A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Bare Metal Self-expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
Phase: NA
Conditions: Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
Sponsor: Boston Scientific Corporation

EMINENT 
Boston Scientific International SA 
 Confidential 
 
ClinicalTrials.gov  
Cover Page 
 
CLINICAL INVESTIGATIONAL PLAN  
 
EMINENT 
 
 
A randomized trial comparing the ELUVIA™ drug-eluting stent versus bare Metal 
self-expanding nitINol stEnts in the treatmeNt of superficial femoral and/or 
proximal popliteal arTeries 
 
NCT Number: 02921230 
CIP nr: S2366 
VERSION: 3.0 
DATE: 23 December 2019 
 
This protocol contains confidential information for use by the Investigators and their designated 
representatives participating in this clinical investigation. The protocol should be held confidential and 
maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific International SA 
 

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CLINICAL INVESTIGATIONAL PLAN  
 
EMINENT 
 
A randomized trial comparing the ELUVIA™ drug-eluting stent versus bare Metal self-expanding 
nitINol stEnts in the treatmeNt of superficial femoral and/or proximal popliteal arTeries 
 
CIP nr: S2366 
VERSION: 3.0 
DATE: 23 December 2019 
 
 
This protocol contains confidential information for use by the Investigators and their designated 
representatives participating in this clinical investigation. The protocol should be held confidential and 
maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific International SA 
 
 
 
Sponsored By: 
Boston Scientific International SA 
Le Val Saint Quentin 
2 Rue René Caudron 
78960 Voisins-Le-Bretonneux 
France 
 

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TABLE OF CONTENTS 
 
1. 
CLINICAL INVESTIGATIONAL PLAN (CIP) APPROVAL PAGE ......................................... 5 
2. 
CIP SIGNATURE PAGE ....................................................................................................... 6 
3. 
CIP EXECUTIVE SUMMARY ............................................................................................... 7 
4. 
ASSESSMENT AND FOLLOW-UP SCHEME .................................................................... 16 
5. 
CONTACT DETAILS .......................................................................................................... 17 
6. 
INTRODUCTION AND RATIONALE .................................................................................. 17 
6.1 
Endovascular Treatment in SFA/PPA ............................................................................ 18 
6.2 
ELUVIA Stent System.................................................................................................... 19 
6.3 
MAJESTIC First Human Use Study ............................................................................... 20 
6.4 
IMPERIAL IDE Study ..................................................................................................... 20 
6.5 
Summary ....................................................................................................................... 21 
7. 
OBJECTIVES ..................................................................................................................... 22 
8. 
ENDPOINTS ....................................................................................................................... 22 
8.1 
Primary Effectiveness Endpoint ..................................................................................... 22 
8.2 
Secondary Endpoint ...................................................................................................... 23 
8.3 
Additional Endpoints ...................................................................................................... 23 
9. 
STUDY DESIGN ................................................................................................................. 24 
9.1 
Scale and Duration ........................................................................................................ 25 
9.2 
Study Flow Chart ........................................................................................................... 26 
10. 
STUDY POPULATION ....................................................................................................... 27 
10.1 
Subject Selection ........................................................................................................... 27 
10.2 
Inclusion Criteria ............................................................................................................ 27 
10.3 
Exclusion Criteria ........................................................................................................... 28 
11. 
DEVICE DESCRIPTION ..................................................................................................... 29 
11.1 
ELUVIA Drug-Eluting Stent System (Test Device) ........................................................ 29 
11.1.1 
Paclitaxel Drug ......................................................................................................... 29 
11.1.2 
Primer Polymer and Drug Matrix Copolymer Carrier ............................................... 29 
11.1.3 
ELUVIA Stent System Product Description ............................................................. 30 
11.1.4 
Test Device Sizes .................................................................................................... 30 
11.2 
Summary of Findings from Non-clinical Studies and Clinical Studies ........................... 30 
11.3 
Device Accountability .................................................................................................... 30 
12. 
METHODS .......................................................................................................................... 31 
12.1 
Screening ...................................................................................................................... 31 
12.2 
Informed Consent .......................................................................................................... 31 
12.3 
Point of Enrolment ......................................................................................................... 32 
12.4 
Study Assessments and Endpoint Measurements ........................................................ 32 
12.4.1 
Pre-Procedure Assessments – Up to 30 Days ........................................................ 32 
12.4.2 
Pre-Procedure Assessments – Up to 7 Days .......................................................... 33 
12.4.3 
Procedure ................................................................................................................ 33 
12.5 
Post-procedure/Pre-hospital Discharge ......................................................................... 35 
12.6 
Angiography .................................................................................................................. 36 
12.7 
Visit Windows ................................................................................................................ 36 
12.8 
Follow-up Visits ............................................................................................................. 36 
12.8.1 
1-Month Follow-up Visit ........................................................................................... 37 
12.8.2 
6-Month Follow-up Visit ........................................................................................... 38 
12.8.3 
12-Month Follow-up Visit ......................................................................................... 38 
12.8.4 
24-Month Follow-up Visit ......................................................................................... 38 
12.8.5 
36-Month Follow-up Visit ......................................................................................... 39 
12.8.6 
48- and 60-Month Follow-up Visits .......................................................................... 39 
12.9 
Trial Completion ............................................................................................................ 39 
12.10 Missed or Late Visits ..................................................................................................... 40 
12.11 Medication ..................................................................................................................... 40 

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12.12 Withdrawal of Individual Subjects .................................................................................. 40 
12.13 Replacement of Individual Subjects after Withdrawal .................................................... 41 
13. 
SUSPENSION OR TERMINATION .................................................................................... 41 
13.1 
Premature Termination of the Study .............................................................................. 41 
13.1.1 
Study-wide Termination or Suspension ................................................................... 41 
13.1.2 
Investigator/Site Termination or Suspension ........................................................... 41 
13.1.3 
Procedures for Termination or Suspension ............................................................. 42 
14. 
SAFETY .............................................................................................................................. 42 
14.1 
Adverse Events ............................................................................................................. 43 
14.2 
Adverse Device Effects.................................................................................................. 44 
14.3 
Serious Adverse Events ................................................................................................ 44 
14.4 
Serious Adverse Device Effects .................................................................................... 44 
14.5 
Unanticipated Serious Adverse Device Effects ............................................................. 44 
14.6 
Device Malfunction/Failure/Deficiency – Device Specific Events .................................. 44 
14.7 
Adverse and serious adverse events reporting ............................................................. 45 
14.8 
Annual Safety Report .................................................................................................... 46 
14.9 
Severity .......................................................................................................................... 46 
14.10 Clinical Events Committee (CEC) .................................................................................. 48 
15. 
POTENTIAL RISKS AND BENEFITS ................................................................................. 48 
15.1 
Anticipated Adverse Events and Risks Associated with Use of the ELUVIA Stent 
System and Implantation of the ELUVIA Stent .......................................................................... 48 
15.2 
Risks Associated with the Test Device Unique to Paclitaxel drug coating .................... 49 
15.3 
Risks associated with Participation in the Clinical Study ............................................... 49 
15.4 
Possible Interactions with Concomitant Medical Treatments ........................................ 50 
15.5 
Risk Minimization Actions .............................................................................................. 50 
15.6 
Anticipated Benefits ....................................................................................................... 50 
15.7 
Risk to Benefit Rationale ............................................................................................... 50 
16. 
STATISTICAL ANALYSIS .................................................................................................. 50 
16.1 
Primary Endpoint ........................................................................................................... 51 
16.1.1 
Primary Effectiveness Endpoint ............................................................................... 51 
16.1.2 
Analysis Sets ........................................................................................................... 52 
16.1.3 
Randomization Scheme ........................................................................................... 52 
16.1.4 
Control of Systematic Error/Bias .............................................................................. 52 
16.1.5 
Number of Subjects per Investigative Site ............................................................... 53 
16.2 
Baseline Data Analyses ................................................................................................. 53 
16.2.1 
Secondary Endpoint and Additional Endpoints ........................................................ 53 
16.2.2 
Interim Analyses ...................................................................................................... 53 
16.2.3 
Subgroup Analyses .................................................................................................. 53 
16.2.4 
Justification of Pooling ............................................................................................. 54 
16.2.5 
Sensitivity Analysis for Missing Data ....................................................................... 54 
16.2.6 
Multivariable Analyses ............................................................................................. 54 
16.2.7 
Analysis Software .................................................................................................... 54 
16.2.8 
Changes to Planned Analyses ................................................................................. 55 
17. 
ETHICAL CONSIDERATIONS ........................................................................................... 55 
17.1 
Regulation Statement .................................................................................................... 55 
17.2 
Recruitment and Consent .............................................................................................. 55 
17.3 
Investigator Responsibilities .......................................................................................... 56 
17.3.1 
Delegation of Responsibility .................................................................................... 57 
17.4 
Ethics Committee........................................................................................................... 57 
17.5 
Sponsor Responsibilities ............................................................................................... 58 
17.5.1 
Role of Sponsor Representatives ............................................................................ 58 
18. 
REIMBURSEMENT AND COMPENSATION FOR SUBJECTS ......................................... 58 
18.1 
Subject Reimbursement ................................................................................................ 58 
18.2 
Compensation of Injury .................................................................................................. 59 
19. 
ADMINISTRATIVE ASPECTS AND PUBLICATION .......................................................... 59 
19.1 
Handling and Storage of Data and Documents ............................................................. 59 

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19.2 
Data Collection and Case Report Forms (CRF) ............................................................ 59 
19.3 
Deviations ...................................................................................................................... 60 
19.4 
CIP Revisions or Amendments ...................................................................................... 60 
19.5 
Annual Progress Report ................................................................................................ 61 
19.6 
End of Study Report ...................................................................................................... 61 
19.7 
Public Disclosure and Publication Policy ....................................................................... 61 
20. 
MONITORING .................................................................................................................... 62 
20.1 
Monitoring Visits ............................................................................................................ 62 
21. 
ABBREVIATIONS AND DEFINITIONS .............................................................................. 63 
21.1 
Abbreviations ................................................................................................................. 63 
21.2 
Definitions ...................................................................................................................... 65 
22. 
REFERENCES ................................................................................................................... 74 
 
 
 
 

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1. CLINICAL INVESTIGATIONAL PLAN (CIP) APPROVAL PAGE 
 
Study Title 
A randomized trial comparing the ELUVIA™ drug-eluting stent versus 
bare Metal self-expanding nitINol stEnts in the treatmeNt of superficial 
femoral and/or proximal popliteal arTeries (EMINENT) 
CIP Number 
S2366 
CIP Version 
3.0 
CIP Date 
23 December 2019 
 
 
 
Prof. Dr. Giovanni Torsello 
Coordinating Clinical Investigator 
 
 
 
 
Date 
Prof. Dr. Yann Goueffic 
Coordinating Clinical Investigator 
 
 
 
 
Date 
Andrew Campbell 
Clinical Trial Manager 
Sponsor representative 
 
 
Date 

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2. CIP SIGNATURE PAGE 
 
Study Title 
A randomized trial comparing the ELUVIA™ drug-eluting stent versus 
bare Metal self-expanding nitINol stEnts in the treatmeNt of superficial 
femoral and/or proximal popliteal arTeries (EMINENT) 
CIP Number 
S2366 
CIP Version 
3.0 
CIP Date 
23 December 2019 
I have reviewed this protocol and agree to adhere to the requirements and responsibilities listed 
herein.  I am trained to the contents of this protocol, percutaneous angioplasty procedures, and the 
specific use of the devices listed in this protocol.  I will ensure that the study is conducted in 
compliance with the protocol, Good Clinical Practices, Declaration of Helsinki, the International 
Standard ISO 14155:2011 and all applicable regulatory requirements.  
 
 
 
 
 
_______________________________ 
 
 
 
_____________________ 
Site Principal Investigator Name (please print or use stamp) 
Site Number 
 
 
 
 
____________________________                           ________________________ 
Site Principal Investigator Signature  
 
Date 
 

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3. CIP EXECUTIVE SUMMARY 
 
PROTOCOL TITLE: A randomized trial comparing the ELUVIA™ drug-eluting stent versus bare 
Metal self-expanding nitINol stEnts in the treatmeNt of superficial femoral and/or proximal popliteal 
arTeries (EMINENT) 
 
CIP Short title 
EMINENT 
CIP number 
S2366 
Sponsor  
Boston Scientific International SA 
Objective 
To confirm the superior effectiveness of the ELUVIA Drug-Eluting Vascular Stent 
System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or 
Proximal Popliteal Artery (PPA) lesions up to 210 mm in length when compared 
against bare metal stents, and collect additional data including health economics 
data. 
Planned 
Indication(s) for 
Use 
The ELUVIA Stent System is intended to improve luminal diameter in the treatment 
of symptomatic de novo or restenotic lesions in the native SFA and/or PPA with 
reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion 
lengths up to 210 mm. 
Test Device 
The ELUVIA Stent is a paclitaxel-eluting, self-expanding nitinol stent developed 
on the same stent and delivery system as the BSC Innova™ Vascular Self-
Expanding Stent System. 
Control Device 
Commercially available stents in Europe. Permitted stents are Supera (Abbott), 
Lifestent 
(CR 
Bard), 
Everflex 
(Covidien/Medtronic), 
S.M.A.R.T. 
Flex 
(Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), 
COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific) 
indicated for improving luminal diameter for the treatment of de novo or restenotic 
symptomatic lesions in native vascular disease of the above-the-knee 
femoropopliteal arteries.  

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Device Sizes 
ELUVIA Stent (Test Device) 
Stent Diameter 
(mm) 
Stent Length (mm) 
Recommended Vessel 
Diameter (mm) 
6 
40, 60, 80, 100, 120, 150 
4.0 – 5.0 
7 
40, 60, 80, 100, 120, 150 
5.0 – 6.0 
The ELUVIA Stent is available in two stent delivery system (SDS) sizes; 75 cm 
and 130 cm. The sheath compatibility is 6 French used with 0.035 inch 
guidewires.  
Self-Expanding Stents - Bare Nitinol (Control Devices) 
Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex 
(Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control 
(Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago 
(Terumo) or Innova (Boston Scientific).   
Study Design 
A prospective, multi-center study confirming the superior effectiveness of the 
ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of 
lesions 30-210 mm long located in the femoropopliteal arteries in subjects with 
symptoms classified as Rutherford categories 2-4.  
The study is a 2:1 randomized (ELUVIA vs Self-Expanding Bare Nitinol Stents), 
controlled, single-blind, superiority trial (RCT). Randomization will be stratified to 
ensure equal distribution of ELUVIA and Self-Expanding Bare Nitinol Stents in 
different lesion length subsets.    
Primary 
Endpoint 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint assesses primary patency at 12 months 
post-procedure. This effectiveness endpoint is designed to demonstrate that the 
12-month primary patency for the ELUVIA treatment group is superior to the 
Self-Expanding Bare Nitinol Stents treatment group.  
Primary vessel patency is defined as a binary endpoint and will be determined to 
be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio 
(PSVR) is ≤ 2.4 at the 12-month follow-up visit in the absence of clinically-driven 
TLR or bypass of the target lesion.  All DUS readings will be assessed by an 
independent core laboratory 

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Secondary 
Endpoint 
Health-Economics 
- 
Walking Improvement at 12 months assessed by change in Six Minute Hall 
Walk (6MHW) / treadmill test from baseline, or preceding any Target Vessel 
Revascularization 
- 
Walking Improvement at 12 months assessed by change in Walking 
Impairment Questionnaire (WIQ) from baseline  
- 
Quality of Life Improvement at 12 months assessed by change in EQ-5D-5L 
™ from baseline, or preceding any Target Vessel Revascularization 
- 
Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-
expanding nitinol stents  
- 
Rate of Primary and Secondary Sustained Clinical Improvement at 12 
months as assessed by changes in Rutherford Classification from baseline 
- 
Rate of Hemodynamic Improvement at 12 months as assessed by changes 
in Ankle-Brachial Index (ABI) from baseline  
Additional 
Endpoints 
- 
Technical success 
- 
Procedural success 
- 
Major Adverse Event (MAE) rate (and individual components) at each time 
point, defined as all causes of death, target limb major amputation and/or 
Target Lesion Revascularization (TLR) 
- 
Primary Patency and Assisted Primary Patency at 6 months, 12 months, 24 
months and 36 months using different DUS PSVRs 
- 
Clinically-driven TLR and clinically-driven Target Vessel Revascularization 
(TVR) Rate at each time point 
- 
Adverse Event Rates (unanticipated, major, serious, device/procedure-
related) at each time point 
- 
Survival rate at 4 years and 5 years post-procedure  
- 
Number of Stent Fractures reported at 12 months and 24 months utilizing 
VIVA definitions 
- 
Distribution of Rutherford Class during follow-up as compared to baseline at 
1 month, 6 months, 12 months, 24 months and 36 months 
- 
Walking Improvement at 1 month, 6 months, 24 months and 36 months 
assessed by change in Walking Impairment Questionnaire (WIQ) from 
baseline 
- 
Quality of Life Improvement at 1 month, 6 months, 24 months and 36 
months assessed by change in EQ-5D-5L™ from baseline 
- 
Rate of Primary and Secondary Sustained Clinical Improvement as 
assessed by changes in Rutherford Classification from baseline at 1 month, 
6 months, 24 months and 36 months 
- 
Rate of Hemodynamic Improvement as assessed by changes in Ankle-
Brachial Index (ABI) from baseline at 1 month, 6 months, 24 months and 36 
months 

