A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
Phase: NA
Conditions: Atherosclerosis of Native Arteries of the Extremities
Sponsor: Boston Scientific Corporation

THESE DOCUMENTS ARE THE PROPERTY OF BOSTON SCIENTIFIC CORPORATION AND SHALL NOT BE REPRODUCED, 
DISTRIBUTED, DISCLOSED OR USED FOR MANUFACTURE OR SALE OF APPARATUS WITHOUT THE EXPRESS WRITTEN 
CONSENT OF BOSTON SCIENTIFIC CORPORATION. 
Boston Scientific 
IMPERIAL Clinical Trial Protocol 
91064058 Rev/Ver AC 
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IMPERIAL
 
A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® PTX® stent 
for treatment of superficiAL femoral and/or proximal popliteal arteries 
 
CLINICAL PROTOCOL 
Study Reference Number S2063 
IDE Number G150171 
 
Sponsored By 
Boston Scientific Corporation 
300 Boston Scientific Way 
Marlborough, MA 01752 
 
European Authorized Representative 
Boston Scientific Limited 
Ballybrit Business Park 
Galway, Ireland 
 
Japanese Representative 
Boston Scientific Japan K.K. 
4-10-2, Nakano Nakano-ku 
Tokyo 164-0001, Japan 
 
New Zealand Representative 
Boston Scientific (Australia) Pty Ltd 
PO Box 322 
Botany 
NSW 1455, Australia 
 
 
 
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 Corporation. 
 
 

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IMPERIAL 
A randomIzed trial coMParing the Eluvia dRug-elutIng stent versus Zilver PTX 
stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
Contact Information 
Role 
Contact  
Clinical Contact 
Debra Jovanovich 
Sr. Clinical Trial Manager 
Peripheral Interventions 
1 Scimed Place 
Maple Grove, MN  55311 
Debra.Jovanovich@bsci.com 
 
Lieve Cornelis 
Clinical Trial Manager 
Green Square 
Lambroekstraat 5D 
1831 Diegem 
Belgium 
Lieve.Cornelis@bsci.com 
 
Rieko Kuribayashi 
Boston Scientific Japan KK 
Project Manager, Project Management 
4-10-2, Nakano Nakano-ku 
Tokyo 164-0001, Japan 
Rieko.Kuribayashi@bsci.com 
 
Coordinating Principal 
Investigator 
William Gray, MD 
System Chief of the Division of Cardiovascular Disease 
Main Line Health 
President, Lankenau Heart Institute 
100 Lancaster Avenue, Suite 356 MOB EAST 
Wynnewood, PA  19096 
 
Coordinating 
Co-Principal 
Investigator 
Prof. Dr. med Stefan Müller-Hülsbeck 
Director and Chairman, Vascular Center 
Head of the Department of Diagnostic and Interventional 
Radiology/Neuroradiology 
Ev. Luth. Diakonissenanstalt Flensburg 
Knuthstrasse 1 
24939 Flensburg 

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Germany 
Investigational Sites 
A list of investigational sites is provided in the Manual Of 
Operations. 
A list of investigational sites in Japan is provided as a separate 
attachment to the protocol for Japanese sites only. 
Vendors/Labs 
A list of vendors/labs involved in the trial is provided in the Manual 
Of Operations. 
 
 
Original Release: July 20, 2015 
Current Version: March 7, 2016 
 
Revision History 
Revision 
Number 
Release 
Date 
Section 
Change 
Reason for Change 
AB 
10-Sep-2015 
1. Title Page 
IDE number and Revision 
History added. 
Administrative change 
for new information. 
2. Synopsis, 11.6 
Required Concomitant 
Medications 
Monotherapy antiplatelet 
requirement clarified.  
Required through 12 months 
and recommended through 60 
months. 
Typographical error 
between synopsis and 
protocol section. 
Entire Protocol 
Align use of efficacy and 
effectiveness. 
Revisions to address 
FDA comments on IDE 
submission. 
2. Synopsis, 12. 
Statistical 
Considerations 
Remove sequential 
hypothesis testing and update 
sensitivity analysis. 
2. Synopsis, 11.12 
Assessment of Whole 
Blood Paclitaxel 
Levels, 13.3 Core 
Laboratories 
Addition of 48/72 hour blood 
draw, increase in subject 
enrollment for PK substudy, 
and increase in number of 
allowed PK sites in US. 
Revisions to address 
FDA comments on IDE 
submission. 
11.15 Missed or Late 
Visits 
Addition of patient locator 
service for missed annual 
visits. 
Revisions to address 
FDA comments on IDE 
submission. 
19.2.Risks Associated 
with the Study 
Device(s) Unique to 
Paclitaxel 
Reference to side effects 
reported by the chemotherapy 
subjects removed. 
Clarification to include 
both paclitaxel and the 
polymer coating in this 
section. 
AC 
7-Mar-2016 
1. Contact Information 
Updated contact for the 
coordinating principal 
investigator Dr. William A. 
Gray. 
Updated due to a move. 

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Revision History 
Revision 
Number 
Release 
Date 
Section 
Change 
Reason for Change 
2. Protocol Synopsis 
Updated to include overview 
of the Long Lesion Substudy 
Updated with overview 
of the Long Lesion 
Substudy 
4.1 Clinical 
Development Program 
Added “and received CE 
Mark Certification in 
February 2016” To paragraph 
2. 
New device approval 
received in February 
2016. 
4.1.4 MAJESTIC First 
Human Use Trial 
Added 12 month MAJESTIC 
results to paragraphs 3 and 4. 
New data available from 
the MAJESTIC study. 
5.1 ELUVIA Drug-
Eluting Stent System 
Added “CE Mark 
Certification for the ELUVIA 
stent system was obtained in 
February 2016” To paragraph 
2. 
New device approval 
received in February 
2016. 
5.4. Device Labeling 
of Investigational 
Device 
Addition and Revision of the 
information appear on the 
product labeling. 
Specify the information 
specific to the Japan 
labels. 
7.1. Primary 
Endpoints 
Primary Effectiveness 
endpoint: correct the 
language for clinically-driven 
TLR (…for ≥50% 
angiographic diameter 
stenosis) 
Correct prior error. 
8.4. Justification for 
the Study Design 
Correct the statement of 
monotherapy antiplatelet 
requirement  
Correct prior error to 
align with the last 
change for monotherapy 
antiplatelet requirement. 
11.9 End of  the Index 
Procedure 
Correct the language of 
removal of the guide catheter 
at end of procedure. 
Correct prior error. 
20. Safety Reporting 
Section updated to include 
MEDDEV 2.7/3 (2015) 
requirements 
Updated with new 
MEDDEV guidelines. 
27. Abbreviations and 
Definitions 
Correct definition for 
Assisted Primary Patency and 
Primary Patency (addition of 
clinically-driven) 
Definition is now 
consistent with 
endpoints and text 
throughout document. 
28. Long Lesion 
Substudy 
Added the Long Lesion 
Substudy 
New substudy to treat 
long lesions. 

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2. Protocol Synopsis 
IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
Objective(s) 
To evaluate the safety and effectiveness of the Boston Scientific Corporation 
(BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for 
treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery 
(PPA) lesions up to 140 mm in length. 
Long Lesion Substudy: To evaluate the safety and effectiveness of the Boston 
Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System 
(ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or 
Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length. 
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 140 mm.  
Long Lesion Substudy: 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 190 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 The Zilver PTX Stent (Cook Medical, Bloomington, IN) is a self-expanding 
nitinol stent coated with the drug paclitaxel and 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.  
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 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
guidewires.  
Zilver PTX Stent (Control Device) 
The Zilver PTX Stent is commercially available in all geographic regions 
included in this global trial.  To meet all inclusion and exclusion criteria, 
Zilver PTX stent diameters of 6 and 7 mm will be allowed in this trial.  
Available Zilver PTX stent lengths range between 20 mm to 120 mm.  Use of 
two overlapping Zilver PTX stents is allowed according to the device 
Instructions for Use (IFU). The system is also available in two SDS sizes; 80 
cm and 125 cm.  The sheath compatibility is also 6 French used with 0.035 
inch guidewires. 
Study Design 
A global, prospective, multi-center trial evaluating the safety and 
effectiveness of the ELUVIA stent versus 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, non-randomized, single-arm, pharmacokinetic (PK) 
substudy and a concurrent, non-blinded, non-randomized, Long Lesion 
substudy. A subject can be enrolled in either the RCT or the PK substudy. A 
subject cannot be enrolled in both of these studies.  
If a subject’s target lesion is longer than that allowed in the RCT and PK 
substudy, the subject may be enrolled in the Long Lesion substudy. 
If a subject is enrolled in the Long Lesion substudy at a site conducting the 
PK substudy and the subject is willing to undergo PK testing, they will also 
follow the blood draw schedule for the PK substudy. 
Planned 
Number of 
Subjects 
Approximately 527-535 subjects will be enrolled in the IMPERIAL trial. 
 465 subjects to receive treatment with either an investigational test device 
(ELUVIA, N=310 subjects) or a control device (Zilver PTX, N=155 
subjects) in the RCT 
 12-20 subjects to receive treatment with the investigational test device 
(ELUVIA) in the PK substudy 
 50 subjects to receive treatment with the investigational test device 
(ELUVIA) in the Long Lesion substudy 
Planned 
Up to 75 study centers worldwide may enroll subjects in the RCT. Regions 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
Number of 
Centers / 
Regions 
that may participate include, but are not limited to, the United States, Canada, 
European Union, Japan and New Zealand. 
Approximately 10 study centers in the US may enroll subjects in the PK 
substudy. 
Any study center participating in the RCT may opt to also enroll subjects in 
the Long Lesion substudy. 
Primary 
Endpoints 
Primary Safety Endpoint 
The primary safety endpoint assesses the occurrence of Major Adverse 
Events (MAEs) defined as all causes of death through 1 month, target limb 
major amputation through 12 months and/or target lesion revascularization 
(TLR) through 12 months.  This safety endpoint is designed to demonstrate 
that the 12-month MAE-free rate for the ELUVIA treatment group is non-
inferior to the control group. 
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 non-
inferior to the Zilver PTX 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.  
Additional 
Endpoints 
 Technical success 
 Procedural success 
 MAE rate at 1 month post-index procedure defined as all causes of death, 
target limb major amputation and/or TLR 
 Primary Patency and Assisted Primary Patency at 6 months, 12 months, 
24 months and 60 months using different 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 
 Non-serious, non-device/procedure-related Adverse Event Rates at each 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
time point through 12 months 
 Stent Fracture Rate at 12 months, 24 months and 60 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 60 months 
 Rate of Primary and Secondary Sustained Clinical Improvement as 
assessed by changes in Rutherford Classification from baseline at 1, 
month, 6 months, 12 months, 24 months and 60 months 
 Rate of Hemodynamic Improvement as assessed by changes in Ankle-
Brachial Index (ABI) from baseline at 1 month, 6 months, 12 months, 24 
months and 60 months 
 Walking Improvement at 12 months assessed by change in Six Minute 
Hall Walk (6MHW) from baseline 
 Walking Improvement and Patient Utility Values assessed at 1 month, 6 
months, 12 months, 24 months and 60 months assessed by change in 
Walking Impairment Questionnaire (WIQ) and EQ-5D™ from baseline 
 Changes in healthcare utilization over time  
 PK parameters calculated for subjects in the PK substudy 
Method of 
Assigning 
Patients 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 RCT or PK substudy.  
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 or receive an investigational device, nor should the 
subject be followed post-procedure per protocol.  
For the RCT, 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 site. After the Investigator successfully crosses the target 
lesion with the guidewire, a randomization custom function within the Rave 
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). 
In the PK substudy and the Long Lesion substudy, subjects will not be 
randomized; all subjects will be treated with the ELUVIA stent. In the PK 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
substudy, subjects will be considered enrolled when the ELUVIA stent is 
introduced into the subject’s vasculature. In the Long Lesion substudy, 
subjects will be considered enrolled when the first ELUVIA stent is 
introduced into the subject’s vasculature. 
Blinding/ 
Unblinding 
IMPERIAL RCT 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 investigational control and test 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. 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 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 Manual of Operations. 
Follow-up 
Schedule 
All RCT, PK substudy, and Long Lesion substudy subjects will be evaluated 
at 1 (30 ±7 days), 6 (182 ±30 days), 12 (365 ±30 days), 24 (730 ±30 days), 36 
(1095 ±30 days), 48 (1460 ±30 days) and 60 (1825 ±30 days) months post-
procedure. 
 Subjects who are randomized but an ELUVIA stent or Zilver PTX 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 safety and effectiveness endpoints will occur 
at the 12-month follow-up visit. 
 All follow-up visits will be conducted in the office/clinic with the 
exception of long-term follow-up visits conducted 36 months (3 years) 
and 48 months (4 years) post-procedure which may be conducted either in 
the office/clinic or via telephone contact. 
Planned protocol-required testing includes the following: 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
 PK substudy subjects will have baseline venous blood drawn followed by 
blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and 
one final blood draw at either 48 hours or 72 hours after placement of the 
ELUVIA stent. Angiography during the index procedure to assess 
technical success and procedural success. 
 DUS at 6 months, 12 months (1 year), 24 months (2 years), and 60 
months (5 years) visits to assess lesion and vessel patency. 
 X-rays at 12 months (1 year), 24 months (2 years), and 60 months (5 
years) visits to assess stent integrity. 
Study Duration The trial 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. 
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 7 years to complete this trial. 
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 compliance for the 
duration of the trial. 
Minimum requirements include: 
 Anti-coagulation therapy administered during the procedure should be 
consistent with current clinical practice. 
 Clopidogrel or ticlopidine starting at least 24 hours prior to the procedure 
or a peri-procedural loading dose (recommended loading dose of 300 mg 
clopidogrel or 200 mg ticlopidine) is given within 2 hours after the end of 
the procedure.   
 Daily administration of aspirin (recommended dose of at least 75 mg) and 
clopidogrel (75 mg) or ticlopidine (200 mg) for the first 60 days post-
index procedure.   
 Antiplatelet monotherapy is required through the 12 month (1 year) 
follow-up and recommended through the 60 month (5 year) follow-up 
(trial completion). 
Note: a subject could be exempt of antiplatelet requirements if he/she 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
requires Coumadin or other similar anti-coagulant due to known 
comorbidities and in the opinion of the investigator the combination of dual 
anti-platelet therapy (DAPT) and anticoagulation could pose an intolerable 
bleeding risk. 
Key Inclusion 
Criteria 
1. Subjects age 18 and older.  
2. Subject (or Legal Guardian if applicable) 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. 
NOTE:  For subjects less than 20 years of age enrolled at a Japanese 
center, the subject’s legal representative, as well as the subject, must 
provide written informed consent. 
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  140 mm 
(Note:  Lesion segment(s) must be fully covered with one 
ELUVIA stent or up to two Zilver PTX stents) 
Long Lesion Substudy:  Total lesion length (or series of lesions) 
>140 mm and  190 mm (Note:  Lesion segment(s) will require 
overlapping of two ELUVIA stents). 
d. For occlusive lesions requiring use of re-entry device, lesion 
length ≤ 120 mm 
Long Lesion Substudy:  For occlusive lesions requiring use of re-
entry device, lesion length > 120 mm and ≤ 170 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. 
Key Exclusion 
Criteria 
1. Previously stented target lesion/vessel. 
2. Target lesion/vessel previously treated with drug-coated balloon < 12 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
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 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 trial, limit the subject’s compliance with the follow-up 
requirements, or impact the scientific integrity of the clinical trial. 
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 investigational 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 another 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 within 30 days of 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
randomization/enrollment. 
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. 
Multiple 
Interventions 
Using Same 
Access Site 
During Index 
Procedure 
Contralateral Limb 
 Iliac lesion(s) in the contralateral limb may be treated during the index 
procedure  under the following conditions: 
− Treatment with a commercially available device occurs prior to 
randomization/enrollment of the target SFA/PPA lesion, and 
− Treatment of the iliac lesion(s) is deemed an angiographic success 
without clinical sequelae (success is measured as <30% residual 
stenosis by visual estimation) 
Target Limb 
 Additional non-target iliac lesions in the target limb  may be treated 
during the index procedure  under the following conditions: 
− Treatment with a non-drug-eluting commercially available device 
occurs prior to randomization/enrollment of the target SFA/PPA 
lesion and 
− Treatment of the iliac lesion is deemed an angiographic success 
without clinical sequelae (success is measured as <30% residual 
stenosis by visual estimation) 
 Tandem lesions in the SFA/PPA may be treated during the index 
procedure, provided that the tandem lesions segment is  140 mm and can 
be covered with only one ELUVIA stent or up to two Zilver PTX stents 
according to each device’s Directions for Use/Instructions for Use 
(DFU/IFU). (Refer to Inclusion criterion 4c.) 
Long Lesion Substudy: Tandem lesions in the SFA/PPA may be treated 
during the index procedure, provided that the tandem lesions segment is > 
140 mm and  190 mm and can be covered with two ELUVIA stents 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
according to the Directions for Use (DFU). (Refer to Inclusion criterion 
4c.) 
 If a second or third stent is required due to complications (e.g., dissection, 
misplacement or under-sizing of the target lesion), the additional stent(s) 
placed should be a study stent of the same type used to treat the target 
lesion. 
Statistical Methods for the RCT 
Primary Safety 
Statistical 
Hypothesis 
The primary safety hypothesis to be tested is that the 12-month MAE-free 
rate in subjects treated with ELUVIA is non-inferior to subjects treated with 
Zilver PTX by a margin of -10% (negative value) at one-sided significance 
level of 5%. 
Primary Safety 
Statistical Test 
Method 
A Farrington-Manning test will be used to assess the one-sided hypothesis of 
non-inferiority in proportions: 
H0: Pt - Pc   ∆ (inferior) 
H1: Pt - Pc  > ∆ (non-inferior) 
where Pt and Pc are the 12-month MAE-free rates for the ELUVIA (test) and 
Zilver PTX (control) groups, respectively, and Δ (delta) is the non-inferiority 
margin of -10% . 
Primary 
Effectiveness 
Statistical 
Hypothesis 
The primary effectiveness hypothesis to be tested is that the 12-month 
primary patency in subjects treated with ELUVIA is non-inferior to subjects 
treated with Zilver PTX by a margin of -10% (negative value) at one-sided 
significance level of 5%. 
Primary 
Effectiveness 
Statistical Test 
Method 
A Farrington-Manning test will be used to assess the one-sided hypothesis of 
non-inferiority in proportions: 
H0: Pt - Pc   ∆ (inferior) 
H1: Pt - Pc  > ∆ (non-inferior) 
where Pt and Pc are the 12-month primary patency for the ELUVIA (test) and 
Zilver PTX (control) groups, respectively, and Δ (delta) is the non-inferiority 
margin of -10%. 
Success 
Criteria for the 
Success Criteria for Primary Safety Endpoint 
ELUVIA will be concluded to be non-inferior to Zilver PTX for device safety 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
RCT 
if the one-sided lower 95% confidence bound on the difference between 
treatment groups (ELUVIA – Zilver PTX) in 12-month MAE-free is greater 
than -0.1. 
Success Criteria for Primary Effectiveness Endpoint 
ELUVIA will be concluded to be non-inferior to Zilver PTX for device 
effectiveness if the one-sided lower 95% confidence bound on the difference 
between treatment groups (ELUVIA – Zilver PTX) in 12-month primary 
patency is greater than -0.1. 
Success Criteria for the RCT 
If the primary safety and the primary effectiveness endpoints are both met, 
the RCT will be considered a success and both device safety and 
effectiveness will be claimed globally. 
Sample Size 
Parameters 
The primary effectiveness endpoint drives the overall sample size. 
Primary Effectiveness Endpoint 
 Power ≥ 80% 
 One-sided significance level (alpha) = 5% 
 Expected ELUVIA 12-month primary patency = 83%  
 Expected Zilver PTX 12-month primary patency = 83% 
 Non-inferiority margin (Δ) = -10%* 
 Allocation (ELUVIA vs. Zilver PTX) = 2:1 
 Attrition rate in 12 months = 15% 
 N = 393 (total) evaluable subjects are required at 12 months (262 
ELUVIA, 131 Zilver PTX) 
 N = 465 (total) subjects are required to be randomized at enrollment (310 
ELUVIA, 155 Zilver PTX) 
*The 10% margin only allows at maximum a 3% difference in observed rates. Assuming 12-
month primary patency of 83.2% (109/131) for Zilver PTX is observed, a minimum 12-
month primary patency of 80.2% (210/262) for ELUVIA will be required to claim non-
inferiority with margin of -10%.   
Primary Safety Endpoint 
 One-sided significance level (alpha) = 5% 
 Expected ELUVIA 12-month MAE-free rate = 90%  
 Expected Zilver PTX 12-month MAE-free rate = 90% 

