A Real World Evaluation of the ELUVIA Drug Eluting Stent in All-Comers With Superficial Femoral Artery and Proximal Popliteal Artery Disease
Conditions: Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
Sponsor: Boston Scientific Corporation

REGAL 
Boston Scientific International SA 
 Confidential 
 
ClinicalTrials.gov  
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CLINICAL INVESTIGATIONAL PLAN  
 
REGAL 
 
 
A Real World Evaluation of the ELUVIA Drug Eluting Stent in All-Comers With 
Superficial Femoral Artery and Proximal Popliteal Artery Disease 
 
NCT Number: NCT03037411 
CIP nr: S2346 
VERSION: 1.0 
DATE: 08 August 2016 
 
This protocol contains confidential information for use by the Investigators and their designated 
representatives participating in this clinical investigation. The protocol should be held confidential and 
maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific International SA 
 

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CLINICAL INVESTIGATIONAL PLAN  
 
REGAL 
 
A Real World Evaluation of the ELUVIATM Drug ElutinG Stent in All-Comers with SuperficiaL 
Femoral Artery and Proximal Popliteal Artery Disease. 
 
CIP nr: S2346 
VERSION: 1.0 
DATE: 08 August 2016 
 
 
This protocol contains confidential information for use by the Investigators and their designated 
representatives participating in this clinical investigation. The protocol should be held confidential and 
maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific International SA. 
 
 
 
     Sponsored By:  
 
 
 
 Supported By: 
Boston Scientific International SA 
Le Val Saint Quentin 
2 Rue René Caudron 
78960 Voisins-Le-Bretonneux 
France 
genae Group 
Justitiestraat 6B 
2018 Antwerp 
Belgium 

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TABLE OF CONTENTS 
 
1. 
CLINICAL INVESTIGATIONAL PLAN (CIP) APPROVAL PAGE ........................................ 4 
2. 
CIP SIGNATURE PAGE .................................................................................................... 5 
3. 
CIP EXECUTIVE SUMMARY ............................................................................................ 6 
4. 
ASSESSMENT AND FOLLOW-UP SCHEME .................................................................. 10 
5. 
CONTACT DETAILS........................................................................................................ 11 
6. 
INTRODUCTION AND RATIONALE ................................................................................ 12 
6.1 
Background ................................................................................................................. 12 
6.2 
ELUVIA Stent System ................................................................................................. 12 
6.3 
MAJESTIC First Human Use Study ............................................................................. 12 
6.4 
IMPERIAL IDE Study .................................................................................................. 13 
6.5 
EMINENT Post-Market Study ...................................................................................... 13 
6.6 
Clinical trial data ELUVIA Stent System ...................................................................... 13 
7. 
OBJECTIVE ..................................................................................................................... 14 
8. 
STUDY ASSESSMENTS ................................................................................................. 14 
9. 
STUDY DESIGN .............................................................................................................. 14 
9.1 
Scale and Duration ..................................................................................................... 15 
9.2 
Study Flow Chart ........................................................................................................ 16 
10. 
STUDY POPULATION ..................................................................................................... 17 
10.1 
Subject Selection ........................................................................................................ 17 
10.2 
Inclusion Criteria ......................................................................................................... 17 
10.3 
Exclusion Criteria ........................................................................................................ 17 
11. 
DEVICE DESCRIPTION .................................................................................................. 17 
11.1 
ELUVIA Drug-Eluting Stent System ............................................................................ 17 
11.1.1 
Paclitaxel Drug ...................................................................................................... 18 
11.1.2 
Primer Polymer and Drug Matrix Copolymer Carrier.............................................. 18 
11.1.3 
ELUVIA Stent System Product Description ........................................................... 18 
11.1.4 
ELUVIA stent Sizes ............................................................................................... 18 
11.2 
Device Accountability .................................................................................................. 19 
12. 
METHODS ....................................................................................................................... 19 
12.1 
Screening .................................................................................................................... 19 
12.2 
Informed Consent ....................................................................................................... 19 
12.3 
Point of Enrollment ...................................................................................................... 20 
12.4 
Study Assessments and Measurements ..................................................................... 20 
12.4.1 
Pre-Procedure Assessments – Up to 30 Days prior to Day 0 ................................ 20 
12.4.2 
Pre-Procedure Assessments – Up to 7 Days prior to Day 0 .................................. 21 
12.4.3 
Procedure – Day 0 ................................................................................................ 21 
12.5 
Post-procedure/Pre-hospital Discharge ....................................................................... 22 
12.6 
Angiography ................................................................................................................ 22 
12.7 
Follow-up .................................................................................................................... 22 
12.7.1 
1-Month Follow-up Visit: Day 15 – 90 (30 days -15 days to +60 days) .................. 23 
12.7.2 
6-Month Follow-up Visit: Day 91 – 273 (182 days ± 91 days) ................................ 23 
12.7.3 
12-Month Follow-up Visit: Day 274 – 456 (365 days ± 91 days) ............................ 24 
12.7.4 
24-Month Follow-up Visit: Day 457 – 760 (730 days -273 days +30 days) ............ 24 
12.8 
Trial Completion .......................................................................................................... 24 
12.9 
Missed or Late Visits ................................................................................................... 24 
12.10 
Medication ................................................................................................................ 25 
12.11 
Withdrawal of Individual Subjects ............................................................................. 25 
12.12 
Replacement of Individual Subjects after Early Termination ..................................... 25 
13. 
SUSPENSION OR TERMINATION .................................................................................. 25 
13.1 
Premature Termination of the Study ............................................................................ 25 
13.1.1 
Study-wide Termination or Suspension ................................................................. 25 
13.1.2 
Investigator/Site Termination or Suspension ......................................................... 26 
13.1.3 
Procedures for Termination or Suspension ........................................................... 26 