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Population  
750 subjects to receive treatment with either the test device (ELUVIA, N=500 
subjects) or a control device (Self-Expanding Bare Nitinol Stents, N=250 subjects). 
Up to 75 study centers in up to 15 European countries may enroll subjects in the 
study. 
Study Duration 
It is expected that the enrolment will take approximately 18 months. 
The study will be considered complete (with regard to the primary endpoint) after 
all subjects have completed the 12 month follow-up visit, were discontinued prior 
to the 12 month follow-up visit, have died, or the last 12 month follow-up visit 
window is closed. 
Subject participation will last approximately 5 years, including time required for 
screening. The trial will be considered complete (with regard to all follow-up) 
after all subjects have completed the 60 month (5 year) follow-up visit, were 
discontinued prior to the 60 month (5 year) follow-up visit, have died, or the last 
60 month (5 year) follow-up visit window is closed. 
It is estimated that it will take approximately 8 years to complete this trial. 
Inclusion 
Criteria 
1. Subjects age 18 and older 
2. Subject is willing and able to provide consent before any study-specific test or 
procedure is performed, signs the consent form, and agrees to attend all 
required follow-up visits 
3. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 
3 or 4 
4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or 
PPA: 
a. Degree of stenosis 70% by visual angiographic assessment 
b. Vessel diameter ≥ 4 and 6 mm 
c. Total lesion length (or series of lesions) ≥ 30 mm and  210 mm (Note:  
Lesion segment(s) must be fully covered with one or two overlapping 
ELUVIA stent(s) or Self Expanding Bare Nitinol stent(s)) 
d. For occluded lesions (chronic occlusions) requiring use of re-entry 
device, lesion length ≤ 180 mm 
e. Target lesion located at least three centimeters above the inferior edge 
of the femur 
5. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with 
at least one of three vessels patent (<50% stenosis) to the ankle or foot with 
no planned intervention 

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Exclusion 
Criteria 
1. Previously stented target lesion/vessel 
2. Target lesion/vessel previously treated with drug-coated balloon <12 months 
prior to randomization/enrollment 
3. Subjects who have undergone prior surgery of the SFA/PPA in the target limb 
to treat atherosclerotic disease 
4. Use of atherectomy, laser or other debulking devices such as Rotarex in the 
target limb SFA/PPA during the index procedure 
5. History of major amputation in the target limb 
6. Documented life expectancy less than 24 months due to other medical co-
morbid condition(s) that could limit the subject’s ability to participate in the 
clinical study, limit the subject’s compliance with the follow-up requirements, 
or impact the scientific integrity of the clinical study 
7. Known hypersensitivity or contraindication to contrast dye that, in the opinion 
of the investigator, cannot be adequately pre-medicated  
8. Known hypersensitivity/allergy to the stent system or protocol related 
therapies (e.g., nitinol, paclitaxel, or structurally related compounds, polymer 
or individual components, and antiplatelet, anticoagulant, thrombolytic 
medications) 
9. Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis 
10. Concomitant renal failure with a serum creatinine >2.0 mg/dL 
11. Receiving dialysis or immunosuppressant therapy 
12. History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) 
within 6 months prior to randomization/enrollment 
13. Unstable angina pectoris at the time of randomization/enrollment 
14. Pregnant, breast feeding, or plan to become pregnant in the next 5 years 
15. Current participation in an investigational drug or device clinical study that has 
not completed the primary endpoint at the time of randomization/ enrollment or 
that clinically interferes with the current study endpoints (Note: studies 
requiring extended follow-up for products that were investigational, but have 
become commercially available since then are not considered investigational 
studies) 
16. Septicemia at the time of randomization/enrollment 
17. Presence of other hemodynamically significant outflow lesions in the target 
limb requiring intervention at the time of the index procedure 
18. Presence of aneurysm in the target vessel 
19. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to 
randomization/enrollment. 

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20. Perforated vessel as evidenced by extravasation of contrast media prior to 
randomization/enrollment. 
21. Heavily calcified lesions. 
22. As applicable by French law, subject who is a protected individual such as an 
incompetent adult or incarcerated person. 
Method of 
Assigning 
Subjects to 
Treatment 
Once the subject has signed the approved study Informed Consent Form (ICF), 
and has met all clinical inclusion and no clinical exclusion criteria, the subject will 
be considered eligible to be enrolled in the study.  
If the subject is found to meet exclusion criteria during the angiographic eligibility 
assessment, the subject will be considered a screen failure and should not be 
randomized and included in the study, nor should the subject be followed post-
procedure per protocol.  
If the subject is found to meet the inclusion criteria during the angiographic phase 
of the procedure, the subject will be considered eligible to be randomized (2:1 
allocation treatment versus control). Randomization will be stratified by lesion 
length (i.e. ≤110 mm vs. >110 mm) for each site. After the Investigator 
successfully crosses the target lesion with the guidewire, a randomization custom 
function within the eCapture electronic data capture (EDC) database will be used 
to assign subjects to the test or control treatment group. Subjects will be 
considered enrolled after they have been successfully randomized (i.e. when a 
treatment assignment is received by the study site).  
Blinding/ 
Unblinding 
The EMINENT study is a single-blind study. Subjects will be blinded to treatment 
assigned and treatment received. All subjects must remain blinded until 
completion of all 12-month follow-up visits (primary endpoint). Packaging of the 
test and control devices are different, therefore the investigator performing the 
procedure will not be blinded to the assigned treatment arm or resulting 
treatment. Study center personnel will be trained not to disclose the treatment 
assignment to the subject to minimize the potential unblinding of the subject. 
Site personnel conducting clinical follow-up will be blinded to a subject’s 
treatment assignment whenever possible, and must remain blinded until 
completion of all 12-month follow-up visits (primary endpoint). Duplex Ultrasound 
Core Laboratory personnel, Angiography Core Laboratory personnel and the 
Clinical Events Committee (CEC) will be blinded to a subject’s treatment 
assignment during the study. Those involved in data analysis for the Sponsor will 
remain blinded until the primary endpoint analysis.  
Instructions regarding the unblinding of a subject for a medical emergency can be 
found in the Unblinding guidelines. 

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Follow-up 
Schedule 
All subjects will be evaluated at 6 (182 ±30 days), , 12 (365 ±30 days), 24 (730 
±30 days), 36 (1095 ±30 days), 48 (1460 ±90 days) and 60 (1825 -90/+30 days) 
months post-procedure.   
Subjects will be evaluated at 1 (30 days -7 days to + 14 days) month if visit is 
local standard of care or if an ELUVIA stent or Self Expanding Bare Nitinol stent 
was not successfully implanted during the Index Procedure. 
• 
Subjects who are randomized but an ELUVIA stent or Self Expanding Bare 
Nitinol stent was not successfully implanted will be followed through the 1-
month follow-up visit only.  Data for assessment of MAE will be collected for 
these subjects; other testing is not required. 
• 
Assessment of the primary effectiveness endpoint and secondary health-
economics endpoint will occur at the 12-month follow-up visit. 
• 
All follow-up visits through 36 months will be conducted in the office/clinic. 
• 
Telephone follow-up visit at 48 months and 60 months post-procedure, and/or 
medical chart review and/or publicly available records consultation, if 
necessary. 
Planned protocol-required testing includes the following: 
• 
Angiography during the index procedure, and during any subsequent 
revascularization procedure, to assess technical success and procedural 
success. 
• 
DUS at 6 months, 12 months (1 year), 24 months (2 years), and 36 months (3 
years) visits to assess lesion and vessel patency. 
• 
X-rays at 12 months (1 year) and 24 months (2 years) visits to assess stent 
integrity will be collected if performed per standard of care. 
• 
Walking Impairment Questionnaire (WIQ) at 1 month, 6 months, 12 months (1 
year), 24 months (2 years), and 36 months (3 years) visits to assess Walking 
Ability 
• 
EQ-5D-5L™ at 1 month, 6 months, 12 months (1 year), 24 months (2 years), 
and 36 months (3 years) visits to assess Quality of Life  
 
In case a subject undergoes a re-intervention of the target vessel, it is 
recommended to perform a walking test (6MWT or treadmill test) and QoL 
questionnaire (EQ-5D-5L™) prior to the Target Vessel Revascularization. 
Required 
Medication 
Therapy 
Investigators must prescribe concomitant anti-coagulant and anti-platelet 
medications consistent with current local clinical practice. Antiplatelet medication 
usage will be collected and reported for the duration of the trial. 
Multiple 
Interventions 
Using Same 
Access Site 
Iliac lesion(s) in both limbs may be treated during the index procedure. 
Iliac lesions in the target limb should be treated prior to the target SFA/PPA 
lesion with commercially available devices (non-drug-eluting in the target limb) 

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During Index 
Procedure 
and treatment must be considered successful (i.e. residual stenosis <30% and no 
clinical events [embolization, perforation]) 
Tandem lesions in the SFA/PPA may be treated during the index procedure, 
provided that the tandem lesions segment is 210 mm and can be covered with 
one or two overlapping ELUVIA stent(s) or Self Expanding Bare Nitinol Stent(s) 
according to each device’s Instructions for Use (IFU/DFU). (Refer to Inclusion 
criterion 4c.) 
If an additional stent is required due to complications (e.g., dissection, 
misplacement or under-sizing of the target lesion), the additional stent(s) placed 
should be of the same type used to treat the target lesion. 
Statistical 
Methods 
Primary Effectiveness Statistical Hypothesis 
The primary effectiveness hypothesis to be tested is that the 12-month primary 
patency in subjects treated with ELUVIA is superior to subjects treated with Self 
Expanding Bare Nitinol Stents at one-sided significance level of 2.5%. 
Primary Effectiveness Statistical Test Method 
The Chi-Square Test will be used to assess the hypothesis of superiority in 
proportions: 
H0: Pt - Pc   0 
H1: Pt - Pc  > 0 (superior) 
where Pt and Pc are the 12-month primary patency for the ELUVIA (test) and Self 
Expanding Bare Nitinol Stents (control) groups, respectively. 
Secondary Health-Economics endpoint 
No formal tests of hypotheses are proposed for the secondary endpoint. 
Statistical comparisons may be performed for exploratory purposes. 
Success Criteria Success Criteria for Primary Effectiveness Endpoint 
ELUVIA will be concluded to be superior to Self-Expanding Bare Nitinol Stents for 
device effectiveness if the one-sided lower 97.5% confidence bound on the 
difference between treatment groups (ELUVIA – Self Expanding Bare Nitinol 
Stents) in 12-month primary patency is greater than zero. 
Success Criteria for the Study 
If the primary effectiveness endpoint is met, the RCT will be considered a 
success.  

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Sample Size 
Parameters 
The primary effectiveness endpoint drives the overall sample size. 
Primary Effectiveness Endpoint 
• 
Power ≥ 85% 
• 
One-sided significance level (alpha) = 2.5% 
• 
To demonstrate 10%* treatment effect in effectiveness: 
• 
Expected ELUVIA 12-month primary patency = 85%  
• 
Expected Self Expanding Bare Nitinol Stents 12-month primary patency = 
75% 
• 
Allocation (ELUVIA vs. Self-Expanding Bare Nitinol Stents) = 2:1 
• 
Attrition rate in 12 months ≤ 16% 
• 
A minimum of 630 evaluable subjects are required at 12 months (ideally 420 
ELUVIA, 210 Self Expanding Bare Nitinol Stents) 
• 
Approximately 750 subjects are planned to be randomized in a 2:1 fashion at 
enrollment 
*The 10% treatment effect represents 7% observed advance. Assuming a 12-month primary 
patency of 75.2% (158/210) is observed for Self Expanding Bare Nitinol Stents, a minimum of 82.1% 
(345/420) for ELUVIA will be required to claim superiority. 
 
 
 

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4. ASSESSMENT AND FOLLOW-UP SCHEME 
 
Procedure/Assessment 
Pre-
procedure3 
During 
Index 
Procedure 
Pre-
Discharge 
1 MFU10 
(30 -7 days 
to + 14 days) 
6 MFU 
(182±30 
days) 
12 MFU 
(365±30 
days) 
24 MFU 
(730±30 
days) 
36 MFU 
(1095±30 
days) 
48MFU 11 
(1460 ± 90 
days) 
60 MFU 11 
(1825 -90 / 
+30 days) 
Prior to TVR 
Informed Consent1 
X 
 
 
 
 
 
 
 
 
 
 
In/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
Demographics &  
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
Laboratory2 
X 
 
 
 
 
 
 
 
 
 
 
Pregnancy test3 
X 
 
 
 
 
 
 
 
 
 
 
ABI 
X 
 
 
X4 
X 
X 
X 
X 
 
 
 
RCC (Rutherford-Becker  
clinical classification) 
X 
 
 
X 
X 
X 
X 
X 
 
 
 
WIQ 
X 
 
 
X 
X 
X 
X 
X 
 
 
 
EQ-5D-5L 
X 
 
 
X 
X 
X 
X 
X 
 
 
X9 
6MHW or treadmill8 
X 
 
 
 
 
X8 
 
 
 
 
X9 
Angiogram5 
 
X 
 
 
 
 
 
 
 
 
 
Randomization  
 
X 
 
 
 
 
 
 
 
 
 
DUS5 
 
 
 
 
X 
X 
X 
X 
 
 
 
X-Ray6 
 
 
 
 
 
X6 
X6 
 
 
 
 
Health Economics 
 
 
 
X 
X 
X 
X 
X 
 
 
 
Medication 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
Adverse Events7 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
1. 
Subject’s consent may be obtained outside the 30 day window leading up to the procedure however, subject’s consent and informed consent form must be signed prior to any study-specific tests or procedures 
2. 
Serum Creatinine and Platelet Count to be measured 
3. 
Performed within 30 days of procedure, except informed consent and except urine or blood pregnancy test required for females of childbearing potential performed within 7 days of procedure 
4. 
ABI measurement may be collected immediately post-procedure through 1 Month Follow-up window (Day 0 – 44) 
5. 
Angiograms and DUS will be sent to the respective core lab for analysis.  Follow-up ultrasounds will not be required for any subject who underwent bypass surgery of the target lesion during the 36-month follow-
up timeframe, or has a documented occluded stent. 
6. 
X-ray only to be performed if per standard of care. If X-ray is done, images to be sent to the core lab for analysis. 
7. 
Reporting required through the end of study for Major Adverse Events, UADEs, and (S)ADEs/Device Deficiencies.   
8. 
Pre-procedure and at 12MFU, either 6MWT or treadmill can be performed, whatever is standard of care. 
9. 
In case a subject undergoes a re-intervention of the target vessel, it is recommended to perform a walking test (6MWT or treadmill test) and QoL questionnaire (EQ-5D-5L™) prior to the TVR 
10. The 1 month visit is only required if the visit is local standard of care or if an ELUVIA stent or Self Expanding Bare Nitinol stent was not successfully implanted during the index procedure. 
11. The 48 month and 60 month visit will be conducted via telephone and/or medical chart review and/or publicly available records consultation. 

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5. CONTACT DETAILS 
Contact information is provided below. This information is subject to change during the 
course of the clinical study. Periodic updates to study contact information will be sent to the 
sites and committees as needed. 
 
Coordinating investigators 
Prof. Dr. Giovanni Torsello 
Sint-Franziskus-Hospital GmbH 
Hohenzollernring 72 
48145 Münster, Germany 
 
Prof. Dr. Yann Goueffic 
Hôpital Paris St Joseph, department of vascular and 
endovascular surgery 
185 Rue Raymond Losserand,  
Paris, 75014-France 
 
Sponsor 
Boston Scientific International SA 
Le Val Saint Quentin 
2 Rue René Caudron 
78960 Voisins-Le-Bretonneux 
France 
 
Clinical contact  
Andrew Campbell 
Boston Scientific, Peripheral Interventions, Clinical 
Three Scimed Place 
Maple Grove, MN USA 
Andrew.Campbell@bsci.com 
 
Investigational Sites 
A list of investigational sites is maintained by the 
sponsor. 
 
Vendors/labs 
A list of vendors/labs involved in the trial is maintained 
by the sponsor. 
 