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IMPERIAL: A randomIzed trial coMParing the ELUVIA™ dRug-elutIng stent versus Zilver® 
PTX® stent for treatment of superficiAL femoral and/or proximal popliteal arteries 
 Non-inferiority margin (Δ) = -10%** 
 Overall sample size is driven by the primary effectiveness endpoint to 
provide at least 92% power to assess the primary safety endpoint 
**The 10% margin only allows at maximum a 4% difference in observed rates. Assuming a 
12-month MAE-free rate of 90.1% (118/131) for Zilver PTX is observed, a minimum 12-
month MAE-free rate of 85.9% (225/262) for ELUVIA will be required to claim non-
inferiority with margin of -10%.   
Sample Size 
and Statistical 
Method for PK 
Substudy 
In order to support the stated objectives for the PK substudy, the sample size 
for this substudy will be 12-20 subjects. 
Descriptive statistics will be presented to describe the PK substudy results. 
Sample Size 
and Statistical 
Method for 
Long Lesion 
Substudy 
The primary effectiveness endpoint assesses the 12-month primary patency. 
There is a non-statistically driven goal (60%) which was developed from the 
historical long stent performance (47.2%; 95% Confidence Interval [30.4%, 
64.5%]) in subjects treated with Innova Bare Metal Stent System and the 
expected enhanced performance (10%) for the ELUVIA Stent System.  
 
 
 

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3. Table of Contents 
1. 
TITLE PAGE  ........................................................................................................................ 1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................... 5 
3. 
TABLE OF CONTENTS ........................................................................................................ 17 
3.1. Table of Figures ...................................................................................................... 22 
3.2. Table of Tables ....................................................................................................... 22 
4. 
INTRODUCTION ................................................................................................................. 24 
4.1. Clinical Development Program ............................................................................. 26 
 
Innova Stent System .................................................................................. 27 
4.1.1.
 
PROMUS Element /PROMUS Element Plus ............................................ 27 
4.1.2.
 
TAXUS Element/ION ............................................................................... 28 
4.1.3.
 
MAJESTIC First Human Use Trial ........................................................... 28 
4.1.4.
 
Summary .................................................................................................... 29 
4.1.5.
5. 
DEVICE DESCRIPTION ....................................................................................................... 29 
5.1. ELUVIA Drug-Eluting Stent System (Investigational Device) .......................... 29 
5.2. Investigational Device Component Description .................................................. 30 
 
Drug Component Description .................................................................... 31 
5.2.1.
5.2.1.1. 
Paclitaxel Drug.......................................................................... 31 
5.2.1.2. 
Primer Polymer and Drug Matrix Copolymer Carrier .............. 31 
5.3. Zilver PTX Drug-Eluting Peripheral Stent (Control) ........................................ 32 
5.4. Device Labeling of Investigational Device ........................................................... 33 
6. 
OBJECTIVES ...................................................................................................................... 33 
7. 
ENDPOINTS ........................................................................................................................ 33 
7.1. Primary Endpoints ................................................................................................. 34 
7.2. Additional Endpoints ............................................................................................. 34 
8. 
DESIGN .............................................................................................................................. 35 
8.1. Scale and Duration ................................................................................................. 36 
8.2. Treatment Assignment........................................................................................... 39 

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8.3. Multiple Interventions Using Same Access Site During Index Procedure........ 40 
 
Contralateral Limb ..................................................................................... 40 
8.3.1.
 
Target Limb ............................................................................................... 40 
8.3.2.
8.4. Justification for the Study Design ......................................................................... 41 
9. 
SUBJECT SELECTION ......................................................................................................... 41 
9.1. Study Population and Eligibility ........................................................................... 41 
9.2. Inclusion Criteria ................................................................................................... 41 
9.3. Exclusion Criteria .................................................................................................. 42 
10. SUBJECT ACCOUNTABILITY .............................................................................................. 44 
10.1. Point of Enrollment ................................................................................................ 44 
10.2. Withdrawal ............................................................................................................. 44 
10.3. Enrollment Controls .............................................................................................. 45 
11. STUDY METHODS .............................................................................................................. 45 
11.1. Data Collection ....................................................................................................... 45 
11.2. Study Candidate Screening ................................................................................... 47 
11.3. Informed Consent .................................................................................................. 47 
11.4. Pre-Procedure Assessments – Up to 30 Days ....................................................... 47 
11.5. Pre-Procedure Assessments – Up to 7 Days ......................................................... 48 
11.6. Required Concomitant Medications ..................................................................... 48 
11.7. Index Procedure ..................................................................................................... 49 
 Non-Target Limb (Contralateral) .............................................................. 49 
11.7.1.
 Target Limb (Treatment of Non-Target Lesions) ...................................... 49 
11.7.2.
 Randomization ........................................................................................... 49 
11.7.3.
 Target Lesion Stent Placement .................................................................. 50 
11.7.4.
11.8. Post-procedure Angiogram ................................................................................... 51 
11.9. End of the Index Procedure .................................................................................. 52 
11.10. 
Post-procedure/Pre-hospital Discharge ................................................. 52 
11.11. 
Angiography ............................................................................................. 52 
11.12. 
Assessment of Whole Blood Paclitaxel Levels ....................................... 53 
11.13. 
Follow-up .................................................................................................. 53 
 1-Month Follow-up Visit (30 days ± 7 days) ............................................ 54 
11.13.1.

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 6-Month Follow-up Visit (182 days ± 30 days) ........................................ 54 
11.13.2.
 12-Month Follow-up Visit (365 days ± 30 days) ...................................... 55 
11.13.3.
 24-Month Follow-up Visit (730 days ± 30 days) ...................................... 55 
11.13.4.
 36-Month Follow-up Visit (1095 days ± 30 days) .................................... 56 
11.13.5.
 48-Month Follow-up Visit (1460 days ± 30 days) .................................... 56 
11.13.6.
 60-Month Follow-up Visit (1825 days ± 30 days) .................................... 56 
11.13.7.
11.14. 
Trial Completion ...................................................................................... 56 
11.15. 
Missed or Late Visits ............................................................................... 56 
11.16. 
Follow-up Visits (Japan only) ................................................................. 57 
11.17. 
Source Documents ................................................................................... 57 
12. STATISTICAL CONSIDERATIONS ....................................................................................... 57 
12.1. Primary Endpoints ................................................................................................. 57 
 Primary Effectiveness Endpoint ................................................................ 58 
12.1.1.
12.1.1.1. Hypotheses for RCT ................................................................. 58 
12.1.1.2. Sample Size for RCT ................................................................ 58 
12.1.1.3. Statistical Methods for RCT ..................................................... 59 
 Primary Safety Endpoints .......................................................................... 59 
12.1.2.
12.1.2.1. Hypotheses ................................................................................ 59 
12.1.2.2. Sample Size ............................................................................... 59 
12.1.2.3. Statistical Methods .................................................................... 60 
 Success Criteria ......................................................................................... 60 
12.1.3.
12.2. General Statistical Methods .................................................................................. 60 
 Analysis Sets .............................................................................................. 60 
12.2.1.
 Randomization Scheme ............................................................................. 61 
12.2.2.
 Control of Systematic Error/Bias ............................................................... 61 
12.2.3.
 Number of Subjects per Investigative Site ................................................ 61 
12.2.4.
12.3. Baseline Data Analyses .......................................................................................... 61 
 Additional Assessments/Measurements .................................................... 61 
12.3.1.
 Pharmacokinetics Parameters .................................................................... 62 
12.3.2.
 Interim Analyses ........................................................................................ 62 
12.3.3.
 Subgroup Analyses .................................................................................... 62 
12.3.4.
 Justification of Pooling .............................................................................. 63 
12.3.5.
 Sensitivity Analysis for Missing Data ....................................................... 63 
12.3.6.
 Multivariable Analyses .............................................................................. 63 
12.3.7.
 Analysis Software ...................................................................................... 64 
12.3.8.

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 Changes to Planned Analyses .................................................................... 64 
12.3.9.
13. DATA MANAGEMENT ........................................................................................................ 64 
13.1. Data Collection, Processing, and Review ............................................................. 64 
13.2. Data Retention ........................................................................................................ 64 
13.3. Core Laboratories .................................................................................................. 65 
14. AMENDMENTS ................................................................................................................... 65 
15. DEVIATIONS ...................................................................................................................... 66 
16. DEVICE/EQUIPMENT ACCOUNTABILITY .......................................................................... 66 
17. COMPLIANCE ..................................................................................................................... 67 
17.1. Statement of Compliance ....................................................................................... 67 
17.2. Investigator Responsibilities ................................................................................. 67 
 Delegation of Responsibility ..................................................................... 69 
17.2.1.
17.3. Institutional Review Board/ Independent Ethics Committee/Research Ethics 
Board ....................................................................................................................... 69 
17.4. Sponsor Responsibilities ........................................................................................ 69 
 Role of Boston Scientific Representatives ................................................ 70 
17.4.1.
17.5. Insurance ................................................................................................................. 70 
18. MONITORING ..................................................................................................................... 71 
19. POTENTIAL RISKS AND BENEFITS .................................................................................... 71 
19.1. Anticipated Adverse Events and Risks Associated with Use of the ELUVIA 
Stent System and Implantation of the ELUVIA Stent ........................................ 71 
19.2. Risks Associated with the Study Device(s) Unique to Paclitaxel ....................... 72 
19.3. Risks associated with Participation in the Clinical Study .................................. 73 
19.4. Possible Interactions with Concomitant Medical Treatments ........................... 73 
19.5. Risk Minimization Actions .................................................................................... 73 
19.6. Anticipated Benefits ............................................................................................... 73 
19.7. Risk to Benefit Rationale ....................................................................................... 73 
20. SAFETY REPORTING .......................................................................................................... 74 
20.1. Reportable Events by investigational site to Boston Scientific .......................... 74 

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20.2. Definitions and Classification ............................................................................... 75 
20.3. Relationship to Study Device(s) ............................................................................ 76 
20.4. Investigator Reporting Requirements .................................................................. 78 
20.5. Boston Scientific Device Deficiencies .................................................................... 79 
20.6. Reporting to Regulatory Authorities / IRBs / IECs / REBs / Investigators ...... 80 
21. INFORMED CONSENT......................................................................................................... 80 
22. COMMITTEES .................................................................................................................... 82 
22.1. Executive Committee ............................................................................................. 82 
22.2. Safety Monitoring Process ..................................................................................... 82 
22.3. Clinical Events Committee (CEC) ........................................................................ 82 
22.4. Independent Data Review (IDR) .......................................................................... 83 
23. SUSPENSION OR TERMINATION ........................................................................................ 83 
23.1 Premature Termination of the Study ................................................................... 83 
23.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRBs/IECs/REBs Approval ................................................................................... 84 
23.3 Requirements for Documentation and Subject Follow-up ................................. 84 
23.4 Criteria for Suspending/Terminating a Study Center ........................................ 84 
24. PUBLICATION POLICY ....................................................................................................... 84 
25. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS .................................................. 85 
25.1. Subject Reimbursement......................................................................................... 85 
25.2. Compensation for Subject’s Health Injury ......................................................... 85 
26. BIBLIOGRAPHY .................................................................................................................. 86 
27. ABBREVIATIONS AND DEFINITIONS .................................................................................. 88 
27.1. Abbreviations ......................................................................................................... 88 
27.2. Definitions ............................................................................................................... 90 
28. IMPERIAL LONG LESION SUBSTUDY ............................................................................. 99 
28.1. Objectives ................................................................................................................ 99 
28.2. Design ...................................................................................................................... 99 

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 Scale and Duration ..................................................................................... 99 
28.2.1.
 Treatment Assignment ............................................................................. 101 
28.2.2.
 Multiple Interventions Using Same Access Site During Index Procedure101 
28.2.3.
28.3. Subject Selection .................................................................................................. 101 
28.4. Subject Accountability ......................................................................................... 102 
28.5. Study Methods ...................................................................................................... 102 
28.6. Statistical Considerations .................................................................................... 103 
 Primary Endpoints ................................................................................... 103 
28.6.1.
28.6.1.1. Primary Effectiveness Endpoint ............................................. 103 
28.6.1.2. Primary Safety Endpoints ....................................................... 103 
 Additional Endpoints ............................................................................... 103 
28.6.2.
 