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14. 
SAFETY........................................................................................................................... 27 
14.1 
Adverse Events ........................................................................................................... 28 
14.2 
Adverse Device Effects ............................................................................................... 28 
14.3 
Serious Adverse Events .............................................................................................. 28 
14.4 
Serious Adverse Device Effects .................................................................................. 29 
14.5 
Unanticipated Serious Adverse Device Effects ........................................................... 29 
14.6 
Device Deficiency/Malfunction – Device Specific Events ............................................. 29 
14.7 
Adverse and serious adverse events reporting............................................................ 30 
14.8 
Annual Safety Report .................................................................................................. 33 
14.9 
Severity ....................................................................................................................... 33 
14.10 
Clinical Events Committee (CEC) ............................................................................. 33 
15. 
POTENTIAL RISKS AND BENEFITS .............................................................................. 33 
15.1 
Risks ........................................................................................................................... 33 
15.2 
Risk Minimization Actions ........................................................................................... 34 
15.3 
Anticipated Benefits .................................................................................................... 34 
15.4 
Risk to Benefit Rationale ............................................................................................. 34 
16. 
STATISTICAL ANALYSIS ................................................................................................ 34 
16.1 
Sample Size ................................................................................................................ 34 
16.2 
Analysis Population ..................................................................................................... 35 
16.3 
Descriptive Statistics ................................................................................................... 35 
16.4 
Assessment Analysis .................................................................................................. 35 
16.5 
Missing Data ............................................................................................................... 35 
16.6 
Subgroup Analysis ...................................................................................................... 35 
16.6.1 
Analysis Software .................................................................................................. 35 
16.6.2 
Changes to Planned Analyses .............................................................................. 36 
17. 
ETHICAL CONSIDERATIONS ......................................................................................... 36 
17.1 
Regulation/Compliance Statement .............................................................................. 36 
17.2 
Investigator Responsibilities ........................................................................................ 36 
17.2.1 
Delegation of Responsibility .................................................................................. 38 
17.3 
Ethics Committee ........................................................................................................ 38 
17.4 
Sponsor Responsibilities ............................................................................................. 38 
17.4.1 
Role of Sponsor Representatives .......................................................................... 39 
18. 
REIMBURSEMENT AND COMPENSATION FOR SUBJECTS ....................................... 39 
18.1 
Subject Reimbursement .............................................................................................. 39 
18.2 
Compensation of Injury ............................................................................................... 39 
19. 
ADMINISTRATIVE ASPECTS AND PUBLICATION ........................................................ 39 
19.1 
Handling and Storage of Data and Documents ........................................................... 39 
19.2 
Data Collection and electronic Case Report Forms (eCRFs) ....................................... 40 
19.3 
Deviations ................................................................................................................... 41 
19.4 
CIP Revisions or Amendments ................................................................................... 41 
19.5 
Annual Progress Report .............................................................................................. 41 
19.6 
End of Study Report .................................................................................................... 41 
19.7 
Public Disclosure and Publication Policy ..................................................................... 42 
20. 
MONITORING ................................................................................................................. 42 
20.1 
Monitoring Visits .......................................................................................................... 43 
21. 
ABBREVIATIONS AND DEFINITIONS ............................................................................ 44 
21.1 
Abbreviations .............................................................................................................. 44 
21.2 
Definitions ................................................................................................................... 46 
22. 
REFERENCES ................................................................................................................ 54 
 
 
 

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1. CLINICAL INVESTIGATIONAL PLAN (CIP) APPROVAL PAGE 
 
Study Title 
A Real World Evaluation of the ELUVIATM Drug ElutinG Stent in All-
Comers with Superficial FemoraL Artery and Proximal Popliteal 
Artery Disease (REGAL) 
CIP Number 
S2346 
CIP Version 
1.0 
CIP Date 
08 August 2016 
 
 
 
Prof. Dr. Carlo Setacci 
Coordinating Clinical Investigator 
 
 
 
 
Date 
Lieve Cornelis 
Clinical Trial Manager 
Sponsor representative 
 
 
 
 
Date 
Evi Petro, PhD 
Clinical Project Manager, genae Belgium 
Author 
 
Date 

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2. CIP SIGNATURE PAGE 
 
Study Title 
A Real World Evaluation of the ELUVIATM Drug ElutinG Stent in All-
Comers with Superficial FemoraL Artery and Proximal Popliteal 
Artery Disease (REGAL) 
CIP Number 
S2346 
CIP Version 
1.0 
CIP Date 
08 August 2016 
I have reviewed this protocol and agree to adhere to the requirements and responsibilities listed 
herein. I am trained to the contents of this protocol, percutaneous angioplasty procedures, and 
the specific use of the device listed in this protocol. I will ensure that the study is conducted in 
compliance with the protocol, Good Clinical Practices, Declaration of Helsinki, the International 
Standard ISO 14155:2011 and all applicable regulatory requirements.  
 
 
 
 
 
_______________________________ 
 
 
 
_____________________ 
Site Principal Investigator Name (please print or use stamp) 
 
Site Number 
 
 
 
 
____________________________       
 
   
 
_____________________ 
Site Principal Investigator Signature  
 
 
 
 
Date 
 

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3. CIP EXECUTIVE SUMMARY 
 
PROTOCOL TITLE: A Real World Evaluation of the ELUVIATM Drug ElutinG Stent in All-Comers 
with SuperficiaL Femoral Artery and Proximal Popliteal Artery Disease (REGAL) 
CIP Short title 
REGAL 
CIP number 
S2346 
Sponsor  
Boston Scientific Corporation 
Objective 
To collect additional data including health economics data to support the use of 
the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating 
Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions. 
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. 
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. 
Device Sizes 
ELUVIA Stent  
Stent Diameter 
(mm) 
Stent Length (mm) 
Recommended 
Vessel 
Diameter (mm) 
6 
40, 60, 80, 100, 120, 150 
4.0 – 5.0 
7 
40, 60, 80, 100, 120, 150 
5.0 – 6.0 
The ELUVIA Stent is available in two stent delivery system (SDS) sizes; 75 cm 
and 130 cm. The sheath compatibility is 6 French used with 0.035 inch 
guidewires.  
Study Design 
A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial 
providing additional data including health economics data to support the use of 
the ELUVIA stent in the treatment of lesions located in the femoropopliteal 
arteries. 
Study 
Assessments 
 