6. INTRODUCTION AND RATIONALE 
Peripheral Arterial Disease (PAD) is the third leading cause of cardiovascular morbidity after 
myocardial infarction (MI) and stroke. Current estimates state that there are over 200 million 
global patients with PAD1,2 with an age–adjusted prevalence ranging from 12 to 20 percent.3,4 
Less than twenty percent of patients with PAD have typical symptoms of intermittent 
claudication such as leg muscle discomfort on exertion that is relieved by rest, or critical limb 
ischemia (CLI) (i.e., rest pain, ulceration or gangrene); whereas, another third have atypical 

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exertional leg symptoms. Notably, the risk of cardiovascular morbidity and mortality is equally 
high in patients with PAD, regardless of the presence of symptoms.5 Non-revascularized lower 
extremity PAD is the most common cause of lower extremity amputation.6 
6.1 Endovascular Treatment in SFA/PPA 
In general, the debate for state-of-the-art therapy in SFA disease involves endovascular 
intervention versus bypass surgery. Historically, surgery is generally reserved for resting pain 
and critical limb ischemia.  However, surgical therapy carries significant morbidity, including 
wound infection, MI and even death. In addition, up to 17 percent of the post-bypass surgery 
patients do not experience satisfactory clinical improvement.7 Over the past decade, 
percutaneous catheter-based techniques have improved such that acute procedural success 
is high even in complex anatomy. Patency rates have also increased with the use of 
atherectomy devices and drug-eluting stents (DES). Often, patients with PAD have 
comorbidities that increase the risk of cardiovascular complications with surgical procedures. 
These factors have led to the adoption of an endovascular first strategy with surgical 
management reserved for selected patients.2,8 
Patients with very short pain-free walking distance are typically candidates for 
revascularization. According to American College of Cardiologists/ American Heart Association 
(ACC/AHA) guidelines, endovascular treatment of SFA disease is indicated for individuals with 
significant disability due to intermittent claudication (IC) or CLI.  
The femoropopliteal segment is a challenging vascular territory and has been among the least 
effective of all endovascular procedures in terms of long-term patency.9,10,11  The SFA is the 
longest artery in the human body and is located between two major flexion points, the knee 
and the hip. The relatively small vessel lumen, in conjunction with a high plaque burden, slow 
flow, and a high frequency of primary occlusions, contributes to considerable technical 
difficulties. In recent years, however, improvements in device technology and the skill-sets of 
the interventionalists have facilitated the treatment of complex lesions, including long-segment 
chronic occlusions with or without moderate calcification. In fact, the current evolution towards 
treating more complex femoropopliteal lesions as seen in the renewed TransAtlantic Inter-
Society Consensus (TASC) II recommendations clearly reflects the continuous evolutions in 
femoropopliteal stent design.12 In most cases, the progression of atherosclerotic flow-limiting 
lesions in the blood vessels of the legs frequently involves the infra-popliteal arteries, resulting 
in a worsening diagnosis of CLI.  
In the past, balloon angioplasty alone was the treatment of choice for the femoropopliteal artery 
segment. The TASC working group suggested that primary success rates were above 90% 
with a very low rate of complications (< 4%). However, within one year, patency failure rates 
above 70% were observed after balloon angioplasty in lesions longer than 10 cm.13 The 
application of self-expanding nitinol stent technology seemed to improve the safety and 
durability of stenting in the SFA.9,14,15,16  The theoretical basis for improved performance with 
the use of nitinol stents is due to the unique properties of nitinol such as flexibility, persistent 
radial force when oversized to a vessel, and ability for crush recovery in these high flexion and 
torsion force areas in the femoropopliteal arteries. In addition, self-expanding nitinol stents are 

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not as prone to external compression as are balloon-expandable stents.  Moreover, due to its 
smaller arterial diameter and complex nature, the femoropopliteal segment does not respond 
well to rigid stents. As such, the most flexible nitinol stent is needed to mitigate stent fracture 
that often occurs in the femoropopliteal arteries. 
Although above the knee use of nitinol Bare Metal Stents (BMS) is safe and feasible, it is 
evidently associated with significant neointimal hyperplasia and early restenosis,17,18 which 
may be due to the chronic external forces on the vessel/stent interface resulting in a chronic 
stimulus for restenosis.19  Therefore, the interest of investigators turned towards the 
pharmaceuticals such as paclitaxel and everolimus to suppress neointimal growth and 
restenosis after stent deployment. DES technology was developed to prevent early thrombosis 
and late luminal loss to potentially improve long-term patency rates for SFA.20  
In a 2014 contemporary systematic review and meta-analysis, authors examined early 
outcomes of PTA, DESs, BMSs, or atherectomy for infrapopliteal atherosclerotic disease.8  A 
total of 42 studies with 52 treatment arms representing 3,660 unique patients were included. 
Technical success rates were higher with bare metal stents (BMS; 98.6%) than with 
atherectomy (92.2%; P <.05) or Percutaneous Transluminal Angioplasty (PTA; 91.2%; P =.01), 
and higher with Drug-Eluting Stents (DES) than with PTA (P <.001). DES use had higher 
primary patency rates than atherectomy (P <.05), BMS use (P <.001), and PTA (P <.01). The 
30-day rate of target lesion revascularization (TLR) was significantly higher with PTA (8.1%) 
than with BMS (2.2%; P <.05) and DES (1.1%; P <.05). Thirty-day rates of major unplanned 
amputation (range, 1.5%-4.4%) and mortality (range, 0.9%-3.3%) were comparable among 
treatment groups. Significant heterogeneity among studies was noted for most PTA outcomes. 
The authors concluded that early failure of percutaneous therapies in patients with 
infrapopliteal atherosclerotic lesions was both device- and technique-dependent. Specialty 
devices designed to reduce technical failure rates may therefore be of benefit in this selected 
group of patients. 
Studies have shown that paclitaxel inhibits neointimal hyperplasia by disrupting normal 
microtubule function, thereby inhibiting smooth muscle cell migration, proliferation, and 
extracellular matrix secretion thus supporting short-term local delivery of paclitaxel for inhibiting 
restenosis in the SFA.21,22 
6.2 ELUVIA Stent System 
Boston Scientific Corporation (BSC) developed the ELUVIA stent, a paclitaxel-eluting, self-
expanding nitinol stent, for use in the femoropopliteal arteries.  
The ELUVIA Stent System leverages many successful BSC programs with global 
commercial approval for safe and efficacious use in subjects, and received CE-mark in 
February 2016. The ELUVIA stent and Stent Delivery System (SDS) is leveraged from the 
Innova™ Stent System, the drug coating polymers are leveraged from the PROMUS 
Element/PROMUS Element Plus Stent System, while the active pharmaceutical compound 
(paclitaxel) is leveraged from the TAXUS Element/ION Stent System. 

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6.3 MAJESTIC First Human Use Study 
The MAJESTIC clinical study was the first BSC clinical study to evaluate a paclitaxel-eluting 
stent on a nitinol platform for use in SFA and/or PPA atherosclerotic lesions from 30 mm to 
110 mm in length.   
MAJESTIC is a prospective, single arm, multicenter clinical study. A total of 57 patients were 
enrolled at 14 centers in Europe, Australia, and New Zealand. Eligibility for the study 
included chronic lower limb ischemia defined as Rutherford categories 2, 3, or 4, and de 
novo or restenotic lesions (≥ 70% stenosis) located in the native superficial femoral artery or 
proximal popliteal artery with reference vessel diameter 4-6 mm and total lesion length ≥ 30 
mm and ≤ 110 mm. The primary effectiveness endpoint was core laboratory-adjudicated 9-
month primary patency (i.e., duplex ultrasound PSVR ≤ 2.5 and absence of TLR or bypass). 
Safety assessments included major adverse events defined as Clinical Events Committee 
(CEC)-adjudicated all-cause death through 1 month, target limb major amputation through 9 
months, and TLR through 9 months.  
Enrollment was completed in March 2014. Mean age (±SD) of the patients was 69.3±9.3 
years and 83% were male; 35% had diabetes and 88% had a history of smoking. Rutherford 
category was 2 for 35%, 3 for 61%, and 4 for 4% of enrolled patients. Mean baseline lesion 
length was 70.8±28.1 mm and percent stenosis of the target lesions was 86.3%±16.2%. As 
presented at the 2015 Charing Cross Congress, the primary effectiveness endpoint of 
primary patency at nine months was 94.4%, with a one-sided lower 95% confidence bound of 
86.3% that exceeded the performance goal of 75%. The nine-month composite MAE rate 
was 3.6%. The 3.6% MAE rate consisted of two TLR events through 9 months, with no all-
cause death through 1 month, and no target limb major amputation through 9 months.   
 
At 12 and 24 months, primary patency was 96.3% and 76.9% respectively.  The composite 
rate of major adverse events (MAEs) through 12 months, 24 months and 36 months was 
3.8%, 7.5% and 15.1% respectively. All MAEs that occurred in the study were TLRs.  No 
stent fractures were identified. 
 
In conclusion, the MAJESTIC results showed that patients whose femoropopliteal arteries 
were treated with the Eluvia stent sustained a high patency and low MAE rate through 36 
months. 
The MAJESTIC clinical investigation is complete.  
6.4 IMPERIAL IDE Study 
IMPERIAL is a global, prospective, multi-center trial evaluating the safety and effectiveness 
of the ELUVIA stent versus the Zilver PTX stent in the treatment of lesions 30-140 mm long 
located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford 
categories 2-4. The trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs 
Zilver PTX), controlled, single-blind, non-inferiority trial (RCT), a concurrent, non-blinded, 

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non-randomized, single-arm, pharmacokinetic (PK) substudy and a concurrent, non-blinded, 
non-randomized, single-arm Long Lesion substudy.  
Up to 75 study centers worldwide enrolled subjects in the RCT. Regions participating include 
the United States, Canada, European Union, Japan and New Zealand. Approximately 10 
study centers in the US enrolled subjects in the PK substudy. Any study center participating 
in the RCT could also enroll subjects in the Long Lesion substudy. 
Enrollment was completed in February 2017.  A total of 524 subjects were enrolled in the 
IMPERIAL trial: 465 subjects received treatment with either the investigational device 
(ELUVIA, N=310 subjects) or a control device (Zilver PTX, N=155 subjects) in the RCT, 13 
subjects received treatment with the investigational device (ELUVIA) in the PK substudy and 
50 subjects received treatment with the investigational device (ELUVIA) in the Long Lesion 
substudy. 
Primary patency at 12 months was 86.8% in the treatment group (Eluvia) and 81.5% in the 
control group (Zilver PTX), with the one-sided lower 95% confidence bound of - 0.66% on the 
difference between the treatment groups being greater than -10% (non-inferiority p-value 
<.0001). Therefore, the primary effectiveness endpoint was met and Eluvia was concluded to 
be non-inferior to Zilver PTX.  
The MAE-free rate at 12 months was 94.9% in the treatment group (Eluvia) and 91.0% in the 
control group (Zilver PTX), with the one-sided lower 95% confidence bound of -0.46% on the 
difference between the treatment groups being greater than -10% (non-inferiority p-value 
<.0001). Therefore, the primary safety endpoint was met and Eluvia is concluded to be non-
inferior to Zilver PTX.  
Also performed was a prespecified post-hoc superiority analysis of primary patency in the 
full-analysis cohort.  
 
 
Eluvia 
N=309 Subjects 
Zilver PTX 
N=156 Subjects 
Relative Risk 
[95% CI] 
Difference 
[95% CI] 
P-value 
Patency at 12 Months 
 
 
 
 
 
Primary Patency1 
86.8% (243/280) 
77.5% (110/142) 
1.12 [1.01, 1.24] 
9.3% [1.4%, 17.3%] 
0.0144 
 
1 Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis 
on DUS and without clinically-driven TLR or, bypass of the target lesion before or on the DUS FU visit 
 
In this head-to-head randomized trial, the primary non-inferiority endpoints for efficacy and 
safety at 12 months were met, and post-hoc analysis of the 12-month patency rate showed 
superiority for Eluvia over Zilver PTX. 
The study is currently in long term follow up and is expected to be complete in 2022. 
6.5 Summary 
There is a large set of clinical data available for devices from which components have been 
leveraged for the ELUVIA Stent System.  Successful results have been seen to date 
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artery stenosis.  The first results of the ELUVIA Stent System (MAJESTIC study) 
demonstrate a favorable effectiveness and safety profile. 
Overall, the ELUVIA stent based on the Innova stent platform with additional paclitaxel 
coating is expected to reduce restenosis and improve long-term vascular patency and quality 
of life (QOL) compared to balloon angioplasty, balloon expandable stents, and nitinol BMS. 
7. OBJECTIVES 
The objective of the EMINENT Randomized Controlled Trial (RCT) is to confirm the superior 
effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating 
Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 210 
mm in length when compared against bare metal stents, and collect additional data including 
health economics data. 
8. ENDPOINTS 
The primary and secondary endpoints and additional endpoints will be evaluated on an 
intent-to-treat analysis and a per-treatment analysis. If a subject is randomized/enrolled but 
an ELUVIA stent or Self Expanding Bare Nitinol stent is not implanted, the subject will be 
followed through the 1 month follow-up visit only.  Data to assess 1 month MAE rate will be 
collected for these subjects; other testing is not required. 
8.1 Primary Effectiveness Endpoint  
The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. 
This effectiveness endpoint is designed to demonstrate that the 12-month primary patency 
for the ELUVIA treatment group is superior to the Self-Expanding Bare Nitinol Stents 
treatment group.  
Primary vessel patency is defined as a binary endpoint and will be determined to be a 
success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at 
the 12-month follow-up visit in the absence of clinically-driven TLR or bypass of the target 
lesion.  All DUS readings will be assessed by an independent core laboratory.  
Notes: 
• 
Vessel patency is defined as freedom from more than 50% stenosis based on DUS 
PSVR comparing data within the treated segment to the proximal normal arterial 
segment. 
• 
A PSVR >2.4 suggests >50% stenosis. 
• 
The stented segment will be assessed for patency as a single segment regardless of the 
number of tandem lesions within the stented segment and regardless of the number of 
stents used to treat the tandem lesions. 
• 
All DUS will be assessed by an independent core laboratory. 

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• 
Clinically-driven: A re-intervention within 5 mm proximal or distal to the original treatment 
segment for > 50% angiographic diameter stenosis in the presence of recurrent 
symptoms (≥ 1 change in Rutherford class) or associated with decreased ABI/TBI of ≥ 
20% or ≥ 0.15 in the treated segment. Tibial Brachial Index (TBI) allowed in cases of 
incompressible vessels.   
8.2 Secondary Endpoint 
For the secondary endpoint Health-Economics data will be collected:  
- 
Walking Improvement at 12 months assessed by change in Six Minute Hall Walk 
(6MHW) / treadmill test from baseline, or preceding any Target Vessel 
Revascularization 
- 
Walking Improvement at 12 months assessed by change in Walking Impairment 
Questionnaire (WIQ) from baseline  
- 
Quality of Life Improvement at 12 months assessed by change in EQ-5D-5L™ from 
baseline, or preceding any Target Vessel Revascularization 
- 
Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol 
stents  
- 
Rate of Primary and Secondary Sustained Clinical Improvement at 12 months as 
assessed by changes in Rutherford Classification from baseline 
- 
Rate of Hemodynamic Improvement at 12 months as assessed by changes in Ankle-
Brachial Index (ABI) from baseline 
8.3 Additional Endpoints 
Additional endpoints that will be evaluated, but are not necessarily powered to make 
statistically based conclusions are as follows: 
- 
Technical success defined as delivery and deployment of the assigned study stent to the 
target lesion to achieve residual angiographic stenosis no greater than 30% assessed 
visually 
- 
Procedural success defined as technical success with no MAEs noted within 24 hours of 
the index procedure 
- 
MAE rate (and individual components) at each time point, defined as all causes of 
death, target limb major amputation and/or TLR 
- 
Survival rate at 4 years and 5 years post-procedure  
- 
Primary Patency and Assisted Primary Patency at 6 months, 12 months, 24 months and 
36 months using different DUS PSVRs 
- 
Clinically-driven TLR and clinically-driven Target Vessel Revascularization (TVR) Rate 
at each time point 
- 
Adverse Event Rates (unanticipated, major, serious, device/procedure-related) at each 
time point 
- 
Number of Stent Fracture reported at 12 months and 24 months utilizing VIVA 
definitions 

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- 
Distribution of Rutherford Class during follow-up as compared to baseline at 1 month, 6 
months, 12 months, 24 months and 36 months 
- 
Walking Improvement at 1 month, 6 months, 24 months and 36 months assessed by 
change in Walking Impairment Questionnaire (WIQ) from baseline 
- 
Quality of Life Improvement at 1 month, 6 months, 24 months and 36 months assessed 
by change in EQ-5D-5L™ from baseline 
- 
Rate of Primary and Secondary Sustained Clinical Improvement as assessed by 
changes in Rutherford Classification from baseline at 1 month, 6 months, 24 months and 
36 months 
- 
Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index 
(ABI) from baseline at 1 month, 6 months, 24 months and 36 months 
9. STUDY DESIGN 
The EMINENT Study is a prospective, multi-center, 2:1 randomized (ELUVIA vs Self-
Expanding Bare Nitinol Stents), controlled, single-blind, clinical trial to confirm the 
effectiveness superiority and collect additional data including health economics data to 
support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) versus 
Self-Expanding Bare Nitinol Stents in the treatment of lesions 30-210 mm long located in the 
femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.  
Both the test device and control devices are Nitinol stents and are CE-marked products 
commercially available in the regions included in this study. Both types of devices have 
already demonstrated their safety and effectiveness for treatment of SFA and/or PPA 
lesions. 
The EMINENT Study is a single blind trial. Subjects will be blinded to treatment assigned and 
treatment received. All subjects must remain blinded until completion of all 12-month follow-
up visits (primary endpoint). Packaging of the test and control devices are different, therefore 
the Investigator performing the procedure will not be blinded to the assigned treatment arm 
or resulting treatment. Study center personnel will be trained not to disclose the treatment 
assignment to the subject to minimize the potential unblinding of the subject. Site personnel 
conducting clinical follow-up assessments will be blinded to a subject’s treatment assignment 
whenever possible, except when clinical follow-up visits are performed by the implanting 
Investigator. Duplex Ultrasound (DUS) Core Laboratory personnel, Angiography Core 
Laboratory personnel and the Clinical Events Committee (CEC) will be blinded to a subject’s 
treatment assignment during the trial.  Those involved in data analysis for the Sponsor will 
remain blinded until the primary endpoint analysis.  
Instructions regarding the unblinding of a subject for a medical emergency can be found in 
the Unblinding Guidelines. 