 
3.1. 
Table of Figures 
Figure 5.2-1: The Chemical Structure of Paclitaxel ............................................................... 31 
Figure 5.2-2: The Chemical Structure of PBMA .................................................................... 31 
Figure 5.2-3: The Chemical Structure of PVDF-HFP ............................................................ 32 
Figure 8.1-1: IMPERIAL RCT Design ................................................................................... 37 
Figure 8.1-2: IMPERIAL PK Substudy Design ..................................................................... 38 
Figure 28.2-1: IMPERIAL Long Lesion Substudy Design .................................................. 100 
 
3.2. 
Table of Tables 
Table 5-1: ELUVIA Stent System Product Description ......................................................... 30 
Table 5-2: Investigational Device Sizes ................................................................................. 30 
Table 5-3: Investigational and Control Product Comparison ................................................. 32 
Table 9-1: Inclusion Criteria ................................................................................................... 42 
Table 9-2: Exclusion Criteria .................................................................................................. 43 
Table 11-1: Data Collection Schedule .................................................................................... 46 
Table 11-2: Blood Draw Schedule for Analysis of Paclitaxel Pharmacokinetics .................. 53 
Table 20-1: Safety Definitions ................................................................................................ 75 
Table 20-2: Criteria for Assessing Relationship of Study Device or Index Procedure to AE 77 

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Table 20-3: Criteria for Assessing Relationship of Antiplatelet Medication to AE ............... 78 
Table 20-4: Investigator Reporting Requirements .................................................................. 78 
Table 27-1: Abbreviations ...................................................................................................... 88 
Table 27-2: Definitions ........................................................................................................... 90 
Table 28-1 Long Lesion Substudy Inclusion Criteria ........................................................... 102 
 

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4. Introduction 
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 8 million 
US and 200 million global patients with PAD (1) (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 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). 
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 
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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 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 
pharmaceutical ingredients 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). Zilver PTX is currently the only paclitaxel-eluting 
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Drug Eluting Peripheral Stents: Zilver PTX  
Zilver PTX is a self-expanding nitinol stent with a polymer-free paclitaxel coating for 
treating the above-the-knee femoropopliteal segment.  Results from the Zilver PTX 
randomized trial showed a positive effect of a paclitaxel-coated nitinol DES in treating 
lesions in femoropopliteal arteries (23). In the RCT, the primary DES group exhibited superior 
clinical safety and effectiveness when compared to the group randomized to treatment with 
PTA alone.  Primary patency at 12 months post-treatment was determined to be 83.1% in the 
group treated with Zilver PTX vs. 32.8% in the group treated with PTA. 
Dake et al also evaluated the Zilver PTX stent in a prospective, single-arm, multicenter 
clinical study (15). The study enrolled 787 patients with symptomatic (Rutherford category 2 - 
6) de novo or restenotic lesions of the above-the-knee femoropopliteal segment. The primary 
endpoint of the study was the event free survival (EFS), defined as freedom from major 
adverse events (MAE) and freedom from worsening of the Rutherford classification by 2 
classes or to class 5 or 6; secondary endpoints were stent patency and stent integrity. Nine 
hundred lesions (24.3% restenotic lesions) were treated with 1,722 Zilver PTX stents; the 
mean lesion length was 99.6 ± 82.1 mm. There were no procedural stent fractures, and the 6-
month and 12-month stent fracture rates were 1.2% (17/1,438 stents) and 1.5% (22/1,432 
stents), respectively. During 12 months of follow-up, ABI and Rutherford classification were 
significantly improved (p=0.001); the mean ABI improved from 0.6 ±0.3 to 0.9±0.2, and the 
median Rutherford classification improved from 3 to 0. 
The combined studies documented high rates of event free survival and primary patency with 
a low incidence of stent fractures and no paclitaxel related adverse events, and supported the 
safety and effectiveness of the Zilver PTX stent in patients with de novo or restenotic lesions 
of the above-the-knee femoropopliteal segment. The authors concluded that the Zilver PTX 
stent was effective in treating SFA lesions. Two-year outcomes from complimentary Zilver 
PTX studies continue to support sustained safety and effectiveness in patients with 
femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to 
provisional BMS placement (24). Five-year outcomes presented at the 2014 VIVA Congress 
showed a 5-year primary patency of 66.4%, a 48% reduction in reinterventions and a 41% 
reduction in restenosis compared to standard care (PTA or stenting data). 
4.1. 
Clinical Development Program 
Similar to the Zilver PTX stent system, an investigational paclitaxel-eluting, self-expanding 
nitinol stent purpose-built by Boston Scientific Corporation (BSC) for use in the 
femoropopliteal arteries has been developed.  
The ELUVIA Stent System leverages many successful BSC programs with global 
commercial approval for safe and efficacious use in subjects and received CE Mark 
Certification 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 
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Innova Stent System 
4.1.1.
The Innova (bare metal) Stent System has CE Mark Certification for the treatment of 
peripheral vascular lesions. 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 self-expanding stent is made of a nickel titanium alloy (nitinol). 
The SuperNOVA clinical trial is currently investigating the Innova Stent System in the 
superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) for worldwide 
regulatory approval.  The SuperNOVA clinical investigation is in the long term follow-up 
phase and is expected to be complete in 2016. Analysis of the 12 month primary endpoint 
data, related to both safety and effectiveness of the Innova Self-Expanding Stent System, is 
complete.  
The Innova Stent System demonstrated a good safety profile. Long-term (12 month) safety 
was evaluated using major adverse events (MAEs) defined as all causes of death through 1 
month, target limb major amputation through 12 months and/or target lesion 
revascularization through 12 months. The primary safety endpoint, MAE-free rate at 12 
months, is 85.8% with a 95% lower confidence bound of 81.1%. The established 
performance goal (PG) was 59.6%. The composite rate of MAEs, including all causes of 
death through 1 month, target limb major amputation and TLR through 12 months, was 
14.2% (38/268). MAEs occurred within acceptable and expected ranges and consisted of no 
deaths, 1 target limb major amputation (0.4%), and 38 TLRs (14.2%).  
The co-primary effectiveness analysis (1) assessed vessel primary patency in stented 
segments treated with the core matrix of stents (20 to 150 mm). The 12 month primary 
patency rate in the core stent matrix is 69.5% with a 95% lower confidence bound of 63.0%. 
The established PG was 66%. 
The co-primary effectiveness analysis (2) assessed vessel primary patency in stented 
segments treated with the entire stent matrix (20 to 200 mm). The 12 month primary patency 
rate in the entire stent matrix is 66.4% with a 95% lower confidence bound of 60.3%. The 
established PG for the entire matrix was 63%. 
Patency rates were influenced by a number of factors including the lesion length, lesion 
location, degree of calcification, and challenging outflow conditions. Treatment with the 
Innova Stent System provided significant improvement in the symptoms and quality of life of 
the subjects enrolled in the SuperNOVA study. The therapy showed a good safety profile and 
remarkable clinical outcomes despite the challenging anatomical characteristics of the 
lesions. 
 
PROMUS Element /PROMUS Element Plus 
4.1.2.
The ELUVIA stent system leverages the same drug coating polymers  used in the PROMUS 
(XIENCE V) and PROMUS Element/PROMUS Element Plus coronary stent platforms; the 
primer polymer of poly (n-butyl methacrylate) (PBMA) and active layer matrix polymer poly 

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(vinylidene fluoride-co- hexafluoropropylene) (PVDF-HFP). These polymers have a robust 
profile with long-term safety and effectiveness for use in drug delivery with coronary stents 
as studied in the PLATINUM clinical trials (25). 
Promus Element received CE Mark certification in October 2009 and PMA approval in 
November 2011 for coronary use. PMDA approval for work horse (WH) stents was received 
in February 2012 followed by approval for Promus Element Plus stents (2.25-3.5 mm) 
including long lesion (LL) size in September 2012. 
 
TAXUS Element/ION 
4.1.3.
BSC’s TAXUS I, TAXUS II and III trials provided proof of concept that paclitaxel-eluting 
stents reduces clinical, angiographic and IVUS indices of restenosis with a comparable safety 
profile to bare-metal stents. The results of the TAXUS IV, V & VI clinical trials led to the 
worldwide approval of the TAXUS2 Express Stent System, followed by, the ATLAS trial for 
the TAXUS Liberté and the PERSEUS trial for TAXUS Element/ION stents. This series of 
clinical trial data has demonstrated long-term clinical safety and effectiveness of paclitaxel-
eluting stent technology.  
In support of these findings, the TAXUS registries (for example, WISDOM, MILESTONE 
II, and OLYMPIA) sponsored by Boston Scientific provide real-world data on paclitaxel-
eluting stents for treatment of coronary lesions in over 34,000 patients worldwide. 
TAXUS Express obtained CE Certification in January 2003 and US PMA Approval in March 
2004.  TAXUS Liberté was CE Certified in September 2005 and US PMA approved in 
October 2008.  TAXUS Element/ION received CE certification in Nov 2008 and FDA 
approval in April 2011. 
 
MAJESTIC First Human Use Trial 
4.1.4.
It was expected that paclitaxel would provide similar long-term safety and effectiveness 
outcomes when evaluated in SFA/PPA atherosclerotic lesions. The MAJESTIC clinical trial 
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 trial. 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 is core laboratory-adjudicated 9-
month primary patency (ie, duplex ultrasound PSVR ≤ 2.5 and absence of TLR or bypass). 
Safety assessments include major adverse events defined as Clinical Events Committee 
(CEC)-adjudicated all-cause death through 1 month, target limb major amputation through 9 
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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 
recently 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 
months, primary patency was 96.1% and the MAE rate was 3.8%; both MAEs were TLRs. 
No stent fractures were identified. 
In conclusion, the MAJESTIC study of the ELUVIA Drug-Eluting Stent in the 
femoropopliteal arteries met its primary effectiveness endpoint with a 9-month primary 
patency rate of 94.4%, accompanied by a low MAE rate (3.6%). The MAJESTIC results 
showed that patients whose femoropopliteal arteries were treated with the Eluvia stent 
sustained a high patency and low MAE rate through 12 months. 
The trial is currently in long term follow up and is expected to be complete in 2017. 
 
Summary 
4.1.5.
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 
demonstrating safety and effectiveness for a variety of indications in coronary and peripheral 
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. 
5. Device Description 
5.1. 
ELUVIA Drug-Eluting Stent System (Investigational Device) 
The Innova self-expanding nitinol stent platform has been CE Mark approved and is the stent 
platform used for ELUVIA.  The same drug-eluting product (paclitaxel) has been widely 
used in coronary stents including the TAXUS Express and TAXUS Liberté programs 
(displayed below).  The ELUVIA stent system will use the same proven polymers as in the 
established PROMUS and PROMUS Element coronary stents. The stent delivery system 
(SDS) is the same used for delivery of the Innova SFA/PPA stent.  Table 5-1 provides an 
overview of the stent system components. 
CE Mark Certification for the ELUVIA stent system was obtained in February 2016. 
 

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Table 5-1: 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 
5.2. 
Investigational Device Component Description 
The ELUVIA stent system is 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 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 IMPERIAL Trial is summarized in the below table. 
Table 5-2: Investigational Device Sizes 
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 
 

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Drug Component Description 
5.2.1.
The stent component of the ELUVIA stent system is a stent with a drug/polymer coating 
formulation consisting of paclitaxel (the active ingredient), and PVDF-HFP Polymer Carrier 
(the inactive ingredient).  
5.2.1.1. 
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. The chemical name is:  Benzenepropanoic acid, β -(benzoylamino) - α - hydroxy -
,6,12b – bis (acetyloxy) - 12- (benzoyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-
4,11- dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11 methano-1H-cyclodeca[3,4]benz[1,2-
b]oxet-9-yl ester,[2aR-[2aα,4β,4aβ,6β,9α (αR*,βS*), 11α,12α,12aα,12bα]], and its chemical 
structure is shown in Figure 5.2-1. 
 
Figure 5.2-1: The Chemical Structure of Paclitaxel 
5.2.1.2. 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 chemical structure of PBMA is 
provided below in Figure 5.2-2. 
 
 
Figure 5.2-2: The Chemical Structure of PBMA 
 

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The drug matrix layer is comprised of a semi-crystalline random copolymer, PVDF – HFP - 
poly(vinylidene fluoride-co-hexafluoropropylene), blended with paclitaxel. The chemical 
structure of PVDF-HFP is provided below in Figure 5.2-3. 
 
 
 
Figure 5.2-3: The Chemical Structure of PVDF-HFP 
5.3. 
Zilver PTX Drug-Eluting Peripheral Stent (Control) 
The control stent that will be used in the IMPERIAL RCT is the FDA approved/CE 
marked/PMDA approved and commercially available Zilver PTX Drug-Eluting Stent System 
(Zilver PTX). Please refer to the Instructions for Use (IFU) for detailed product description. 
The Zilver PTX Stent System is a nitinol self-expanding stent coated with the drug 
paclitaxel. 
The matrix of stent sizes available for the Zilver PTX control devices for use in this trial is 
similar to that supplied for the ELUVIA test devices with the exception of the 150 mm stent 
lengths which are only available in the ELUVIA test matrix. However, multiple stent 
placements are allowed for treatment of lesions up to 140 mm in length. Please refer to the 
Zilver PTX IFU for product information and recommendations. 
Table 5-3: Investigational and Control Product Comparison 
Characteristic 
ELUVIA Stent System 
Zilver PTX Stent System* 
Stent material 
Nitinol  
Nitinol  
Drug product 
Paclitaxel  
Paclitaxel  
Nominal Paclitaxel Content 
Range (based on stent length 
and diameter) 
0.167µg/mm2  
3µg/mm2 
Polymer(s) 
Primer Layer: poly(n-butyl 
methacrylate) (PBMA) 
Active Layer: poly (vinylidene 
fluoride-co-hexafluoropropylene) 
(PVDF-HFP) 
No carrier 
Delivery working length 
75 cm, 130 cm 
80 cm, 125 cm 
Stent delivery system (SDS) 
6 F tri-axial system  
6 Fr coaxial system 
6 Fr tri-axial system 
Catheter shaft outer diameter 
(OD) 
0.080 +/- 0.002 inches 
Coaxial ≤ 0.083 inches 
Triaxial OD unknown 

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Stent strut thickness 
0.0039 inches strut width, 0.0086 
inches strut wall 
0.00466 inches strut width** 
0.00753 inches strut wall**  
*Zilver PTX Summary of Safety and Effectiveness (www.fda.gov) 
** Zilver PTX Stent Testing, Boston Scientific internal document 90823327 
5.4. 
Device Labeling of Investigational Device 
A copy of the Directions for Use (DFU) for the ELUVIA Stent System will be included in 
the Manual of Operations. The study device is labeled on the back and side of the outer 
carton, and on the inside sterile pouch. Packaging will include peelable, self-adhesive labels 
for each unit shipped. The labeling will include the following information. 
 Product Name 
 Universal Part Number (UPN) 
 Serial number 
 Lot number 
 Stent dimensions (stent diameter and stent length in mm) , and Stent delivery system size 
(in cm) 
 Expiration (use by) date 
The following statements appear on the ELUVIA product labeling for clinical distribution. 
Caution: Investigational Device. Limited by Federal Law (USA) to Investigational Use. 
Specifically, the following statement appears on the product labeling in relevant local 
languages:  Exclusively for Clinical Investigations. 
Device labeling will be provided in local language(s) per national regulations. In Japan, 
identification code, local contact information, and storage condition also appear on the 
product labeling. 
6. Objectives 
The objective of the IMPERIAL Randomized Controlled Trial (RCT) is to evaluate the 
safety and effectiveness of the Boston Scientific (BSC) ELUVIA drug eluting stent for 
treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 
mm in length.  
7. Endpoints 
The primary endpoints and additional assessments will be evaluated on an intent-to-treat 
analysis and a per-treatment analysis. If a subject is randomized/enrolled but the stent is not 

