the severity of the venous disease of the patient. The rVCSS includes 9 hallmarks of 
venous disease, each scored on a severity scale from 0 to 3.  
 
Table taken from: Vasquez, M, et al. Revision of the venous clinical severity score: Venous outcomes consensus statement: Special 
communication of the American Venous Forum Ad Hoc Outcomes Working Group. J. Vasc Surg 2010; 52(5): 1387-1396. 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 47 of 55 
APPENDIX 7 VISUAL ANALOG SCALE 
The visual analog scale (VAS) will be used as an assessment tool to determine the amount of 
pain that the patient is feeling. This assessment will be performed after the Patient Informed 
Consent Form is obtained. The assessment can be administered by either an investigator or 
research coordinator. The VAS will not be used in any analysis at this time.  
VAS Instructions  
 Site personnel should complete the header information and date completed prior to 
handing the forms to the subject. 
 Have the subject write on a hard surface with a black ball point pen.  
 Have the subject read the instructions on the form.  
 Ask the subject if they have any questions regarding the instructions.  
 Have the subject complete the form on their own. Site personnel cannot mark the form.  
 Inform the patient that the vertical mark that they make must cross through the 
horizontal line 
 When the subject has completes the VAS, review it to ensure the vertical mark crosses 
the horizontal line and that there is only one mark on the line. 
 If there is more than one mark on the horizontal line have the patient draw a line 
through the mark that they wish to eliminate and have them initial and date the 
correction.  
 Site personnel should never instruct or suggest where the mark should be placed on the 
vertical line. 
 Record the mark measure in mm with the ruler provided by AngioDynamics. This 
measurement must be made in millimeters. 
 Please also record your initials and date the measurement was made. 
 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 48 of 55 
Visual Analog Scale (VAS)* 
Place a single vertical mark on the line below indicating the total amount of leg pain you currently are feeling. 
 
Below to be completed by your healthcare professional 
Measurement (mm): _________________________ 
Date of Assessment: _________________________ 
Measured By: _______________________________ 
*A 10-cm baseline is recommended for VAS scales. 
From: Acute Pain Management: Operative or Medical Procedures and Trauma, Clinical Practice Guideline No. 1. AHCPR 
Publication No. 92-0032; February 1992. Agency for Healthcare Research & Quality, Rockville, MD; pages 116-117. 
No Pain 
The worst pain you 
could imagine 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 49 of 55 
APPENDIX 8 VEINES QOL 
The Veines-QOL/Sym Questionnaire will be used as an assessment tool to determine the 
patients Chronic Venous Disorders of the Leg (CVDL) symptomology, limitations in daily 
activities due to CVDL, and psychological impact, as well as questions asking about the time 
of day the leg problem is most intense. This assessment will be performed after the Patient 
Informed Consent has been obtained. The assessment can be administered by either an 
investigator or research coordinator. The scores of the VEINES-QOL/Sym will be calculated 
for patients. The scores will be evaluated to determine the difference of the baseline scores 
to the various scores collected at follow up time points.  
Patient Instructions 
You have Chronic Venous Disorder of the Leg. In this survey, we are interested in finding out 
more about the effects of your leg problem on your daily activities, both at home and at 
work. This information will give us a better idea about how to treat such problems. 
Thank you for participating in this study. This questionnaire includes questions about your 
health in general and about your leg problem, as well as questions about your life and usual 
activities. It will take about 10 minutes to complete. 
Thank you for your help. 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 50 of 55 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 51 of 55 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 52 of 55 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 53 of 55 
APPENDIX 9 ULCER MEASUREMENT 
Use the ruler to measure the longest and widest aspect of the wound surface in 
centimeters; multiply length x width. 
Pick the depth, thickness, most appropriate to the wound using these additional 
descriptions: 
1 = tissues damaged but no break in skin surface. 
2 = superficial, abrasion, blister or shallow crater. Even with, &/or elevated above skin 
surface (e.g., hyperplasia). 
3 = deep crater with or without undermining of adjacent tissue. 
4 = visualization of tissue layers not possible due to necrosis. 
5 = supporting structures include tendon, joint capsule. 
Record the date of measurement 
Measurement 
Baseline 
1 month 
3 month 
6 month 
9 month 
12 month 
L x W cm 
 
 
 
 
 
 
Depth 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 54 of 55 
PROTOCOL REVISION HISTORY 
Date 
Version 
Description of 
Modifications 
Rationale for Modification 
May 28, 2014 
1.0 
Initial Release 
IDE protocol submitted to FDA for approval 
September 18, 2014 
1.1 
Statistical updates, 
Administrative 
updates, addition of 
protocol revision 
history and change log 
Incorporated FDA statistical considerations 
from IDE approval letter dated June 27, 2014 
 

AngioDynamics, Inc. 
VenaCure Endovenous Laser Treatment (EVLT) 
400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins 
CIP No.: PV-VC300 Version 1.3 
CONFIDENTIAL 
Page 55 of 55 
PROTOCOL CHANGE LOG 
Version # 
Modified 
Change 
Type 
Section/Paragraph 
Change Description 
1.0 
Initial 
Release 
Entire document 
IDE protocol submitted to FDA 
1.1 
Revision 
Title Page 
Revised date, version number 
1.1 
Revision 
Synopsis 
Revised Sponsor Contact, Sample Size 
1.1 
Revision 
Table of Contents 
Updated 
1.1 
Revision 
6.2 Determination of 
Sample Size 
Incorporated FDA statistical considerations from 
IDE approval letter dated June 27, 2014 
1.1 
Revision 
6.3 Baseline and 
Demographics 
Characteristics 
Clarified how “continuous variables” will be 
summarized. Added “95% confidence intervals will 
be utilized” 
1.1 
Revision 
6.4.3 Safety Population 
Added “lead-in patients are included in safety 
population” 
1.1 
Deletion 
6.5.3.1 Primary Ablation… 
Deleted “95% confidence interval” language 
1.1 
Deletion 
6.5.3.5 Ulcer Healing 
Deleted “95% confidence interval” language 
1.1 
Revision 
6.6 Missing Data 
Incorporated FDA statistical considerations from 
IDE approval letter dated June 27, 2014. Defined 
“sensitivity analysis of missing data” and methods 
of imputation 
1.1 
Revision 
Protocol Revision History 
Addition of Protocol Revision History 
1.1 
Revision 
Protocol Change Log 
Addition of Protocol Change Log 
1.2 
Revision 
Synopsis, Sponsor Contact 
Update Sponsor Contact