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9.1 Scale and Duration 
750 subjects will be enrolled in the EMINENT study to receive treatment with either the test 
device (ELUVIA, N=500 subjects) or a control device (Self-Expanding Bare Nitinol Stents, 
N=250 subjects). 
The study will be conducted in up to 75 study centers in up to 15 European countries. 
All subjects will be screened according to the protocol inclusion and exclusion criteria. 
Subjects meeting all inclusion criteria and no exclusion criteria will be randomized in a 2:1 
allocation to either ELUVIA or Self-Expanding Bare Nitinol Stent. Randomization will be 
stratified to ensure equal distribution of ELUVIA and Self-Expanding Bare Nitinol Stents in 
lesions ≤110mm long and in lesions >110mm long. 
Clinical follow-up will be required at the following time points: pre-discharge, 1 month (if 
standard of care), 6 months, 12 months, 24 months and 36 months post index procedure.  
At 48 months and 60 months a telephone follow-up visit is required.  If telephone visit is not 
completed, a medical chart review and/or publicly available records consultation will occur to 
verify survival status. 
The enrollment period is expected to last approximately 18 months.  No investigative site will 
be allowed to enroll more than 20 percent (150 subjects) of the total study population. The 
study will be considered complete (with regard to the primary endpoint) after all 
randomized/enrolled subjects have completed the 12 month follow-up visit, were 
discontinued prior to the 12 month follow-up visit, have died, or the last 12 month follow-up 
visit window is closed. 
The study will be considered complete (with regard to all follow-up) after all randomized 
subjects have completed the 60 month (5 year) follow-up visit, were discontinued prior to the 
60 month (5 year) follow-up visit, have died, or the last 60 month (5 year) follow-up visit 
window is closed. 
It is estimated that it will take approximately 8 years to complete this study.   

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9.2 Study Flow Chart 
 
 
 
 
 
Required Regulatory Documents Obtained 
Site Initiated and Trained 
Informed 
Consent 
Signed 
Inclusion/Exclusion met 
Indicate on screening log as Screen 
Failure 
Guidewire crossed Target Lesion 
Obtain Randomization Code (2:1) 
500 treated with ELUVIA stent 
250 treated with Control stent 
Stent successfully implanted 
Post-procedure / pre-discharge assessments 
In office follow-up evaluations at: 
1 Month, 6 Month, 12 Month, 24 Month and 36 Month 
Telephone follow-up visit and/or medical chart review and/or publicly 
available records at: 
48 Month and 60 Month 
Pre-discharge assessments 
Follow-up Evaluation at 1 
Month in office 
No 
Yes 
Yes 
No 
No 
Yes 
End of Study 
No 

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10. STUDY POPULATION 
10.1 Subject Selection 
The intended population for this study are subjects who present with a lesion of 30-210 mm 
long located in the femoropopliteal arteries with symptoms classified as Rutherford 
categories 2-4. 
Because selection of subjects, treatment of subjects, and evaluation of study data are 
potential sources of bias, methods are incorporated in the study design including (but not 
limited to): 
• 
Subjects will be screened to confirm eligibility for enrollment with the pre-defined 
inclusion/exclusion criteria prior to enrollment. 
• 
Demographics and medical history will be collected at baseline to allow assessment 
of characteristics that may influence study endpoints. 
• 
Data collection requirements and study procedures will be standardized across all 
study sites.  
• 
All investigational site personnel will be trained on and required to follow the Clinical 
Investigation Plan. 
• 
Regular monitoring visits will be conducted to verify source data and adherence to the 
Clinical Investigation Plan and applicable regulations. 
• 
An independent Clinical Events Committee (CEC) will be assigned to review and 
adjudicate the following endpoints and major adverse events reported by the trial 
Investigators: All Deaths, TLR, TVR, Target limb amputations, Stent Thrombosis. 
• 
A Core Laboratory will be used to analyze angiography, DUS and X-ray images for 
the related endpoint evaluations.  
To summarize, potential sources of bias that may be encountered in this clinical investigation 
have been considered and minimized by careful study design. 
10.2 Inclusion Criteria 
For inclusion in the study subjects must fulfil ALL of the following criteria: 
1. Subjects age 18 and older 
2. Subject is willing and able to provide consent before any study-specific test or 
procedure is performed, signs the consent form, and agrees to attend all required 
follow-up visits 
3. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4 
4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA: 
a. Degree of stenosis 70% by visual angiographic assessment 
b. Vessel diameter ≥ 4 and 6 mm 

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c. Total lesion length (or series of lesions) ≥ 30 mm and 210 mm (Note:  Lesion 
segment(s) must be fully covered with one or two overlapping ELUVIA stent(s) 
or Self Expanding Bare Nitinol stent(s)) 
d. For occluded lesions (chronic occlusions) requiring use of re-entry device, 
lesion length ≤ 180 mm 
e. Target lesion located at least three centimeters above the inferior edge of the 
femur 
5. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at 
least one of three vessels patent (<50% stenosis) to the ankle or foot with no planned 
intervention 
10.3 Exclusion Criteria 
Subjects are excluded if ANY of the following criteria are met: 
1. Previously stented target lesion/vessel 
2. Target lesion/vessel previously treated with drug-coated balloon <12 months prior to 
randomization/enrollment 
3. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat 
atherosclerotic disease 
4. Use of atherectomy, laser or other debulking devices such as Rotarex in the target limb 
SFA/PPA during the index procedure 
5. History of major amputation in the target limb 
6. Documented life expectancy less than 24 months due to other medical co-morbid 
condition(s) that could limit the subject’s ability to participate in the clinical study, limit the 
subject’s compliance with the follow-up requirements, or impact the scientific integrity of 
the clinical study 
7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the 
investigator, cannot be adequately pre-medicated 
8. Known hypersensitivity/allergy to the test stent system or protocol related therapies (e.g., 
nitinol, paclitaxel, or structurally related compounds, polymer or individual components, 
and antiplatelet, anticoagulant, thrombolytic medications) 
9. Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis 
10. Concomitant renal failure with a serum creatinine >2.0 mg/dL 
11. Receiving dialysis or immunosuppressant therapy 
12. History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 
months prior to randomization/enrollment 
13. Unstable angina pectoris at the time of randomization/enrollment 
14. Pregnant, breast feeding, or plan to become pregnant in the next 5 years 

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15. Current participation in an investigational drug or device clinical study that has not 
completed the primary endpoint at the time of randomization/enrollment or that clinically 
interferes with the current study endpoints (Note: studies requiring extended follow-up for 
products that were investigational, but have become commercially available since then 
are not considered investigational studies) 
16. Septicemia at the time of randomization/enrollment 
17. Presence of other hemodynamically significant outflow lesions in the target limb requiring 
intervention at the time of the index procedure. 
18. Presence of aneurysm in the target vessel 
19. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/ 
enrollment 
20. Perforated vessel as evidenced by extravasation of contrast media prior to 
randomization/enrollment 
21. Heavily calcified lesions 
22. As applicable by French law, subject who is a protected individual such as an 
incompetent adult or incarcerated person 
11. DEVICE DESCRIPTION 
11.1 ELUVIA Drug-Eluting Stent System (Test Device) 
The ELUVIA stent system is manufactured by Boston Scientific Corporation and comprised 
of the implantable endoprosthesis and the stent delivery system (SDS). The stent is a laser 
cut self-expanding stent composed of a nickel titantium alloy (nitinol). On both the proximal 
and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the 
stent to aid in placement. The stent is constrained within a 6 F delivery system. The delivery 
system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle 
shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The 
delivery system is compatible with 0.035 in (0.89 mm) guidewires. 
The ELUVIA stent system carries a drug/polymer coating formulation consisting of paclitaxel 
(the active ingredient), and PVDF-HFP Polymer Carrier (the inactive ingredient).  
CE-mark for the ELUVIA stent system was obtained in February 2016. 
11.1.1 
Paclitaxel Drug 
The active pharmaceutical ingredient is semi-synthetic paclitaxel. Semi-synthetic paclitaxel is 
synthesized from precursor compounds isolated from a spectrum of Taxus species and 
hybrids.  
11.1.2 
Primer Polymer and Drug Matrix Copolymer Carrier 
The ELUVIA stent contains a primer polymer layer PBMA - poly (n-butylmethacrylate) 
between the bare metal stent and drug matrix layer. The drug matrix layer is comprised of a 

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semi-crystalline random copolymer, PVDF – HFP - poly(vinylidene fluoride-co-
hexafluoropropylene), blended with paclitaxel.  
11.1.3 
ELUVIA Stent System Product Description 
Characteristic 
ELUVIA Stent System 
Stent material 
Nitinol  
Drug product 
Paclitaxel  
Nominal Paclitaxel Content 
Range (based on stent length 
and diameter) 
0.167µg/mm2  
Polymer(s) 
Primer Layer: poly(n-butyl methacrylate) (PBMA) 
Active Layer: poly (vinylidene fluoride-co-
hexafluoropropylene) (PVDF-HFP) 
Delivery working length 
75 cm, 130 cm 
Stent delivery system (SDS) 
6 F tri-axial system  
Catheter shaft outer diameter 
0.080 +/- 0.002” 
Stent strut thickness 
0.0039“strut width, 0.0086“ strut wall thickness 
11.1.4 
Test Device Sizes 
The ELUVIA stent is available in a variety of diameters and lengths.  The delivery system is 
offered in two working lengths (75 cm and 130 cm).  The ELUVIA stent matrix included in the 
EMINENT Study is summarized in the below table. 
SDS size 
ELUVIA Stent sizes (mm) 
75 cm 
6.0 x 40, 6.0 x 60, 6.0 x 80, 6.0 x 100, 6.0 x 120, 6.0 x 150 
130 cm 
6.0 x 40, 6.0 x 60, 6.0 x 80, 6.0 x 100, 6.0 x 120, 6.0 x 150 
75 cm 
7.0 x 40, 7.0 x 60, 7.0 x 80, 7.0 x 100, 7.0 x 120, 7.0 x 150 
130 cm 
7.0 x 40, 7.0 x 60, 7.0 x 80, 7.0 x 100, 7.0 x 120, 7.0 x 150 
11.2 Summary of Findings from Non-clinical Studies and Clinical Studies 
A summary of all pre-clinical test results and the first clinical study performed with the 
ELUVIA stent system can be found in the Investigator’s Brochure (IB). 
11.3 Device Accountability 
Since both the test device and the control device are commercially available CE-marked 
devices, all devices used within the study will be used off-the-shelf. The Investigator must 
ensure that the device is used only in accordance with the Clinical Investigational Plan, 
IFU/DFU and IB.  

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The Principal Investigator or an authorized designee shall keep records documenting the use 
of test devices and control devices, which shall include the following for each identification of 
each device (lot number or unique code): 
• 
Stent diameter and stent length 
• 
Date of use 
• 
Subject identification 
Written procedures may be required by national regulations. 
 
12. METHODS 
The data collection schedule for the EMINENT study is summarized in section 4. 
12.1 Screening 
A Screening Log will be maintained by each investigational site to document selected 
information about subjects who have been screened for the study. For subjects who fail to 
meet the EMINENT trial eligibility criteria, including the reason for screen failure. 
12.2 Informed Consent 
Prior to any study-related procedure a signed informed consent form has to be obtained from 
every subject. 
The investigator or responsible medical staff (as allowed per national law) will explain the 
nature, purpose and risks of the study and provide the subject with a copy of the patient 
information sheet.  
The person obtaining consent will avoid any coercion or undue improper influence on or 
inducement of the subject to participate. They will not waive or appear to waive the subject's 
legal rights. They will use native non- technical language that is understandable to the 
subject. The refusal of a subject to participate in the study or a subject's decision to withdraw 
from the study must never interfere with the patient-doctor relationship.  
The subject will be given sufficient time to consider the implications of study participation 
before making a decision.  
Study personnel should explain to the subject that even if the subject agrees to participate in 
the trial and signs the ICF, catheterization may demonstrate that the subject is not a suitable 
candidate for the trial. 
Should there be any amendments to the Clinical Investigational Plan, which would directly 
affect the subjects' participation in the study, e.g. a change in any procedure, the informed 
consent form must be amended to incorporate this modification and all subjects must agree 
to sign this amended informed consent form to confirm that they re-consent to continue their 
participation in the study.  

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The original signed copy of the patient’s informed consent form must be maintained in the 
study files. The subject should receive a copy of the signed informed consent form. The 
consent process and subject’s study participation should be indicated in the patient’s medical 
records. 
12.3 Point of Enrolment  
Once the subject has signed the Informed Consent Form, and has met all clinical inclusion 
and no clinical exclusion criteria, the subject will be considered eligible to be enrolled in the 
trial. If the subject is found to meet exclusion criteria during the angiographic eligibility 
assessment, the subject will be considered a screen failure and should not be 
enrolled/randomized, nor should the subject be followed post-procedure per protocol.  
If the subject is found to meet the eligibility criteria during the angiographic phase of the 
procedure, the subject will be considered eligible to be randomized/enrolled. After the 
Investigator successfully crosses the target lesion with the guidewire, the subject will be 
randomized using the eCapture EDC database to either the test device group or the control 
device group. Subjects will be considered enrolled in the study after they have been 
successfully randomized (i.e. when a treatment assignment is received by the study site). 
12.4 Study Assessments and Endpoint Measurements 
12.4.1 
Pre-Procedure Assessments – Up to 30 Days 
The following pre-procedure data must be collected within 30 days prior to the index 
procedure (unless otherwise specified) for all subjects: 
• 
Demographics and medical history 
• 
Physical assessment including: 
o Rutherford Category Assessment 
o Ankle-Brachial Indices (ABI) measurements 
• 
Laboratory tests 
o Serum creatinine 
o Platelet Counts 
• 
Confirmation that all clinical inclusion/exclusion eligibility criteria have been met 
• 
6-Minute Hall Walk or treadmill test (whatever is standard of care) 
• 
Administer Questionnaire Assessments 
o Walking Impairment Questionnaire (WIQ) 
o EQ-5D-5L 

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12.4.2 
Pre-Procedure Assessments – Up to 7 Days 
The following pre-procedure data must be collected within 7 days prior to the index 
procedure (unless otherwise specified) for all subjects: 
• 
Pregnancy test for females of childbearing potential with analysis per local practice 
(serum and/or urine) 
• 
Antiplatelet medication usage (if applicable) 
12.4.3 
Procedure 
Investigators will manage the cardiovascular risk factors and comorbidities for all subjects 
according to standard care.  Investigators should ensure close monitoring of the amount of 
contrast for subjects with elevated serum creatinine levels and consider preventive measures 
(medication and hydration) to reduce the risk of contrast-induced nephropathy (CIN).  
Diagnostic angiography of the lower extremities must be performed using standard 
techniques to confirm angiographic eligibility of the target lesion. Visual angiographic 
assessment may be used to determine if criteria are met. 
Angiographic images must be sent to the Angiographic Core Laboratory for evaluation. 
A 
Treatment of iliac lesions  
Using the same access site, Iliac lesion(s) in both limbs may be treated during the index 
procedure. 
Iliac lesions in the target limb should be treated prior to the target SFA/PPA lesion with 
commercially available devices (non-drug-eluting in the target limb) and treatment must be 
considered successful (i.e. residual stenosis <30% and no clinical events [embolization, 
perforation]) 
If the above criteria are not met, the subject may not be randomized, but may be rescreened 
for eligibility after 30 days. 
Besides the target lesion, only iliac lesions can be treated during the index procedure. If 
nonTarget, nonIliac lesions in either limb are to be treated they must be treated in a separate 
procedure either before or after the index procedure.   
B 
Randomization  
The start of the index procedure is defined as the time of guide catheter insertion into the 
sheath for the target limb SFA/PPA interventional procedure. 
During catheterization, the following procedures and assessments must be completed for the 
Target Lesion.  
• 
Perform angiography according to the Core Lab guidelines. 
• 
Confirm angiographic eligibility criteria of the target lesion or tandem lesion(s). 
• 
Cross target lesion using guidewire or re-entry device. 