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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. 
7.1. 
Primary Endpoints 
Primary Safety Endpoint 
The primary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) 
defined as all causes of death through 1 month, target limb major amputation through 12 
months and/or target lesion revascularization (TLR) through 12 months.  This safety 
endpoint is designed to demonstrate that the 12-month MAE-free rate for the ELUVIA 
treatment group is non-inferior to the Zilver PTX control group. 
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 non-inferior to the Zilver PTX control 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.   
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 (26). 
 The stented segment will be assessed for patency as a single segment regardless of the 
number of tandem lesions within the stented segment. 
 All DUS will be assessed by an independent core laboratory. 
 Clinically-driven: A reintervention 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.   
7.2. 
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 
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 Procedural success defined as technical success with no MAEs noted within 24 hours of 
the index procedure 
 MAE rate at 1 month post-index procedure defined as all causes of death, target limb 
major amputation and/or TLR 
 Primary Patency and Assisted Primary Patency at 6 months, 12 months, 24 months and 
60 months using different PSVRs 
 Clinically-driven TLR and Target Vessel Revascularization (TVR) Rate at each time 
point 
 Adverse Event Rates (unanticipated, major, serious, device/procedure-related) at each 
time point 
 Non-serious non-device/procedure-related Adverse Event Rates at each time point 
through 12 months 
 Stent Fracture Rate at 12 months, 24 months and 60 months utilizing VIVA definitions 
(27) 
 Distribution of Rutherford Classification during follow-up as compared to baseline at 1 
month, 6 months, 12 months, 24 months and 60 months 
 Rate of Primary and Secondary Sustained Clinical Improvement as assessed by changes 
in Rutherford Classification from baseline at 1 month, 6 months, 12 months, 24 months 
and 60 months 
 Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index 
(ABI) from baseline at 1 month, 6 months, 12 months, 24 months and 60 months 
 Walking Improvement at12 months assessed by change in Six Minute Hall Walk 
(6MHW) from baseline 
 Walking Improvement and Patient Utility Values assessed at 1 month, 6 months, 12 
months, 24 months and 60 months assessed by change in Walking Impairment 
Questionnaire and EQ-5D from baseline 
 Changes in healthcare utilization over time 
 PK parameters calculated for subjects in the PK substudy 
8. Design 
The IMPERIAL Trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs 
Zilver PTX), controlled, single-blind, non-inferiority trial (RCT) and a concurrent, non-
blinded, non-randomized, single-arm, pharmacokinetic (PK) substudy.  
A subject can be enrolled in the RCT or the PK substudy. A subject cannot be enrolled in 
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8.1. 
Scale and Duration 
Approximately 477 - 485 subjects will be enrolled in the IMPERIAL trial. 
 465 subjects to receive treatment with either an investigational test device (ELUVIA, 
N=310 subjects) or a control device (Zilver PTX, N=155 subjects) in the RCT 
 12-20 subjects to receive treatment with the investigational test device (ELUVIA) in the 
PK substudy 
The RCT will be conducted in up to 75 sites worldwide in the United States (US), Europe, 
Japan, New Zealand and Canada with a minimum of 465 subjects planned for randomization. 
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 Zilver PTX, respectively. 
 N = 465 subjects randomized at enrollment (310 ELUVIA, 155 Zilver PTX) 
 Minimum of 393 evaluable subjects required at 12 months (262 ELUVIA, 131 Zilver 
PTX) 
Clinical follow-up will be required at the following time points: pre-discharge, 1 month, 6 
months, 12 months, 24 months, 36 months, 48 months and 60 months post index procedure.  
In addition, 12-20 subjects (United States only) will be enrolled in the PK substudy and will 
have baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 
3, 4, 6, 12, 24 and either 48 or 72 hours after placement of the ELUVIA study stent to 
evaluate plasma paclitaxel levels through a pharmacokinetic (PK) sub-study. 
The enrollment period is expected to last approximately 12 months. Fifty percent of 
enrollment is anticipated in the United States.  No investigative site will be allowed to enroll 
more than 20 percent of the total study population. The trial 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 7 years to complete this study.   
Figure 8.1-1 and Figure 8.1-2 show the schematic of the RCT and PK substudy design, 
respectively. 
 
 

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Figure 8.1-1: IMPERIAL RCT Design 
 
 
 
Do Not Enroll 
NO 
NO 
Site Initiation and Training / Investigational 
Devices Delivered 
Guidewire crosses target lesion 
Obtain randomization code (2:1) 
310 treated with ELUVIA 
investigational stent 
155 treated with Zilver PTX 
commercial stent 
Post-procedure / Pre-discharge Assessments 
Follow-up Evaluations 
1 Month, 6 Month, 12 Month, 24 Month follow-
up in office 
36 Month and 48 Month follow-up via telephone 
or in office 
60 Month follow-up in office 
End of Study 
Required Regulatory Documents Obtained 
 
Will subject sign informed consent? 
 
Does subject meet eligibility criteria? 
 Stent Successfully Implanted? 
NO 
Pre-discharge Assessments 
Follow-up Evaluation at 
1 month in office 
Do Not Enroll 
NO 

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Figure 8.1-2: IMPERIAL PK Substudy Design 
 
 
 
Do Not Enroll 
NO 
NO 
Site Initiation and Training / Investigational 
Devices Delivered 
Guidewire successfully crosses target lesion 
Baseline Blood Draw, T=0 
 
12-20 treated with ELUVIA investigational stent 
Post-procedure / Pre-discharge Assessments; 
additional blood draws at 10, 30 minutes, 1, 2, 3, 
4, 6, 12, 24 and 48 or 72 hours after stent placed 
Follow-up Evaluations 
1 Month, 6 Month, 12 Month, 24 Month  
follow-up in office/clinic 
36 Month and 48 Month follow-up via telephone 
or in office 
60 Month follow-up in office/clinic 
End of Study 
Required Regulatory Documents Obtained 
  
Will subject sign informed consent? 
  
Does subject meet inclusion criteria? 
  
ELUVIA stent successfully implanted? 
NO 
Pre-discharge Assessments 
Follow-up Evaluation 
1 month in office 
Do Not Enroll 
NO 

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8.2. 
Treatment Assignment 
Once the subject has signed the Institutional Review Board (IRB)/Independent Ethics 
Committee (IEC)/Research Ethics Board (REB)-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 RCT or PK substudy.  
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 or 
receive an investigational device, nor should the subject be followed post-procedure per 
protocol.  
For the RCT, 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 (2:1 
allocation treatment versus control). Randomization will be stratified by site. After the 
guidewire successfully crosses the target lesion, a randomization custom function within the 
Rave 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 center). 
In the PK substudy, subjects will not be randomized; all subjects will be treated with the 
ELUVIA stent. Subjects will be considered enrolled when the ELUVIA stent is introduced 
into the subject’s vasculature. 
IMPERIAL RCT 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 investigational control and test 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 Manual of Operations. 
 
 

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8.3. 
Multiple Interventions Using Same Access Site During Index Procedure 
 
Contralateral Limb 
8.3.1.
Iliac Lesion 
Using the same access site, iliac lesion(s) in the contralateral limb may be treated during the 
index procedure under the following conditions: 
 Treatment with a commercially available device occurs prior to 
randomization/enrollment of the target SFA/PPA lesion, 
 Treatment of the iliac lesion(s) is deemed an angiographic success without clinical 
sequelae (success is measured as <30% residual stenosis by visual estimation). 
 If the above criteria are not met, the subject may not be randomized into the RCT or PK 
substudy but may be rescreened for eligibility after 30 days. 
 
Target Limb 
8.3.2.
Iliac Lesion 
Using the same access site, additional non-target iliac lesions in the target limb may be 
treated during the index procedure under the following conditions: 
 Treatment with a non-drug-eluting commercially available device occurs prior to 
randomization/enrollment of the target SFA/PPA lesion, and 
 Treatment of the iliac lesion is deemed an angiographic success without clinical sequelae 
(success is measured as <30% residual stenosis by visual estimation). 
 If the above criteria are not met, the subject may not be randomized into the RCT or PK 
substudy but may be rescreened for eligibility after 30 days. 
Target Lesion 
The target lesion is a lesion selected by the Investigator for treatment with either the 
investigational device 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  140 mm and can be covered with only one 
ELUVIA stent or up to two Zilver PTX stents according to each device’s DFU/IFU.  For 
occlusive lesions requiring the use of a re-entry device, the target lesion length must be ≤ 120 
mm allowing the target lesion and re-entry area to be covered with one ELUVIA stent or up 
to two Zilver PTX stents (Refer to Inclusion criterion 4c and 4d). 
NOTE:  If a second or third stent is required due to complications (e.g., dissection, 
misplacement or under-sizing of the target lesion), the additional stent placed should be a 
study stent of the same type used to treat the target lesion. 

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8.4. 
Justification for the Study Design 
The IMPERIAL RCT will evaluate the safety and effectiveness of the ELUVIA stent for the 
treatment of atherosclerotic lesion(s) in native SFA and/or PPA vessels compared with the 
Zilver PTX stent. The Zilver PTX stent was chosen as the control device because it is the 
only commercially available self-expanding nitinol drug-eluting stent approved for treatment 
of SFA and/or PPA lesions. As reported in Table 5-3, the test and control stent platforms 
have many similarities and deliver the same drug, paclitaxel. Safety and performance has 
been demonstrated for the ZILVER PTX stent which is CE Marked, has received FDA and 
PMDA approval and is commercially available in the regions included in this RCT. The 
study design is consistent with the Draft FDA Guidance for Industry: “Coronary Drug-
Eluting Stents – Nonclinical and Clinical Studies,” March 2008 as there is no published draft 
guidance for peripheral drug-eluting stents. Similar to coronary DES studies, a PK sub-study 
will further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment 
of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPA. 
During the trial, dual anti-platelet therapy (DAPT) is required for at least 60 days post index 
procedure, with antiplatelet monotherapy required through the 12 month (1 year) follow-up 
and recommended through the 60 month (5 year) follow-up (trial completion). Ongoing 
dynamic data safety monitoring will be performed throughout the trial to minimize subject 
risk. All enrolled subjects receiving the study stent will be followed for 5 years post index 
procedure. 
9. Subject Selection  
9.1. 
Study Population and Eligibility 
Clinical and angiographic inclusion and exclusion criteria are included in Table 9-1 and 
Table 9-2, respectively. Prior to randomization/enrollment, a subject must meet all of the 
clinical and angiographic inclusion criteria and none of the clinical and angiographic 
exclusion criteria. 
9.2. 
Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 9-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 9.3) is 
met. 

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Table 9-1: Inclusion Criteria 
Inclusion 
Criteria 
1. Subjects age 18 and older.  
2. Subject (or Legal Guardian if applicable) 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. 
NOTE:  For subjects less than 20 years of age enrolled at a Japanese 
center, the subject’s legal representative, as well as the subject, must 
provide written informed consent. 
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  140 mm 
(Note:  Lesion segment(s) must be fully covered with one 
ELUVIA stent or up to two Zilver PTX stents) 
d. For occlusive lesions requiring use of re-entry device, lesion length 
≤ 120 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. 
 
9.3. 
Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 9-2) will be excluded from this 
clinical investigation. 

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Table 9-2: Exclusion Criteria 
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 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 investigational 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 another 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 within 30 days of 

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randomization/enrollment. 
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. 
 
10. Subject Accountability 
10.1. Point of Enrollment 
Once the subject has signed the IRB/IEC/REB-approved study ICF, 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 or receive an investigational device, 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, a randomization 
custom function within the Rave EDC database will be used to assign RCT subjects to the 
test or control treatment group. Subjects will be considered enrolled in the RCT after they 
have been successfully randomized (i.e. when a treatment assignment is received by the 
study site). 
For subjects enrolled in the PK substudy, the point of enrollment occurs when the ELUVIA 
stent is introduced into the subject’s vasculature. 
10.2. Withdrawal 
All subjects randomized in the clinical study (including those withdrawn from the clinical 
study or lost to follow-up) shall be accounted for and documented.  
While trial withdrawal is discouraged, subjects may choose to withdraw from the trial at any 
time, with or without reason and without prejudice to further treatment. Withdrawn subjects 
will not undergo any additional trial follow-up, nor will they be replaced (the justified sample 
size considers an estimated allowance for attrition). The reason for withdrawal will be 
recorded (if given) in all cases of withdrawal. The Investigator may discontinue a subject 
from participation in the trial if the Investigator feels that the subject can no longer fully 
comply with the requirements of the trial or if any of the trial procedures are deemed 
potentially harmful to the subject. Data that have already been collected on withdrawn 

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subjects will be retained and used for analysis but no new data will be collected after 
withdrawal.  
10.3. Enrollment Controls 
The IMPERIAL trial will implement a formal Enrollment Communication Plan.  The plan 
will outline the specific activities and responsibilities of BSC employees and representatives, 
and nature and timing of communications to Investigators during the enrollment period and 
as enrollment draws to a close. 
The objective of the plan is to minimize the risk of enrollment beyond the protocol-specified 
overall enrollment cap, including regional and site-specific caps.  
11. Study Methods 
11.1. Data Collection 
The data collection schedule for the IMPERIAL trial is summarized in Table 11-1. 
 

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Table 11-1: Data Collection Schedule 
Procedure/Assessment 
Pre-
procedure[2] 
During 
Index 
Procedure 
Pre- 
Discharge 
1-month 
(307 
days) 
6-month 
(18230 
days) 
12-month 
(36530 
days) 
 24-month 
 (73030 
days) 
36-month[5] 
(109530 
days) 
48-month[5] 
(1460 ± 30 
days) 
60-month 
(1825 ± 
30 days) 
Informed Consent[1] 
X 
 
 
 
 
 
 
 
 
 
Confirm Inclusion/Exclusion 
X 
X 
 
 
 
 
 
 
 
 
Demographics and Medical 
History, Height and Weight 
X 
 
 
  
 
 
 
 
 
 
Serum Creatinine 
X 
 
 
 
 
 
 
 
 
 
Pregnancy Test[2] 
X 
 
 
 
 
 
 
 
 
 
Complete Blood Count (CBC) 
and platelet count 
X 
 
 
 
 
 
 
 
 
 
ABI Measurements 
X 
 
 
X[3] 
X 
X 
X 
 
 
X 
Rutherford Categorization 
X 
 
 
X 
X 
X 
X 
 
 
X 
Walking Impairment 
Questionnaire (WIQ) 
X 
 
 
X 
X 
X 
X 
 
 
X 
EQ-5D Questionnaire 
X 
 
 
X 
X 
X 
X 
 
 
X 
6 Minute Hall Walk (6MHW) 
X 
 
 
 
 
X 
 
 
 
 
Angiogram[4] 
 
X 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
Venous blood draw for 
subjects in PK sub-study 
 
X[6] 
X 
 
 
 
 
 
 
 
Medication Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events Assessment 
 
X 
X 
X 
X 
X 
X[7] 
X[7] 
X[7] 
X[7] 
Duplex Ultrasound[4] 
 
 
 
 
X 
X 
X 
 
 
X 
X-Ray[4] 
 
 
 
 
 
X 
X 
 
 
X 
[1] Subject’s consent obtained and informed consent form signed prior to any study-specific tests or procedures 
[2] Performed within 30 days of procedure, except urine or blood pregnancy test required for females of childbearing potential performed within 7 days of procedure 
[3] ABI measurement may be collected immediately post-procedure through 1 Month Follow-up window (Day 0 – 37). 
[4] Angiograms, Ultrasounds and X-rays will be sent to the respective core lab for analysis.  Follow-up angiograms, ultrasounds and x-rays 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. 
[5] The 36 month and 48 month visit may be conducted in the office or by telephone. 
[6] Up to 24 hours prior to stent placement. 
[7] Reporting required through the end of trial for SAEs, UADEs and ADEs/Device Deficiencies.  AEs not related to the investigational device or procedure reported only through 12 
month follow-up visit. 

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11.2. Study Candidate Screening 
A Screening Log will be maintained by each investigational site to document selected 
information about subjects who fail to meet the IMPERIAL trial eligibility criteria, including 
the reason for screen failure. 
11.3. Informed Consent 
Before any study specific tests or procedures are performed, subjects who meet the clinical 
eligibility criteria will be asked to sign the IRB/IEC/REB-approved study ICF. Subjects must 
be given ample time to review the ICF and have questions answered before signing. For 
subjects less than 20 years of age at Japanese sites, the subject and the subject’s legal 
representative must sign the study ICF. 
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.  
Refer to section 10.1 for definition of point of enrollment. 
11.4. 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 obtained 
 Physical assessment including: 
o Weight and height 
o Rutherford Category Assessment 
o Ankle-Brachial Indices (ABI) measurements 
 Laboratory tests 
o Serum creatinine 
o Complete blood count (CBC) with platelets 
 Confirmation that all clinical inclusion/exclusion eligibility criteria have been met 
 6-Minute Hall Walk 
 Administer Questionnaire Assessments 
o Walking Impairment Questionnaire (WIQ) 
o EQ-5D 

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11.5. 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) 
11.6. Required Concomitant Medications 
Protocol-required concomitant medications must be reported in the electronic case report 
form (eCRF) from the time of the pre-procedure visit through the 60 month (5 year) follow-
up visit. Information pertaining to the use of antiplatelet medications including dose changes, 
medication interruptions, and medication cessation, must be documented. Additional 
concomitant medications may be prescribed at the discretion of the treating physician 
according to standard of care. 
Minimum antiplatelet medication requirements include: 
Antiplatelet medication usage will be collected and reported for compliance for the duration 
of the trial. 
Minimum requirements include: 
 Anti-coagulation and anti-platelet therapy administered during the procedure should be 
consistent with current clinical practice (28).  
 Clopidogrel or ticlopidine starting at least 24 hours prior to the procedure or a peri-
procedural loading dose (recommended loading dose of 300 mg clopidogrel or 200 mg 
ticlopidine) is given within 2 hours after the end of the procedure.   
 Daily administration of aspirin (recommended dose of at least 75 mg) and clopidogrel (75 
mg) or ticlopidine (200 mg) for the first 60 days post-index procedure.   
 Antiplatelet monotherapy is required through the 12 month (1 year) follow-up and 
recommended through the 60 month (5 year) follow-up (trial completion). 
A subject could be exempt of antiplatelet requirements if he/she requires Coumadin or other 
similar anti-coagulant due to known comorbidities and in the opinion of the investigator the 
combination of dual anti-platelet therapy (DAPT) and anticoagulation could pose an 
intolerable bleeding risk. 
Note: The same strategy for selection of antiplatelet therapy should be used for ELUVIA and 
Zilver PTX subjects (i.e., treatment assignment should not influence antiplatelet agent 
selection or duration of therapy). Refer to the assigned stent’s DFU/IFU for antiplatelet 
information. 

