A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Self-Expanding Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D
Conditions: Peripheral Arterial Disease
Sponsor: Veryan Medical Ltd.

MIMICS-3D Protocol Revision 02, 03 August 2016 
Veryan Medical Limited / Confidential 
 
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A prospective, multicentre observational study to evaluate 
the BioMimics 3D Self-Expanding Stent System in the 
treatment of peripheral arterial disease:  MIMICS-3D 
 
 
 
Protocol Number:  MIMICS-3D 
 
Revision: 02 
Date:   03 August 2016 
 
Sponsor: 
 
 
 
 
Veryan Medical Ltd 
Block 11, Galway Technology Park 
Parkmore, Galway, 
Co. Galway, Ireland 
Telephone:  +353 (91) 750 040 
Facsimile:   +353 (91) 750 031 
CONFIDENTIAL 
DO NOT COPY 
This study Protocol contains confidential information for use by the principal investigators and their designated 
representatives participating in this study. It should be held confidential and maintained in a secure location. It should not 
be copied or made available for review by any unauthorised person or firm. 
 
 

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Investigator’s Signature Page 
 
Study Title: 
A prospective, multicentre observational study to evaluate the BioMimics 3D 
Self-Expanding Stent System in the treatment of peripheral arterial disease:  
MIMICS-3D  
PROTOCOL NUMBER 
& ISSUE: 
02, 03 August 2016 
Study Centre: 
_____________________________________________ 
(Print name of study centre) 
 
I, the undersigned, have read and understand the Protocol specified above and agree with its content. 
I agree to perform and conduct the Study as described in the Protocol. In addition, when applicable, I 
agree to enlist sub-investigators who also agree to perform and conduct the Study as described in the 
Protocol. I will provide copies of this Protocol and all pertinent information to the Study personnel under 
my supervision and my hospital Ethics Committee/ Institutional Review Board. I will discuss this material 
with them and ensure they are fully informed regarding the conduct of the Study according to 
Declaration of Helsinki, and any local and national regulations. 
 
 
___________________________________________________________________ 
SITE PI – Print Name 
 
 
___________________________________________________________________ 
SITE PI – Signature 
 
 
_______________________ 
DATE 
 
 
 

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TABLE OF CONTENTS 
CONTENTS 
PROTOCOL SUMMARY ........................................................................................................... 5 
1.0 
INTRODUCTION AND BACKGROUND........................................................................ 7 
1.1 
Introduction ............................................................................................................................ 7 
1.2 
Literature Summary ............................................................................................................. 7 
1.3 
Disease Process ................................................................................................................... 7 
1.4 
Alternative Treatments / Interventions .............................................................................. 7 
 
 
 
 
 
 
1.6 
Clinical experience with BioMimics 3D Stent System ..................................................... 9 
1.7 
BioMimics 3D Study Purpose ............................................................................................. 9 
2.0 
STUDY DEVICE ............................................................................................................. 9 
2.1 
Intended Use ......................................................................................................................... 9 
2.2 
CE Mark Status ................................................................................................................... 10 
2.3 
Device Preparation and Deployment Procedure ........................................................... 10 
2.4 
BioMimics 3D stent and delivery system size matrix .................................................... 10 
3.0 
STUDY PLAN ............................................................................................................... 10 
3.1 
Study Objective ................................................................................................................... 10 
3.2 
Design .................................................................................................................................. 10 
3.3 
Enrolment ............................................................................................................................ 10 
3.4 
Study Duration and Follow-Up ......................................................................................... 10 
4.0 
ENDPOINTS AND SUBJECT POPULATION ............................................................. 10 
4.1 
Primary Outcome Measures ............................................................................................. 10 
4.1.1 
Primary safety endpoint: .................................................................................... 10 
4.1.2 
Primary effectiveness endpoint: ....................................................................... 10 
4.2 
Secondary Outcome Measures ........................................................................................ 10 
4.3 
Eligibility Criteria ................................................................................................................. 11 
4.3.1 
Inclusion Criteria ................................................................................................. 11 
4.3.2 
Exclusion Criteria ................................................................................................ 11 
5.0 
SCREENING AND ENROLMENT................................................................................ 11 
5.1 
Screening............................................................................................................................. 11 
5.2 
Informed Consent ............................................................................................................... 12 
5.3 
Enrolment ............................................................................................................................ 12 
5.4 
Withdrawal ........................................................................................................................... 12 
6.0 
DATA COLLECTION PROCEDURES ......................................................................... 12 
6.1 
Visit Schedule ..................................................................................................................... 12 
6.2 
Baseline ............................................................................................................................... 13 
6.3 
Index Procedure ................................................................................................................. 13 
6.4 
Follow-Up............................................................................................................................. 14 
6.5 
Medications ......................................................................................................................... 14 
7.0 
ADVERSE EVENTS ..................................................................................................... 14 
7.1 
Adverse Event definitions ................................................................................................. 14 
7.2 
Adverse Event Reporting Requirements ........................................................................ 15 
7.2.1 
General Reporting Requirements .................................................................... 15 
7.2.2 
Reporting Requirements for Serious and Major Adverse Events ............... 15 
7.2.3 
Device Failures and Malfunctions .................................................................... 16 

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8.0 
RISK/BENEFIT ASSESSMENT ................................................................................... 16 
8.1 
Risks ..................................................................................................................................... 16 
8.2 
Risk Minimization ............................................................................................................... 17 
8.3 
Potential Benefits ............................................................................................................... 17 
9.0 
STATISTICAL ANALYSIS PLAN ................................................................................ 17 
9.1 
Analysis Population ............................................................................................................ 17 
9.2 
Population Demographics ................................................................................................. 18 
9.3 
Primary Endpoint Analysis ................................................................................................ 18 
9.4 
Secondary Endpoint Analysis ........................................................................................... 18 
9.5 
Site Poolability .................................................................................................................... 18 
9.6 
Sample Size ........................................................................................................................ 18 
9.7 
Handling of Missing Data .................................................................................................. 19 
9.8 
Interim Analysis .................................................................................................................. 19 
10.0 
ETHICAL, QUALITY ASSURANCE AND ADMINISTRATIVE ASPECTS ................. 19 
10.1 
Sponsor Responsibilities ................................................................................................... 19 
10.2 
Investigator Responsibilities ............................................................................................. 19 
10.3 
Selection of Clinical Sites & Investigators ...................................................................... 19 
10.4 
Investigator Training .......................................................................................................... 19 
10.5 
EC/IRB Approvals .............................................................................................................. 20 
10.6 
Required Documentation .................................................................................................. 20 
10.7 
Clinical Data Collection ..................................................................................................... 20 
10.8 
Device Accountability ......................................................................................................... 21 
10.9 
Subject Compensation ...................................................................................................... 21 
10.10 
Confidentiality ..................................................................................................................... 21 
10.11 
Monitoring ............................................................................................................................ 21 
10.12 
Audits and Inspections ...................................................................................................... 21 
10.13 
Protocol Compliance/ Deviations ..................................................................................... 21 
10.14 
Investigational Site Termination ....................................................................................... 22 
10.15 
Clinical Events Committee ................................................................................................ 22 
11.0 
RECORDS, REPORTS AND PUBLICATION ........................................................................... 22 
11.1 
Record Retention ............................................................................................................... 22 
11.2 
Reporting Timelines ........................................................................................................... 22 
11.3 
Study Reports ..................................................................................................................... 23 
11.4 
Publication Policies ............................................................................................................ 23 
12.0 
STUDY DEFINITIONS .................................................................................................. 24 
13.0 
REFERENCES ............................................................................................................. 28 
APPENDIX A – INSTRUCTIONS FOR USE (IFU) ................................................................. 30 
 
Table 1: Data Collection Schedule ...................................................................................... 13 
Table 2: MIMICS-3D investigator reporting timelines........................................................... 22 
 
Figure 1: Forces on the femoropopliteal artery during lower limb movement ......................... 8 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
Study Title: 
A prospective, multicentre observational study to evaluate the BioMimics 
3D Self-Expanding Stent System in the treatment of peripheral arterial 
disease:  MIMICS-3D 
Study Objective:  
The MIMICS-3D Study will evaluate safety, effectiveness and device 
performance within a real-world clinical population of patients undergoing 
femoropopliteal intervention. 
Study Device & intended 
use 
BioMimics 3D Self-Expanding Stent System.  
Device will be used in accordance with CE Mark approved indication and 
all approved and commercially available stent sizes will be included in this 
study.  
Study Design: 
Prospective, multicentre, observational study (non-investigational) 
Device Regulatory Status: CE Mark was approved in November 2012.   
Estimated Enrolment: 
Minimum of 500 patients  
Subject Population: 
Patients who receive treatment with Veryan’s BioMimics 3D Stent System 
in accordance with the current approved CE Mark indication for use as 
stated in the Instructions for Use (IFU). 
Clinical Sites: 
Up to 40 sites in any country where CE mark is recognised and device is 
legally marketed 
Study Follow-Up:  
After index procedure on Day 0, patients will be evaluated at 30 days then 
12, 24, and 36 months. 
Study Duration: 
First patient enrolled August 2016 
Last patient enrolled August 2018 
Last patient, last visit August 2021 
 
Primary Outcome 
Measures: 
Primary safety endpoint: 
The primary outcome measure for safety will be a composite of major 
adverse events (MAE) comprising death, any major amputation performed 
on the index limb or clinically-driven target lesion revascularisation 
(CDTLR) through 30 days. 
 