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• 
After target lesion is crossed by the guidewire, access the randomization custom 
function in eCapture EDC to randomize subject. 
• 
If randomized to ELUVIA, retrieve an appropriately sized test stent from commercial 
inventory to adequately cover the target lesion with one or two stents, if necessary. 
• 
If randomized to the control group, retrieve an appropriately sized control stent from 
commercial inventory of the per-protocol allowed self-expanding stents - Bare Nitinol 
(Supera, Lifestent, Everflex, S.M.A.R.T. Flex, S.M.A.R.T. Control, Pulsar, 
COMPLETE SE, Misago or Innova) to adequately cover the target lesion with one or 
two stents, if necessary. 
Note: If difficulties are encountered when accessing the randomization custom function in the 
eCapture EDC system, the subject should not be enrolled in the trial.  
Note: Bypassing the randomization process and manually assigning treatment type is not 
allowed. 
C 
Target Lesion Stent Placement 
The target lesion is a lesion selected by the Investigator for treatment with either the test or 
control device. The target lesion must meet all angiographic selection criteria. The target 
lesion may include two or more tandem lesions, provided that the entire segment of tandem 
lesions is 210 mm and can be covered with one single stent or two overlapping stents 
(ELUVIA or Control stent) according to each device’s IFU/DFU.  For occluded lesions 
(chronic occlusions) requiring the use of a re-entry device, the target lesion length must be ≤ 
180 mm allowing the target lesion and re-entry area to be covered with one or two stent(s) 
(ELUVIA or Control stent) (Refer to Inclusion criterion 4c and 4d). 
Procedural information must be reported (specific data fields are noted in the electronic 
database). Refer to the IFU/DFU for detailed instructions about delivery system preparation 
and placement of the ELUVIA stent or the Control stent. 
Procedural recommendations: 
Use of a radiopaque ruler or other standard is recommended to help with calibration. 
Optimal target lesion/vessel preparation is recommended. 
Pre-dilation of the target lesion with optimally sized balloon(s) (nominal size of artery) is 
recommended before stent placement, but is at the discretion of the implanting Investigator. 
After stent placement, the Investigator should ensure that the stent is in full contact with the 
arterial wall. In order to achieve full contact, post-dilatation may be performed at the 
discretion of the Investigator.  Drug coated balloons cannot be used for pre- or post-dilating 
the target vessel.  Peri-stent dissections should be treated conservatively, with low pressure 
prolonged balloon inflation, or with additional study stent implantation per standard practice. 
Haziness, lucency, or filling defects within or adjacent to the stent, and angiographic 
complications such as distal thromboemboli or no reflow, should also be treated per standard 

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practice. All angiographic complications that occur should be documented by angiography 
and submitted to the Angiographic Core Laboratory for analysis. 
ELUVIA 
Prior to use of the test device, the treating physician must carefully read and be familiar 
with the entire DFU. The ELUVIA DFU must be followed for implanting the test stent. 
Anticoagulant therapy should be consistent with guideline practices and the hospital 
standard of practice during the procedure. 
Control Self-Expandable Bare Nitinol Stent 
Prior to use of the control device, the treating physician must carefully read and be 
familiar with the entire IFU packaged with the commercial stent. Anticoagulant therapy 
should be consistent with guideline practices and the hospital standard of practice during 
the procedure. 
NOTE:  If an additional stent is required due to complications (e.g., dissection, misplacement 
or under-sizing of the target lesion), the additional stent placed should be a stent of the same 
type used to treat the target lesion. 
D 
Post-procedure Angiogram 
Perform the post-procedure angiography according to the Angiographic Core Laboratory 
procedure guidelines. The final angiogram must be performed and recorded, including distal 
run-off. Angiographic images must be sent to the angiographic core laboratory for evaluation. 
E 
End of the Index Procedure 
The end of the index procedure is defined as the time the guide (catheter or sheath) is 
removed (post final angiography). The introducer(s) sheaths should be removed as per 
standard local practice. The following procedures must be completed:  
• 
Document procedural, target lesion, pre-dilatation, post-dilatation (if applicable), and 
study stent information on the appropriate eCRFs 
• 
Record antithrombotic medications 
• 
Complete AE assessment (SADEs, UADEs and ADEs/Device Deficiencies) 
• 
Finalize angiographic procedure film and related required documentation to submit to 
the Core Laboratory per instructions set in the Core Lab Guidelines. 
12.5 Post-procedure/Pre-hospital Discharge 
The subject may be discharged from the hospital when clinically stable at the Investigator’s 
discretion. The following assessments must be completed prior to hospital discharge.  
• 
Medication assessment 
• 
AE assessment (SADEs, UADEs and ADEs/Device Deficiencies) 
• 
Health care costs associated with index procedure 
It is important that trial site personnel review the trial requirements with the subject to 
maximize compliance with the follow-up schedule and required medication regimen. It is also 

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important that trial site personnel instruct subjects to return for follow-up assessments 
according to the trial event schedule. Study staff should establish a date for the follow-up visit 
with the subject and if possible, schedule the visit at the time of hospital discharge. 
Note: Subjects will be blinded to treatment assigned and treatment received. All subjects 
must remain blinded until completion of all 12-month follow-up visits (primary endpoint). 
12.6 
Angiography 
All subjects will undergo angiographic assessment during the index procedure per standard 
of care. Subjects requiring reintervention of the target vessel during the 36 month follow-up 
period will undergo angiographic assessment at the time of reintervention as standard of 
care. 
Angiographic data and images collected during the index procedure and during any 
reinterventions of the target vessel during the 36 month follow-up period must be forwarded 
to the Angiographic Core Laboratory for analysis. Angiograms performed at outside 
institutions should also be sent to the Core Laboratory. Angiograms will be centrally 
assessed by the Angiographic Core Laboratory, for qualitative and quantitative analysis. 
12.7 
Visit Windows 
Table 12.7-1: Protocol Visit Windows 
Visit 
Visit windows 
Informed consent 
Prior to any trial procedures 
Pre-procedure 
Testing ≤ 30 days prior to procedure unless otherwise specified 
Index Procedure 
Time point = zero 
1 month post procedure 
30 days (-7/+14 days) from procedure date 
6 months post procedure 
182 days (+/- 30 days) from procedure date 
12 months post procedure 
365 days (+/- 30 days) from procedure date 
24 months post procedure 
730 days (+/- 30 days) from procedure date 
36 months post procedure 
1095 days (+/- 30 days) from procedure date 
Table 12.7-2: Telephone/medical chart/public record Follow-up Windows 
Telephone call/Medical chart/public record 
Target Date 
48-Months 
1460 days (+/- 90 days) from procedure date 
60-Months 
1825 days (- 90/+30 days) from procedure date 
12.8 
Follow-up Visits 
EMINENT is a single blind trial. Site personnel conducting clinical follow-up will be blinded to 
a subject’s treatment assignment whenever possible.  
All randomized/enrolled subjects who receive a test or control stent, will be evaluated prior to 
discharge from the index procedure and at 1 month (if local standard of care), 6 months, 12 
months, 24 months, 36 months, 48 months, and 60 months after the index procedure.  

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Subjects who underwent advancement of the test or control stent system into the body but a 
stent was not implanted will be considered enrolled and will be followed for safety through 
the 1-month follow-up visit only. Data for assessment of MAE will be collected for these 
subjects; other testing is not required.  
For each follow-up visit, the results of the subjects’ clinical status and functional testing 
(Rutherford Categorization and ABI) should be completed prior to initiating the DUS imaging, 
if required.  Subjects requiring re-intervention should be treated according to the 
Investigator’s discretion and standard of care. These subjects should receive an approved, 
commercially available treatment (if appropriate).  
Note: Follow-up ultrasounds will not be required for any subject who underwent bypass 
surgery of the target lesion during the 60 month follow-up timeframe, or has a documented 
occluded stent. 
Note: In case a subject undergoes a re-intervention of the target vessel, it is recommended 
to perform a walking test (6MWT or treadmill test) and QoL questionnaire (EQ-5D-5L™) prior 
to the Target Vessel Revascularization. 
As documented in section 12.10, a minimum of 3 attempts (i.e., 2 phone calls followed by a 
certified letter, or other traceable letter) shall be made to contact the subject or subject’s next 
of kin to complete the follow-up visits.  
If a visit is not completed, contact attempts will be documented in the medical chart and a 
medical chart review and/or publicly available records review will occur to asses and report 
survival status.  
Requirements of each follow-up evaluation are described below. 
12.8.1 1-Month Follow-up Visit 
Subjects will be evaluated 1 month after the index procedure, if the 1 month visit is local 
standard of care. The following assessments must be performed during the 1 Month office 
visit.  For enrolled subjects who did not have a stent implanted, the AE assessment is 
required; no other tests are required. Site personnel conducting clinical follow-up will be 
blinded to a subject’s treatment assignment whenever possible. 
• 
Rutherford Categorization  
• 
ABI Measurements (may be collected immediately post-procedure through 1 Month 
Follow-up window [Day 0 – 44]) 
• 
Walking Impairment Questionnaire 
• 
EQ-5D-5L Questionnaire 
• 
Healthcare utilization information (including health care costs collected via standardized form) 
• 
Adverse Events Assessment (protocol defined Major Adverse Events, SADEs, UADEs 
and ADEs/Device Deficiencies) 
• 
Medication Assessment 

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12.8.2 6-Month Follow-up Visit 
All enrolled subjects must be evaluated 6 months after the index procedure. The following 
assessments must be performed during the 6 Month office visit.  Site personnel conducting 
clinical follow-up will be blinded to a subject’s treatment assignment whenever possible. 
• 
Rutherford Categorization 
• 
ABI Measurements 
• 
Walking Impairment Questionnaire 
• 
EQ-5D-5L Questionnaire 
• 
DUS of stented segment performed according to the Core Lab guidelines 
• 
Healthcare utilization information (including health care costs collected via standardized form) 
• 
Adverse Events Assessment (protocol defined Major Adverse Events, SADEs, UADEs 
and ADEs/Device Deficiencies) 
• 
Medication Assessment 
12.8.3 12-Month Follow-up Visit 
All enrolled subjects must be evaluated 12 months after the index procedure. The following 
assessments must be performed during the 12 Month office visit.  Site personnel conducting 
clinical follow-up will be blinded to a subject’s treatment assignment whenever possible. 
• 
Rutherford Categorization 
• 
ABI Measurements 
• 
6-Minute Hall Walk or treadmill test (whatever is standard of care) 
• 
Walking Impairment Questionnaire 
• 
EQ-5D-5L Questionnaire 
• 
DUS of stented segment performed according to the Core Lab guidelines 
• 
X-ray of the stented segment (only if performed per standard of care) 
• 
Healthcare utilization information (including health care costs collected via standardized form) 
• 
Adverse Events Assessment (protocol defined Major Adverse Events, SADEs, UADEs 
and ADEs/Device Deficiencies) 
• 
Medication Assessment 
 
Subjects and site personnel conducting clinical follow-up may be unblinded after completion 
of this visit, following confirmation from the Sponsor (after completion of all 12-month follow-
up visits). 
12.8.4 24-Month Follow-up Visit 
All enrolled subjects must be evaluated 24 months after the index procedure. The following 
assessments must be performed during the 24 Month office visit.   
• 
Rutherford Categorization 
• 
ABI Measurements 
• 
Walking Impairment Questionnaire 
• 
EQ-5D-5L Questionnaire 
• 
DUS of stented segment performed according to the Core Lab guidelines 

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• 
X-ray of the stented segment (only if performed per standard of care) 
• 
Healthcare utilization information (including health care costs collected via standardized form) 
• 
Adverse Events Assessment (protocol defined Major Adverse Events, SADEs, UADEs 
and ADEs/Device Deficiencies) 
• 
Medication Assessment 
12.8.5 36-Month Follow-up Visit 
All enrolled subjects must be evaluated 36 months after the index procedure. The following 
assessments must be performed during the 36 Month office visit. 
• 
Rutherford Categorization 
• 
ABI Measurements 
• 
Walking Impairment Questionnaire 
• 
EQ-5D-5L Questionnaire 
• 
DUS of stented segment performed according to the Core Lab guidelines 
• 
Healthcare utilization information (including health care costs collected via standardized form) 
• 
Adverse Events Assessment (protocol defined Major Adverse Events, SADEs, UADEs 
and ADEs/Device Deficiencies) 
• 
Medication Assessment 
12.8.6 48- and 60-Month Follow-up Visits 
At 48 months and 60 months post procedure, a telephone follow-up visit will occur with the 
subject.  If a telephone visit is not completed, a medical chart review and/or publicly available 
records review will be conducted to asses and report survival status.  
Data Collection Requirements for the 48- and 60-months telephone/medical chart review/ 
publicly available records follow-ups: 
• 
Adverse Events Assessment (protocol defined Major Adverse Events, SADEs, UADEs 
and ADEs/Device Deficiencies) 
• 
Survival status 
 
As documented in section 12.10, a minimum of 3 attempts (i.e., 2 phone calls followed by a 
certified letter, or other traceable letter, if necessary) shall be made to contact the subject or 
subject’s next of kin to complete the 48- and 60-Month telephone visits.  Contact attempts 
will be documented in the medical chart. 
12.9 Trial Completion 
The trial will be considered complete (with regard to the primary endpoints) after all subjects 
have completed the 12-month follow-up visit, were discontinued prior to the 12-month follow-
up visit, have died or the follow-up visit window is closed. 
The trial will be considered complete (with regard to all follow-up) after all subjects have 
completed the 60 month (5 year) follow-up visit, were discontinued prior to the 60 month (5 
year) follow-up visit, have died or the follow-up visit window is closed. 

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12.10 Missed or Late Visits 
Every effort must be made by the site to retain study subjects for the duration of the study.   
A minimum of 3 attempts (i.e., 2 phone calls followed by a certified letter, or other traceable 
letter, if necessary) should be made to contact the subject or subject’s next of kin for each 
missed follow-up visit and this information should be documented in the source.  Missed or 
late visits will be recorded as Protocol Deviations.  
No subject will be considered lost to follow-up prior to the 12 Month follow-up visit in order to 
make every effort to collect evaluable data for the primary endpoint.  A subject will be 
considered lost to follow-up after the subject: 
1. misses 2 consecutive annual follow-up visits without due cause and 
2. medical chart review/public records consultation are inconclusive as to subject’s 
survival status. 
12.11 
Medication 
Investigators must prescribe concomitant anti-coagulant and anti-platelet medications 
consistent with current local clinical practice. Antiplatelet medication usage will be collected 
and reported in the electronic case report form (eCRF) from the time of the pre-procedure 
visit through the 36 month (3 year) follow-up visit. Additional concomitant medications may 
be prescribed at the discretion of the treating physician according to standard of care. 
12.12 Withdrawal of Individual Subjects 
Subjects may leave the study at any time for any reason and without any consequences. The 
investigator or designee will try to obtain the reason for study withdrawal and document this 
in the source data.  
If a subject chooses to withdraw from the study, no further study-specific evaluation(s) should 
be performed, and no additional data will be collected. The sponsor may retain and continue 
to use any data collected prior to the withdrawal of consent, unless specified differently by 
the subject. The subject will return to the care of their personal physician. 
Subjects voluntarily withdrawing from the trial will be asked to participate in a limited capacity 
allowing their medical status to be followed by telephone contact, medical chart review, or by 
other agreed upon method.  
If a subject decides not to continue participation in a limited capacity, the investigator will not 
access their medical record or other confidential records for new purposes related to the 
study; however, study data collected prior to their withdrawal may be reviewed and publicly 
available records may be consulted prior to or after their withdrawal. Note: this applies to all 
withdrawn subjects (e.g., withdrawn by investigator). 
If a subject is withdrawn from the study, the investigator will promptly inform the subject and 
sponsor. Withdrawn subjects will be followed according to the investigational center’s 
standard procedures. Serious adverse device-effects that are still ongoing at the end of the 
subject’s participation in the trial will be followed up for resolution status. 

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12.13 
Replacement of Individual Subjects after Withdrawal  
Subjects who exit the study prematurely will not be replaced. 
13. SUSPENSION OR TERMINATION 
13.1 Premature Termination of the Study  
Early termination of the study is the closure of the clinical study that occurs prior to meeting 
defined endpoints. Early termination is possible for the whole study or a single site. Study 
suspension is a temporary postponement of study activities related to enrollment. 
Suspension is possible for the whole study or a single site. 
13.1.1 
Study-wide Termination or Suspension 
The sponsor reserves the right to terminate the study at any stage but intends to exercise 
this right only for valid scientific or administrative reasons and reasons related to protection 
of subjects. Investigators, associated Ethics Committees (ECs), and regulatory authorities, 
as applicable, will be notified in writing in the event of study termination. Possible reasons for 
premature study termination include, but are not limited to: 
• 
The occurrence of unanticipated adverse device effects that present a significant or 
unreasonable risk to subjects enrolled in the study 
• 
An enrollment rate far below expectation that prejudices the conclusion of the study 
• 
A decision on the part of the sponsor to suspend or discontinue development of the 
device 
13.1.2 
Investigator/Site Termination or Suspension  
Possible reasons for clinical investigator or site termination or suspension include but are not 
limited to: 
• 
Failure to obtain initial Ethics Committee approval or annual renewal of the study, if 
applicable 
• 
Persistent non-compliance to the Clinical Investigation Plan (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups) 
• 
Lack of or insufficient enrollment 
• 
Noncompliance to regulations and/or the terms of the Clinical Trial Agreement (e.g. 
failure to submit data in a timely manner, failure to follow up on data queries and 
monitoring findings in a timely manner, etc.) 
• 
Ethics Committee suspension of the site 
• 
Fraud or fraudulent misconduct is discovered 
• 
Investigator request (e.g. no longer able to support the study) 

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13.1.3 
Procedures for Termination or Suspension 
A 
Sponsor-initiated and regulatory authority-initiated 
• 
Sponsor will promptly inform the clinical investigators of the termination or suspension 
and the reasons and inform the Regulatory Authority(ies) where required. 
• 
In the case of study termination or suspension for reasons other than a temporary 
Ethics Committee approval lapse, the investigator will promptly inform the Ethics 
Committee. 
• 
In the case of study termination, the investigator must inform the Subjects and may 
inform the personal physician (if allowed) of the subjects to ensure appropriate care 
and follow-up is provided. 
• 
In the case of a study suspension, subject enrollment must stop until the suspension 
is lifted by sponsor and approved by the applicable committees/authorities. 
• 
In the case of a study suspension, enrolled subjects should continue to be followed 
out of consideration of their safety, rights and welfare. 
B 
Investigator-initiated 
• 
The investigator will inform sponsor and provide a detailed written explanation of the 
termination or suspension. 
• 
The investigator will promptly inform the institution (where required per regulatory 
requirements). 
• 
The investigator will promptly inform the Ethics Committee and sponsor will promptly 
inform the Regulatory Authority (where applicable). 
• 
The investigator will promptly inform the subjects and/or the personal physician of the 
subjects to ensure appropriate care and follow-up is provided. 
• 
In the case of a study suspension, subjects enrolled should continue to be followed 
out of consideration of their safety, rights and welfare. 
C 
Ethics Committee or Regulatory Authority-initiated 
• 
The investigator will inform sponsor and provide a detailed written explanation of the 
termination or suspension within 5 business days. 
• 
Subject enrollment must stop until the suspension is lifted. 
• 
Subjects already enrolled should continue to be followed in accordance with Ethics 
Committee/ Regulatory Authority policy or its determination that an overriding safety 
concern or ethical issue is involved. 
14. SAFETY 
It is the responsibility of the investigator to assess and report to sponsor any event 
experienced by the study subject after randomization/enrollment, whether during or 
subsequent to the procedure, and which falls under any of following categories: 
• 
All Device and/or Procedure Related (Serious) Adverse Events 
• 
All Device Deficiencies  

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• 
Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
• 
All Events which meet the per-protocol definition of Major Adverse Event (note: for 
target limb amputations, both minor and major amputations should be reported) 
• 
All Target Vessel Revascularizations (TVR) 
• 
New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the trial.  
Death should not be recorded as an AE, but should only be reflected as an outcome of a 
specific SAE (see below for AE definitions).  
Refer to Section 15 for the known risks associated with the study device(s). 
Device deficiencies and other device issues should not be reported as AEs. Instead, they 
should be reported on the appropriate eCRF per the study CRF Completion Guidelines. If an 
AE results from a device deficiency or other device issue, the AE should be reported on the 
appropriate eCRF. 
14.1 Adverse Events  
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
any untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the medical device. 
NOTE 1: This definition includes events related to the test device or the comparator 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
Adverse events will be monitored throughout the study. Investigators must obtain all 
information available to determine the causality and outcome of the AE and to assess 
whether it meets the criteria for classification as a serious adverse device effect requiring 
immediate notification to the sponsor or its designated representative. All reported ADEs will 
be documented on the appropriate CRF and will include the event description [diagnosis – 
only signs or symptoms in case underlying diagnosis is not (yet) known], onset, resolution, 
seriousness, severity, cause and action taken. The investigator must assess causality and 
severity for all ADEs. 
All ADEs will be followed by the Investigator until resolution or until the end of study 
participation. 