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11.7. Index Procedure 
Investigators will manage the cardiovascular risk factors and comorbidities for all patients 
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. 
 Non-Target Limb (Contralateral) 
11.7.1.
Using the same access site, non-target iliac lesion(s) in the contralateral limb may be treated 
during the index procedure under the following conditions: 
 Treatment with a commercially available device occurs prior to 
randomization/enrollment of the target SFA/PPA lesion, 
 Treatment of the iliac lesion(s) is deemed an angiographic success without clinical 
sequelae (success is measured as <30% residual stenosis by visual estimation). 
 If the above criteria are not met, the subject may not be randomized into the RCT or PK 
substudy but may be rescreened for eligibility after 30 days. 
 Target Limb (Treatment of Non-Target Lesions) 
11.7.2.
Using the same access site, additional non-target iliac lesions in the target limb may be 
treated during the index procedure under the following conditions: 
 Treatment with a non-drug-eluting commercially available device occurs prior to 
randomization/enrollment of the target SFA/PPA lesion, and 
 Treatment of the iliac lesion is deemed an angiographic success without clinical sequelae 
(success is measured as <30% residual stenosis by visual estimation). 
 If the above criteria are not met, the subject may not be randomized into the RCT or PK 
substudy but may be rescreened for eligibility after 30 days. 
 Randomization  
11.7.3.
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. 

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During catheterization, the following procedures and assessments must be completed for the 
Target Lesion.  
 Perform angiography according to the Angiographic Core Laboratory procedure 
guidelines. 
 Confirm angiographic eligibility criteria of the target lesion or tandem lesion(s). 
 Cross target lesion using guidewire or re-entry device. 
 After target lesion is crossed by the guidewire, access the randomization custom 
function in Rave EDC to randomize subject in the RCT or enroll subject in the PK 
substudy. 
 If randomized to ELUVIA, retrieve an appropriately sized investigational stent to 
adequately cover the target lesion with one stent. 
 If randomized to Zilver PTX, retrieve one or two appropriately sized control stent(s) 
from commercial inventory. 
 For PK substudy subjects, obtain baseline blood draw prior to ELUVIA stent system 
advancement into the subject’s vasculature. 
Note: If difficulties are encountered when accessing the randomization custom function in 
the Rave EDC system that may put the subject at risk, the subject should not be enrolled in 
the trial. The subject should be treated per standard of care but must not receive an 
investigational study stent. 
Note: Bypassing the randomization process and manually assigning treatment type is not 
allowed. 
 Target Lesion Stent Placement 
11.7.4.
Procedural information must be reported (specific data fields are noted in the electronic 
database). Refer to the DFU/IFU for detailed instructions about delivery system preparation 
and placement of the ELUVIA stent or the Zilver PTX 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. Record the following information on pre-dilation balloon(s) used: 
o Maximum balloon diameter (mm) inflated 

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o Maximum pressure (atmospheres) inflated 
o Maximum length of time (seconds) inflated 
 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.  Record the following information on post-dilation 
balloon(s) used: 
o Maximum balloon diameter (mm) inflated 
o Maximum pressure (atmospheres) inflated 
o Maximum length of time (seconds) inflated 
 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 practice. All angiographic complications that occur should be documented by 
angiography and submitted to the Angiographic Core Laboratory for analysis. 
ELUVIA 
The Directions For Use (DFU) for the ELUVIA Stent System is provided in the Manual of 
Operations. Prior to use of the device, the treating physician must carefully read and be 
familiar with the entire DFU. The ELUVIA DFU must be followed for implanting the 
investigational stent. Anticoagulant therapy should be consistent with guideline practices and 
the hospital standard of practice during the procedure. 
Zilver PTX 
As a reference, a sample Instructions for Use (IFU) for the Zilver PTX Stent System is 
provided in the Manual of Operations. 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. 
11.8. 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. 

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11.9. 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  
 Finalize angiographic procedure film and related required documentation to submit to the 
Core Laboratory per instructions set in the Manual of Operations. 
11.10. 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.  
 Venous blood draws for subjects enrolled in the PK substudy as described in Section 
11.12. 
 Medication assessment 
 AE assessment  
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 important that trial site personnel instruct subjects to return for follow-up assessments 
according to the trial event schedule in Table 11-1. 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: Randomized 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). 
11.11. Angiography 
All RCT and PK substudy subjects will undergo angiographic assessment during the index 
procedure per standard of care. Subjects requiring reintervention of the target vessel during 
the 60 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 60 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. 

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11.12. Assessment of Whole Blood Paclitaxel Levels 
The PK profile of the ELUVIA stent will be analyzed for subjects enrolled in the PK 
substudy. A total of 11 venous blood samples will be attempted and drawn according to the 
schedule shown in Table 11-2. 
SFA stenting is most often performed as an out-patient procedure and sampling time points 
greater than 12 hours post-procedure will require most subjects to return to the research site 
for blood draws beyond the 12 hours post-stenting.  
To encourage all enrolled PK subjects to return to the research site for blood draws scheduled 
after release from the out-patient procedure, approximately 50% of subjects will return 48 
hours after placement of the study stent and approximately 50% will return 72 hours after 
placement of the study stent. 
A stipend will be provided to cover lodging or travel expenses incurred by subjects as a result 
of participation in the PK substudy in accordance with pertinent country laws and regulations 
and per the study site’s regulations. 
All samples must be forwarded to the PK core laboratory for analysis of whole blood 
paclitaxel levels. 
Instructions for blood sample collection, storage, and shipment are provided in the PK core 
laboratory Instruction Manual. 
Table 11-2: Blood Draw Schedule for Analysis of Paclitaxel Pharmacokinetics 
Day 
Blood Draw Schedule 
Before stent placement 
Up to 24 hours  prior to placement of study stent 
After stent placement 
Day 0 
10 minutes (±5 minutes) after placement of study stent 
30 minutes (±10 minutes) after placement of study stent 
1 hour (±10 minutes) after placement of study stent 
2 hours (±10 minutes) after placement of study stent 
3 hours (±15 minutes) after placement of study stent 
4 hours (±15 minutes) after placement of study stent 
6 hours (±30 minutes) after placement of study stent 
12 hours (±60 minutes) after placement of study stent 
Day 1 
24 hours (±4 hours) after placement of study stent 
Day 2-3 
48 hours (±8 hours) after placement of study stent 
or 
72 hours (±8 hours) after placement of study stent 
11.13. Follow-up 
IMPERIAL RCT is a single blind trial. Site personnel conducting clinical follow-up will be 
blinded to a subject’s treatment assignment whenever possible.  

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All randomized/enrolled subjects who receive a test or control stent, ELUVIA or Zilver PTX 
will be evaluated prior to discharge from the index procedure and at 1 month, 6 months, 12 
months, 24 months, 36 months, 48 months, and 60 months after the index procedure.  
Subjects who underwent advancement of the ELUVIA or Zilver PTX 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 reintervention should be treated according to the 
Investigator’s discretion and standard of care. These subjects should receive an approved, 
commercially available treatment (if appropriate) and must not receive an investigational 
device for retreatment.  
Note: Follow-up angiograms, ultrasounds and x-rays 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. 
Requirements of each follow-up evaluation are described below. 
 1-Month Follow-up Visit (30 days ± 7 days) 
11.13.1.
All enrolled subjects must be evaluated 1 month after the index procedure. 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 – 37]) 
 Walking Impairment Questionnaire 
 EQ-5D Questionnaire 
 Adverse Events Assessment 
 Medication Assessment 
 6-Month Follow-up Visit (182 days ± 30 days) 
11.13.2.
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 

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 EQ-5D Questionnaire 
 Adverse Events Assessment 
 Medication Assessment 
 DUS of stented segment performed according to the DUS Core Laboratory procedure 
guidelines 
 12-Month Follow-up Visit (365 days ± 30 days) 
11.13.3.
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 
 Walking Impairment Questionnaire 
 EQ-5D Questionnaire 
 Adverse Events Assessment 
 Medication Assessment 
 DUS of stented segment performed according to the DUS Core Laboratory procedure 
guidelines 
 X-ray of the stented segment performed according to the X-ray Core Laboratory 
procedure guidelines 
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). 
 24-Month Follow-up Visit (730 days ± 30 days) 
11.13.4.
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 Questionnaire 
 Adverse Events Assessment (SAEs, UADEs and ADEs/Device Deficiencies) 
 Medication Assessment 
 DUS of stented segment performed according to the DUS Core Laboratory procedure 
guidelines 
 X-ray of the stented segment performed according to the X-ray Core Laboratory 
procedure guidelines 

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 36-Month Follow-up Visit (1095 days ± 30 days) 
11.13.5.
All enrolled subjects must be evaluated 36 months after the index procedure. The following 
assessments must be performed during the 36 Month office or telephone visit. 
 Adverse Events Assessment (SAEs, UADEs and ADEs/Device Deficiencies) 
 Medication Assessment 
 48-Month Follow-up Visit (1460 days ± 30 days) 
11.13.6.
All enrolled subjects must be evaluated 48 months after the index procedure. The following 
assessments must be performed during the 48 Month office or telephone visit. 
 Adverse Events Assessment (SAEs, UADEs and ADEs/Device Deficiencies) 
 Medication Assessment 
 60-Month Follow-up Visit (1825 days ± 30 days) 
11.13.7.
All enrolled subjects must be evaluated 60 months after the index procedure. The following 
assessments must be performed during the 60 Month office visit. 
 Rutherford Categorization 
 ABI Measurements 
 Walking Impairment Questionnaire 
 EQ-5D Questionnaire 
 Adverse Events Assessment (SAEs, UADEs and ADEs/Device Deficiencies) 
 Medication Assessment 
 DUS of stented segment performed according to the DUS Core Laboratory procedure 
guidelines 
 X-ray of the stented segment performed according to the X-ray Core Laboratory 
procedure guidelines 
11.14. 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. 
11.15. Missed or Late Visits 
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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. For subjects who miss their 12 Month 
follow-up visit (primary endpoint), BSC will provide site’s access to a patient locator service 
(if allowed by the site’s IRB/IEC/REB).  A subject will be considered lost to follow-up after 
the subject misses 2 consecutive annual follow-up visits without due cause. No subject will 
be considered lost to follow-up prior to the 24 Month follow-up visit in order to make every 
effort to collect evaluable data for the primary endpoint. 
11.16. Follow-up Visits (Japan only) 
Data from the IMPERIAL trial collected through 12 months will be submitted as the primary 
data set for Japanese market approval. Follow-up beyond 12 months will continue as planned 
in this protocol. Once the investigational device is granted regulatory approval in Japan, 
subjects will continue protocol required follow-up as part of a postmarket clinical trial (by 
interpreting the word “trial” in this protocol as “post-market clinical trial”). 
11.17. Source Documents 
It is preferable that original source documents (see Table 27-2 for definition) are maintained, 
when available. Where copies of the original source document as well as printouts of original 
electronic source documents are retained, it is required that the copies be signed and dated by 
a member of the investigation center team with a statement that it is a true reproduction of 
the original source document. 
12. Statistical Considerations 
The sample size justification and the powered analyses for the primary endpoints described 
in this section are mainly for the RCT. For the PK substudy, the sample size determination is 
arbitrary and the analysis is based on observation. The details of all statistical analyses will 
be described in the Statistical Analysis Plan. 
12.1. Primary Endpoints 
The overall sample size in the RCT is justified by hypothesis parameters and driven by the 
primary effectiveness endpoint to preserve adequate statistical testing power for both primary 
effectiveness and safety endpoints.  
The primary hypotheses are planned for being tested simultaneously at the specified one-
sided significance level of 5% each without adjustment.  
There is no primary endpoint for the PK substudy. 

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 Primary Effectiveness Endpoint 
12.1.1.
The 12-month primary patency is chosen to be assessed for the primary effectiveness 
endpoint in the RCT. The goal is set to demonstrate that the primary patency for the 
ELUVIA treatment group (i.e. Test) is non-inferior to the Zilver PTX treatment group (i.e. 
Control) through 12 months post-procedure. For the definition of primary patency, refer to 
the section 7.1 Primary Endpoints. 
12.1.1.1. Hypotheses for RCT 
The primary effectiveness hypothesis to be tested is that the 12-month primary patency in the 
Test Group is non-inferior to the Control Group by a margin of -10% (negative value) at one-
sided significance level of 5%. 
The null hypothesis (H0) states that there is no marginal treatment effect of the Test Device 
vs. the Control Device as opposed to the alternative hypothesis (H1) which states that there is 
a marginal treatment effect. The hypotheses inequalities are shown below: 
H0: Pt - Pc   ∆ (inferior) 
H1: Pt - Pc  > ∆ (non-inferior) 
where Pt and Pc are the 12-month primary patency for the Test Device and Control Device, 
respectively, and Δ (delta) is the non-inferiority margin of -10%. 
12.1.1.2. Sample Size for RCT 
The primary effectiveness endpoint drives the overall sample size. Approximately 465 
subjects are planned to be enrolled in the RCT. The sample size justification for the RCT is 
based on the following assumptions.  
 Expected ELUVIA (test) rate = 83.0% 
 Expected Zilver PTX (control) rate = 83.0% 
 Non-inferiority margin (Δ) = (-10%) 
 Test significance level () = 0.05 (1-sided) 
 Power (1) > 0.80 
 Expected rate of attrition = 15% 
The expected 12-month primary patency for both the Test Group and Control Group are 
estimated to be 83% based on the recent publication. Given a margin of -10% for the 
treatment effect (Test minus Control) and a sample size allocation (Test vs. Control) of 2 to 
1, a minimum of total 393 subjects (262 in the Test Group and 131 in Control Group) will be 
required at 12 months to provide at least 80% power under a one-sided 5% significance level. 
Using a margin of -10% only allows the Test Group to be inferior to the Control group in 
terms of 12-month observed primary patency by a maximum of 3%. That is, assuming that 
the observed primary patency in the Control Group is 83.2% (109/131), the observed 12-

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month primary patency in the Test Group will need to be at least 80.2% (210/262) in order to 
claim non-inferiority in the RCT.  
Considering no more than 15% attrition rate in 12 months, approximately 465 subjects are 
required in a 2:1 randomized scheme in the RCT to achieve 393 subjects to be evaluable at 
12 months.  
12.1.1.3. Statistical Methods for RCT 
A non-inferiority test for the difference in 12-month primary patency will be used to assess 
the effectiveness hypotheses. The standard error will be estimated by the solution to the 
maximum likelihood equation (Farrington and Manning, 1990). The p-value and/or 95% 
confidence interval will be constructed based on statistics under this approach. 
The non-inferiority for device effectiveness will be claimed if the one-sided lower 95% 
confidence bound on the observed difference between treatment groups (Test minus Control) 
in 12-month primary patency is greater than -0.1. This corresponds to the p-value from the 
one-sided non-inferiority test is less than 0.05.  
 Primary Safety Endpoints 
12.1.2.
The 12-month MAE-free rate is selected to be assessed for the primary safety composite 
endpoint. The safety goal is designed to demonstrate that Test Group is non-inferior to 
Control Group in terms of MAE-free rate through 12 months post-procedure. The 
components of MAE refer to the section 7.1 Primary Endpoints. 
12.1.2.1. Hypotheses 
The primary safety hypothesis to be assessed is that the 12-month MAE-free rate in the Test 
Group is non-inferior to Control Group by a margin of -10% (negative value) at a one-sided 
significance level of 5%. 
The null hypothesis (H0) states that there is no marginal treatment effect of the Test Group 
vs. the Control Group as opposed to the alternative hypothesis (H1) states that there is a 
marginal treatment effect. The hypotheses inequalities are shown below: 
H0: Pt - Pc   ∆ (inferior) 
H1: Pt - Pc  > ∆ (non-inferior) 
where Pt and Pc are the 12-month MAE-free rate for the Test Group and Control Group, 
respectively, and Δ (delta) is the non-inferiority margin of -10%. 
12.1.2.2. Sample Size  
The overall sample size determined by the primary effectiveness endpoint is to provide at 
least 92% statistical power to assess the primary safety endpoint. The statistical power for the 
primary safety endpoint is calculated by the succeeding assumptions. 