Primary effectiveness endpoint: 
The primary outcome measure for effectiveness will be freedom from 
clinically-driven target lesion revascularisation (CDTLR) through 12 
months. 
Secondary Outcome 
Measures: 
1. Acute technical success defined as the achievement of a final residual 
diameter stenosis ≤30% at the end of the procedure   
2. Acute procedural success defined as both acute technical success and 
absence of the following adverse events: death, stroke, MI, acute onset 
of limb ischemia, index bypass graft or treated segment thrombosis, 
and/or need for urgent/emergent vascular surgery, within 72 h of the 
index procedure.  
3. Incidence of individual components of MAE (death, any major 
amputation performed on the index limb or CDTLR) at 30 days, 12, 
24and 36 months 
4. Overall rate and incidence of adverse events from Day 0 through 
completion of study follow-up at Month 36. 
5. Stent patency rate assessed by duplex ultrasound, as available, 
determined at Months 12, 24 and 36.  This will be assessed using 
values of PSVR >2.0, >2.4; >2.5; and >3.5 each to indicate loss of 
patency on duplex ultrasound. 

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6. Clinical outcome: comparison of Rutherford Clinical Category 
measured at Baseline, Day 30, Months 12 24 and 36.  
7. Functional outcome: comparison of the ankle brachial index (ABI) 
measurement at Baseline, within 30 days after index procedure, then 
at Months 12, 24 and 36. 
8. Incidence of reported stent fractures through 36 months. 
9. Operator assessment of device use 
Inclusion Criteria: 
1. Patient is age ≥18 and ≤85 years at date of consent. 
2. Patient has provided written informed consent for participation in 
the study prior to index procedure. 
3. Patient has documented symptomatic peripheral arterial disease 
scheduled for treatment with the BioMimics 3D stent in accordance 
with the approved CE Mark indication and Instructions for Use 
(IFU) 
Exclusion Criteria: 
1. Patients whose lesions cannot be crossed with a wire and/or 
balloon catheter and cannot be dilated sufficiently to allow passage 
of the delivery system. 
2. Patients with a history of intolerance or adverse reaction to 
antiplatelet and/or anticoagulation therapies, bleeding diathesis, 
severe hypertension or renal failure. 
3. Patients with known hypersensitivity to nickel-titanium.  
4. Patient has a comorbidity that in the Investigator’s opinion would 
limit life expectancy to less than 12 months. 
5. Patient is pregnant or breastfeeding. 
6. Patient is unable or is unwilling to comply with site standard of care 
procedures and follow-up visit schedules for patients undergoing 
femoropopliteal intervention. 
Sponsor 
Veryan Medical Limited, Block 11, Galway Technology Park, Parkmore, 
Galway, Co. Galway, Ireland 
Principal Investigators: 
Dr Michael Lichtenberg (Arnsberg, Germany) 
Study Management: 
Veryan Medical Ltd., Galway, Ireland 
Monitoring: 
Veryan Medical Ltd., Galway, Ireland 
Data Management: 
Veryan Medical Ltd., Galway, Ireland 
 
 
 

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1.0 
INTRODUCTION AND BACKGROUND  
1.1 
Introduction 
The MIMICS-3D Study is a prospective, multicentre, observational study of the BioMimics 3D Stent 
System in patients undergoing endovascular intervention to relieve symptomatic peripheral arterial 
disease of the femoropopliteal artery. The Study is designed to enable the collection, analysis and 
reporting of data from “real-world” use of the BioMimics 3D Stent System used in accordance with the 
Instructions for Use (IFU) associated with the product’s CE Mark approval.  
Data collection will include that relating to safety, effectiveness and device performance and the period 
of observation during which data will be collected will extend from the index procedure through 3 years 
(36 months), according to the standard follow-up practice of the enrolling institution.   
1.2 
Literature Summary 
Atherosclerosis is a chronic vascular disease that can manifest itself in the coronary, neurovascular and 
peripheral vascular beds with end organ and distal extremity vascular impact. Specifically, peripheral 
arterial disease (PAD) is a common manifestation of atherosclerosis and is a chronic occlusive arterial 
disease caused by plaque build-up in the arterial lumen that leads to diminished blood flow. The rising 
prevalence of PAD with increasing age, and within a population increasingly at risk from obesity and 
diabetes, is a major international health care issue with substantial economic ramifications. A recent 
estimate concluded that the global prevalence of PAD presently exceeds a quarter of a billion and that 
this number grew by more than 20% in the period 2000 to 2010 1.  Patients with PAD have an increased 
risk of myocardial infarction, stroke, and death. Major risk factors for the development of PAD include 
family history, age, hypertension, cigarette smoking, diabetes, and dyslipidaemia; the greatest risk 
factors being diabetes and smoking. The treatment of PAD is initially directed at a combination of 
lifestyle or behavioural modification and medical management to hopefully slow the disease and 
symptom progression. When these methods fail to provide symptomatic relief, revascularisation may 
be achieved through endovascular or surgical approach. 
1.3 
Disease Process 
Anatomically, 70% of PAD lesions are present in the femoropopliteal and tibial arteries with more than 
50% of all PAD interventions involving the superficial femoral and popliteal arteries 2. Femoropopliteal 
disease is characterised by long, diffuse obstructive or occlusive lesions that create a unique slow-flow 
and high resistance environment. 
1.4 
Alternative Treatments / Interventions 
The treatment of the femoropopliteal arteries using endovascular treatments has gained popularity with 
patients and physicians alike due to these procedures being less invasive, and potentially with fewer 
complications, than the surgical options 2.  Percutaneous transluminal angioplasty (PTA) is one of the 
simplest endovascular methods to treat PAD, but the technical success and durability of this technique 
are often dependent on the lesion morphology 3.   
Endovascular stenting with Nitinol stents has become an established and widely used treatment for 
femoropopliteal lesions, specifically the SFA and proximal popliteal arteries with reported patency rates 
above 80% at 12 months4,5. However, despite improvements in stent design, restenosis is a limiting 
factor as a result of intimal hyperplasia following stent placement 6. The mechanism for the development 
of restenosis is multi-factorial but may include vessel injury during angioplasty, stent implantation, sub-
optimal flow conditions and mechanical factors.  