Health Economics:  
o Walking Improvement and Quality of Life Improvement at 1 month, 6 
months, 12 months and 24 months as assessed by change in Walking 
Impairment Questionnaire (WIQ) and EQ-5D-5L™ from baseline 
o Health care costs associated with index procedure 
o Changes in healthcare utilization over time and associated health care 
costs 
o Rate of Primary and Secondary Sustained Clinical Improvement at 1 
month, 6 months, 12 months and 24 months as assessed by changes in 
Rutherford Classification from baseline 

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o Rate of Hemodynamic Improvement at 1 month, 6 months, 12 months 
and 24 months as assessed by changes in Ankle-Brachial Index (ABI) 
from baseline 
 
Technical success 
 
Procedural success 
 
Major Adverse Event (MAE) rate (and individual components) at each follow-
up visit, defined as all causes of death, target limb major amputation and/or 
Target Lesion Revascularization (TLR) 
 
Primary Patency and Assisted Primary Patency at 6 months, 12 months and 
24 months assessed by duplex ultrasound (DUS) Peak Systolic Velocity Ratio 
(PSVRs). Primary vessel patency is defined as a binary endpoint and will be 
determined to be a success when the DUS PSVR is ≤ 2. 4 at the 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. 
 
Clinically-driven TLR and clinically-driven TVR Rate at each follow-up visit 
 
Adverse Event Rates (unanticipated, major, serious, device/procedure-
related) at each time point 
 
Distribution of Rutherford Class during follow-up as compared to baseline at 1 
month, 6 months, 12 months and 24 months 
Population  
500 subjects to receive treatment with the ELUVIA Drug Eluting Stent. 
Up to 30 study centers in up to 10 European countries may enroll subjects in the 
study.  
Study 
Duration 
It is expected that the enrollment will take approximately 12 months. 
Subject participation will last approximately 2 years. The trial will be considered 
complete after all subjects have completed the 24 month (2 year) follow-up visit, 
were discontinued or withdrawn prior to the 24 month (2 year) follow-up visit, 
have died, or the last 24 month (2 year) follow-up visit window is closed. 
It is estimated that it will take approximately 4 years to complete this trial. 
Inclusion 
Criteria 
1. Subjects age 18 and older 
2. Subject is willing and able to provide written consent before any study-specific 
test or procedure is performed, and agrees to attend all follow-up visits 
3. De novo, restenotic or (re)occluded lesions in the native femoro-popliteal 
arteries, with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, 
suitable for endovascular treatment 
Exclusion 
Criteria 
1. Subject is pregnant or planning to become pregnant during the course of the 
study 
2. Life expectancy of less than 1 year (which is defined as documented life 
expectancy less than 12 months due to other medical co-morbid condition(s) 
that could limit the subject’s ability to participate in the clinical follow-up, limit 
the subject’s compliance with the standard of care follow-up, or impact the 
scientific integrity of the trial) 
3. Known allergy to the ELUVIA stent system or any of its components, 

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concomitant medication, contrast agents (that cannot be medically managed), 
4. Subject enrolled in an investigational study that has not reached primary 
endpoint at the time of enrollment or that clinically interferes with the current 
study assessments (Note: studies requiring extended follow-up for products 
that were investigational, but have become commercially available since then 
are not considered investigational studies) 
Informed 
Consent 
Process and 
Point of 
Enrollment 
Once the subject has signed the approved Informed Consent Form (ICF), and has 
met all inclusion and no exclusion criteria, the subject will be considered eligible to 
be enrolled in the study.  
If the subject is found to not meet the inclusion criteria during the angiographic 
eligibility assessment, the subject will be considered a screen failure and should 
not be included in the study, nor should the subject be followed post-procedure per 
protocol.  
A subject is considered enrolled when the ELUVIA stent system is advanced into 
the patient’s vasculature. 
Follow-up 
Schedule 
Subject evaluation is recommended at following time points post-procedure, but is 
dependent on the local standard of care follow-up schedule:  
 
1 month: 30 days -15 days to +60 days (Day 15 – 90),  
 
6 months: 182 days ±91 days (Day 91 – 273), 
 
12 months: 365 days ±91 days (Day 274 – 456), and 
 
24 months: 730 days -273 days to +30 days (Day 457 – 760) 
Subjects who are enrolled but an ELUVIA 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. 
All follow-up visits will be conducted in the office/clinic as per standard of care. 
Planned protocol-required testing includes the following: 
 
Angiography during the index procedure to assess technical success and 
procedural success. 
 
DUS at 6 months, 12 months (1 year) and 24 months (2 years) to assess 
lesion and vessel patency, as per standard of care. 
 
Walking Impairment Questionnaire (WIQ) at 1 month, 6 months, 12 months (1 
year) and 24 months (2 years) visits to assess Walking Ability. 
 
EQ-5D-5L™ at 1 month, 6 months, 12 months (1 year) and 24 months (2 years) 
to assess Quality of Life. 
 
Rutherford Categorization, as per standard of care  
 
ABI Measurements, as per standard of care 
Required 
Medication 
Investigators are recommended to prescribe concomitant anti-coagulant and anti-
platelet medications consistent with current local clinical practice. Antiplatelet and 

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Therapy 
anti-coagulant medication usage will be collected and reported for the duration of 
the trial. 
Statistical 
Methods 
No formal tests of hypotheses are proposed for the REGAL assessments. 
Statistical comparisons may be performed for exploratory purposes. 
Analysis 
Subgroups 
Additional exploratory analysis of all assessments may be performed for the 
following subgroups: 
 
Age and gender 
 
Co-morbidities (e.g. diabetes, renal insufficiency, etc.) 
 
Peripheral Artery Disease classification (e.g. ABI, Rutherford, etc.) 
 
Lesion location (e.g. proximal, mid, distal SFA, PPA, etc.) 
 
Type of stenosis (e.g. de novo, restenotic, etc.) 
 
Lesion length, degree of stenosis, calcification 
 
TASC classification 
 
Lesion preparation (e.g. scoring balloons, cutting balloons, atherectomy 
devices, etc.)  
 
Bail out stent implantation (diameter, length, stent size etc.) 
 
Treatment approach (e.g. sub-intimal, intra-luminal, etc.) 
 