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14.2 Adverse Device Effects 
An adverse device effect (ADE) is an AE related to the use of a medical device. 
NOTE 1: This definition includes adverse events resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, the 
installation, the operation, or any malfunction of the medical device. 
NOTE 2: This definition also includes any event that is a result of a use error or intentional 
abnormal use of the medical device. 
14.3 Serious Adverse Events  
An adverse event is defined as serious (SAE), whenever the adverse event  
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient hospitalization or prolongation of existing hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness, or 
5) injury or permanent impairment to a body structure or a body function, 
c) led to fetal distress, fetal death or a congenital abnormality or birth defect 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the 
Clinical Investigational Plan, without a serious deterioration in health, is not 
considered a serious adverse event. 
14.4 Serious Adverse Device Effects 
A serious adverse device effect (SADE) is an adverse device effect that has resulted in any 
of the consequences characteristic of a serious adverse event.  
14.5 Unanticipated Serious Adverse Device Effects 
An unanticipated serious adverse device effect (USADE) is a serious adverse device effect 
which by its nature, incidence, severity or outcome has not been identified in the current 
version of the risk analysis report. 
NOTE: Anticipated serious adverse device effect (ASADE) is an effect which by its 
nature, incidence, severity or outcome has been identified in the risk analysis report. 
14.6 Device Malfunction/Failure/Deficiency – Device Specific Events 
Device deficiency is the inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance.  
NOTE: Device deficiencies include malfunctions, use errors, and inadequacy in the 
information supplied by the manufacturer. 
Device malfunction means the failure of a medical device to perform in accordance with its 
intended purpose when used in accordance with the IFU/DFU, IB or Clinical Investigational 
Plan. 

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Device Deficiencies (DD) and other device issues should not be reported as AEs. Instead, 
they should be reported on the appropriate eCRF per the study CRF Completion Guidelines. 
If an AE results from a device deficiency or other device issue, the AE should be reported on 
the appropriate eCRF.  
Device malfunction/failures/deficiencies may or may not result in the subject experiencing 
harmful effect. All AEs/SAEs associated with a device failure are by definition device-related. 
14.7 Adverse and serious adverse events reporting 
Timely, accurate, and complete reporting and analysis of safety information for clinical 
studies are crucial for the protection of subjects. Reporting and analysis of safety data are 
mandated by regulatory authorities worldwide. Since the safety reporting requirements and 
classification systems vary for each Regulatory Authority, requirements from all geographies 
are taken into account for the collection and reporting of safety information. 
Subjects will be carefully monitored during the study for possible adverse events. Any 
adverse event that occurs after the time of randomization/enrollment through end of study 
participation will be fully evaluated by the Investigator. Appropriate treatment will be initiated 
and the study follow up will continue as completely as possible. 
The Investigator will document all observations and clinical findings of adverse events, 
including the nature, severity and relationship, on the appropriate CRFs.  
The Investigator is required to report all SADEs to the Sponsor within 3 calendar days of 
awareness of the event. UADEs/USADEs need to be reported to the Sponsor within 1 
business day of awareness of the event. Initial reporting may be done by phone, fax, email or 
by completing the applicable CRF form with as much information as available at that time. In 
case of urgent questions regarding safety reporting, please contact the study contact as 
indicated in your study contact list. 
Additionally, device deficiencies should be reported to the Sponsor within 3 calendar days of 
awareness. 
ADEs should be reported in a timely manner (recommended within 10 business days) of 
awareness. 
Furthermore, the Investigator must follow their local Ethics Committee policy for 
SADE/UADE/USADE reporting. If required by national regulations or Ethics Committee, 
device deficiencies that could have led to a SADE should be reported to the Sponsor or 
designee and Ethics Committee within 3 calendar days of awareness of the event. 
As additional information becomes available, the Investigator will record all adverse device 
effects (anticipated and unanticipated) and device deficiencies on the appropriate CRFs. 
In case of Major Adverse Events, copies of source documentation which contain significant 
information related to the event such as discharge letters, surgery reports, consultation 
letters, ECGs, laboratory results, etc. are required for evaluation of the event. Copies of such 
documentation shall be obtained from the investigator, blinded / de-identified as to the 
subjects’ identity, and provided to the Sponsor or designee. 

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Regarding subject deaths, it is requested that a copy of the death certificate and a copy of 
the autopsy report (if applicable), be sent to the sponsor or designee when available. Any 
other source documents related to the death should also be provided to the sponsor or 
designee. In the event that no source documents are available, the PI is required to describe 
the circumstances of the subject’s death in a letter, e-mail or other written communication. 
UADEs/USADEs have special reporting requirements. The Sponsor will notify the sites, ECs 
and regulatory bodies as per country specific regulations. 
14.8 Annual Safety Report 
In addition to the expedited reporting of SADEs, the sponsor will submit, at a minimum once 
a year throughout the clinical study, an annual safety report to the involved ethical 
committees and competent authorities of the concerned Member States if required. This 
annual safety report can be combined with the annual progress report. 
14.9 Severity  
The investigator will use the following definitions to determine the severity of an adverse 
event:  
- 
Mild:  Awareness of a sign or symptom that does not interfere with the subject’s 
usual activity or is transient, resolved without treatment and with no sequelae.  
- 
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. Relationship to the device or 
procedure 
The investigator will use the following definitions to assess the relationship to the device 
or procedure:  
Not Related:  
Relationship to the device or procedure can be excluded when: 
- 
the event is not a known side effect of the product category the device belongs to 
or of similar devices and procedures; 
- 
the event has no temporal relationship with the use of the device or the 
procedure; 
- 
the event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible; 
- 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the event; 
- 
the event involves a body-site or an organ not expected to be affected by the 
device or procedure; the event can be attributed to another cause (e.g. an 

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underlying or concurrent illness/ clinical condition, an effect of another device, 
drug, treatment or other risk factors); 
- 
the event does not depend on a false result given by the device used for 
diagnosis, when applicable; harms to the subject are not clearly due to use error; 
- 
In order to establish the non-relatedness, not all the criteria listed above might be 
met at the same time, depending on the type of device/procedures and the event. 
Unlikely Related: 
The relationship with the use of the device or procedure seems not relevant and/or the 
event can be reasonably explained by another cause, but additional information may be 
obtained. 
Possibly Related:  
The relationship with the use of the device or procedure is weak but cannot be ruled out 
completely. Alternative causes are also possible (e.g. an underlying or concurrent 
illness/clinical condition or/and an effect of another device, drug or treatment). Cases 
were relatedness cannot be assessed or no information has been obtained should also 
be classified as possible related. 
Probably Related:  
The relationship with the use of the device or procedure seems relevant and/or the event 
cannot reasonably be explained by another cause, but additional information may be 
obtained.  
Causal Relationship:  
The event is associated with the device or with procedure beyond reasonable doubt 
when: 
- 
the event is a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- 
the event has a temporal relationship with device use/application or procedure; 
- 
the event involves a body-site or organ that 
▪ 
the device or procedure are applied to; 
▪ 
the device or procedure have an effect on; 
- 
the event follows a known response pattern to the medical device (if the response 
pattern is previously known); 
- 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically feasible); 
- 
other possible causes (e.g. an underlying or concurrent illness/clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
- 
harm to the subject is due to error in use; 

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- 
the event depends on a false result given by the device used for diagnosis, when 
applicable; 
- 
In order to establish the relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedure and the event 
If the relationship between any adverse event and the use of the device is considered to 
be unlikely, possibly or probably related, that event will be classified as an ADE or SADE. 
14.10 Clinical Events Committee (CEC) 
The CEC is an independent group of individuals with no affiliation with BSC. Committee 
membership will include practitioners of peripheral endovascular procedures, as well as other 
experts with the necessary therapeutic and subject matter expertise to review and adjudicate 
the following endpoints and major adverse events reported by the trial Investigators: 
- 
All Deaths 
- 
Target Lesion Revascularizations 
- 
Target Vessel Revascularizations 
- 
Target limb amputations 
- 
Stent Thrombosis 
CEC members will be blinded to a subject’s treatment assignment during the trial. 
Responsibilities, qualifications, membership, and committee procedures are outlined in the 
CEC charter. 
15. POTENTIAL RISKS AND BENEFITS 
15.1 Anticipated Adverse Events and Risks Associated with Use of the ELUVIA 
Stent System and Implantation of the ELUVIA Stent 
The risks associated with the implantation of a stent in the SFA/PPA may include, but are not 
limited to the following: 
• 
Allergic reaction (to drug/polymer, contrast, device or other) 
• 
Bleeding/Hemorrhage 
• 
Death 
• 
Embolization (air, plaque, thrombus, device, tissue or other) 
• 
Extremity ischemia/amputation 
• 
Hematoma 
• 
Need for urgent intervention or surgery  
• 
Pseudoaneurysm formation 
• 
Renal insufficiency or failure 
• 
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• 
Sepsis/infection 
• 
Thrombosis / thrombus 
• 
Tissue ischemia / necrosis 
• 
Transient hemodynamic instability (hypotensive/hypertensive episodes) 
• 
Vasospasm 
• 
Vessel injury, including perforation, trauma, rupture and dissection 
• 
Vessel occlusion 
15.2 Risks Associated with the Test Device Unique to Paclitaxel drug coating 
Certain side effects and discomforts have been reported in subjects that have received 
paclitaxel in intravenous forms as part of chemotherapy treatment.  These subjects may have 
other comorbid conditions and/or have received concomitant medications that may also 
contribute to the reported side effects.  Under these circumstances the dose is delivered 
throughout the body by the blood and in doses hundreds of times higher than the total 
amount on the coated stent for use in the proposed clinical trial.  
Potential adverse events that may be unique to the paclitaxel drug coating are: 
• 
Allergic/immunologic reactions to drug (paclitaxel or structurally-related compounds) 
or the polymer stent coating (or its individual components) 
• 
Alopecia 
• 
Anemia 
• 
Gastrointestinal symptoms 
• 
Hematologic dyscrasia (including leukopenia, neutropenia, and thrombocytopenia) 
• 
Hepatic enzyme changes 
• 
Histologic changes in the vessel wall, including inflammation, cellular damage or 
necrosis 
• 
Myalgia/arthralgia 
• 
Peripheral neuropathy 
It is unlikely with the total dosages and the way paclitaxel is coated onto the stent and 
delivered in the vessel that the side effects associated with intravenous, high dose 
chemotherapy would occur. There may be other potential adverse events that are 
unforeseen at this time. 
15.3 Risks associated with Participation in the Clinical Study 
There may be additional risks linked to the procedure, and follow-up testing which are 
unforeseen at this time. All testings planned for the follow-up period are standard of care, 
with the exception of the quality of life questionnaires, which don’t cause any additional risk.  

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A signal for increased risk of late mortality has been identified following the use of paclitaxel-
coated balloons and paclitaxel-eluting stents for femoropopliteal arterial disease beginning 
approximately 2-3 years post-treatment compared with the use of non-drug coated devices.  
There is uncertainty regarding the magnitude and mechanism for the increased late mortality 
risk, including the impact of repeat paclitaxel-coated device exposure. Physicians should 
discuss this late mortality signal and the benefits and risks of available treatment options with 
their patients.  
15.4 Possible Interactions with Concomitant Medical Treatments 
In addition to the aforementioned risks associated with the implantation of stents and the use 
of paclitaxel, the use of standard of care prolonged dual antiplatelet therapy after stent 
implantation may increase the risk of bleeding. Refer to the local package insert for further 
information on drug interactions and side effects associated with paclitaxel or 
antithrombotic/antiplatelet medications. 
15.5 Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
15.6 Anticipated Benefits 
Whether the subject receives the ELUVIA stent or another commercially available stent, they 
will receive an effective treatment of a narrowed upper leg artery and improvement in the 
symptoms of the peripheral artery disease. 
Furthermore, medical science and future patients may benefit from the results of this study.  
15.7 Risk to Benefit Rationale 
The ELUVIA stent is a CE-marked device and has been proven to be suitable for its intended 
purpose. There are no unacceptable residual risks/intolerable risks and all applicable risks 
have been addressed through the provision of appropriate DFU. Evaluation of the risks and 
benefits that are expected to be associated with the use of the ELUVIA stent demonstrate that 
when used under the conditions intended, the benefits associated with the use of the ELUVIA 
stent should outweigh the risks. 
16. 
STATISTICAL ANALYSIS 
The details of all statistical analyses will be described in the Statistical Analysis Plan. 

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16.1 Primary Endpoint 
The overall sample size is justified by hypothesis parameters and driven by the primary 
effectiveness endpoint to preserve adequate statistical testing power for the primary 
effectiveness endpoint. 
16.1.1 
Primary Effectiveness Endpoint 
The 12-month primary patency is chosen to be assessed for the primary effectiveness 
endpoint. The goal is set to demonstrate that the primary patency for the ELUVIA treatment 
group (i.e. Test) is superior to the Self Expanding Bare Nitinol Stents treatment group (i.e. 
Control) through 12 months post-procedure. For the definition of primary patency, refer to 
section 8.1. 
A 
Hypotheses 
The primary effectiveness hypothesis to be tested is that the 12-month primary patency in 
the Test Group is superior to the Control Group at one-sided significance level of 2.5%. 
The null hypothesis (H0) states that there is no treatment effect between Test vs. Control as 
opposed to the alternative hypothesis (H1) which states that there is a treatment effect. The 
hypotheses inequalities are shown below: 
H0: Pt - Pc   0  
H1: Pt - Pc  > 0 (superior) 
where Pt and Pc are the 12-month primary patency for Test and Control, respectively. 
B 
Sample Size 
The primary effectiveness endpoint drives the overall sample size. Approximately 750 
subjects are planned to be enrolled. The sample size justification is based on the following 
assumptions:  
• 
Expected ELUVIA (Test) 12-month primary patency = 85% 
• 
Expected Self Expanding Bare Nitinol Stents (Control) 12-month primary patency rate = 
75% 
• 
Test significance level () = 2.5% (1-sided) 
• 
Power (1−) ≥ 85% 
• 
Expected rate of attrition in 12 months ≤ 16% 
With a sample size allocation (Test vs. Control) of 2 to 1, a minimum of 630 evaluable 
subjects in total (ideally 420 in the Test Group and 210 in Control Group) will be required at 
12 months to provide at least 85% power under a one-sided 2.5% significance level. 
The trial will demonstrate 10% treatment effect which represents 7% observed advance. 
Assuming a 12-month primary patency of 75.2% (158/210) is observed for Self Expanding 
Bare Nitinol Stents, a minimum of 82.1% (345/420) for ELUVIA will be required to claim 
superiority. 