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1.5.2 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
1.6 
Clinical experience with BioMimics 3D Stent System 
Veryan has conducted a prospective, multicentre, randomised study (Mimics study) to evaluate the 
safety and effectiveness of BioMimics 3D Stent System in the superficial femoral and proximal popliteal 
arteries (Mimics study).  Data from this study was used as a basis for Veryan’s application for CE Mark 
approval, which was approved in November 2012.  The device was made available commercially in 
2015. 
A further study in the superficial femoral and proximal popliteal arteries (MIMICS-2 study) is currently 
enrolling at sites in the US, Germany and Japan to provide data for regulatory approval in the US and 
other countries (https://clinicaltrials.gov/ct2/show/NCT02400905).  The first patient was enrolled in 
June 2015.  It is anticipated that enrolment will be completed by August 2016, and the study will 
therefore be complete after 3 years’ follow-up in 2019.   
1.7 
BioMimics 3D Study Purpose 
The BioMimics 3D Study is designed to enable the collection, analysis, reporting and presentation of 
data from use of the BioMimics 3D Stent System purchased by the hospital or clinic and used in 
accordance with the Instructions for Use associated with the product’s CE Mark approval. The intent of 
this post-market observational study is to increase the understanding of the performance of the 
BioMimics 3D Stent System in a larger population of patients representative of a real-world situation.  
In addition, a broader cohort of interventionalists (i.e., angiologists, cardiologists, radiologists and 
vascular surgeons) will be included than that so far involved in Veryan’s clinical evaluation. 
There is an extensive body of literature supporting femoropopliteal stenting including in ‘real-world’ 
registries 12–14 The principles of evaluating safety at 30 days and effectiveness (patency of the stented 
segment) at 12 months are well-established clinical endpoints for such a real-world registry. However, 
the specific attributes of the BioMimics 3D stent (promotion of swirling blood flow and improved 
biomechanical compatibility within the femoropopliteal artery) have the potential for chronic outcome 
benefits supporting the longer term follow-up objective of this study. 
2.0 
STUDY DEVICE  
2.1 
Intended Use 
The BioMimics 3D Self-Expanding Stent System will be used in accordance with the current approved 
CE Mark indication for use as stated in the Instructions for Use (IFU).  
The current IFU is included in Appendix A. 

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2.2 
CE Mark Status 
CE Mark was approved in November 2012.   
2.3 
Device Preparation and Deployment Procedure 
The BioMimics 3D Stent will be prepared and deployed as described in the IFU that accompanies each 
device.  
Procedures for patient preparation and follow-up, including medication and vascular access, will be 
according to hospital / institutional standard of care. 
2.4 
BioMimics 3D stent and delivery system size matrix 
All CE Mark approved and commercially available stent sizes will be included in this study. The current 
size matrix can be found in the IFU. 
3.0 
STUDY PLAN 
3.1 
Study Objective 
The MIMICS-3D Study will evaluate safety, effectiveness and device performance within a real-world 
clinical population of patients undergoing femoropopliteal intervention. 
3.2 
Design 
Prospective, multicentre, observational study (non-investigational) of patients who receive treatment 
with Veryan’s BioMimics 3D Stent System. 
3.3 
Enrolment 
A minimum of 500 patients will be enrolled in the study.  The study will be conducted at up to 40 centres 
in any country where CE Mark is recognised and the device is legally marketed.   
A minimum of 50 patients treated with drug coated balloon (DCB) will be enrolled (DCB cohort). All 
primary and secondary endpoints will be assessed separately for this cohort. 
3.4 
Study Duration and Follow-Up 
It is anticipated that enrolment will commence in August 2016 and is expected to continue until August 
2018.  The last patient visit is expected in 2021. 
Patient follow up will be in accordance with standard of care.  Data will be collected according to the 
following schedule: baseline (medical history), index procedure through discharge, 30 days (± 7 days), 
12 months (365 days ± 60 days), 24 months (730 days ± 60 days) and 36 months (1095 days ± 60 
days).   Follow-up may be conducted by clinic visit or telephone, according to site standard of care. 
4.0 
ENDPOINTS AND SUBJECT POPULATION 
4.1 
Primary Outcome Measures 
4.1.1 
Primary safety endpoint: 
The primary outcome measure for safety will be a composite of major adverse events (MAE) comprising 
death, any major amputation performed on the index limb or clinically-driven target lesion 
revascularization (CDTLR) through 30 days. 
4.1.2 
Primary effectiveness endpoint: 
The primary outcome measure for effectiveness will be freedom from clinically-driven target lesion 
revascularization (CDTLR) through 12 months. 
4.2 
Secondary Outcome Measures 
 
Acute technical success defined as the achievement of a final residual diameter stenosis <30% 
at the end of the procedure   

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 
Acute procedural success defined as both acute technical success and absence of the following 
adverse events: death, stroke, MI, acute onset of limb ischemia, index bypass graft or treated 
segment thrombosis, and/or need for urgent/emergent vascular surgery, within 72 h of the index 
procedure. 
 
Incidence of individual components of MAE (death, any major amputation performed on the 
index limb or CDTLR) at 30 days, 12, 24 and 36 months 
 
Overall rate and incidence of adverse events from Day 0 through completion of study follow-up 
at Month 36. 
 
Stent patency rate assessed by duplex ultrasound, as available, determined at Months 12, 24 
and 36.  This will be assessed using values of PSVR >2.0, >2.4; >2.5; and >3.5 each to indicate 
loss of patency on duplex ultrasound. 
 
Clinical outcome: comparison of Rutherford Clinical Category measured at Baseline, Day 30, 
Months 12 24 and 36.  
 
Functional outcome: comparison of the ankle brachial index (ABI) measurement at Baseline, 
within 30 days after index procedure, then at Months 12, 24 and 36. 
 
Incidence of reported stent fractures through 36 months. 
 
Operator assessment of device use 
4.3 
Eligibility Criteria  
Patients are required to meet ALL the following criteria in order to be included in this study: 
4.3.1 
Inclusion Criteria 
1. Patient is age ≥18 and ≤85 years at date of consent. 
2. Patient has provided written informed consent for participation in the study prior to index 
procedure. 
3. Patient has documented symptomatic peripheral arterial disease scheduled for treatment with 
the BioMimics 3D stent in accordance with the approved CE indication and Instructions for Use 
(IFU) 
4.3.2 
Exclusion Criteria 
1. Patients whose lesions cannot be crossed with a wire and/or balloon catheter and cannot be 
dilated sufficiently to allow passage of the delivery system. 
2. Patients with a history of intolerance or adverse reaction to antiplatelet and/or anticoagulation 
therapies, bleeding diathesis, severe hypertension or renal failure. 
3. Patients with known hypersensitivity to nickel-titanium.  
4. Patient has a comorbidity that in the Investigator’s opinion would limit life expectancy to less 
than 12 months. 
5. Patient is pregnant or breastfeeding. 
6. Patient is unable or is unwilling to comply with site standard of care procedures and follow-up 
visit schedules for patients undergoing femoropopliteal intervention. 
5.0 
SCREENING AND ENROLMENT  
5.1 
Screening 
All consecutive patients who meet the eligibility criteria should be considered for enrolment in the study.  
Sites should maintain a cumulative log of all enrolled patients.  The Investigator or designee should 

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determine potential eligibility according to Section 4.3.  Patients who meet all criteria should be provided 
with further information on the study in accordance with the procedures in Section 5.2.   
5.2 
Informed Consent 
Written Consent for Data Collection with the Ethics Committee (EC)/Institutional Review Board (IRB) 
approved consent form will be obtained for all patients prior to Study procedure and collection of any 
Study-specific information. There are no additional procedures or tests required in addition to routine 
standard of care.  
The patient shall be given adequate time to read the Written Consent for Data Collection consent form 
and have the data collection and data transmission procedures explained prior to signing the Informed 
Consent form. All patients providing informed consent for data collection are to receive copies of their 
signed informed consent documentation. The consent process may be obtained up to 30 days prior to 
enrolment in the Study. 
5.3 
Enrolment 
All patients who provide written informed consent for the Study, meet all eligibility criteria and are treated 
with BioMimics 3D stent system will be considered enrolled in the Study. If the BioMimics 3D Stent 
System is inserted into the vasculature and treatment is attempted, but the procedure is aborted without 
delivery of a stent, only device failure and malfunction information and/or device related adverse events 
should be collected, if applicable. 
Patients who are consented but the BioMimics 3D Stent System is not inserted into the vasculature will 
be considered screen failures.  No data will be collected on screen failures. 
Patients who are enrolled and treated, but who are later discovered to not meet all of the eligibility 
criteria will remain in the Study for follow-up and a Protocol Deviation form will be completed. 
Patients who are enrolled and undergo staged treatment using BioMimics 3D Stent System in both 
limbs will be considered a single enrolment. Procedural information for both limbs will be collected. 
For the purpose of this study, the point of enrolment is time of index procedure. 
5.4 
Withdrawal 
Patients may withdraw at any time from the Study without prejudice; participation is entirely voluntary.  
If a subject prematurely terminates from the Study, the reason for termination will be recorded in the 
eCRF.  
The Investigator should follow all unresolved serious adverse events until the events are resolved, the 
subject is lost to follow-up, the subject has withdrawn consent, the subject completes the Study follow-
up, or the adverse event is otherwise explained.   
All reasonable efforts will be made to obtain complete data for all subjects; however, missing 
observations will occur due to loss to follow-up, withdrawal, or variation in site standard of care 
assessments. Site shall make all reasonable efforts to contact subjects who do not respond to follow-
up requests. In the event patient does not respond to a final contact attempt via certified letter, patient 
will be considered lost to follow-up. Patients who withdraw consent after treatment will have their data 
evaluated until the time of their withdrawal (unless consent for data retention is removed in accordance 
with local or national regulations). Patients who withdraw or are lost to follow-up will not be replaced. 
 