QoL (e.g. pain level, WIQ) 
 
 
 

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4. ASSESSMENT AND FOLLOW-UP SCHEME 
Data collection schedule per standard of care 
 
Pre-
procedure2 
During Index 
Procedure 
Day 0 
Pre-
Discharge 
1MFU 
(Day 15-90) 
6MFU 
(Day 91-273) 
12MFU 
(Day 274-456) 
24MFU 
(Day 457-760 
Informed Consent1 
X 
 
 
 
 
 
 
In/exclusion criteria 
X 
X 
 
 
 
 
 
Demographics 
& 
Medical History, Height 
and Weight 
X 
 
 
 
 
 
 
Serum Creatinine 
X 
 
 
 
 
 
 
Platelet count 
X 
 
 
 
 
 
 
Pregnancy test2 
X 
 
 
 
 
 
 
ABI 
X 
 
 
X3 
X 
X 
X 
RCC (Rutherford-Becker 
clinical classification) 
X 
 
 
X 
X 
X 
X 
WIQ 
X 
 
 
X 
X 
X 
X 
EQ-5D-5L 
X 
 
 
X 
X 
X 
X 
DUS4 
 
 
 
 
X 
X 
X 
Health Economics 
 
X 
 
X 
X 
X 
X 
Medication 
X 
X 
X 
X 
X 
X 
X 
X
Adverse Events5 
X 
X 
X 
X 
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 – 90) 
4. DUS images will be sent to the respective core lab for analysis. Follow-up ultrasounds will not be required for any subject who underwent bypass surgery of the target lesion 
during the 24-month follow-up timeframe, or has a documented occluded stent. 
5. Reporting required through the end of study for UADEs and (S)ADEs/Device Deficiencies.  
 

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5. CONTACT DETAILS 
Contact information is provided below. This information is subject to change during the 
course of the clinical study. Periodic updates to study contact information will be sent to the 
sites and committees as needed. 
 
Coordinating investigator 
Prof. Dr. Carlo Setacci 
Policlinico Santa Maria alle Scotte di Siena  
Viale Mario Bracci 13 
53100 Siena, Italy 
 
Sponsor 
Boston Scientific International SA 
Le Val Saint Quentin 
2 Rue René Caudron 
78960 Voisins-Le-Bretonneux 
France 
Study contact  
Evi Petro 
genae Belgium nv 
Justitiestraat 6B 
2018 Antwerp, Belgium 
Evi.petro@genae.com 
Lieve Cornelis 
Boston Scientific, Peripheral Interventions, Clinical 
Green Square, Lambroekstraat 5D 
1831 Diegem, Belgium 
Lieve.cornelis@bsci.com 
CRO, Data Management, 
Regulatory & Safety 
genae group 
Justitiestraat 6B 
2018 Antwerp, Belgium 
Core Lab 
corelab Black Forest GmbH  
Südring 15  
79189 Bad Krozingen 
Germany 
 
List of principal investigators and investigation sites will be maintained separately and is 
available upon request. 
 

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6. INTRODUCTION AND RATIONALE 
6.1 Background 
Peripheral Arterial Disease (PAD) is the third leading cause of cardiovascular morbidity after 
myocardial infarction (MI) and stroke. Over the past decade, percutaneous catheter-based 
techniques have improved such that acute procedural success is high even in complex 
anatomy. This has led to the adoption of endovascular treatment as the first strategy 
treatment in PAD-patients.  
The femoropopliteal segment is a challenging vascular territory and has been among the 
least effective of all endovascular procedures in terms of long-term patency1,2,3. 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. More specific, the application of self-expanding nitinol 
stent technology seemed to improve the safety and durability of stenting in the SFA due to its 
unique properties 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 
arteries1,4,5,6. In addition, self-expanding nitinol stents are not as prone to external 
compression as are balloon-expandable stents. 
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,7,8 which 
may be due to the chronic external forces on the vessel/stent interface resulting in a chronic 
stimulus for restenosis9. Therefore, the interest of investigators turned towards 
pharmaceuticals such as paclitaxel 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 SFA10. 
6.2 ELUVIA Stent System 
Boston Scientific Corporation (BSC) developed the ELUVIA stent, a paclitaxel-eluting, self-
expanding nitinol stent, for use in the femoropopliteal arteries.  
The ELUVIA Stent System leverages many successful BSC programs with global 
commercial approval for safe and efficacious use in subjects, and received CE-mark in 
February 2016. The ELUVIA stent and Stent Delivery System (SDS) is leveraged from the 
Innova™ Stent System, the drug coating polymers are leveraged from the PROMUS 
Element/PROMUS Element Plus Stent System, while the active pharmaceutical compound 
(paclitaxel) is leveraged from the TAXUS Element/ION Stent System. 
6.3 MAJESTIC First Human Use Study 
The MAJESTIC clinical study was the first BSC clinical study with the ELUVIA stent system.  
Enrollment was completed in March 2014, 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%. 

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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. 
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 study is currently in long term follow up and is expected to be complete in 2017. 
6.4 IMPERIAL IDE Study 
IMPERIAL is a global, prospective, multi-center trial evaluating the safety and effectiveness 
of the ELUVIA stent versus the Zilver PTX stent. 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, single-arm Long Lesion substudy.  
Approximately 527 - 535 subjects will be enrolled in the IMPERIAL trial. 
Up to 75 study centers worldwide will enroll subjects in the RCT. Regions participating 
include the United States, Canada, European Union, Japan and New Zealand.  
The study is currently in the enrollment phase and is expected to be complete in 2022. 
6.5 EMINENT Post-Market Study 
EMINENT is a prospective, multi-center study confirming the superior effectiveness of the 
ELUVIA stent versus Self-Expanding Bare Nitinol Stents. The study is a 2:1 randomized 
(ELUVIA vs Self-Expanding Bare Nitinol Stents), controlled, single-blind, superiority trial 
(RCT). 
750 subjects will be enrolled in the EMINENT trial. Up to 75 study centers in up to 10 
European countries may enroll subjects in the study. 
The study is currently in the start-up phase and is expected to be complete in 2021. 
6.6 Clinical trial data ELUVIA Stent System 
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 intended to reduce restenosis and improve long-term vascular patency and quality 
of life (QOL) compared to balloon angioplasty, balloon expandable stents, and nitinol BMS. 