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Taking into account the assumed attrition rate of 16%, this amounts to the enrollment of 
approximately 750 subjects 
C 
Statistical Methods 
A superiority test for the difference in 12-month primary patency will be used to assess the 
effectiveness hypotheses. The p-value and/or one-sided lower 97.5% confidence interval will 
be constructed based on statistics under this approach. 
D 
Success Criteria 
The following success criteria are defined for the study. 
ELUVIA will be concluded to be superior to Self-Expanding Bare Nitinol Stents for device 
effectiveness if the one-sided lower 97.5% confidence bound on the difference between 
treatment groups (Test minus Control) in 12-month primary patency is greater than zero.  
This corresponds to the p-value less than 0.025. 
If the primary effectiveness endpoint is met, the study will be considered a success.General 
Statistical Methods 
16.1.2 
Analysis Sets 
The as-randomized (i.e. intent-to-treat or ITT) population will be the primary analysis set for 
assessing the primary effectiveness endpoint. The per-protocol and/or the as-treated 
population will be assessed for reference. 
For the as-randomized analysis, all subjects who sign the written ICF and are randomized in 
the trial will be included in the analysis population, regardless of whether the subjects receive 
the assigned treatment. For the per-protocol analysis, only randomized subjects who receive 
the assigned treatment will be included in the analysis population.  For as-treated analysis, 
all subjects in the per-protocol population will be included based on the actual Test or Control 
device that each subject received (i.e. including cross-over subjects). 
16.1.3 
Randomization Scheme 
Randomization to treatment will be stratified by study site and lesion length. A computer 
generated list of random treatment allocations (i.e., a randomization schedule) will be used to 
assign subjects to treatments in a 2:1 ratio of Test Group to Control Group by lesion length 
(i.e. ≤110 mm vs. >110 mm) for each study site. This list will be specific to the subject’s site. 
Random permuted blocks of varying sizes will be employed to ensure approximate balance 
of treatment allocation within each stratum. 
16.1.4 
Control of Systematic Error/Bias 
Selection of subjects will be made from the Investigators’ general or professional referral 
population. All subjects meeting the inclusion/exclusion criteria and who have signed the 
protocol-specific ICF will be eligible for enrollment in the trial. Consecutively eligible subjects 
should be enrolled into the trial to minimize selection bias. Study subjects will be randomly 
assigned to a treatment group within the investigational site. In determining subject eligibility 

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for the study, the investigator’s assessment of imaging will be used. However, the 
Angiographic Core Laboratory will independently analyze the angiograms and the data 
obtained from the core laboratory will be used for analyses. An independent CEC composed 
of medical experts will adjudicate safety assessments, as defined in the CEC Charter. 
16.1.5 
Number of Subjects per Investigative Site 
Study sites will not be allowed to randomize more than 10% (N=75) of the total number of 
randomized subjects without prior approval from the sponsor. No study site will be allowed to 
enroll more than 20% (N=150) of the total number of randomized subjects. 
16.2 Baseline Data Analyses 
Baseline covariates will be summarized for this study. Subject baseline demographics and 
clinical characteristics, site-reported and core lab reported lesion characteristics, procedure 
assessment, device information, and medication usage will be summarized using descriptive 
statistics. The analysis unit may be (but will not be limited to) by subject, lesion, procedure, 
or device.  
The selected baseline covariates may be compared for ‘like-to-like’ in the Test Group verses 
the Control Group with appropriate statistical tests for discrete and continuous variables. 
16.2.1 
Secondary Endpoint and Additional Endpoints  
The secondary endpoint and additional endpoints refer to (but are not limited to) health 
economics, technical/procedural success, safety/effectiveness endpoints, stent fracture, any 
type of ADE rates, survival rates, distribution of Rutherford classification, hemodynamic 
improvement at time points that data is collected.  
No formal tests of hypotheses are proposed for the secondary endpoint and additional 
endpoints. Statistical comparisons may be performed for exploratory purposes. No formal 
inferences are planned on the secondary endpoint and additional endpoints and therefore 
alpha-adjustments for multiple comparisons will not be used. 
16.2.2 
Interim Analyses  
No formal interim analyses are planned for the purpose of stopping this study early for 
declaring effectiveness or for futility. 
16.2.3 
Subgroup Analyses 
Primary endpoint, secondary endpoint and/or additional endpoints will be summarized and 
treatment groups may be compared in each subgroup identified by the following categories 
(but not limited to): 
• 
Region 
• 
Race 
• 
Gender (male vs. female) 
• 
Age (≥ 65 and <65) 

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• 
Diabetic status (medically-treated vs. non-diabetic) 
• 
Lesion characteristics (vessel diameter/lesion length) 
• 
Stent matrix (stent diameter/length) 
• 
Subjects treated with single stent/multiple stents (e.g. overlapping) 
• 
Other significant predictors identified by regression models 
No formal tests of hypotheses are proposed for subgroups and therefore alpha-adjustment 
for multiple comparisons is not required. 
16.2.4 
Justification of Pooling 
The poolability analysis regarding the primary endpoint across sites will be assessed. Due to 
the 2:1 randomization scheme using random permuted blocks employed within each site, 
there will be at least 2 subjects from the Test Group and one subject from the Control Group. 
Therefore the poolability method is described as below. 
The sites with enrollment of 6 subjects or more are reported individually. 
The sites with enrollment of 5 or less subjects are pooled into super-sites according to their 
geographical closeness so that the combined super-sites would have 6 or more enrolled 
subjects. If a super-site has 6 or more subjects and at least 2 subjects in each treatment 
group, the pooling of this super-site should stop and the pooling of the next super-site should 
start. 
If the p-value of poolability test in the logistic regression model for the primary endpoint is > 
0.15, the treatment effect will be presented for overall across all sites. If the p-value is  0.15, 
the treatment effect will be presented by each site or super-site in addition to the overall 
across all sites. 
16.2.5 
Sensitivity Analysis for Missing Data 
Sensitivity analyses for the primary effectiveness endpoint assessment will be conducted to 
assess the impact of missing data on the result’s robustness. In addition to the use of the 
worst-case analysis, the tipping point analysis will be performed for the ITT analysis set to 
consider all combinations of present/absent for all subjects with missing primary outcome in 
the Test Group and the Control Group.  
16.2.6 
Multivariable Analyses 
Univariate and multivariable analyses will be performed to assess the effect of potential 
predictors for the primary effectiveness endpoint in a logistic regression model. Clinically 
meaningful baseline covariates will be selected in the regression model. The study is not 
primarily designed to identify significant risk factors and all results should be interpreted with 
clinical meaningful aspects. 
16.2.7 
Analysis Software 
All statistical analyses will be performed and validated by the independent CRO using the 
Statistical Analysis Software (SAS), version 9.2 or later (Copyright © 2002-2010 by SAS 

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Institute Inc., Cary, North Carolina 27513, USA. All rights reserved). BSC will review 
statistical reports. 
16.2.8 
Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the primary 
analyses (i.e. unblinding) will be documented in an amended Statistical Analysis Plan 
approved prior to performing the primary hypotheses testing. Changes from the planned 
statistical methods after performing the analyses will be documented in the clinical study 
report along with a reason for the deviation. 
17. 
ETHICAL CONSIDERATIONS 
17.1 Regulation Statement 
This study will be performed in accordance with the World Medical Association Declaration of 
Helsinki, ISO 14155:2011(E) and all local legal and regulatory requirements. 
In addition to following the governing regulations, any additional requirements of the 
individual study site’s Ethics Committee and Regulatory Authority will also be followed by the 
study site(s) where applicable. 
Ethics Committee and where applicable Regulatory Authority approval for the study is required 
prior to beginning the study. A copy of the approvals must be sent to the sponsor prior to 
enrolling the first subject. 
The study will be publicly registered prior to first enrollment in accordance with the 2007 
Food and Drug Administration Amendments Act (FDAAA) and Declaration of Helsinki on 
http://clinicaltrials.gov (PL 110-85, Section 810(a)). 
17.2 Recruitment and Consent 
This study is to be performed in accordance with all applicable data protection laws. All data 
and information concerning subjects and their participation in this study are considered 
confidential by the sponsor and its designees. Only authorized Investigators and Sponsor or 
designated personnel will have access to confidential records. The Ethics Committee and other 
regulatory authorities also have the right to inspect and copy records pertinent to the study. All 
public reporting of the results of the study will eliminate identifiable references to subjects. 
The Investigator, or an individual designated by the investigator, must obtain written informed 
consent from the eligible subject prior to the first study-specific procedure using the most recent 
approved informed consent document.  
The process of obtaining informed consent must be consistent with the Declaration of Helsinki. 
The study subject must be given the opportunity to ask questions to, and receive answers 
from, the investigator or study personnel prior to signing the consent document.  

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17.3 Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the investigational 
plan/protocol, ISO 14155, ethical principles that have their origins in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing EC, and prevailing local and/or 
country laws and/or regulations, whichever affords the greater protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• 
Prior to beginning the study, sign the Clinical Study Agreement and Protocol Signature 
page documenting his/her agreement to conduct the study in accordance with the 
protocol. 
• 
Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the center team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• 
Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• 
Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• 
Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• 
Record, report, and assess (seriousness and relationship to the device/procedure), per 
protocol requirements, every adverse device effect and observed device deficiency. 
• 
Report to the sponsor, per the protocol requirements, all device deficiencies that could 
have led to a SADE. 
• 
Report to the EC any SADEs and device deficiencies that could have led to a SADE, if 
required by the national regulations or this protocol or by the EC, and supply the sponsor 
with any additional requested information related to the safety reporting of a particular 
event. 
• 
Maintain the device tracking of the test and control devices, ensuring that the device is 
used only by authorized/designated users and in accordance with this protocol and 
instructions/directions for use. 
• 
Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
monitor and respond to questions during monitoring visits. 
• 
Allow and support regulatory authorities and the EC when performing auditing activities. 

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• 
Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local EC requirements. 
• 
Provide adequate medical care to a subject during and after a subject’s participation in 
the clinical study in the case of adverse events, as described in the ICF. 
• 
Inform the subject of the nature and possible cause of any adverse events experienced. 
• 
Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• 
Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded clinical investigations, as needed. 
• 
Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• 
Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided with 
some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• 
Inform, with the subject’s approval or when required by national regulations, the subject’s 
personal physician about the subject’s participation in the clinical investigation. 
• 
Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• 
Ensure that an adequate investigational site team and facilities exist and are maintained 
and documented during the clinical investigation. 
• 
Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
17.3.1 Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the investigator is responsible for providing appropriate 
training and adequate supervision of those to whom tasks are delegated. The investigator is 
accountable for regulatory violations resulting from failure to adequately supervise the 
conduct of the clinical study. 
17.4 Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational site will provide to the sponsor 
documentation verifying that their EC is registered or that registration has been submitted to 
the appropriate agency, as applicable according to national/regulatory requirements. 
A copy of the written EC and where appropriate Regulatory Authority approval of the protocol 
(or permission to conduct the study) and Informed Consent Form, must be received by the 

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sponsor before recruitment of subjects into the study. Prior approval must also be obtained 
for other materials related to subject recruitment or which will be provided to the subject. 
Annual EC approval and renewals will be obtained throughout the duration of the study as 
required by local/country or EC requirements. Copies of the Investigator’s reports and the EC 
continuance of approval must be provided to the sponsor. 
17.5 Sponsor Responsibilities 
All information and data sent to the sponsor concerning subjects or their participation in this 
study will be considered confidential by the sponsor and will be kept confidential in 
accordance with all applicable laws and regulations. Only authorized sponsor personnel 
and/or a sponsor representative including Contract Research Organization (CRO), will have 
access to these confidential records. Authorized regulatory personnel have the right to 
inspect and copy all records pertinent to this study. Study data collected during this study 
may be used by the sponsor for the purposes of this study, publication, and to support future 
research and/or other business purposes, such as overseeing and improving the 
performance of its device, new medical research and proposals for developing new medical 
products and procedures. All data used in the analysis and reporting of this study or shared 
with a third-party researcher will be without identifiable reference to specific subjects. 
Information received during the study will not be used to market to subjects; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes. 
17.5.1 Role of Sponsor Representatives 
Sponsor personnel can provide technical support to the investigator and other Health Care 
Personnel (collectively HCP) as needed during stent implant and testing required by the 
protocol during the index procedure. Support may include HCP training, addressing HCP 
questions, or providing clarifications to HCPs concerning the operation of the test device. 
Sponsor personnel will not do the following:  
• 
Practice medicine 
• 
Provide medical diagnosis or treatment to subjects 
• 
Discuss a subject’s condition or treatment with a subject  
• 
Independently collect critical study data (defined as primary or secondary endpoint data) 
• 
Enter data in electronic data capture systems or on paper case report forms 
18. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS 
18.1 Subject Reimbursement 
Travel expenses incurred by subjects as a result of participation in the study will be 
reimbursed if requested in accordance with pertinent country laws and regulations and per 
the study site’s regulations. 

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18.2 Compensation of Injury  
The sponsor has insurance, in accordance with national regulations, covering the costs of 
treatment of subjects in the event of study related injuries. 
19. ADMINISTRATIVE ASPECTS AND PUBLICATION 
19.1 Handling and Storage of Data and Documents 
The investigators must maintain adequate and accurate records to document the conduct of 
the study and substantiate the study data. These documents include those required by 
applicable regulations, and the subjects’ source documents, as described below.   
Regulatory documents are those documents that individually and collectively permit 
evaluation of the study compliance with applicable regulations and the quality of the data 
produced.    
These documents will be filed in an Investigator Study File provided by the sponsor or 
designee.  This file shall be used to facilitate and ensure filing of all relevant regulatory 
documents during and after the study. The investigator will be responsible for keeping the 
Investigator’s Study File updated and ensuring that all required documents are filed. The file 
will be inspected during monitoring visits.   
Source documents are original hospital records, clinical charts, screening log, subject 
identification lists, enrolment logs, original laboratory reports, memoranda, pharmacy 
dispensing records, recorded data from automated instruments, transcriptions certified after 
verification as being accurate, microfiches, photographic negatives, microfilm, magnetic or 
electronic media, x-rays, subject’s files, and records kept at pharmacy, laboratories and 
medico-technical departments involved in the study. The investigator must maintain source 
documents for each subject in the study.  
All information recorded on the CRFs must be traceable to these source documents.  The 
investigator shall arrange for the retention of all study documents and records, including 
subject records, CRFs, device inventory/accountability logs, signed informed consent forms 
and the subject identification list, after completion or discontinuation of the study for the 
minimum period as required per local regulation.   
19.2 Data Collection and Case Report Forms (CRF)  
Clinical data are collected at designated time points throughout the study. Electronic Case 
Report Forms (eCRFs) will be used to collect all patient data during the course of the study.  
eCRFs must be fully completed for each subject and signed by the Investigator when 
complete.  Data may be stored in a secure, password-protected database which will be 
backed up periodically. Data will be reviewed using programmed and manual data checks.  
Data queries will be made available to study sites for resolution. Study management reports 
may be generated by the sponsor (or delegate) to monitor data quality and study progress. 
At the end of the study, the data will be frozen and retained by the sponsor for a period of 
five (5) years, or as required by local regulation. 

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Good Clinical Practice Guidelines require that Investigators maintain information in the study 
subject’s medical records that corroborate data collected in the CRFs.    
The Investigator or designated individual shall be responsible for recording all study data on 
the CRFs provided by the sponsor.  The Investigator is required to sign the CRF on the 
appropriate page(s) to verify that he/she has reviewed and agrees with the recorded data.   
The Investigator will allow the monitor and/or representative of the Sponsor, and any 
regulatory body to review and inspect the study files, subject CRFs, subject medical records 
and other related study documents as required.  Completed CRFs will be verified by the 
appointed monitor at the investigational site at regular intervals throughout the study. Missing 
or unclear data will be investigated by the monitor and will be retrieved and clarified by study 
personnel as necessary throughout the study. The sponsor or their authorized representative 
may request additional documentation from the investigator such as physician procedure 
notes or physician written summaries when adverse events are observed and reported.   
19.3 Deviations 
The investigator is not allowed to deviate from the Clinical Investigational Plan, except to 
maintain the subject’s rights, protect the life and physical well-being of a subject in an 
emergency, or the scientific integrity of the investigation. All protocol deviations shall be 
documented and a justification for any missed assessments shall be provided on the 
Protocol Deviation Case Report Form.  
The sponsor (or delegate) is responsible for analyzing deviations, assessing their 
significance, and identifying any additional corrective and/or preventive actions (e.g. amend 
the Clinical Investigational Plan, conduct additional training, or terminate the investigation). 
Repetitive or serious investigator compliance issues may result in initiation of a corrective 
action plan with the investigator and site, and in some cases, necessitate suspending 
enrollment until the problem is resolved or ultimately terminating the investigator's 
participation in the study. Sponsor (or delegate) will provide site-specific reports to 
investigators summarizing information on deviations that occurred at the investigational site 
on a periodic basis. 
19.4 CIP Revisions or Amendments  
During the course of the study, a revision or an amendment to the Clinical Investigational 
Plan may be necessary. Any revision or amendment, including justification for the 
modification, must be submitted to and approved by the study site’s Ethics Committee and if 
applicable to the relevant Regulatory Authority according to local requirements prior to 
implementation of the amendment, unless the modifications increase Subject safety. 
Any revisions or amendment(s) that affect the informed consent form require a revised, 
Sponsor and Ethics Committee approved informed consent form, before changes in study 
procedures are implemented. These requirements should in no way prevent any immediate 
action from being taken by the Investigator or by the Sponsor to preserve the safety of any 
Subjects included in the study, as necessary. If an immediate change to the Clinical 

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Investigational Plan is felt to be necessary by the Investigator and is implemented by him/her 
for safety reasons, the Sponsor, and EC if required, should be immediately notified. 
19.5 Annual Progress Report 
The sponsor/investigator will submit a summary of the progress of the study to the involved 
ethics committees once a year or according to the national / local requirements.  
Information will be provided on the date of inclusion of the first subject, numbers of subjects 
included and numbers of subjects that have completed the study, serious adverse device 
effects, UADEs, device deficiencies, protocol deviations, revisions, and amendments.  
19.6 End of Study Report 
The sponsor (or delegate) will notify the involved Ethics Committees and where appropriate 
the Regulatory Authority of the end of the study within a period of 90 days. The end of the 
study is defined as the last subject’s last visit.  
In case the study is ended prematurely, the sponsor (or delegate) will notify the involved 
Ethics Committees and where appropriate the Regulatory Authorities within 15 days, 
including the reasons for the premature termination. 
If required by the national regulations, the investigator/sponsor will submit a final study report 
with the results of the study, including any publications/abstracts of the study, to the involved 
Ethics Committee and, if applicable, the Regulatory Authority within one year from the end of 
the study.  
19.7 Public Disclosure and Publication Policy 
In accordance with the sponsor’s Corporate Policy on the Conduct of Human Subject 
Research, the sponsor requires disclosure of its involvement as a sponsor or financial 
supporter in any publication or presentation relating to a sponsor’s study or its results. In 
accordance with the sponsor’s Corporate Policy for the Conduct of Human Subject 
Research, the sponsor will submit study results for publication (regardless of study outcome) 
following the conclusion or termination of the study. The sponsor adheres to the 
Contributorship Criteria set forth in the Uniform Requirements of the International Committee 
of Medical Journal Editors (ICMJE; http://www.icmje.org). In order to ensure the public 
disclosure of study results in a timely manner, while maintaining an unbiased presentation of 
study outcomes, sponsor personnel may assist authors and investigators in publication 
preparation provided the following guidelines are followed. 
• 
All authorship and contributorship requirements as described above must be followed. 
• 
Sponsor involvement in the publication preparation and the sponsor Publication Policy 
should be discussed with the Coordinating Principal Investigator(s) and/or Executive 
Committee at the onset of the project. 
• 
The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission. 
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The study data, analytic methods, and study materials for this clinical trial may be made 
available to other researchers in accordance with the Boston Scientific Data Sharing Policy 
(https://www.bostonscientific.com/).  
20. MONITORING  
It is the responsibility of the Sponsor to ensure proper monitoring of this clinical study per 
regulations. Trained Sponsor personnel or delegates appointed by the Sponsor may perform 
study monitoring at the study site in order to ensure that the study is conducted in 
accordance with the Clinical Investigational Plan, the Clinical Study Agreement, and 
applicable regulatory and local requirements. The Sponsor, or delegates, must therefore be 
allowed access to the subjects’ case histories (clinic and hospital records, and other source 
data/ documentation) upon request as per the consent form, Research Authorization (where 
applicable) and Clinical Study Agreement. The principal investigator should also be available 
during monitoring visits. 
20.1 Monitoring Visits 
Monitoring visits may be conducted periodically to assess site study progress, the 
investigator’s adherence to the Clinical Investigational Plan, regulatory compliance, 
maintenance of records and review of source documents against subject CRFs. Monitors 
review site regulatory and study compliance by identifying findings of non-compliance and 
communicating those findings along with recommendations for preventative/corrective 
actions to site personnel. Monitors may work with study personnel to determine appropriate 
corrective action recommendations and to identify trends within the study or at a particular 
site. 
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, 
study compliance, number of adverse events, number of deviations, findings from previous 
monitoring visits and any suspected inconsistency in data that requires investigation. 
Regulatory documents may be reviewed at each study site. Monitoring for the study will be 
done in accordance to the study monitoring plan. Monitoring will be based on the Key Risk 
Indicators (Risk Based Monitoring) as described in the Risk Based Monitoring Plan. 
 