6.0 
DATA COLLECTION PROCEDURES 
6.1 
Visit Schedule 
Study participation will last for a total of 36 months (± 60 days). Data collection will be completed at 
baseline index hospitalisation, 30 days (± 7 days), 12 months (365 days ± 30 days), 24 months (730 
days ± 60 days) and 36-months (1095 days ± 60 days).  Follow-up may be by clinic visit or telephone 
according to site standard of care. 
A summary schedule of the data collection for tests and evaluations is in Table 1.  Data should only be 
collected if tests and evaluations are completed per standard of care. 

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 
Procedure time 
 
Concomitant peripheral procedures  
 
Adverse events and device observations 
 
Device use questionnaire (completed by operator) 
 
Concomitant antiplatelet and anticoagulant medication 
6.4 
Follow-Up 
The following data will be collected at Day 30 (± 7 days), Month 12 (365 days ± 30 days), Month 24 
(730 days ± 60 days) and Month 36 (1095 days ± 60 days) post Index Procedure: 
 
Relevant medical history including peripheral interventions (target limb) 
 
Physical examination (as available)  
o 
Ankle Brachial Index (ABI, or TBI, if applicable)  
o 
Rutherford Clinical Category 
 
Concomitant antiplatelet and anticoagulant medication 
 
Imaging data including patency assessment, evidence of stent fracture 
 
Adverse events 
6.5 
Medications 
Patients should be prescribed antiplatelet medication in accordance with site standard of care and the 
recommendations in the IFU. 
Use of aspirin, clopidogrel and other antiplatelet and anticoagulant use will be recorded from baseline 
through 36 months. 
7.0 
ADVERSE EVENTS  
For the purpose of this Study all potentially device-related and procedure-related adverse events, major 
adverse events, and all vascular adverse events in the target limb will be documented throughout the 
36-month visit and reported to Sponsor via the eCRF.  
The Sponsor shall review all adverse events for their relationship to the Study device(s) and/or 
procedures and comparative anticipated safety event rates. The Sponsor will conduct evaluations of 
any device-related event per standard operating procedures.   
An independent Clinical Events Committee (CEC) will be responsible for systematic review and 
adjudication of all Major Adverse Events including death, and all potentially device- -related adverse 
events.  
7.1 
Adverse Event definitions 
Adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs in subjects, whether or not related to the investigational device or procedure. In addition, 
the definition of AE applies to any event with an onset during enrolment / index procedure or to any 
underlying diseases, present at baseline, that exacerbate in severity post study procedure. Therefore, 
an underlying disease that was present at the time of enrolment is not reported as an AE, but any 
increase in the severity of the underlying disease is to be reported as an AE. This definition includes 
events occurring during the follow-up period. 
Adverse Device Effect (ADE) / Device-Related Adverse Event: an adverse device effect (or device-
related adverse event) is defined as any untoward adverse effect when, in the judgment of the 
Investigator, the clinical event has a reasonable time sequence associated with use of the 
investigational device and is unlikely to be attributed to concurrent disease or other procedures or 
medications. It is reasonable to believe that the device directly caused or contributed to the adverse 
event. 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate 
Instructions for Use, deployment, implantation, installation, or operation, or any malfunction of 
the investigational medical device.  
NOTE 2: This definition includes any event resulting from user error or from intentional misuse 
of the investigational medical device. 

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Procedure-Related Adverse Event: an adverse event is considered to be procedure-related when, in 
the judgment of the Investigator, it is reasonable to believe that the event is associated with the assigned 
study procedure and is not specific to the Study device (i.e., BioMimics 3D Stent System) used. Other 
products, surgical techniques, or medications required specifically for the procedure are likely to have 
contributed to the occurrence of the event. 
A serious adverse event is defined as an adverse event that: 
 
Led to death,  
 
Led to a serious deterioration in the health of the subject, that either resulted in: 
o 
a life-threatening illness or injury, or 
o 
a permanent impairment of a body structure or a body function, or 
o 
in-patient hospitalisation or prolongation of existing hospitalisation 
o 
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to body structure or a body function, or 
 
Led to foetal distress, foetal death or a congenital abnormality or birth defect.  
NOTE: Planned hospitalisation for a pre-existing condition or elective cosmetic procedures, or a 
procedure required by the investigational plan without serious deterioration in health, is not considered 
a serious adverse event. 
Major Adverse Event (MAE) 
For the purposes of this study, the definition of a major adverse event includes: 
 
Death 
 
Any major amputation performed on the target limb  
 
Clinically-driven target lesion revascularisation 
7.2 
Adverse Event Reporting Requirements 
7.2.1 
General Reporting Requirements 
The following adverse events should be recorded on the eCRF through 36 months post-index 
procedure: 
 
All potentially device and/or procedure-related adverse events  
 
All major adverse events (MAE) 
 
All vascular adverse events in the target limb. 
The report should include: description of event, severity, duration, action taken, treatment outcome and 
relationship of the adverse experience to the study device and/or procedure (i.e., unrelated, possibly 
related, related or relationship not assessable). 
The following definitions for rating severity of adverse events will be used: 
Mild:  
Awareness of signs or symptoms, but easily tolerated; are of minor irritant type; causing 
no loss of time from normal activities; symptoms would not require medication or a 
medical evaluation; signs or symptoms are transient. 
Moderate:  
Interferes with the subject’s usual activity and/or requires symptomatic treatment. 
Severe:  
Symptom(s) causing severe discomfort and significant impact of the subject’s usual 
activity and requires treatment. 
All reportable events should be followed until resolution or the end of the study. 
7.2.2 
Reporting Requirements for Serious and Major Adverse Events 
All serious and potentially device and/or procedure-related, MAE and vascular adverse events in the 
target limb must be reported to the Sponsor within 24 hours of knowledge of the event or by the end of 
the next working day. This may be done via phone, fax, email or eCRF. 
Sponsor will review all reported events for potential reporting in accordance with MEDDEV 2.12.1, Rev 
8 (2013) "Guidelines on a Medical Devices Vigilance System”. Sponsor may request medical record 
documentation (e.g., procedure notes, operative notes, discharge summary, relevant progress notes, 
imaging, or lab studies) to facilitate this review. 

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The Sponsor will determine whether all of the local Investigators need to be informed immediately of an 
SAE or UADE, or whether this can be postponed until the next regularly scheduled study update. 
The Investigator is responsible for reporting applicable serious adverse events to their EC/IRB as 
required by EC/IRB procedures and local/national regulations.  A copy of each EC/IRB safety report will 
be provided to Sponsor. 
7.2.3 
Device Failures and Malfunctions 
All device observations / performance issues, malfunctions or failures of the Veryan BioMimics 3D 
stent, whether or not associated with an adverse event must be reported via the eCRF within 24 hours 
of knowledge of the event or by the end of the next working day. 
Sponsor will review all reported events for potential reporting in accordance with MEDDEV 2.12.1, Rev 
8 (2013) "Guidelines on a Medical Devices Vigilance System”. Sponsor may request medical record 
documentation (e.g., procedure notes, operative notes, discharge summary, relevant progress notes, 
imaging, or lab studies) to facilitate this review. 
8.0 
RISK/BENEFIT ASSESSMENT 
8.1 
Risks 
The BioMimics 3D Stent System is being used in accordance with the approved CE Mark indication and 
Instructions for Use.  As with all procedures that utilise techniques for introducing a catheter into a 
vessel, complications may occur. These complications as listed in the instructions for use include, but 
are not limited to: 
 
Allergic reaction to Nitinol 
 
Allergic/anaphylactoid reaction 
 
Amputation 
 
Aneurysm 
 
Angina/coronary ischemia 
 
Arrhythmia 
 
Arterial occlusion/restenosis of the treated lesion/vessel without reintervention 
 