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7. OBJECTIVE 
The objective of the REGAL study is to collect additional data including health economics 
data to support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) 
for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions. 
8. STUDY ASSESSMENTS 
The following study assessments will be assessed during the course of the REGAL study: 
 
Health economics:  
o Walking Improvement and Quality of Life Improvement at 1 month, 6 months, 12 
months and 24 months as assessed by change in Walking Impairment Questionnaire 
(WIQ) and EQ-5D-5L™ from baseline 
o Health care costs associated with index procedure 
o Changes in healthcare utilization over time and associated health care costs 
o Rate of Primary and Secondary Sustained Clinical Improvement at 1 month, 6 
months, 12 months and 24 months as assessed by changes in Rutherford 
Classification from baseline 
o Rate of Hemodynamic Improvement at 1 month, 6 months, 12 months and 24 
months as assessed by changes in Ankle-Brachial Index (ABI) from baseline 
 
Technical success 
 
Procedural success 
 
Major Adverse Event (MAE) rate (and individual components) at each follow-up visit, 
defined as all causes of death, target limb major amputation and/or Target Lesion 
Revascularization (TLR) 
 
Primary Patency and Assisted Primary Patency at 6 months, 12 months and 24 months 
assessed by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVRs). Primary 
vessel patency is defined as a binary endpoint and will be determined to be a success 
when the DUS PSVR is ≤ 2.4 at the 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. 
 
Clinically-driven TLR and clinically-driven TVR Rate at each follow-up visit 
 
Adverse Event Rates (unanticipated, major, serious, device/procedure-related) at each 
follow-up visit 
 
Distribution of Rutherford Class during follow-up as compared to baseline at 1 month, 6 
months, 12 months and 24 months 
9. STUDY DESIGN 
The REGAL study is a European, prospective, multi-center Post Market Clinical Follow-up 
(PMCF) trial providing additional data including health economics data to support the use of 
the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.  
The ELUVIA stent is CE-marked and commercially available in the regions included in this 
study, and has already demonstrated its safety and effectiveness for treatment of 

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symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) 
and/or proximal popliteal artery (PPA) with reference vessel diameters (RVD) ranging from 
4.0-6.0 mm. 
9.1 Scale and Duration 
500 subjects will be enrolled in the REGAL study to receive treatment with the ELUVIA Stent 
system. 
The study will be conducted in up to 30 study centers in up to 10 European countries. 
All subjects will be screened according to the protocol inclusion and exclusion criteria and will 
be considered eligible to be enrolled in the study once a signed informed consent form is in 
place.  
If the subject is found to not meet the inclusion criteria during the angiographic eligibility 
assessment, the subject will be considered a screen failure and should not be included in the 
study, nor should the subject be followed post-procedure per protocol. 
A subject is considered enrolled when the ELUVIA stent system is advanced into the 
patient’s vasculature. 
Clinical follow-up is required as per standard of care and data will be collected at the 
following time points: pre-discharge, 1 month, 6 months, 12 months and 24 months post 
index procedure.  
Subjects who are enrolled but an ELUVIA 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. 
The enrollment period is expected to last approximately 12 months. No investigative site will 
be allowed to enroll more than 20 percent (100 subjects) of the total study population. The 
study will be considered complete after all subjects have completed the 24 month (2 year) 
follow-up visit, were discontinued prior to the 24 month (2 year) follow-up visit, have died, or 
the last 24 month (2 year) follow-up visit window is closed. 
It is estimated that it will take approximately 4 years to complete this study.  
 
 

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9.2 Study Flow Chart 
 
 
 
 

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10. STUDY POPULATION 
10.1 Subject Selection 
The Intended population for the REGAL study are ‘real world’-patients with symptomatic de-
novo, restenotic, or (re)occluded lesions in the native superficial femoral artery (SFA) and/or 
proximal popliteal artery with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, 
suitable for endovascular treatment. 
10.2 Inclusion Criteria 
For inclusion in the study subjects must fulfil ALL of the following criteria: 
1. Subjects age 18 and older 
2. Subject is willing and able to provide written consent before any study-specific test or 
procedure is performed and agrees to attend all follow-up visits 
3. De novo, restenotic or (re)occluded lesions in the native femoro-popliteal arteries, 
with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for 
endovascular treatment 
10.3 Exclusion Criteria 
Subjects are excluded if ANY of the following criteria are met: 
1. Subject is pregnant or planning to become pregnant during the course of the study 
2. Life expectancy of less than 1 year (which is defined as documented life expectancy less 
than 12 months due to other medical co-morbid condition(s) that could limit the subject’s 
ability to participate in the clinical follow-up, limit the subject’s compliance with the 
standard of care follow-up, or impact the scientific integrity of the trial) 
3. Known allergy to the ELUVIA stent system or any of its components, concomitant 
medication, contrast agents (that cannot be medically managed) 
4. Subject enrolled in an investigational study that has not reached primary endpoint at the 
time of enrollment or that clinically interferes with the current study assessments (Note: 
studies requiring extended follow-up for products that were investigational, but have 
become commercially available since then are not considered investigational studies) 
11. DEVICE DESCRIPTION 
11.1 ELUVIA Drug-Eluting Stent System  
The ELUVIA stent system is manufactured by Boston Scientific Corporation and comprised 
of the implantable endoprosthesis and the stent delivery system (SDS). The stent is a laser 
cut self-expanding stent composed of a nickel titantium alloy (nitinol). On both the proximal 
and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the 
stent to aid in placement. The stent is constrained within a 6F delivery system. The delivery 
system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle 