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The expected 12-month MAE-free rate for both Test and Control Groups are estimated to be 
90% based on the recent publication. Given a margin of -10% for the treatment effect, the 
total 393 evaluable subjects at 12 months will provide at least 92% power for the primary 
safety endpoint at a one-sided 5% significance level. 
The margin of -10% only allows the Test Group to be inferior to the Control Group in terms 
of 12-month observed MAE-free rate by a maximum of 4%. That is, assuming that the 12-
month MAE-free rate in the Control Group is 90.1% (118/131), the observed12-month MAE-
free rate in the Test Group will need to be at least85.9% (225/262) in order to claim non-
inferiority in the RCT. 
12.1.2.3. Statistical Methods 
The non-inferiority test described in the primary effectiveness endpoint will be used for the 
primary safety endpoint.  
The non-inferiority for the device safety will be concluded if the one-sided lower 95% 
confidence bound on the observed difference between treatment groups (Test minus Control) 
in 12-month MAE-free rate is greater than -0.1. This corresponds to the p-value from the 
one-sided non-inferiority test is less than 0.05. 
 Success Criteria 
12.1.3.
The following success criteria are defined for the RCT. 
ELUVIA will be concluded to be non-inferior to Zilver PTX for device safety if the one-
sided lower 95% confidence bound on the difference between treatment groups (ELUVIA – 
Zilver PTX) in 12-month MAE-free is greater than -0.1. 
ELUVIA will be concluded to be non-inferior to Zilver PTX for device effectiveness if the 
one-sided lower 95% confidence bound on the difference between treatment groups 
(ELUVIA – Zilver PTX) in 12-month primary patency is greater than -0.1. 
If the primary safety and the primary effectiveness endpoints are both met, the RCT will be 
considered a success and both device safety and effectiveness will be claimed. 
12.2. General Statistical Methods 
 Analysis Sets 
12.2.1.
The as-randomized (i.e. intent-to-treat or ITT) population will be the primary analysis set for 
assessing non-inferiority of the Test Group to the Control Group. 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 receive the 
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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). 
 Randomization Scheme 
12.2.2.
Randomization to treatment will be stratified by study site. 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. 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 site. 
 Control of Systematic Error/Bias 
12.2.3.
Selection of subjects will be made from the Investigators’ general or professional referral 
population. All subjects meeting the inclusion/exclusion criteria and 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 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.  
 Number of Subjects per Investigative Site 
12.2.4.
Study sites will not be allowed to randomize more than 10% (N=46) 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=93) of the total number of randomized subjects.   
12.3. Baseline Data Analyses 
Baseline covariates will be summarized for the RCT and the PK substudy. Subject baseline 
demographics and clinical characteristics, site-reported and core lab reported lesion 
characteristics, procedure assessment, device information, and medication compliance 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. 
 Additional Assessments/Measurements  
12.3.1.
Additional assessments may refer to (but not limit to) technical/procedural success, 
safety/effectiveness endpoints, stent fracture, any type of AE rates, distribution of Rutherford 

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classification, hemodynamic improvement, walking improvement at time points that data is 
collected.  
No formal tests of hypotheses are proposed for additional assessments. Statistical 
comparisons may be performed for exploratory purposes. No formal inferences are planned 
on the additional assessments and therefore alpha-adjustments for multiple comparisons will 
not be used. 
  Pharmacokinetics Parameters 
12.3.2.
Values for the following paclitaxel PK parameters will be calculated by a standard non-
compartment analysis for subjects in the PK substudy. 
 Maximum observed blood concentration (Cmax) 
 First time of occurrence of Cmax (tmax) will be the actual observed values 
 Terminal phase rate constant (λz) will be estimated from log-linear regression analysis of 
the terminal phase of the blood concentration-time profile 
 Associated apparent terminal phase half-life (t½) will be calculated as t½ = ln(2/λz) 
 Area under the blood concentration versus time curve from time zero to 1 hour (AUC0-1), 
time zero to 24 hours (AUC0-24), time zero to the time of the last quantifiable 
concentration (AUC0-t) and extrapolated to infinite time (AUC0-∞) will be calculated by a 
combination of linear and logarithmic trapezoidal methods 
 Percentage of AUC0-∞ obtained by extrapolation (%AUCex) will be calculated as [(AUC0 
∞ – AUC0-t)/AUC0-∞] × 100 
 Total blood clearance (CL) 
For AUC calculation, the linear method will be employed for all incremental trapezoids 
arising from increasing concentrations and the logarithmic trapezoidal method will be used 
for those arising from decreasing concentrations. 
Descriptive statistics (mean, standard deviation, sample size, 95% confidence interval) will 
be used to summarize these parameters for subjects in the PK substudy. No formal statistical 
testing will be done for these parameters. 
 Interim Analyses  
12.3.3.
No formal interim analyses are planned for the purpose of stopping this study early for 
declaring effectiveness or for futility. 
 Subgroup Analyses 
12.3.4.
Primary endpoints and/or additional assessments will be summarized and treatment groups 
may be compared in each subgroup identified by the following categories (but not limit to): 
 Region 

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 Race 
 Gender (male vs. female) 
 Age (≥ 65 and < 65) 
 Diabetic status (medically-treated vs. non-diabetic) 
 Lesion characteristics (vessel diameter/lesion length) 
 Stent matrix (stent diameter/length) 
 Other significant predictors identified by regression models 
No formal tests of hypotheses are proposed for subgroups and therefore alpha-adjustment for 
multiple comparisons will not be used. 
 Justification of Pooling 
12.3.5.
The poolability analysis regarding the primary safety 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 safety 
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. 
 Sensitivity Analysis for Missing Data 
12.3.6.
Sensitivity analyses for the primary safety and effectiveness endpoints 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.  
 Multivariable Analyses 
12.3.7.
Univariate and multivariate analyses will be performed to assess the effect of potential 
predictors for the primary safety/effectiveness endpoint in a logistic regression model. 
Clinically meaningful baseline covariates will be selected in the regression model. 

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 Analysis Software 
12.3.8.
All statistical analyses will be performed using the Statistical Analysis Software (SAS), 
version 9.2 or later (Copyright © 2002-2010 by SAS Institute Inc., Cary, North Carolina 
27513, USA. All rights reserved). 
 Changes to Planned Analyses 
12.3.9.
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 analyses. 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. 
13. Data Management 
13.1. Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by Medidata. All changes 
made to the clinical data will be captured in an electronic audit trail and available for review 
by Boston Scientific Corporation (BSC) or its representative. The associated RAVE software 
and database have been designed to meet regulatory compliance for deployment as part of a 
validated system compliant with laws and regulations applicable to the conduct of clinical 
studies pertaining to the use of electronic records and signatures. Database backups are 
performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the EDC system and will 
be issued to the site for appropriate response. Site staff will be responsible for resolving all 
queries in the database. 
13.2. Data Retention 
The Investigator or Investigational site will maintain, at the investigative site, in original 
format all essential study documents and source documentation that support the data 
collected on the study subjects in compliance with ICH/GCP guidelines.  Documents must be 
retained for at least 2 years after the last approval of a marketing application or until at least 2 

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years (at least 3 years in Japan) have elapsed since the formal discontinuation of the clinical 
investigation of the product. These documents will be retained for a longer period of time by 
agreement with BSC or in compliance with other local regulations. It is BSC’s responsibility 
to inform the Investigator when these documents no longer need to be maintained. The 
Investigator will take measures to ensure that these essential documents are not accidentally 
damaged or destroyed. If for any reason the Investigator withdraws responsibility for 
maintaining these essential documents, custody must be transferred to an individual who will 
assume responsibility and BSC must receive written notification of this custodial change.  
In Japan, BSC must maintain necessary essential documents for 5 years from the date of the 
marketing application approval (or during the period of user-results evaluation, if applicable 
and if longer than 5 years) or until 3 years have elapsed since the formal discontinuation of 
the clinical investigation of the device, whichever is longer. 
If study follow-up is continued beyond 5 years in Japan as part of a postmarket clinical trial 
after receiving marketing approval, the Investigator and Site must retain essential documents 
during the period of user-results evaluation, and BSC must retain essential documents in 
accordance with Good Postmarketing Surveillance Practice and Test of Medical Devices 
(Ministrial Ordinance 38, 23 March, 2005). 
13.3. Core Laboratories 
Core laboratories will be established for the central assessment of key data collected during 
the IMPERIAL trial.  Detailed guidelines for the collection, analysis, and interpretation of the 
following data will be provided in the Manual of Operations.  The following core 
laboratories have been assigned for this trial: 
 Angiographic: to assess angiograms taken during the index procedure and during any 
subsequent revascularization procedure. 
 Ultrasound: to assess duplex ultrasounds taken during the follow-up period (6-month, 12-
month, 24-month, and 60-month visits) for primary patency. 
 X-Ray: to assess x-rays taken during the follow-up period (12-month, 24-month and 60 
month visits) for stent integrity. (Note: Additional X-rays will be collected at Japanese 
sites in the event of a TLR/TVR and in those cases when, in the opinion of the 
investigator, an X-ray should be performed). 
 Pharmacokinetics: to assess whole blood baseline paclitaxel levels and at defined time 
points through 48/72 hours post-index procedure. 
14. Amendments  
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals (e.g., 
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15. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/IEC/REB of any deviation from the investigational plan to 
protect the life or physical well-being of a subject in an emergency, and those deviations 
which affect the scientific integrity of the clinical investigation. Such notice shall be given as 
soon as possible, but no later than 5 working days after the emergency occurred, or per 
prevailing local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using EDC. Sites may also be 
required to report deviations to the IRB/IEC/REB, per local guidelines and government 
regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, center re-training, or 
discontinuation) will be put into place by the sponsor. 
16. Device/Equipment Accountability 
The investigational devices/equipment shall be securely maintained, controlled, and used 
only in this clinical study. The randomization custom function of the Rave EDC system will 
be used to track subjects and device allocations during the study.  
BSC shall keep records to document the physical location of all ELUVIA investigational 
devices from shipment of investigational devices to the investigation sites until return or 
disposal. 
The Principal Investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the ELUVIA investigational devices, which shall include 
the following: 
 Date of receipt 
 Identification of each investigational device (batch number or unique code) 
 Expiry date, as applicable 
 Date of use 
 Subject identification 
 Date on which the investigational device was returned, if applicable 
 Date of return of unused, expired, or malfunctioning investigational devices, if 
applicable. 

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The Principal Investigator or an authorized designee shall keep records documenting the use 
of the commercially available Zilver PTX control devices, which shall include the following 
for each control device attempted/implanted: 
 Identification of each device (lot number or unique code) 
 Stent diameter and stent length 
 SDS size 
 Date of use 
 Subject identification 
Written procedures may be required by national regulations. 
17. Compliance 
17.1. Statement of Compliance 
This study will be conducted in accordance with ISO 14155 Clinical Investigation of Medical 
Devices for Human Subjects-GCP, or the relevant parts of the ICH Guidelines for GCP, 
ethical principles that have their origins in the Declaration of Helsinki, and pertinent 
individual country laws and regulations. The study shall not begin until the required 
approval/favorable opinion from the IRB/IEC/REB and/or regulatory authority has been 
obtained, if appropriate. Any additional requirements imposed by the IRB/IEC/REB or 
regulatory authority shall be followed, if appropriate. 
17.2. Investigator Responsibilities 
The Principal Investigator of an investigational center 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 IRB/IEC/REB, 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 
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 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) every 
adverse event and observed device deficiency. 
 Report to BSC, per the protocol requirements, all SAEs and device deficiencies that 
could have led to a SADE. 
 Report to the IRB/EC/REB and regulatory authorities any SAEs and device deficiencies 
that could have led to a SADE, if required by the national regulations or this protocol or 
by the IRB/EC/REB, and supply BSC with any additional requested information related 
to the safety reporting of a particular event. 
 Maintain the device accountability records and control of the device, ensuring that the 
investigational 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 IRB/IEC/REB when performing 
auditing activities. 
 Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/IEC/REB requirements. 
 Provide adequate medical care to a subject during and after a subject’s participation in a 
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. 

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 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 investigation 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. 
 Delegation of Responsibility 
17.2.1.
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. 
17.3. Institutional Review Board/ Independent Ethics Committee/Research Ethics Board 
Prior to gaining Approval-to-Enroll status, the investigational center will provide to the 
sponsor documentation verifying that their IRB/IEC/REB is registered or that registration has 
been submitted to the appropriate agency, as applicable according to national/regulatory 
requirements. 
A copy of the written IRB/IEC/REB and/or competent authority approval of the protocol (or 
permission to conduct the study) and Informed Consent Form, must be received by BSC 
before recruitment of subjects into the study and shipment of investigational product. Prior 
approval must also be obtained for other materials related to subject recruitment or which 
will be provided to the subject. 
Annual IRB/IEC/REB approval and renewals will be obtained throughout the duration of the 
study as required by local/country or IRB/IEC/REB requirements. Copies of the 
Investigator’s reports and the IRB/IEC/REB continuance of approval must be provided to 
BSC. 
17.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 

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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 BSC 
for the purposes of this study, publication, and to support future research and/or other 
business purposes. All data used in the analysis and reporting of this study will be without 
identifiable reference to specific subject name. 
BSC will keep subjects’ health information confidential in accordance with all applicable 
laws and regulations.  BSC may use subjects’ health information to conduct this research, as 
well as for additional purposes, such as overseeing and improving the performance of its 
device, new medical research and proposals for developing new medical products or 
procedures, and other business purposes. 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. 
The clinical trial organization in Japan, including investigational sites in Japan, is provided as 
a separate attachment to the protocol only in Japan. 
Also, BSC or Boston Scientific Japan (BSJ) may utilize contract research organizations 
(CROs) or other contractors to act as their representative for carrying out designated tasks. 
Responsibilities for these entities are defined in the applicable contracts or agreements. 
Contact information for the CROs is provided as a separate attachment to the protocol only in 
Japan or in the Manual of Operation (MOP) for Japanese sites.  
 Role of Boston Scientific Representatives 
17.4.1.
BSC 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 investigational 
device. 
Boston Scientific 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 without the approval and 
presence of the HCP 
 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 
17.5. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 

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18. Monitoring 
Monitoring will be performed during the study, according to the study Monitoring Plan, to 
assess continued compliance with the current, approved protocol/amendments and applicable 
regulations. In addition, the monitor verifies that study records are adequately maintained, 
that data are reported in a satisfactory manner with respect to timeliness, adequacy, and 
accuracy, and that the Investigator continues to have sufficient staff and facilities to conduct 
the study safely and effectively. Pre-defined thresholds for protocol deviation and 
compliance once met or exceeded, can also trigger increased monitoring frequency and/or the 
implementation of corrective action plans at clinical sites. For the IMPERIAL trial, source 
documents include, at a minimum but are not limited to, the ICF; patient medical records, 
including nursing records and catheterization laboratory records; diagnostic imaging records; 
laboratory results; reports of SAEs; and device accountability logs. Data documented in the 
eCRF relevant to device deficiencies, relationship of AE to study device(s), index procedure, 
antiplatelet medication; and the anticipated assessment of ADEs, may be considered source 
data for the study. 
The Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, and appropriate regulatory authorities. In the event that the 
original medical records cannot be obtained for a subject that is seen by a non-study 
physician at a non-study institution, all reasonable attempts must be made to obtain 
photocopies of the original source documents for review. Photocopies of original source 
documents related to MAEs that are adjudicated by the CEC (from either the study site or a 
non-study institution, if applicable) must also be made available for submission to the BSC 
Safety Group. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Investigator and 
relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
19. Potential Risks and Benefits 
19.1. 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 

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 Hematoma 
 Need for urgent intervention or surgery  
 Pseudoaneurysm formation 
 Renal insufficiency or failure 
 Restenosis of stented artery 
 Sepsis/infection 
 Thrombosis / thrombus 
 Tissue ischemia / necrosis 
 Transient hemodynamic instability (hypotensive/hypertensive episodes) 
 Vasospasm 
 Vessel injury, including perforation, trauma, rupture and dissection 
 Vessel occlusion 
19.2. Risks Associated with the Study Device(s) Unique to Paclitaxel 
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. 