Arterial occlusion/restenosis of the treated lesion/vessel with intervention 
 
Arterial occlusion/thrombus, near the puncture site 
 
Arteriovenous fistula 
 
By-pass surgery 
 
Death related to procedure 
 
Death unrelated to procedure 
 
Deployment failure 
 
Device failure 
 
Embolisation, arterial 
 
Embolisation, stent 
 
Fever 
 
Haematoma bleed at needle, device path: nonvascular procedure 
 
Haematoma bleed, puncture site: vascular procedure 
 
Haematoma bleed, remote site 
 
Haemorrhage/bleeding requiring a blood transfusion 
 
Hypersensitivity reactions 
 
Hypotension/hypertension 
 
Incorrect positioning of the stent requiring further stenting or surgery 
 
Infection/abscess formation at access site 
 
Intimal injury/dissection 
 
Ischemia requiring intervention 
 
Ischemia/infarction of tissue/organ 
 
Liver failure 
 
Local infection 
 
Myocardial infarction 
 
Open surgical repair 

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 
Pain 
 
Pancreatitis 
 
Partial stent deployment leading to surgical repair 
 
Pneumothorax 
 
Pseudoaneurysm 
 
Pulmonary embolism 
 
Radiation injury 
 
Renal failure 
 
Respiratory arrest 
 
Septicaemia/bacteraemia 
 
Shock 
 
Spasm 
 
Stent fracture 
 
Stent kinking 
 
Stent malapposition 
 
Stent migration 
 
Stroke 
 
Thrombosis 
 
Tissue necrosis 
 
Venous occlusion/thrombosis, near the puncture site 
 
Worsened claudication/rest pain 
8.2 
Risk Minimization 
As with any endovascular procedure, appropriate safety precautions will be followed. In addition, this 
Protocol provides additional steps to minimize risk to study subjects. These include the following: 
 
Investigator Selection & Training: All investigators are required to be appropriately 
qualified by education, training and expertise in peripheral interventional techniques and 
placement of intravascular stents. 
 
Subject Screening: Patient selection will be in accordance with the Protocol and the IFU. 
Patients with known contraindications e.g. history of intolerance or adverse reaction to 
antiplatelet and/or anticoagulation therapies, bleeding diathesis, severe hypertension or 
renal failure, known hypersensitivity to nickel-titanium will not be eligible for the Study. 
8.3 
Potential Benefits 
Prior human clinical experience in a population of 60 subjects has validated that the BioMimics 3D Stent 
System can be used to safely and effectively stent the femoropopliteal arteries, resulting in acute and 
long term luminal patency. Clinical study populations are defined by eligibility criteria more restrictive 
than the device IFU which may limit the application of results to a broader population.  The MIMICS-3D 
Study is intended to evaluate the safety and effectiveness of the BioMimics 3D Stent System in a larger 
“real-world” clinical population. 
9.0 
STATISTICAL ANALYSIS PLAN 
The analysis of the data from this study will be primarily descriptive.  Continuous endpoints will be 
summarized by N, mean, standard deviation, median, minimum, and maximum.  Categorical or binary 
endpoints will be summarised by N and percentage with confidence intervals as appropriate. Kaplan 
Meier plots will be used to display and summarise time to event data. 
The planned sample size for analysis is at least 500 patients which is believed to be adequate to provide 
an accurate characterisation of BioMimics 3D in a “real-world” clinical settings.  
9.1 
Analysis Population 
 
Intention-to-Treat (ITT) Analysis Set: includes all enrolled subjects. 
 
Modified Intention-to-Treat (mITT) Analysis Set: includes all enrolled subjects in whom the 
BioMimics 3D Stent System is implanted. Those subjects in whom the procedure is aborted 
without implantation of a stent will be excluded from this analysis set. This is the primary 

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analysis set for the primary safety and effectiveness endpoints, as well as secondary and 
exploratory endpoints. 
 
Per-Protocol (PP) Analysis Set: includes all enrolled subjects in whom the BioMimics 3D Stent 
System is implanted and who met all inclusion/exclusion criteria with no major protocol 
deviations. Those subjects in whom the procedure is aborted without implantation of a stent will 
be excluded from this analysis set. This is a secondary analysis set for the primary safety and 
effectiveness endpoints, as well as secondary endpoints. 
While mITT is intended as the primary analysis set for all safety and effectiveness endpoints, the primary 
safety and effectiveness endpoints will additionally be evaluated in the ITT and PP analysis sets as 
supportive information. All subjects excluded from mITT analysis set will be described and the reasons 
for aborted procedures, if any, detailed. 
A separate analysis will be conducted for the DCB cohort. 
9.2 
Population Demographics 
The demographics and medical history will be presented in tabular form for all subjects enrolled in this 
study (ITT analysis set). Means, standard deviations, and sample size will be used to summarise 
continuous characteristics such as age. Frequencies and percentages will be used to summarise 
categorical characteristics such as gender. Demographic and medical history data will be additionally 
tabulated for the mITT and PP analysis sets. 
9.3 
Primary Endpoint Analysis 
Endpoints will be analysed using the modified intention-to-treat analysis set. An additional supportive 
analysis will be conducted in the ITT and PP analysis sets for the primary safety and effectiveness 
endpoints. All available data will be used for each endpoint and no imputations will be done. 
The primary safety endpoint of MAE at 30 days will be presented as frequency and percentage and the 
2-sided 95% confidence interval will be calculated via Agresti-Coull.   
Similarly, the primary outcome measure for effectiveness, clinically-driven target lesion 
revascularisation (TLR) through 12 months, will be presented as frequency and percentage and the 2-
sided 95% confidence interval will be calculated via Agresti-Coull. 
9.4 
Secondary Endpoint Analysis 
All secondary endpoints will be tabulated. Means, standard deviations and sample size will be used to 
summarise continuous characteristics. Distributions of continuous data will be examined and if non-
normality is exhibited, medians and interquartile ranges will be presented. Frequencies and 
percentages will be used to summarise categorical characteristics. Measures collected serially over 
time (for example, Rutherford Clinical Category) will be presented at each time point, and the measure 
at each time point will be compared to the baseline measure as well as tested for trends. All available 
data will be used for each endpoint and no imputations will be done. The mITT analysis set will be used 
for these analyses.  As a secondary analysis, the PP analysis set will be displayed. 
9.5 
Site Poolability  
Poolability of study subjects across investigational sites will be explored by comparing the primary 
outcome measure across site. Testing of the primary outcomes will be conducted across site at a two-
sided alpha=0.15 level using a chi-square test, unadjusted for covariates. If differences between sites 
exist at the alpha=0.15 level, summary statistics will be presented for each site. Any differences by 
study site will be discussed in the study report. If substantial differences emerge, a sensitivity analysis 
of the primary outcomes may be performed by excluding outlying sites from the analysis. 
9.6 
Sample Size 
This study is not powered for formal statistical hypothesis testing and is intended to be descriptive in 
nature.  Assuming an MAE rate of 90% to 99%, the corresponding width of the 95% confidence interval 
would range from 5.5% to 2%, respectively.  Similarly, assuming an event rate of 75% for CDTLR at 12 
months, the width of the 95% confidence interval would be approximately 8% allowing for up to 10% 
attrition. Thus, it is felt that enrolling 500 subjects provides adequate precision to estimate the primary 
endpoint event rates in this cohort.   

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9.7 
Handling of Missing Data 
No imputation of missing data is planned. Subjects who have ascertainment of status at a later out-of-
window date (for example, subjects who are known to be free of MAE past 30 days but missed the 30 
day visit) are not considered missing as their status is known and their data will be used. 
9.8 
Interim Analysis 
There is no interim analysis planned with the purpose of altering the protocol or planned statistical 
analyses. Interim analyses may be undertaken for the purpose of presentations or publication. 
10.0 
ETHICAL, QUALITY ASSURANCE AND ADMINISTRATIVE ASPECTS  
10.1 
Sponsor Responsibilities 
Veryan Medical Ltd., as Sponsor is responsible for the overall conduct and quality of the Study, including 
the assurance that the Study complies with Declaration of Helsinki, relevant Data Protection regulations 
and all relevant international standards and regulations applicable to medical device registries.  Veryan 
will ensure that all applicable national regulatory and Data Protection approvals are in place prior to 
commencement of the Study at each site.  Veryan will implement systems to select and train 
investigators, collect data, oversee the quality of the Study and monitor investigator compliance with 
their responsibilities as detailed in this Protocol. 
10.2 
Investigator Responsibilities 
The Investigators are responsible for ensuring that this Study is conducted according to this Protocol, 
Declaration of Helsinki, relevant Data Protection regulations, and any other local, national or EC/IRB 
requirements that apply to registries at their site. 
It is also the Investigator’s responsibility to ensure that all sub-investigators and staff assisting with this 
Study have the appropriate qualifications and that they complete training on the Protocol procedures, 
and that patient confidentiality is respected.  Other Investigator responsibilities are detailed throughout 
Section 10.0. 
10.3 
Selection of Clinical Sites & Investigators 
Veryan is responsible for selection of sites for Study participation based upon review of the following 
criteria: 
 
Investigator(s) are appropriately qualified by education, training and expertise in peripheral 
interventional techniques and placement of intravascular stents. 
 