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shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The 
delivery system is compatible with 0.035 in (0.89 mm) guidewires. 
The ELUVIA stent system carries a drug/polymer coating formulation consisting of paclitaxel 
(the active ingredient), and PVDF-HFP Polymer Carrier (the inactive ingredient).  
CE-mark for the ELUVIA stent system was obtained in February 2016. 
11.1.1 
Paclitaxel Drug 
The active pharmaceutical ingredient is semi-synthetic paclitaxel. Semi-synthetic paclitaxel is 
synthesized from precursor compounds isolated from a spectrum of Taxus species and 
hybrids.  
11.1.2 
Primer Polymer and Drug Matrix Copolymer Carrier 
The ELUVIA stent contains a primer polymer layer PBMA - poly (n-butylmethacrylate) 
between the bare metal stent and drug matrix layer. The drug matrix layer is comprised of a 
semi-crystalline 
random 
copolymer, 
PVDF 
– 
HFP 
- 
poly(vinylidene 
fluoride-co-
hexafluoropropylene), blended with paclitaxel.  
11.1.3 
ELUVIA Stent System Product Description 
Characteristic 
ELUVIA Stent System 
Stent material 
Nitinol  
Drug product 
Paclitaxel  
Nominal Paclitaxel Content 
Range (based on stent length 
and diameter) 
0.167µg/mm2  
Polymer(s) 
Primer Layer: poly(n-butyl methacrylate) (PBMA) 
Active Layer: poly (vinylidene fluoride-co-
hexafluoropropylene) (PVDF-HFP) 
Delivery working length 
75 cm, 130 cm 
Stent delivery system (SDS) 
6 F tri-axial system  
Catheter shaft outer diameter 
0.080 +/- 0.002” 
Stent strut thickness 
0.0039“ strut width, 0.0086“ strut wall thickness 
11.1.4 
ELUVIA stent Sizes 
The ELUVIA stent is available in a variety of diameters and lengths. The delivery system is 
offered in two working lengths (75 cm and 130 cm). The ELUVIA stent matrix included in the 
REGAL Study is summarized in the below table. 
SDS size 
ELUVIA Stent sizes (mm) 
75 cm 
6.0 x 40, 6.0 x 60, 6.0 x 80, 6.0 x 100, 6.0 x 120, 6.0 x 150 

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SDS size 
ELUVIA Stent sizes (mm) 
130 cm 
6.0 x 40, 6.0 x 60, 6.0 x 80, 6.0 x 100, 6.0 x 120, 6.0 x 150 
75 cm 
7.0 x 40, 7.0 x 60, 7.0 x 80, 7.0 x 100, 7.0 x 120, 7.0 x 150 
130 cm 
7.0 x 40, 7.0 x 60, 7.0 x 80, 7.0 x 100, 7.0 x 120, 7.0 x 150 
11.2 Device Accountability 
Since the ELUVIA stent is a commercially available CE-marked device, all devices used 
within the study will be used off-the-shelf. The Investigator must ensure that the device is 
used only in accordance with the Directions for Use (DFU).  
The Principal Investigator or an authorized designee shall keep records documenting the use 
of the ELUVIA stent, which shall include the following information for each device used (lot 
number or unique code): 
 
Stent diameter and stent length 
 
Date of use 
 
Subject identification 
Written procedures for device accountability may be required by national regulations. 
12. METHODS 
The data collection schedule for the REGAL study is summarized in section 4. 
12.1 Screening 
A Screening and Enrollment Log will be maintained by each investigational site to document 
selected information about all subjects who meet (or fail to meet) the REGAL trial eligibility 
criteria, including the reason for screen failure. 
Study investigators are expected to follow standard of care testing to diagnose and screen 
subjects for inclusion in the study.  
12.2 Informed Consent 
Prior to collection of any of the subject’s data, a signed informed consent form must be 
obtained from every subject using the most recently approved ICF. 
The process of obtaining informed consent must be consistent with the Declaration of 
Helsinki. The investigator or responsible medical staff (as allowed per national law) will 
explain the nature, purpose and risks of the study and provide the subject with a copy of their 
personally signed and dated informed consent form (ICF).  
The person obtaining consent will avoid any coercion or undue improper influence on or 
inducement of the subject to participate. They will not waive or appear to waive the subject's 
legal rights. They will use native non-technical language that is understandable to the 
subject. The refusal of a subject to participate in the study or a subject's decision to withdraw 
from the study must never interfere with the patient-doctor relationship.  

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The subject will be given sufficient time to ask questions, to receive answers and to consider 
the implications of study participation before making a decision and thus before signing the 
consent document.  
Study personnel should explain to the subject that even if the subject agrees to participate in 
the trial and signs the ICF, catheterization may demonstrate that the subject is not a suitable 
candidate for the trial. Should there be any amendments to the Clinical Investigational Plan 
(CIP), which would directly affect the subjects' participation in the study, e.g. a change in any 
significant patient-facing procedure, the ICF must be amended to incorporate this 
modification and all subjects must agree to sign this amended ICF to confirm that they re-
consent to continue their participation in the study.  
The original signed copy of the subject’s ICF must be maintained in the study files. The 
subject should receive a copy of the signed ICF. The consent process and subject’s study 
participation should be documented in the patient’s medical records. 
12.3 Point of Enrollment  
Once the subject has signed the Informed Consent Form, and has met all inclusion and no 
exclusion criteria, the subject will be considered eligible to be enrolled in the study.  
If the subject is found to not meet the inclusion criteria during the angiographic eligibility 
assessment, the subject will be considered a screen failure and should not be enrolled, nor 
should the subject be followed post-procedure per protocol. A subject is considered enrolled 
when the ELUVIA stent system is advanced into the patient’s vasculature. 
12.4 Study Assessments and Measurements 
12.4.1 
Pre-Procedure Assessments – Up to 30 Days prior to Day 0 
The following pre-procedure data will be collected within 30 days prior to the index procedure 
(unless otherwise specified) for all subjects: 
 
Demographics and medical history 
 
Physical assessment including: 
o Weight and height 
o Rutherford Category Assessment 
o Ankle-Brachial Indices (ABI) measurements 
 
Laboratory tests 
o Serum creatinine 
o Platelet Count 
 
Confirmation that all inclusion/exclusion eligibility criteria have been met 
 
Administer Questionnaire Assessments 
o Walking Impairment Questionnaire (WIQ) 
o EQ-5D-5L 