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19.3. 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 testing planned for the follow-up period is standard of care with 
the exception of the x-ray requirements during follow-up. These additional requirements 
should not create additional risk to the subject over treatment with an already approved stent 
system. 
In addition, risks associated with venipuncture and the additional blood draws required in the 
PK substudy include, but are not limited to: 
 Ecchymosis 
 Hematoma 
 Infection/inflammation 
 Pain 
19.4. 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 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. 
19.5. 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. 
19.6. Anticipated Benefits 
Potential anticipated benefits include the effective treatment of atherosclerotic SFA/PPA 
lesions with improvement in the symptoms of disease. However, the ELUVIA stent is an 
investigational device and these potential benefits may or may not actually be present. 
19.7. Risk to Benefit Rationale 
The ELUVIA stent is expected 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 Directions for Use (DFU). Evaluation of the risks and 
benefits that are expected to be associated with the use of the ELUVIA stent demonstrate that 

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when used under the conditions intended, the benefits associated with the use of the ELUVIA 
stent should outweigh the risks. 
20. Safety Reporting 
20.1. Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
 All Adverse Events (until 12 month follow-up) 
 All Device Related Adverse Events/Device Related Serious Adverse Events 
 All Serious Adverse Events 
 All Device Deficiencies  
 Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
 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. 
Any AE experienced by the study subject after randomization/enrollment, whether during or 
subsequent to the procedure, must be recorded in the eCRF. 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the investigational trial. For centers in Austria cancer must 
always be reported as a Serious Adverse Event. 
Death should not be recorded as an AE, but should only be reflected as an outcome of a 
specific SAE (see Table 20-1 for AE definitions).  
Refer to Section 19 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. 
In-patient hospitalization is defined as the subject being admitted to the hospital (≥ 24 hours), 
with the following exceptions. 
 A hospitalization for routine follow-up per standard of care. 

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 A hospitalization that is uncomplicated and elective/planned (i.e., planned prior to 
enrollment) does not have to be reported as an SAE or AE. 
 If complications or AEs occur during an elective/planned (i.e., planned prior to 
enrollment) hospitalization after enrollment, the complications and AEs must be reported 
as AEs or SAEs if they meet the protocol-specified definitions. However, the original 
elective/planned hospitalization(s) itself should not be reported as an SAE. 
20.2. Definitions and Classification 
Adverse event definitions for the IMPERIAL trial are provided in Table 20-1. 
Administrative edits were made to combine definitions from ISO 14155-2011 and MEDDEV 
2.7/3 (2015). In addition, country-specific definitions may apply per local reporting 
requirements. 
Table 20-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3(2015) 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, whether or not related to the investigational 
medical device.  
NOTE 1: This includes events related to the investigational medical device 
or 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 the investigational medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3(2015) 
Adverse event related to the use of an investigational medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies 
or inadequacies in the instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or 
intentional abnormal use of the investigational medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3(2015) 
Adverse event that: 
 Led to death, 
 Led to  serious deterioration in the health of the subject, that either 
resulted in:  
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolongation of existing hospitalization, or 
o medical or surgical intervention to prevent life-threatening illness, or 
o injury or permanent impairment to a body structure or a body function 
 Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 

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Table 20-1: Safety Definitions 
Term 
Definition 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3(2015) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Unanticipated Adverse Device 
Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree 
of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare 
of subjects. 
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3(2015) 
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 1: 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. 
Device Deficiency 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3(2015) 
An Inadequacy of an investigational medical device related to its identity, 
quality, durability, reliability, safety or performance. This may include 
malfunctions, use error, or inadequacy in the information supplied by the 
manufacturer. 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 
20.3. Relationship to Study Device(s) 
The Investigator must assess the relationship of the AE to the study device as related or 
unrelated. Criteria are defined in Table 20-2.  
 

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Table 20-2: Criteria for Assessing Relationship of Study Device or Index Procedure to 
AE 
Classification 
Description 
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 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 
o the device or procedure are applied to; 
o 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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Table 20-2: Criteria for Assessing Relationship of Study Device or Index Procedure to 
AE 
Classification 
Description 
- 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. 
The Investigator must assess the relationship of the AE to the antiplatelet medication as 
related or unrelated.  Criteria are defined in Table 20-3. 
Table 20-3: Criteria for Assessing Relationship of Antiplatelet Medication to AE 
Classification 
Description 
Unrelated 
The adverse event is determined to be due to a concurrent illness or effect of a 
device/drug and is not determined to be potentially related to the antiplatelet 
medication. 
Related 
The adverse event is determined to be potentially related to the antiplatelet medication, 
and an alternative etiology is equally or less likely compared to the potential 
relationship to antiplatelet medication. 
20.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 20-4. An 
Event Document Checklist included in the MOP specifies the required source documents for 
events requiring CEC adjudication. 
Table 20-4: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
(MEDDEV 2.7/3 (2015):  
CLINICAL INVESTIGATIONS: 
SERIOUS ADVERSE EVENT 
REPORTING UNDER DIRECTIVES 
90/385/EEC AND 93/42/EEC) 
Unanticipated Adverse Device 
Effect / Unanticipated Serious 
Adverse Device Effect 
(UADE/USADE) 
Complete AE eCRF page with all 
available new and updated 
information.  
 
 Within 1 business day of first 
becoming aware of the event. 
 Terminating at the end of the 
trial 
Serious Adverse Event (SAE)  
Complete AE eCRF page with all 
available new and updated 
information.  
 Within 3 calendar days of first 
becoming aware of the event or 
as per local/regional regulations. 
 Reporting required through the 
end of the trial 
Provide all relevant source 
documentation (unidentified) for 
events to be adjudicated by CEC. 
 When documentation is 
available 

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Table 20-4: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
(MEDDEV 2.7/3 (2015):  
CLINICAL INVESTIGATIONS: 
SERIOUS ADVERSE EVENT 
REPORTING UNDER DIRECTIVES 
90/385/EEC AND 93/42/EEC) 
Serious Adverse Device Effects 
(SADE) 
Complete AE eCRF page with all 
available new and updated 
information. 
 Within 3 calendar days of first 
becoming aware of the event or 
as per local/regional regulations.  
 Reporting required through the 
end of the study 
Provide all relevant source 
documentation (unidentified) for 
events to be adjudicated by CEC. 
 When documentation is 
available 
Device Deficiencies (including but 
not limited to failures, malfunctions, 
and product nonconformities) 
Note:  Any Investigational Device 
Deficiency that might have led to a 
serious adverse event if a) suitable 
action had not been taken or b) 
intervention had not been made or c) 
if circumstances had been less 
fortunate is considered a reportable 
event. 
Complete Device Deficiency 
eCRF with all available new and 
updated information.  
 Within 3 calendar days of first 
becoming aware of the event or 
per local/regional regulations. 
 Reporting required through the 
end of the trial 
Adverse Event (AE) including 
Adverse Device Effects (ADE) 
Complete AE eCRF page, which 
contains such information as date 
of AE, treatment of AE, 
resolution, assessment of 
seriousness and relationship to the 
device.  
 In a timely manner  (e.g. 
Recommend within 10 business 
days) after becoming aware of 
the information 
 ADE reporting required through 
the end of the trial 
 AE reporting required through 
the 12 month follow-up.  
Abbreviations: CEC=Clinical Events Committee; eCRF=electronic case report form 
20.5. Boston Scientific Device Deficiencies 
All investigational device deficiencies (including but not limited to failures, malfunctions, 
use errors, product nonconformities, and inadequacy in the information supplied by the 
manufacturer) will be documented and reported to BSC. If possible, the device(s) should be 
returned to BSC for analysis. Instructions for returning the investigational device(s) will be 
provided in the Manual of Operations. If it is not possible to return the device, the 
investigator should document why the device was not returned and the final disposition of the 
device. Device failures and malfunctions should also be documented in the subject’s medical 
record. 

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Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not adverse events. However, an adverse event that results from a 
device failure or malfunction, would be recorded as an adverse event on the appropriate 
eCRF. 
Any Device Deficiency that might have led to a SAE if a) suitable action had not been taken 
or b) intervention had not been made or c) if circumstances had been less fortunate is 
considered a reportable event. 
Device deficiencies may include, but are not limited to the following: 
 Stent fracture, migration, and/or misplacement/jumping 
 Packaging or labeling deficiency 
 Difficulty advancing or tracking stent delivery system 
20.6. Reporting to Regulatory Authorities / IRBs / IECs / REBs / Investigators 
BSC will notify all participating study centers if SAEs/SADEs occur which imply a possible 
increase in the anticipated risk of the procedure or use of the device or if the occurrence of 
certain SAEs/SADEs demands changes to the protocol or the conduct of the study in order to 
further minimize the unanticipated risks. 
BSC is responsible for reporting AE and device deficiencies information to all participating 
investigators, IRBs/IECs/REBs, and regulatory authorities as applicable according to local 
reporting requirements. 
BSC, Investigator, or Site must notify the IRB/IEC/REB of any UADEs, USADEs, SADEs, 
SAEs, device deficiencies, and other CEC events as applicable according to local reporting 
requirements (refer to Section 22.3 for information pertaining to the CEC and CEC Events). 
A copy of the Investigator’s reports and other relevant reports (if applicable) to the 
IRB/IEC/REB must be provided to BSC in accordance with local requirements. 
Safety reporting on the control device, which is approved in all regions at the time of the trial 
initiation, will be handled separately according to local regulations. 
21. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
all subjects or their legally authorized representative. For patients less than 20 years of age 
enrolled at a Japanese center, the patient’s legal representative, as well as the patient, must 
provide written informed consent. The Investigator is responsible for ensuring that Informed 
Consent is obtained prior to the use of any investigational devices, study-required procedures 
and/or testing, or data collection. 
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable. The ICF must be 

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approved by BSC or its delegate (e.g. CRO), the center’s IRB/IEC/REB, or central IRB, if 
applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative center’s IRB/IEC/REB. Any modification requires approval from BSC prior to 
use of the form. The ICF must be in a language understandable to the subject and if needed, 
BSC will assist the center in obtaining a written consent translation. Translated consent forms 
must also have IRB/IEC/REB approval prior to their use. Privacy language shall be included 
in the body of the form or as a separate form as applicable. 
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
 be conducted by the Principal Investigator or designee authorized to conduct the process, 
 include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
 avoid any coercion of or undue influence of subjects to participate, 
 not waive or appear to waive subject’s legal rights, 
 use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
 provide ample time for the subject to consider participation and ask questions if 
necessary, 
 ensure important new information is provided to new and existing subjects throughout the 
clinical study. 
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the center and a copy of the signed and dated document and 
any other written information must be given to the person signing the form. In Japan, 
Informed Consent signature can be replaced by printed name and seals of appropriate 
individuals. 
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements (e.g., FDA requirement is within 5 working days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g. IRB/IEC/REB), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 

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an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/IEC/REB. The new version of the ICF must be approved 
by the IRB/IEC/REB. Boston Scientific approval is required if changes to the revised ICF are 
requested by the center’s IRB/IEC/REB. The IRB/IEC/REB will determine the subject 
population to be re-consented. 
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. A Screening Log will be maintained by the investigational site to 
document select information about candidates who fail to meet the trial eligibility criteria, 
including, but not limited to, the reason for screen failure. 
22. Committees 
22.1. Executive Committee 
An Executive Committee composed of BSC Clinical Management and selected Coordinating 
Principal Investigator(s) will be convened. This committee will be responsible for the overall 
conduct of the study which will include protocol development, study progress, subject safety, 
overall data quality and integrity, and timely dissemination of study results through 
appropriate scientific sessions and publications. As appropriate the Executive Committee 
may request participation of IMPERIAL Investigators on the committee. 
22.2. Safety Monitoring Process 
To promote early detection of safety issues, the independent Clinical Events Committee 
(CEC) and Independent Data Review (IDR) will provide evaluations of safety events. 
Success of this program requires dynamic collection of unmonitored data as soon as the event 
is reported. This is expedited through BSC’s Safety Group, which is responsible for 
coordinating the collection of information for the subject dossier from Medidata Rave EDC 
database that is entered by the centers and core laboratories. During regularly scheduled 
monitoring visits, clinical research monitors will support the dynamic reporting process 
through their review of source document information. 
22.3. 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 
 TLR 

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 TVR 
 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. 
Contact information for the CEC is included in the Manual of Operations for Japanese sites. 
22.4. Independent Data Review (IDR) 
The independent data reviewer (IDR) provides external oversight and review for potential 
safety concerns. The IDR is a physician expert in peripheral interventional therapy who is not 
participating in the clinical study and has no affiliation with BSC. 
Aggregate accumulating safety data will be reviewed to monitor for the incidence of MAEs 
and other trends that would warrant modification or termination of the trial. During the 
course of the trial, data will be supplied to and reviewed by the IDR in blinded fashion (i.e., 
group A and group B). If, after review of blinded data, the IDR wants to review unblinded 
data, a request will be made to the Executive Committee for consideration and final decision. 
Any IDR recommendations for clinical study modification or termination because of 
concerns over subject safety or issues relating to data monitoring or quality control will be 
submitted in writing to BSC for consideration. 
Contact information for the IDR is included in the Manual of Operations for Japanese sites. 
23. Suspension or Termination 
23.1 
Premature Termination of the Study 
BSC 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 IRBs/IECs/REBs, 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 following. 
 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 BSC to suspend or discontinue development of the device. 

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23.2 
Termination of Study Participation by the Investigator or Withdrawal of 
IRBs/IECs/REBs Approval 
Any investigator or IRBs/IECs/REBs in the IMPERIAL trial may discontinue participation in 
the study or withdrawal approval of the study, respectively, with suitable written notice to 
BSC. Investigators, associated IRBs/IECs/REBs, and regulatory authorities, as applicable, 
will be notified in writing in the event of these occurrences. 
23.3 
Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating centers by BSC. The 
IRB/IEC/REB and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB/IEC/REB terminates participation in the study, participating 
investigators, associated IRBs/IECs/REBs, and regulatory authorities, as applicable, will be 
notified in writing. Detailed information on how enrolled subjects will be managed thereafter 
will be provided by BSC. 
In the event an investigator terminates participation in the study, study responsibility will be 
transferred to a co-investigator, if possible. In the event there are no opportunities to transfer 
investigator responsibility; detailed information on how enrolled subjects will be managed 
thereafter will be provided by BSC. 
The investigator must return all documents and investigational product to BSC, unless this 
action would jeopardize the rights, safety, or welfare of the subjects. 
23.4 
Criteria for Suspending/Terminating a Study Center 
BSC reserves the right to stop the inclusion of subjects at a study center at any time after the 
study initiation visit if no subjects have been enrolled, if enrollment is significantly slower 
than expected, or if the study center has multiple or severe protocol violations and 
noncompliance without justification and/or fails to follow remedial actions. 
In the event of termination of investigator participation, all study devices will be returned to 
BSC unless this action would jeopardize the rights, safety or well-being of the subjects. The 
IRB/IEC/REB and regulatory authorities, as applicable, will be notified. All subjects enrolled 
in the trial at the center will continue to be followed. The Principal Investigator at the center 
must make provision for these follow-up visits unless BSC notifies the investigational center 
otherwise. 
24. Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
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results for publication (regardless of study outcome) following the conclusion or termination 
of the study. Boston Scientific Corporation 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, BSC 
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. 
 BSC involvement in the publication preparation and the BSC 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. 
25. Reimbursement and Compensation for Subjects 
25.1. Subject Reimbursement 
Travel expenses (and other expense for Japan only) 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. 
25.2. Compensation for Subject’s Health Injury 
Boston Scientific Corporation will purchase an insurance policy to cover the cost of potential 
health injury for study subjects, as required by applicable law.  
 