Investigator(s) are appropriately qualified for commercial supply of BioMimics3D stent in 
accordance with Veryan requirements.  This includes completion of all relevant training and/or 
case support. 
 
Investigator(s) are willing to conduct the Study in accordance with this Protocol and all 
applicable local and national regulatory requirements, including Informed Consent 
requirements. 
 
Adequate staff to comply with Study data collection and reporting standards. 
 
Appropriate facilities, resources and equipment to conduct the Study including ability to 
support EDC requirements 
 
Willing to allow access to representatives of the Sponsor and/or regulatory authorities for data 
monitoring/audit. 
10.4 
Investigator Training 
It is a prerequisite for site selection that investigators are appropriately qualified for commercial supply 
of BioMimics3D stent in accordance with Veryan requirements.  This includes completion of all relevant 
training and/or case support.  No additional device training or support is required for Study participation. 
Veryan will ensure that Investigators and site staff are trained in the Study Protocol, including consent 
requirements, and data collection procedures.  Training may be completed by on-site visit, WebEx 
and/or web-based training modules. 

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10.5 
EC/IRB Approvals 
The Investigator at each site is responsible for obtaining EC/IRB approval for the Protocol and the 
Informed Consent documents prior to enrolment of the first Study patient at site. The Sponsor must 
also review and approve the final Informed Consent documents prior to their use. The Sponsor must 
receive a copy of EC/IRB final approval letter and the final approved Informed Consent. 
The Investigator is responsible for ensuring that all applicable local, national, and Declaration of Helsinki 
requirements are met when completing the informed consent process. Written, Informed Consent is to 
be obtained for all patients prior to enrolment. 
The Investigator or clinical site staff will not make amendments to this Protocol or the Informed Consent 
form without PRIOR written approval from the Sponsor. All approved amendments must then be 
submitted to the local EC/IRB, as appropriate for approval. 
If the Investigator’s IRB or EC withdraws their approval to conduct this study for any reason, the 
Investigator must notify the Sponsor as soon as possible, but in no event later than five working days 
after the withdrawal of the approval. 
The Investigator must submit and, where necessary, obtain approval from the EC/IRB for all subsequent 
significant Protocol amendments and significant changes to the Informed Consent form. The 
Investigator should notify the EC/IRB of deviations from the Protocol and safety reports in accordance 
with local procedures. 
The Investigator will be responsible for obtaining annual EC/IRB approval and renewal, where 
applicable, throughout the duration of the study. Copies of the Investigator’s reports and the EC/IRB 
continuance of approval must be sent to Veryan. 
10.6 
Required Documentation 
The Investigator will maintain all CRFs, source documents and all Study documents and 
correspondence as required by applicable regulatory requirements for the duration of the study.   
The following documents should be provided to the Sponsor before Study starts: 
 
Copy of EC/IRB approval and membership list and any other relevant local approvals. 
 
Copy of the EC/IRB approved Informed Consent form and any other approved patient 
information. 
 
Financial disclosures for the Investigator and sub-Investigator(s), if applicable. 
 
Signed and dated Protocol Signature page. 
 
Current signed and dated curriculum vitae for each Investigator and sub-Investigator. 
 
Fully executed study agreement, including financial agreement. 
10.7 
Clinical Data Collection 
Standardised electronic case report forms (eCRF) will be used to collect complete and accurate records 
of the clinical data.  The Investigator and/or staff under his/her direction is responsible for accurately 
recording the clinical data for this Study and submitting it to the Sponsor in a timely manner.  All data 
from the trial will be entered into eCRF via a secure, web-based system with password protection. All 
data should be entered completely and promptly.   Data will be remotely reviewed and queried to identify 
inconsistent or missing data and any adverse events.  
Investigators are required to maintain adequate source documents including laboratory results, 
supporting medical records, and signed Informed Consent forms. These will be used during on-site 
monitoring visits to verify data contained on the completed eCRF.  For source documents, corrections 
should be made in a manner that does not obscure or eliminate the original error, by striking through 
the original data with one line, and initialling and dating the change, along with the reason for the change 
(if not obvious). 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the eCRFs 
and in all other required reports. Data reported on the eCRFs which are derived from source documents 
must be consistent with the source documents or the discrepancies need to be justified in a documented 
rationale, signed and dated by the (principal) investigator, to be filed in the subject file. 

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Only authorised persons can complete an eCRF. An eCRF shall be signed by investigators as specified 
on the Delegated Tasks List included in the Investigator Site File. 
The Electronic Data Capture (EDC) system maintains an audit trail on entries, changes or corrections 
in eCRFs. If a person only authorised to complete an eCRF makes changes to an already signed eCRF, 
the investigator shall re-sign this eCRF. 
10.8 
Device Accountability 
Sites will use devices supplied according to standard hospital/clinic procedures for the supply of 
commercial products.  Device size, lot number and expiry dates will be recorded in the eCRF.  No other 
device accountability procedures will apply. 
10.9 
Subject Compensation 
Study patients will not be reimbursed or compensated for their time in participating in the trial.  
10.10 
Confidentiality  
Confidentiality of subjects will be maintained throughout the Study. A unique identification code will be 
assigned to each participating patient. Any data that may be published in abstracts, scientific journals, 
or presented at medical meetings will reference a unique Study code and will not reveal the patient’s 
identity. The Investigator, Sponsor and their representatives will make every reasonable effort to protect 
patient confidentiality. 
10.11 
Monitoring 
Veryan will designate appropriately qualified monitors to review compliance with Protocol and data 
collection procedures, to assess the accuracy and completeness of eCRF data and record retention.  
These will be assessed by remote data review and periodic on-site visits.  Frequency and timing of on-
site monitoring will be determined by Veryan based on review of factors including, but not limited to 
enrolment rate, adverse event reporting and Protocol compliance. 
The Investigator will make available all regulatory documents, completed eCRF, Informed Consent 
documents, source documentation and other relevant records for enrolled subjects at the site. It is 
important that the Investigator and other relevant site personnel are available for consultation with the 
clinical monitor during the monitoring visits and that sufficient time is devoted at the site to the monitoring 
process. 
10.12 
Audits and Inspections 
The Investigator will allow representatives of the Sponsor, EC/IRB and applicable regulatory agencies 
to inspect all trial records, eCRF, and corresponding portions of the subject’s office and/or hospital 
medical records at regular intervals throughout the trial. These inspections are for the purposes of 
verifying adherence to the Protocol, completeness and exactness of the data being transcribed into the 
eCRF, and compliance with regulatory agency regulations. 
The Investigator will inform the Sponsor in advance if they are to be audited or inspected by any 
regulatory agencies. The Sponsor or the Sponsor’s designee will also inform the site if they are made 
aware of a pending audit or inspection by a regulatory agency. 
The Investigator and/or designees must be available to respond to reasonable requests by authorised 
Sponsor, CRO and regulatory agency representatives during the monitoring and inspection process. 
The Investigator must provide the Sponsor with copies of all correspondence that may affect the review 
of the current study (i.e., Inspection Observations) or their qualification as an Investigator in clinical 
studies conducted by the Sponsor. The Sponsor will provide any needed assistance to the clinical site 
for regulatory audits, if any. 
10.13 
Protocol Compliance/ Deviations 
The Investigators are responsible for ensuring that this Study is conducted according to this Protocol.  
All deviations from the Protocol must be reported to the Sponsor. 
Investigators shall be required to obtain prior approval from the Sponsor before initiating deviations 
from the Protocol, except where necessary to protect the life or physical well-being of a subject in 