 

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21. ABBREVIATIONS AND DEFINITIONS 
21.1 Abbreviations 
Abbreviation 
Terminology 
ABI 
Ankle Brachial Index 
ACC/AHA 
American College of Cardiology/American Heart Association 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BSC 
Boston Scientific Corporation 
CE 
Conformité Européenne (meaning European Conformity) 
CEC 
Clinical Events Committee 
CIN 
Contrast-Induced Nephropathy 
CRF 
Case Report Form 
CVA 
Cerebrovascular Accident 
DES 
Drug Eluting Stent 
DUS 
Duplex Ultrasound 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDAAA 
Food and Drug Administration Amendments Act 
ICF 
Informed Consent Form 
ITT 
Intent to Treat 
MAE 
Major Adverse Event 
PPA 
Proximal Popliteal Artery 
PSVR 
Peak Systolic Velocity Ratio 
PTA 
Percutaneous Transluminal Angioplasty 

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Abbreviation 
Terminology 
QA 
Quantitative Angiography 
RCC 
Rutherford-Becker clinical classification 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SDS 
Stent Delivery System 
SFA 
Superficial Femoral Artery 
TBI 
Tibial Brachial Index 
TLR 
Target Lesion Revascularization 
TVR 
Target Vessel Revascularization 
UADE 
Unanticipated Adverse Device Effect 
VIVA 
Vascular InterVentional Advances 
WIQ 
Walking Impairment Questionnaire 
6MHW 
Six Minute Hall Walk 
 
 

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21.2 Definitions 
Term 
Definition 
AMPUTATION 
• 
Major Amputation: amputation of the lower limb at the ankle 
level or above. 
• 
Minor Amputation: amputation of the lower limb below the ankle 
level, i.e. forefoot or toes. 
ANKLE-BRACHIAL 
INDEX (ABI) 
The ratio between the systolic pressure measured at the ankle and 
the systolic pressure measured in the arm as follows:  
• 
Ankle: The systolic pressure will be measured in the target limb 
at the arteria dorsalis pedis and/or the arteria tibialis posterior. 
If both pressures are measured, the highest pressures will be 
used for the ABI calculation.  
• 
Brachial: The systolic pressure will be measured in both arms, 
and the highest of both pressures will be used for the ABI 
calculation. 
ASSISTED 
PRIMARY 
PATENCY 
Percentage (%) of lesions without TLR and those with TLR (not 
due to complete occlusion or by-pass) that reach endpoint without 
restenosis. 
CALCIFICATION 
Readily apparent densities seen within the artery wall and site of 
lesion as an x-ray-absorbing mass. 
CEREBRO-
VASCULAR 
ACCIDENT (CVA) 
An acute symptomatic episode of neurological dysfunction 
attributed to a vascular cause lasting more than 24 hours or lasting 
24 hours or less with a brain imaging study or autopsy showing 
infarction.  
COMPLICATION 
An undesirable clinical event that results in death, injury, or 
invasive intervention. Complications may include, but are not 
limited to perforation, occlusion, intimal flap, dissection, loss of side 
branch, distal embolization, hypotension, hematoma, arrhythmias, 
etc. Complications may or may not be related to the device(s). 

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Term 
Definition 
DEATH 
All deaths are considered cardiac unless an unequivocal non-
cardiac cause can be established. Specifically, an unexpected 
death in subjects with coexisting potentially fatal non-cardiac 
diseases (e.g. Cancer, infection) should be classified as cardiac. 
All death events will be submitted to CEC and will be categorized 
as: 
Cardiac death: any death due to immediate cardiac cause (e.g. MI, 
low-output failure, fatal arrhythmia). Unwitnessed death and death 
of unknown cause will be classified as cardiac death. This includes 
all procedure related deaths including those related to concomitant 
treatment. 
Vascular death: death due to cerebrovascular disease, pulmonary 
embolism, ruptured aortic aneurysm, dissecting aneurysm, or other 
vascular cause. 
Non-cardiovascular death:  any death not covered by the above 
definitions, including death due to infection, sepsis, pulmonary 
causes, accident, suicide, or trauma. 
DIAMETER 
STENOSIS 
The maximal narrowing of the target lesion relative to the reference 
vessel diameter. 
DISSECTION- 
NHLBI GRADE 
TYPES 
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 or 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 vessel occlusion. 
DISTAL 
EMBOLIZATION 
Migration of a filling defect, or thrombus, to distally occlude the 
target vessel or one of its branches. 

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Term 
Definition 
EQ-5D-5L™ 
Descriptive system of health-related quality of life states consisting 
of the EQ-5D descriptive system and the EQ visual analogue scale 
(EQ VAS). The EQ-5D consists of five dimensions (mobility, self-
care, usual activities, pain/discomfort, anxiety/depression) each of 
which can take one of five responses. The responses record five 
levels of severity (no problems/slight problems/moderate 
problems/severe problems/extreme problems) within a particular 
EQ-5D dimension. The EQ VAS records the respondent’s self-
rated health on a vertical, visual analogue scale where the 
endpoints are labelled ‘Best imaginable health state’ and ‘Worst 
imaginable health state’. This information can be used as a 
quantitative measure of health outcome as judged by the individual 
respondents. 
HEMATOMA 
A localized swelling filled with blood resulting from a break in a 
blood vessel. 
HEMODYNAMIC 
IMPROVEMENT 
Improvement of ABI by ≥0.1 or to an ABI ≥ 0.90 as compared to the 
pre-procedure value without the need for repeat revascularization. 
HYPOTENSION 
Systolic blood pressure < 80 mmHg lasting more than 30 minutes 
or requiring intervention (e.g. pacing, IABP, intra venous 
vasopressors to sustain systolic blood pressure). This excludes 
transient hypotension or vagal reactions, which are self-limited or 
readily reversible. 
INTIMAL FLAP 
An extension of the vessel wall into the arterial lumen.  
LESION LENGTH 
Measured as the distance from the proximal shoulder to the distal 
shoulder of the lesion, in the view that demonstrates the stenosis in 
its most elongated projection. 
MAJOR ADVERSE 
EVENT (MAE) 
MAE is defined as all causes of death, target limb major 
amputation and/or Target Lesion Revascularization (TLR) 
PERFORATION 
Perforations are classified as follows: 
Angiographic perforation: perforation detected by the clinical site 
or Angiographic Core Laboratory at any point during the procedure. 
Clinical perforation: perforation requiring additional treatment 
(including efforts to seal the perforation), or resulting in significant 
hemodynamic compromise, abrupt closure, or death. 

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Term 
Definition 
PRIMARY 
PATENCY 
Percentage (%) of lesions that reach endpoint without a 
hemodynamically significant stenosis on DUS and without TLR or, 
bypass of the target lesion. 
PRIMARY 
SUSTAINED 
CLINICAL 
IMPROVEMENT 
Endpoint determined to be a success when there is an 
improvement in Rutherford classification of one or more categories 
as compared to pre-procedure without the need for repeat TLR. 
PROCEDURAL 
SUCCESS 
Technical success with no MAEs noted within 24 hours of the index 
procedure. 
PSEUDO-
ANEURYSM 
An encapsulated hematoma in communication with an artery. 
REPEAT 
INTERVENTION 
(PERCUTANOUS 
AND/OR 
SURGERY) 
Either repeat percutaneous transluminal angioplasty (PTA) or 
artery bypass surgery, performed subsequently to the subject 
leaving the cath lab after the index procedure.  
REFERENCE 
VESSEL 
DIAMETER (RVD) 
OF NORMAL 
ARTERY 
SEGMENT 
Angiographic measurement of the artery proximal and/or distal to 
the lesion intended for treatment. 
RESTENOSIS 
DUS systolic velocity ratio (SVR) >2.4 suggest stenosis >50%. 

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Term 
Definition 
RUTHERFORD / 
BECKER 
CLASSIFICATION 
Categor
y 
Clinical Description 
Objective Criteria 
0 
Asymptomatic 
Normal Treadmill /stress test 
1 
Mild claudication 
Completes treadmill exercise; 
ankle pressure (AP) after 
exercise <50mm Hg, but >25 mm 
Hg less than BP 
2 
Moderate claudication 
Between categories 1 and 3 
3 
Severe claudication 
Cannot complete treadmill 
exercise and AP after exercise 
<50 mm Hg 
4 
Ischemic rest pain 
Resting AP <40 mm Hg, flat or 
barely pulsatile ankle or 
metatarsal pulse volume 
recording (PVR); toe pressure 
(TP) <30 mm Hg 
5 
Minor tissue loss – 
nonhealing ulcer, focal 
gangrene with diffuse 
pedal edema 
Resting AP <60 mm Hg, ankle or 
metatarsal (MT) PVR flat or 
barely pulsatile; TP <40 mm Hg  
6 
Major tissue loss – 
extending above TM level 
Same as Category 5 
SECONDARY 
SUSTAINED 
CLINICAL 
IMPROVEMENT 
Endpoint determined to be a success when there is an 
improvement in Rutherford classification of one or more categories 
as compared to pre-procedure including those subjects with repeat 
TLR. 
SOURCE DATA 
All information in original records and certified copies of original 
records of clinical findings, observations, or other activities in a 
clinical investigation, necessary for the reconstruction and 
evaluation of the trial. Source data are contained in the source 
documents (original records or certified copies). 
SOURCE 
DOCUMENT 
Original documents, data or records. 
Examples:  Hospital records, laboratory notes, device 
accountability records, photographic negatives, radiographs, 
records kept at the investigation site, at the laboratories and at the 
medico-technical departments involved in the clinical investigation. 

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Term 
Definition 
STENT FRACTURE 
A break in one or more places of the stent.  The following 
definitions will be used to determine the type and extent of stent 
fracture (to be assessed by the x-ray core laboratory):3 
• 
Grade 0: No Strut fractures  
• 
Grade I: single strut fracture 
• 
Grade II: multiple strut fractures 
• 
Grade III: stent fracture(s) with preserved alignment of the 
components 
• 
Grade IV: stent fracture(s) with mal-alignment of the 
components 
• 
Grade V: Stent fracture(s) in a trans-axial spiral configuration 
STENT 
THROMBOSIS 
The occurrence of either of the following: 
1. Angiographic documentation (or any other imaging modality if 
angiography not available) of an acute, complete occlusion of a 
previously successfully treated lesion and/or 
2. Angiographic documentation (or any other imaging modality if 
angiography not available) of a flow-limiting thrombus within, or 
adjacent to, a previously successfully treated lesion  
Acute stent thrombosis is defined as occurring 24 hours following 
the clinical study procedure.  
Subacute stent thrombosis is defined as occurring >24 hours to 
30 days following the clinical study procedure.  
Late stent thrombosis is defined as >30 days to 365 days following 
the clinical study procedure. 
Very late stent thrombosis is defined as >365 days following the 
clinical study procedure. 
TARGET LESION 
A target lesion is identified as a clinical study lesion intended to be 
treated with a test or control device during the index procedure. 

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Term 
Definition 
TARGET LESION 
REVASCULARIZAT
ION (TLR) 
Any surgical or percutaneous intervention to the target lesion(s) 
after the index procedure when one of the following situations is 
present:  
 
• 
A target lesion revascularization will be considered clinically-
driven if it occurs within 5 mm proximal or distal to the original 
treatment segment with diameter stenosis 50% by quantitative 
angiography (QA) and the subject has recurrent symptoms (≥ 1 
change in Rutherford Classification or associated with 
decreased ABI/TBI of ≥ 20% or ≥ 0.15 in the treated segment. 
TBI allowed in cases of incompressible vessels.) 
• 
A target lesion revascularization for an in-lesion diameter 
stenosis less than 50% might also be considered a MAE by the 
CEC if the subject has recurrent symptoms (≥ 1 change in 
Rutherford Classification or associated with decreased ABI/TBI 
of ≥ 20% or ≥ 0.15 in the treated segment. TBI allowed in cases 
of incompressible vessels.) 
TARGET VESSEL 
Target vessel is defined as the vessel containing the target 
lesion(s).  If the target lesion is entirely within the right superficial 
femoral artery, then the target vessel is the right superficial femoral 
artery.  If the target lesion extends from the right superficial femoral 
artery into the right proximal popliteal artery, then both the right 
superficial femoral artery and right proximal popliteal artery would 
be considered part of the target vessel. 
TARGET VESSEL 
REVASCULARIZAT
ION (TVR) 
Any surgical or percutaneous intervention to the target vessel(s) 
after the index procedure when one of the following situations is 
present:  
  
• 
A target vessel revascularization will be considered as 
clinically-driven if the culprit lesion stenosis is 50% by QA and the 
subject has recurrent symptoms (≥ 1 change in Rutherford 
Classification or associated with decreased ABI/TBI of ≥ 20% or ≥ 
0.15 in the treated segment. TBI allowed in cases of 
incompressible vessels.) 
 

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Term 
Definition 
TRANSATLANTIC 
INTER-SOCIETAL 
CONSENSUS 
(TASC) LESION 
GUIDELINES 
Type A lesion: 
• 
Single stenosis  10 cm in length. 
• 
Single occlusion   5 cm in length. 
 
Type B lesion: 
• 
Multiple lesions (stenoses or occlusions), each  5cm 
• 
Single stenosis or occlusion   15cm not involving the infra 
geniculate popliteal artery 
• 
Single or multiple lesions in the absence of continuous tibial 
vessels to improve inflow for a distal bypass 
• 
Heavily calcified occlusion   5cm in length 
• 
Single popliteal stenosis 
 
Type C lesion: 
• 
Multiple stenoses or occlusions totaling > 15cm with or without 
heavy calcification 
• 
Recurrent stenoses or occlusions that need treatment after two 
endovascular interventions 
 
Type D lesion: 
• 
Chronic total occlusions of the CFA or SFA (>20cm, involving 
the popliteal artery) 
• 
Chronic total occlusion of the popliteal artery and proximal 
trifurcation vessels 
TECHNICAL 
SUCCESS 
Delivery and deployment of the assigned study stent to the target 
lesion to achieve residual angiographic stenosis no greater than 
30% assessed visually. 
THROMBUS 
(ANGIOGRAPHIC) 
Discrete, mobile intraluminal filling with defined borders 
with/without associated contrast straining; these are classified as 
either absent or present. 
TOTAL 
OCCLUSION 
Lesion with no flow; implies 100% diameter stenosis. 
VASCULAR 
COMPLICATION 
An occurrence of hematoma >5 cm, pseudoaneurysm, 
arteriovenous (AV) fistula, or need for vascular surgical repair. 

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Term 
Definition 
VESSEL PATENCY 
Freedom from more than 50% stenosis based on duplex ultrasound 
(DUS) peak systolic velocity ratio (PSVR) comparing data within 
the treated segment to the proximal normal arterial segment. A 
PSVR > 2.4 suggests >50% stenosis.  All DUS readings are 
assessed by an independent core lab. 
WALKING 
IMPAIRMENT 
QUESTIONNAIRE 
(WIQ) 
The WIQ is a functional-assessment questionnaire that evaluates 
walking ability with regard to speed, distance and stair climbing 
ability as well as the reasons that walking ability might be limited. 
Range of scores is between 0% and 100% with 100% being the 
best and 0% being the worst score. 
 
 
 
 

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