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12.4.2 
Pre-Procedure Assessments – Up to 7 Days prior to Day 0 
The following pre-procedure data will be collected within 7 days prior to the index procedure 
(unless otherwise specified) for all subjects: 
 
Pregnancy test for females of childbearing potential with analysis per local practice 
(serum and/or urine) 
 
Antiplatelet medication usage (if applicable) 
12.4.3 
Procedure – Day 0 
Investigators will manage the cardiovascular risk factors and comorbidities for all subjects 
according to standard care. Investigators should ensure close monitoring of the amount of 
contrast for subjects with elevated serum creatinine levels and consider preventive measures 
(medication and hydration) to reduce the risk of contrast-induced nephropathy (CIN).  
Diagnostic angiography of the lower extremities should be performed using standard 
techniques. Visual angiographic assessment may be used to determine if criteria are met. 
Treatment of Target Lesion 
The start of the index procedure is defined as the time of guide catheter insertion into the 
sheath for the SFA/PPA interventional procedure. The target lesion will be treated per DFU. 
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 
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. 

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ELUVIA 
Prior to use of the ELUVIA stent, the treating physician must carefully read and be familiar 
with the entire DFU. The ELUVIA DFU must be followed for implanting the ELUVIA stent. 
Anticoagulant therapy should be consistent with guideline practices and the hospital standard 
of practice during the procedure. 
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 
preferably be an ELUVIA stent as well. 
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 will 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  
12.5 Post-procedure/Pre-hospital Discharge 
The subject may be discharged from the hospital when clinically stable at the Investigator’s 
discretion. The following assessments will be completed prior to hospital discharge: 
 
Medication assessment 
 
AE assessment (SADEs, UADEs and ADEs/Device Deficiencies) 
 
Health care costs associated with index procedure 
It is important that trial site personnel review the trial follow-up requirements with the subject 
to maximize compliance with the follow-up schedule and medication regimen. It is also 
important that trial site personnel discuss the subject’s return for follow-up assessments 
according to the trial event schedule. It is advised that the study staff schedules a date for 
the first follow-up visit with the subject at the time of hospital discharge. 
12.6 Angiography 
All subjects will undergo angiographic assessment during the index procedure per standard 
of care. Subjects requiring re-intervention of the target vessel during the 24 month follow-up 
period will undergo angiographic assessment at the time of re-intervention as standard of 
care. 
12.7 Follow-up 
All enrolled subjects will be evaluated prior to discharge from the index procedure and at 
approximately 1 month, 6 months, 12 months and 24 months after the index procedure. 
Subject evaluation is recommended at these time points, but is dependent on the local 
standard of care follow-up schedule. 

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Subjects who underwent advancement of the ELUVIA stent system into the vasculature 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.  
The results of the subjects’ clinical status and functional testing (Rutherford Categorization 
and ABI) should be completed prior to initiating the DUS imaging, if required. Subjects 
requiring re-intervention should be treated according to the Investigator’s discretion and 
standard of care. These subjects should receive an approved, commercially available 
treatment (if appropriate).  
Note: Follow-up ultrasounds will not be required for any subject who underwent bypass 
surgery of the target lesion during the 24 month follow-up timeframe, or has a documented 
occluded stent. 
Follow-up evaluation is required as per local practice and data will be collected for following 
assessments:  
12.7.1 1-Month Follow-up Visit: Day 15 – 90 (30 days -15 days to +60 days) 
During the 1 Month office visit, the following data will be collected: 
 
Walking Impairment Questionnaire 
 
EQ-5D-5L Questionnaire 
 
Healthcare utilization information (including health care costs) 
 
Adverse Events Assessment (SADEs, UADEs and ADEs/Device Deficiencies) 
 
Medication Assessment 
 
The following assessments will be performed during the 1 Month office visit, as per local 
standard of care: 
 
Rutherford Categorization  
 
ABI Measurements (may be collected immediately post-procedure through 1 Month 
Follow-up window [Day 0 – 90]) 
12.7.2 6-Month Follow-up Visit: Day 91 – 273 (182 days ± 91 days) 
During the 6 Month office visit, the following data will be collected: 
 
Walking Impairment Questionnaire 
 
EQ-5D-5L Questionnaire 
 
Healthcare utilization information (including health care costs) 
 
Adverse Events Assessment (SADEs, UADEs and ADEs/Device Deficiencies) 
 
Medication Assessment 
 
The following assessments will be performed during the 6 Month office visit, as per local 
standard of care: 
 
Rutherford Categorization (prior to DUS) 
 
ABI Measurements (prior to DUS) 

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 
DUS of stented segment performed according to the Core Lab guidelines 
12.7.3 12-Month Follow-up Visit: Day 274 – 456 (365 days ± 91 days) 
During the 12 Month office visit, the following data will be collected: 
 
Walking Impairment Questionnaire 
 
EQ-5D-5L Questionnaire 
 
Healthcare utilization information (including health care costs) 
 
Adverse Events Assessment (SADEs, UADEs and ADEs/Device Deficiencies) 
 
Medication Assessment 
 
The following assessments will be performed during the 12 Month office visit, as per local 
standard of care: 
 
Rutherford Categorization (prior to DUS) 
 
ABI Measurements (prior to DUS) 
 
DUS of stented segment performed according to the Core Lab guidelines 
12.7.4 24-Month Follow-up Visit: Day 457 – 760 (730 days -273 days +30 days) 
During the 24 Month office visit, the following data will be collected: 
 
Walking Impairment Questionnaire 
 
EQ-5D-5L Questionnaire 
 
Healthcare utilization information (including health care costs) 
 
Adverse Events Assessment (SADEs, UADEs and ADEs/Device Deficiencies) 
 
Medication Assessment 
 
The following assessments will be performed during the 24 Month office visit, as per local 
standard of care: 
 
Rutherford Categorization (prior to DUS) 
 
ABI Measurements (prior to DUS) 
 
DUS of stented segment performed according to the Core Lab guidelines 
12.8 Trial Completion 
The trial will be considered complete after all subjects have completed the 24 month (2 year) 
follow-up visit, were discontinued prior to the 24 month (2 year) follow-up visit, have died or 
the follow-up visit window is closed. 
12.9 Missed or Late Visits 
Follow-up-visits are performed per local practice and every effort must be made by the site to 
retain study subjects for the duration of the study. Missed or late visits are however not 
considered a protocol deviation if they are not standard of care per the site’s patient care 
policies.  
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 