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Final Report to the EC/IRB 
Within 3 months of Study completion. 
11.3 
Study Reports 
All information and data generated in association with the study will be held in strict confidence and 
remains the sole property of the Sponsor. The Investigator agrees to use this information for the sole 
purpose of completing the study and for no other purpose without prior approval of the Sponsor. 
The Sponsor will submit all required reports to regulatory authorities throughout the study. 
Upon receipt of the final Study data and the final reports from each centre, the Sponsor will complete a 
final Study report. Copies of the final report will be provided to each Investigator.  
11.4 
Publication Policies 
Publications and presentations will be coordinated by Veryan to allow the use of all available data. The 
following publication policy will have to be adhered to by all participating investigation sites: 
Authorship on any publication(s) will be assigned according to substantial contributions to conception 
and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it 
critically for important intellectual content and final approval of the version to be published. This is in 
accordance with the Vancouver principles (The Uniform Requirements for Manuscripts Submitted to 
Biomedical Journals: Writing and Editing for Biomedical Publication, ICMJE, October 2008), as agreed 
upon by the editors of all major medical journals.  The number of authors will be dependent on the 
regulations of the concerning journal with a maximum of 10 authors. Names of all participating 
investigators will appear in the Acknowledgment of the paper. 
Based on the principle that Veryan owns the Study data, a single investigation site may access and use 
the data provided by itself for scientific publications following prior approval by Veryan. 
Pooling data from several investigation sites for publication purposes, national projects and international 
projects all require prior approval by Veryan. 
Veryan as the owner of the data can use the data and/or any results derived from the data or 
publications based on that data for marketing purposes, further research and development of devices 
or educational use. 
Participating subjects will not be identified by name in any published reports about the Study. This Study 
will be registered with www.clinicaltrials.gov. 
 
 

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12.0 
STUDY DEFINITIONS 
Access Site Haemorrhage: Bleeding from the access site which requires transfusion, hospitalisation 
(either admission or extended stay), or further treatment for management. Haemorrhage needing ≥ 1 
unit RBCs will be considered a serious adverse event. 
Access Site Infection: Culture-proven wound infection or presumptive treatment with antibiotics for 
clinically diagnosed wound infection. 
Acute procedural success: defined as both acute technical success and absence of the following 
adverse events: death, stroke, MI, acute onset of limb ischemia, index bypass graft or treated segment 
thrombosis, and/or need for urgent/emergent vascular surgery, within 72 h of the index procedure15.  
Acute technical success: defined as the achievement of a final residual diameter stenosis ≤30% at 
the end of the procedure)15  
Allergic Reaction: An allergic reaction characterised by rash, upper respiratory congestion, urticaria, 
shortness-of-breath, or general collapse (anaphylaxis). 
Amputation:  
 
Major: any requirement for amputation of the target limb above the ankle. 
 
Minor: any requirement for amputation of the of the target limb below the ankle. 
Anaemia:  Decrease from baseline in red blood cells, haemoglobin, or total blood volume that is 
associated with haemodynamic changes or requires transfusion, or a drop in haematocrit to below 26%. 
An anaemic event requiring ≥2 units packed red blood cells (PRBC) will be considered an SAE. 
Angina, unstable:  Angina that increases in frequency, intensity, or duration, which occurs at rest, or 
which is new in onset. Unstable angina is a syndrome that is intermediate between stable angina and 
myocardial infarction: it is characterised by an accelerating or "crescendo" pattern of chest pain that 
lasts longer than stable angina, occurs at rest or with less exertion than stable angina, or is less 
responsive to medication. Unstable angina and myocardial infarction are considered acute coronary 
syndromes. 
Ankle Brachial Index (ABI):  The ratio of systolic blood pressure measured at the ankle to systolic 
blood pressure measured at the brachial artery. It is used to predict the severity of peripheral arterial 
disease (PAD). ABIs >0.9-1.2 = normal, ≤ 0.9 = peripheral arterial disease, < 0.4 = severe peripheral 
arterial disease (ischemic pain and ulceration). ABI > 1.2 is likely due to incompressible arteries and is 
commonly observed in association with long-standing diabetes mellitus, extreme old age, or calcinosis. 
Instructions for ABI Calculations: 
1. Obtain systolic blood pressures (SBP) for both arms (brachials) and both ankles [posterior 
tibials (PT) & dorsalis pedals (DP)]. 
2. Divide the higher of the two SBPs for each leg (highest between the PT and DP) by the 
higher of the two arm pressures to get the right and left ABIs. 
Arterial Occlusion / Thrombosis at Groin Puncture Site:  Angiographic or ultrasonographic evidence 
of occlusion at the puncture site limiting antegrade flow to the distal limb. 
Arterial Perforation/Rupture/Puncture of an Arterial Wall:  Classified as follows: 
Angiographic perforation: Perforation detected by the clinical site at any point during the 
procedure. 
Clinical perforation: Perforation requiring additional treatment (including efforts to seal the 
perforation), or resulting in significant extravasation of blood from the site, abrupt closure, limb 
ischemia or death. 
Arteriovenous Fistula (AVF): An abnormal passage or communication between an artery and a vein 
which may be due to the percutaneous introduction of ancillary devices (e.g., needles, catheters, guide 
wires) confirmed by imaging studies. 
Bleeding Complication (Major): Bleeding resulting in ≥3 g/dl decrease in hemoglobin (if haemoglobin 
level not available, a decrease in haematocrit of ≥ 10%), or necessitating transfusion of >1 unit of 
PRBC’s /whole blood, or necessitates surgery/endoscopic intervention. 

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Access site: Bleeding from the arteriotomy site which requires transfusion, hospitalisation 
(either admission or extended stay), or further treatment for management. 
Cardiac Arrhythmia: Electrical disruption of the heart rhythm requiring specific medication, DC shock, 
or pacemaker insertion to address condition. 
Cardiogenic Shock: Subject presents with SBP < 80 mm Hg for more than 30 minutes unresponsive 
to fluids or requiring intravenous vasopressor agent or an intra-aortic balloon pump (IABP). 
Cerebral Vascular Accident (CVA): See Stroke. 
Classification of Calcification: Intimal and medial vessel wall calcification at the target lesion site as 
assessed by high intensity fluoroscopy and digital subtraction angiography (DSA) assessed in the AP 
projection 16. 
Peripheral Arterial Calcium Scoring System (PACSS): 
Grade 0: No visible calcium at the target lesion site. 
Grade 1: Unilateral calcification <5cm: a) intimal calcification; b) medial calcification; c) mixed type. 
Grade 2: Unilateral calcification ≥5cm: a) intimal calcification; b) medial calcification; c) mixed type. 
Grade 3: Bilateral calcification <5cm: a) intimal calcification; b) medial calcification; c) mixed type. 
Grade 4: Bilateral calcification ≥5cm: a) intimal calcification; b) medial calcification; c) mixed type. 
Closure, Abrupt: Occurrence of new (during the index procedure), persistent slow, reduced, or loss of 
flow within the target vessel that requires intervention other than the index or adjunct treatment. Abrupt 
closure may also be referred to as acute occlusion if there is a total loss of flow.  
Closure, Late: Target lesion site occlusion that occurs greater than 30 days after the index procedure 
is completed. 
Closure, Subacute: Target lesion site occlusion that occurs after the index procedure is completed 
(e.g., the subject has left the treatment area) and within 30 days of procedure. 
Contrast-Induced Nephropathy: Associated with contrast agent resulting in > 25% increase in serum 
creatinine or an absolute value of > 0.5 mg/dl. 
Contrast Media Reaction: An allergic reaction, immediate or delayed, associated with the intravascular 
administration of contrast media that results in symptoms (e.g. itching, hives) or physiologic changes 
requiring treatment (e.g. anaphylactic reaction) or death. 
Critical Limb Ischemia (CLI): Clinical manifestation of peripheral arterial disease characterised by 
Rutherford Clinical Scale Category of 4-6. 
Death:  Death is divided into 2 categories:  
Cardiovascular death is defined as death due to any of the following: 
1. Acute myocardial infarction. 
2. Sudden cardiac death. 
3. Death due to heart failure. 
4. Death due to stroke. 
5. Death due to other cardiovascular causes. 
6. Death not attributable to any other cause (e.g., undetermined cause of death). 
Non-cardiovascular death is defined as a death not due to cardiovascular causes (as listed 
above). 
Deep Vein Thrombosis (DVT): Thrombosis of a deep vein, as confirmed by imaging study or direct 
visualization. 
Femoropopliteal: DVT involvement limited to the superficial femoral or popliteal veins, with or 
without distal (e.g. toward foot) DVT involvement, based on duplex ultrasound exam. 
Iliofemoral: DVT involvement of the common or external iliac veins or the common femoral 
vein, with or without distal (e.g. toward foot) DVT involvement, based on duplex ultrasound 
exam. 
De Novo Lesion: An obstructive or occlusive lesion without previous endovascular or surgical 
intervention 