 

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26. Bibliography 
1. Litsky J, Chanda A, Stilp E, Lanksy A, Mena C. "Critical evaluation of stents in the 
peripheral arterial disease of the superficial femoral artery - Focus on the paclitaxel 
eluting stent." Med Devices (Auckl) 7, no. 1 (2014): 149-156. 
2. Kakkar AM, Abbott JD. "Percutaneous versus surgical management of lower extremity 
peripheral artery disease." Curr Atheroscler Rep 17, no. 2 (2015): 479. 
3. Aghel A, Armstrong EJ. "Recent advances in self-expanding stents for use in the 
superficial femoral and popliteal arteries." Expert Rev Cardiovasc Ther 12, no. 7 (July 
2014): 833-842. 
4. Katsanos K, Tepe G, Tsetis D, Fanelli F. "Standards of practice for superficial femoral 
and popliteal artery angioplasty and stenting." Cardiovasc Intervent Radiol 37, no. 3 
(June 2014): 592-603. 
5. Kapsis C, Gurm HS. "Current approach to the diagnosis and treatment of femoral 
popliteal artery angioplasty and stenting." Current Cardiology Reviews 5, no. 4 
(November 2009): 296-311. 
6. Gandhi S, Sakhuja R, Slouvut DP. "Recent advances in percutaneous management of 
iliofemoral and superficial femoral artery disease." Cardiology Clinics 29, no. 3 (August 
2011): 381-394. 
7. Das, T. "Optimal therapeutic approaches to femoropopliteal artery intervention." 
Catheter Cardio Interven 63, no. 1 (September 2004): 21-30. 
8. Razavi MK, Mustapha JA, Miller LE. "Contemporary systematic review and meta-
analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic 
disease." J Vasc Interv Radiol 25, no. 10 (2014): 1489-1496. 
9. Schillinger M, Minar E. "Claudication: Treatment options for femoropopliteal disease." 
Progress in Cardiovascular Diseases 54, no. 1 (2011): 41-46. 
10. Tepe G. Schmehl J, Heller S, Wiesinger B, Claussen CD, Duda SH. "Superficial femoral 
artery: Current Treatment Options." European Radiology 16, no. 6 (June 2006): 1316-
1322. 
11. Erwin PA, Shishehbor MH. "Contemporary managmenet of femoral popliteal 
revascularization." Intervent Cardiol Clinics 3, no. 4 (2014): 517-530. 
12. Bosiers M, Deloose K, Verbist J, Peeters P. "Present and future of endovascular SFA 
treatment: Stents, stent-grafts, drug coated balloons and drug coated stents." J Cardiol 
Surg 49, no. 2 (April 2008): 159-65. 
13. Nakgawa Y, Yajima J, Oikawa Y, et al. "Clinical outcomes after percutaneous peripheral 
intervention for chronic total occlusion of the superficial femoral arteries: Comparison 
between self-expandable nitinol stent and stainless steel stent." (Journal of Cardiology) 
53, no. 3 (June 2009): 417-421. 
14. Laird JR, Katzen BT, Scheinert D, et al. "Nitinol stent implantation versus balloon 
angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: 
Twelve month results from the RESILIENT randomized trial." Circulation: 
Cardiovascular Interventions 3, no. 3 (June 2010): 267-276. 

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15. Dake MD, Scheinert D, Tepe G, et al. "Nitinol stents with polymer-free paclitaxel coating 
for lesions in the superficial femoral and popliteal arteries above the knee: Twelve-month 
safety and effectivess results from the Zilver PTX single-arm clinical study." J Endovasc 
Therapy 18, no. 5 (2011): 613-23. 
16. Laird JR, Katzen BT, Scheinert D, et al. "Nitinol stent implantation vs. balloon 
angioplasty for lesions in the superficial femoral and proximal popliteal arteries of 
patients with claudication: Three-year follow-up from the RESILIENT randomized trial." 
J Endovasc Ther 19, no. 1 (2012): 1-9. 
17. G.Ansel. "Drug-eluting stents are widely applicable: The choice of drug is the only 
differential factor when treating the patient." Vascular 18, no. Suppl 2 (June 2010): S52-
53. 
18. Mongiardo A, Curcio A, Spaccarotella C, Parise S, Indolfi C. "Molecular mechanisms of 
restenosis after percutaneous peripheral angioplasty and approach to endovascular 
therapy." Current Drug Targets - Cardiovasc Haematol Disorders 4, no. 3 (September 
2004): 275-87. 
19. G.Ansel. "What is the next big thing in cardiac revascularization?" Vascular 18, no. 
Suppl 2 (June 2010): S54. 
20. Bosiers M, Deloose K, Keirse K, Verbist J, Peeters R. "Are drug-eluting stents the future 
of SFA treatment?" J Cardiovasc Surg 51, no. 1 (February 2010): 115-19. 
21. Tepe G, Zeller T, Albrecht T, et al. "Local delivery of paclitaxel to inhibit restenosis 
during angioplasty of the leg." New Eng J Med 358, no. 7 (February 2008): 689-99. 
22. Werk M, Langner S, Reinkensmeier B, et al. "Inhibition of restenosis in femoropopliteal 
arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot 
trial." Circulation 118, no. 13 (September 2008): 1358-65. 
23. Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al. "Paclitaxel-eluting 
stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal 
disease : Twelve-month Zilver PTX randomized study results." Circulation Cardiovasc 
Interven 4 (2011): 495-504. 
24. Dake MD, Ansel GM, Jaff MR, et al. "Sustained safety and effectiveness of paclitaxel 
eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX 
randomized and single-arm clinical studies." J Am Coll Cardiol 61, no. 24 (2013): 2417-
27. 
25. Stone GW, Teirstein PS, Meredith IT, et al. "A Prospective, Randomized Evaluation of a 
Novel Everolimus-Eluting Stent: the PLATINUM trial." J Am Coll Cardiol 57 (2011): 
1700-1708. 
26. Schlager O, Francesconi M, Haumer M, Dick P, Sabeti S, Amighi J, et al. Duplex 
Sonography Versus Angiography for Assessment of Femoropopliteal Arterial Disease in 
a "Real-World" Setting. J Endovasc Ther 14 (2007): 452-9. 
27. Rocha-Singh KJ, et al. "Performance Goals and Endpoint Assessments for Clinical Trials 
of Femoropopliteal Bare Nitinol Stents in Patients with Symptomatic Peripheral Arterial 
Disease." Catheter Cardiovasc Interven 69 (2007): 910-19. 
28. Rooke TW, et al. 2011 ACCF / AHA Focused Update of the Guideline for the 
Management of Patients with Peripheral Artery Disease (Updating the 2005 Guideline): 

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A Report of the American College of Cardiology Foundation/American Heart 
Association Task Force. 
 
27. Abbreviations and Definitions 
27.1. Abbreviations 
Table 27-1: 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 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CVA 
Cerebrovascular Accident 
DFU 
Directions for Use 
DSA 
Digital Subtraction Angiography 
DUS 
Duplex Ultrasound 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 

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Abbreviation 
Terminology 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IEC 
Institutional Ethics Committee 
ITT 
Intent to Treat 
IRB 
Institutional Review Board 
MAE 
Major Adverse Event 
PMDA 
Pharmaceutical Medical Device Agency 
PPA 
Proximal Popliteal Artery 
PSVR 
Peak Systolic Velocity Ratio 
PTA 
Percutaneous Transluminal Angioplasty 
QA 
Quantitative Angiography 
REB 
Research Ethic Board 
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 
UPN 
Universal Product Number 
VIVA 
Vascular InterVentional Advances 
 
 

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27.2. Definitions 
Terms are defined in Table 27-2 
Table 27-2: 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. 
ARRHYTHMIA 
Any variation from the normal rhythm of the heartbeat, including 
but not limited to, sinus arrhythmia, premature beats, heart block, 
ventricular or atrial fibrillation, ventricular tachycardia, or atrial 
flutter. 
ASSISTED 
PRIMARY 
PATENCY 
Percentage (%) of lesions without clinically-driven TLR and those 
with clinically-driven TLR (not due to complete occlusion or by-
pass) that reach endpoint without restenosis. 
BLEEDING 
COMPLICATION 
Includes, but is not limited to, intracranial hemorrhage, GI bleeding, 
hematoma, bleeding at percutaneous catheterization site, and/or 
retroperitoneal bleeding. Bleeding that requires surgery qualifies as 
an SAE. 
CALCIFICATION 
Readily apparent densities seen within the artery wall and site of 
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Term 
Definition 
CEREBRO-
VASCULAR 
ACCIDENT (CVA) 
CEREBRO-VASCULAR ACCIDENT / STROKE 
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.  
CLINICAL 
DETERIORATION 
Downgrade in Rutherford classification of 1 or more categories as 
compared to pre-procedure. 
COMPLETE 
BLOOD COUNT 
(CBC) 
A blood test used to measure several components and features of 
blood, including:  Red Blood Cells, White Blood Cells, Hemoglobin, 
Hematocrit and Platelets. 
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 investigational 
product(s). 
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. 

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Term 
Definition 
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. 
EQ-5D™ 
Descriptive system of health-related quality of life states consisting 
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. 
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. 

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Term 
Definition 
MINIMAL LUMEN 
DIAMETER 
The vessel diameter as measured at the most narrow point of the 
lesion. 
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. 
PRIMARY 
PATENCY 
Percentage (%) of lesions that reach endpoint without a 
hemodynamically significant stenosis on DUS and without 
clinically-driven 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. 
PRODUCT NON-
CONFORMITY 
A departure of a quality characteristic from its intended level or state 
that occurs with a severity sufficient to cause an associated product 
or service not to meet a specification requirement.  
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. 

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Term 
Definition 
RESTENOSIS 
DUS systolic velocity ratio (SVR) > 2.4 suggest stenosis >50%. 
RUTHERFORD / 
BECKER 
CLASSIFICATION 
Category Clinical Description 
Objective Criteria 
0 
Asymptomatic 
Normal Treadmill /stress test 
1 
Mild claudication 
Completes treadmill exercise; ankle 
pressure (AP) after exercise < 50 mm 
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 MT 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 clinical study device during the index procedure. 

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Term 
Definition 
TARGET LESION 
REVASCULARIZATION 
(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 
REVASCULARIZA
TION (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.) 
 A target vessel revascularization for a culprit 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.) 

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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  5 cm 
 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 > 15 cm 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 (> 20 cm, 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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28. IMPERIAL Long Lesion Substudy 
28.1. Objectives 
The objective of the Long Lesion Substudy is to evaluate the safety and effectiveness of the 
Boston Scientific (BSC) ELUVIA drug eluting stent for treating Superficial Femoral (SFA) 
and/or Proximal Popliteal Artery (PPA) lesions > 140 mm and ≤ 190 mm in length. 
28.2. Design 
The IMPERIAL Trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs 
Zilver PTX), controlled, single-blind, non-inferiority trial (RCT), a concurrent, non-blinded, 
non-randomized, single-arm, pharmacokinetic (PK) substudy and a concurrent, non-blinded, 
non-randomized, single-arm, Long Lesion substudy.  
This section describes the Long Lesion substudy only. 
 Scale and Duration 
28.2.1.
Approximately 50 subjects will be enrolled in the IMPERIAL Long Lesion substudy. 
All subjects will receive treatment with the investigational test device (ELUVIA) in the Long 
Lesion substudy. 
The Long Lesion substudy will be conducted in any site already participating in the 
IMPERIAL Trial that is interested in adding this substudy group. 
Clinical follow-up will be required at the following time points: pre-discharge, 1 month, 6 
months, 12 months, 24 months, 36 months, 48 months and 60 months post index procedure.  
Testing required at these visits is described in Section 11.13 of the IMPERIAL protocol. 
If patients are enrolled at a site conducting the PK substudy and are willing to undergo PK 
testing, they will have baseline venous blood drawn followed by blood draws at 10 minutes, 
30 minutes, 1, 2, 3, 4, 6, 12, 24 and either 48 or 72 hours after placement of the final 
ELUVIA study stent to evaluate plasma paclitaxel levels. 
The enrollment period will run concurrent with the IMPERIAL Trial. 
Figure 28.2-1 shows the schematic of the Long Lesion substudy design. 
 
 

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Figure 28.2-1: IMPERIAL Long Lesion Substudy Design 
 
Do Not Enroll 
NO 
NO 
Site Training on Long Lesion Protocol 
requirements  
Guidewire successfully crosses target lesion 
Subject enrolled at site participating in PK 
testing and consents to PK blood draws? 
 
Post-procedure / Pre-discharge Assessments 
Follow-up Evaluations 
1 Month, 6 Month, 12 Month, 24 Month  
follow-up in office/clinic 
36 Month and 48 Month follow-up via telephone 
or in office 
60 Month follow-up in office/clinic 
End of Study 
Required Regulatory Documents Obtained 
  
Will subject sign informed consent? 
  
Does subject meet inclusion criteria? 
  
ELUVIA stent successfully implanted? 
Baseline Blood Draw, T=0 
 
Additional blood draws at 10, 30 
minutes, 1, 2, 3, 4, 6, 12, 24 and 48 or 
72 hours after final ELUVIA stent 
placed 
 
YES 
NO 
Pre-discharge Assessments 
Follow-up Evaluation 1 Month in office 
NO 

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 Treatment Assignment 
28.2.2.
Once the subject has signed the IRB/IEC/REB-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 Long Lesion substudy.  Subjects can be 
simultaneously consented for the RCT and the Long Lesion substudy as the lesion groups do 
not overlap.  Once the lesion length is determined via angiographic assessment, the subject 
would be placed into the appropriate group (i.e. the RCT for lesions 40-140 mm in length or 
the Long Lesion substudy for lesions from 140-190 mm in length). 
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 or 
receive an investigational device, nor should the subject be followed post-procedure per 
protocol.  
All subjects will be treated with the ELUVIA Stent System.  It is expected that two Eluvia 
stents will be overlapped in order to cover the entire lesion.  Subjects will be considered 
enrolled when the first ELUVIA stent is introduced into the subject’s vasculature.  
 Multiple Interventions Using Same Access Site During Index Procedure 
28.2.3.
Target Limb 
The target lesion may include two or more tandem lesions, provided that the entire segment 
of tandem lesions is > 140 mm and  190 mm and can be covered with two ELUVIA stents 
according to the Directions for Use (DFU).  For occlusive lesions requiring the use of a re-
entry device, the target lesion length must be > 120 mm and ≤ 170 mm allowing the target 
lesion and re-entry area to be covered with two ELUVIA stents (Refer to Inclusion criterion 
4c and 4d). 
28.3. Subject Selection 
Study Population and Eligibility 
 
Clinical and angiographic inclusion criteria are included in Table 28-1. Exclusion criteria are 
identical to the IMPERIAL Trial population and are detailed in Section 9.3 of the 
IMPERIAL protocol.  Prior to enrollment, a subject must meet all of the clinical and 
angiographic inclusion criteria and none of the clinical and angiographic exclusion criteria. 

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Table 28-1 Long Lesion Substudy Inclusion Criteria 
Inclusion 
Criteria 
1. Subjects age 18 and older.  
2. Subject (or Legal Guardian if applicable) 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. 
NOTE:  For subjects less than 20 years of age enrolled at a Japanese 
center, the subject’s legal representative, as well as the subject, must 
provide written informed consent. 
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) > 140 mm and  190 mm 
(Note:  Lesion segment(s) will require overlapping of two 
ELUVIA stents) 
d. For occlusive lesions requiring use of re-entry device, lesion length 
> 120 mm and ≤ 170 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. 
28.4. Subject Accountability 
Subject accountability is as described in Section 10. 
28.5. Study Methods 
Subjects enrolled in the Long Lesion substudy will follow the Data Collection schedule 
outlined in Section 11.1.  If a subject in the Long Lesion substudy is enrolled at a PK 
substudy site and consents to PK testing, assessment of whole blood paclitaxel levels will be 
completed as described in Section 11.12.  Follow-up visits will continue through 5 years 
post-procedure.  
 

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28.6. Statistical Considerations 
Statistical considerations are as defined in Section 12.  The details of all statistical analyses 
will be described in the Statistical Analysis Plan. 
 Primary Endpoints 
28.6.1.
The sample size determination for the long lesion substudy is arbitrary and not statistically 
driven.  
28.6.1.1. Primary Effectiveness Endpoint 
The primary effectiveness endpoint assesses the 12-month primary patency. There is a non-
statistically driven goal (60%) which was developed from the historical long stent 
performance (47.2%; 95% Confidence Interval [30.4%, 64.5%]) in subjects treated with 
Innova Bare Metal Stent System and the expected enhanced performance (10%) for the 
ELUVIA Stent System. 
Statistical Methods 
The non-statistically driven performance goal will be compared against the observed 12-
month primary patency in the evaluable long-lesion subjects. If the observed 12-month 
primary patency is greater than or equal to 60%, the ELUVIA Stent System will be 
considered to have acceptable effectiveness performance in the long lesion population. 
28.6.1.2. Primary Safety Endpoints 
The primary safety endpoint assesses the 12-month MAE-free rate.  It is expected that the 
MAE-free rate will be similar to the rates observed by the ELUVIA stent group observed in 
the RCT.  The MAE-free Rate as well as its individual components will be reported 
separately for this subgroup.  
 Additional Endpoints 
28.6.2.
All additional endpoints described in Section 7.2 will be reported separately for this 
subgroup.