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Device Failure: A device that is used in accordance with the Instructions for Use, but does not perform 
according to the Instructions for Use and negatively impacts the treatment. 
Device Malfunction: A malfunction or deterioration should be understood as a failure of a device to 
perform in accordance with its INTENDED PURPOSE when used in accordance with the 
MANUFACTURER’s instructions. 
Dissection: Disruption of an arterial wall resulting in separation of the intimal layer. May or may not be 
flow limiting. 
Dissection Classifications (National Heart, Lung and Blood Institute – NHLBI) 
Type A: Small radiolucent area within the lumen of the vessel disappearing with the passage 
of the contrast material. 
Type B: Appearance of contrast medium parallel to the lumen of the vessel disappearing within 
a few cardiac cycles. 
Type C: Dissection protruding outside the lumen of the vessel persisting after passage of the 
contrast material. 
Type D: Spiral shaped filling defect with our without delayed run-off of the contrast material in 
the antegrade flow. 
Type E: Persistent luminal filling defect with delayed run-off of the contrast material in the distal 
lumen. 
Type F: Filling defect accompanied by total coronary occlusion. 
Embolisation, Distal: Any distal emboli confirmed by imaging. 
Embolisation, Symptomatic: Clinical signs or symptoms of distal emboli detected in the treated limb 
distal to the treated lesion after the index procedure or noted angiographically and requiring mechanical 
or pharmacologic means to improve flow. This includes new abrupt occlusions or filling defects. 
Enrolment: Subjects who are consented and meet all inclusion criteria and none of the exclusion 
criteria and are treated or treatment is attempted with the study device will be considered enrolled into 
the study.  
Haematoma: Collection of blood (or its degradation products) which exceeds 5 cm in diameter, requires 
treatment, or prolongs hospitalisation. 
Hypertension: Systolic BP >140 mmHg, or diastolic >90 mmHg requiring specific medical therapy. 
Hypotension: Any prolonged systolic blood pressure <80 mmHg associated with symptoms and 
requiring intravenous vasopressor medications. 
Infection, access site: Infection at the vascular access site, documented by lab culture or clinical 
evidence requiring medical treatment (irrigation, debridement, antibiotics, etc.) to resolve.  
Infection, systemic: Systemic infection documented by positive lab culture or clinical evidence, 
requiring medical treatment to treat and resolve. 
Intention to Treat (ITT): The principle of including outcomes of all subjects in the analysis who are 
enrolled and treated (attempted or completed) into the study, regardless of noncompliance, Protocol 
deviations, or withdrawal. 
Limb Ischemia: Deficient supply of oxygenated blood to the tissues in the limbs that is due to 
obstruction of the inflow of arterial blood characterised by pain and/or discoloration of the limb and/or 
tissue loss. 
Luminal Patency: Restenosis <50% as determined by angiography or duplex ultrasound. 
Major Adverse Event (MAE):  An MAE comprises all-cause death, any major amputation performed 
on the target limb or clinically-driven target lesion revascularisation. 
Myocardial Infarction (MI): Evidence of myocardial necrosis in a clinical setting consistent with 
myocardial ischemia. 
Patency, Primary Stent: Patency is defined as the composite of (1) freedom from more than 50% 
restenosis within the stented segment and (2) freedom from clinically-driven target lesion 
revascularisation (TLR). 

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Patency, Tibioperoneal Run-Off: Subject has at least one patent tibioperoneal run-off vessel with 
<50% stenosis confirmed by angiography. 
Perforation: Puncture of an arterial wall. 
Pseudoaneurysm: Disruption of the arterial wall characterised by an out-pouching or pocket with 
swirling, flowing blood outside of the confines of the arterial lumen. 
Recurrent Occlusion: Occlusion (i.e. total obstruction of vessel lumen) after a successful canalisation.   
Recurrent Thrombosis: Thrombosis (i.e. sub-total obstruction of vessel lumen) following successful 
treatment. 
Reference Vessel Diameter, Proximal (RVDprox): Diameter of normal vessel immediately proximal to 
the treated segment. 
Reference Vessel Diameter, Distal (RVDdist): Diameter of normal vessel immediately distal to the 
treated segment. 
Renal Failure (Acute): Acute post-operative renal insufficiency resulting in one or more of the following: 
(a) increase of > 1.0 mg/dl in serum creatinine from most recent prior measured level, and current 
measured absolute value is > 2.0 mg/dl; (b) a new requirement for dialysis. 
Renal Insufficiency: An increase in serum creatinine of ≥ 1.0 mg/dl over previous value requiring 
medical treatment but which does not require dialysis to resolve. 
Respiratory Failure: New onset of respiratory insufficiency that requires placement of endotracheal 
tube and/or pneumothorax with or without chest tube. 
Respiratory Insufficiency: Deterioration of subject’s respiratory efforts that require supportive or 
medical treatment. 
Restenosis: Reoccurrence of narrowing or blockage or target lesion. Recurrence of ≥ 50% diameter 
stenosis within ± 5 mm proximal and/or distal to the target lesion as measured by duplex ultrasound or 
angiography 
Retroperitoneal Bleed: Bleeding into the back of the abdomen from a vascular access or puncture 
site. 
Rutherford Clinical Category Scale: Clinical scale identifying three grades of claudication and three 
grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss 17.  
Category 
Clinical Description 
0 
Asymptomatic 
1 
Mild claudication 
2 
Moderate claudication 
3 
Severe claudication 
4 
Ischemic rest pain 
5 
Minor tissue loss 
6 
Ulceration or gangrene 
Stent Fracture: Defined as clear interruption of stent strut observed in a minimum of two projections, 
determined by core lab examination of X-ray images. 
Stent Strut Fracture Types: 18, 19 
Type 0: No strut fractures.  
Type I: 
Single strut fracture only. 
Type II: Multiple single strut fractures that can occur at different sites.  
Type III: Multiple strut fractures resulting in complete transection of the stent, without 
displacement of the stent segments. 
Type IV:  Multiple strut fractures resulting in displacement of segments of the stent. 
Type V: Spiral strut fracture. 
Stroke: Any neurological deficit lasting 24 hours or longer, or lasting less than 24 hours with a brain 
imaging study showing infarction consistent with deficit. May be further categorized as:  
 
Ischemic Stroke: neurologic deficit meeting the study definition for Stroke that is attributed to 
thromboembolic event. 

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 
Haemorrhagic Stroke: neurologic deficit meeting the study definition for Stroke that is attributed 
to bleeding into brain tissue, epidural, subdural, or subarachnoid space; or a combination of 
these sites. 
Target Lesion Revascularisation, Clinically-driven (CDTLR): Revascularisation of the target lesion 
with objective evidence of recurrent symptoms associated with an angiographic determination of ≥50% 
stenosis and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated 
with the index limb). 
Target Limb: Any symptomatic limb that contains the target lesion and all vessels from aortic bifurcation 
to the foot. 
Target Vessel Revascularisation, Clinically-driven (CDTVR): Revascularisation of the target vessel 
with objective evidence of recurrent symptoms associated with an angiographic determination of ≥50% 
stenosis and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated 
with the index limb). 
Thrombocytopenia: A persistent decrease in the number of blood platelets to subnormal levels. 
Thrombus: Blood clot that obstructs a blood vessel. 
Transient Ischemic Attack: A neurological event where symptoms last for less than 24 hours, with no 
evident permanent functional impairment. 
Walking Impairment Questionnaire (WIQ): A measure of subject-perceived walking performance for 
patients with PAD and/or intermittent claudication. This questionnaire estimates walking distance, 
walking speed, and stair climbing. Improvement is defined as an increase of walking distance 
 
13.0 
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APPENDIX A – INSTRUCTIONS FOR USE (IFU) 
The Instructions for Use in this appendix are current at the time of protocol finalisation.  In the event of 
an update to the approved IFU, this Appendix will be updated administratively.