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missed follow-up visit and this information should be documented in the source. A subject will 
be considered lost to follow-up after the subject misses 2 consecutive follow-up visits without 
due cause.  
12.10 Medication 
Investigators are recommended to prescribe concomitant anti-coagulant and anti-platelet 
medications consistent with current local clinical practice. Antiplatelet and anti-coagulant 
medication usage will be collected and reported in the electronic case report form (eCRF) 
from the time of the pre-procedure visit through the 24 month (2 year) follow-up visit. 
Additional concomitant medications may be prescribed at the discretion of the treating 
physician according to standard of care. 
12.11 Withdrawal of Individual Subjects 
Subjects may leave the study at any time for any reason and without any consequences. The 
investigator or designee will try to obtain the reason for study withdrawal and document this 
in the source data.  
If a subject chooses to withdraw from the study, no additional data will be collected. The 
sponsor may retain and continue to use any data collected prior to the withdrawal of consent, 
unless specified differently by the subject. The subject will return to the care of their chosen 
physician. 
An investigator may discontinue a subject from the study, with or without the subject’s 
consent, for any reason that may, in the Investigator’s opinion, negatively affect the well-
being of the subject. If a subject is withdrawn from the study, the investigator will promptly 
inform the subject and sponsor. 
12.12 Replacement of Individual Subjects after Early Termination  
Subjects who exit the study prematurely will not be replaced. 
13. SUSPENSION OR TERMINATION 
13.1 Premature Termination of the Study  
Early termination of the study is the closure of the clinical study that occurs prior to meeting 
defined endpoints. Early termination is possible for the whole study or a single site.  
Study suspension is a temporary postponement of study activities related to enrollment. 
Suspension is possible for the whole study or a single site. 
Investigators, associated Ethics Committees and regulatory authorities, as applicable, will be 
notified in writing in the event of study suspension or termination. 
13.1.1 
Study-wide Termination or Suspension 
The sponsor reserves the right to terminate the study at any stage but intends to exercise 
this right only for valid scientific or administrative reasons and reasons related to protection 

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of subjects. Investigators, associated Ethics Committees (ECs), and regulatory authorities, 
as applicable, will be notified in writing in the event of study suspension or termination. 
Possible reasons for premature study suspension or termination include, but are not limited 
to: 
 
The occurrence of unanticipated adverse device effects that present a significant or 
unreasonable risk to subjects enrolled in the study 
 
An enrollment rate far below expectation that prejudices the conclusion of the study 
 
A decision on the part of the sponsor to suspend or discontinue commercialization of the 
device 
13.1.2 
Investigator/Site Termination or Suspension  
Possible reasons for clinical investigator or site termination or suspension include but are not 
limited to: 
 Failure to obtain initial Ethics Committee approval or annual renewal of the study, if 
applicable 
 Persistent non-compliance to the Clinical Investigation Plan (e.g. failure to adhere to 
inclusion/exclusion criteria) 
 Lack of or insufficient enrollment 
 Noncompliance to regulations and/or the terms of the Clinical Trial Agreement (e.g. failure 
to submit data in a timely manner, failure to follow up on data queries and monitoring 
findings in a timely manner, etc.) 
 Ethics Committee suspension of the site 
 Fraud or scientific misconduct is discovered 
 Investigator request (e.g. no longer able to support the study) 
 
Associated Ethics Committees and regulatory authorities, as applicable, will be notified by 
the sponsor in writing in the event of investigator/site suspension or termination. 
13.1.3 
Procedures for Termination or Suspension 
A 
Sponsor-initiated  
 Sponsor will promptly inform the clinical investigators of the termination or suspension and 
the reasons and inform the Regulatory Authority(ies), where required. 
 In the case of study termination or suspension for reasons other than a temporary Ethics 
Committee approval lapse, the investigator will promptly inform the Ethics Committee. 
 In the case of study termination, the investigator must inform the subjects and may inform 
the personal physician (if allowed) of the subjects to ensure appropriate care and follow-
up is provided. 
 In the case of a study suspension, subject enrollment must stop until the suspension is 
lifted by sponsor and approved by the applicable ethics committees/regulatory authorities. 
 In the case of a study suspension, enrolled subjects should continue to be medically 
followed by the investigator out of consideration of their safety, rights and welfare. 

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B 
Investigator-initiated 
 The investigator will inform sponsor and provide a detailed written explanation of the 
termination or suspension at least 30 days prior to the planned termination or suspension. 
 The investigator will promptly inform the institution (where required per regulatory 
requirements). 
 The investigator will promptly inform the Ethics Committee and sponsor will promptly 
inform the Regulatory Authority (where applicable). 
 The investigator will promptly inform the subjects and/or the personal physician of the 
subjects to ensure appropriate care and follow-up is provided. 
 In the case of a study suspension, subjects enrolled should continue to be medically 
followed by the investigator out of consideration of their safety, rights and welfare. 
C 
Ethics Committee or Regulatory Authority-initiated 
 The investigator will inform sponsor and provide a detailed written explanation of the 
termination or suspension within 5 business days. 
 Subject enrollment must stop until the suspension is lifted. 
 Subjects already enrolled should continue to be medically followed in accordance with 
Ethics Committee/ Regulatory Authority policy. 
14. SAFETY 
It is the responsibility of the investigator to assess and report to the sponsor, by means of 
recording in the e-CRF, any event which occurs in any of following categories, after 
enrollment, whether during or subsequent to the procedure: 
 
All Device and/or Procedure Related Adverse Events and Serious Adverse Events 
 
All Device Deficiencies  
 
Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
 
All Events which meet the per-protocol definition of Major Adverse Event (note: for 
target limb amputations, both minor and major amputations should be reported) 
 
New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the trial.  
Death should not be recorded as an AE, but should only be reflected as an outcome of a 
specific SAE (see below for AE definitions).  
Refer to the DFU for the known risks associated with the study device(s). 

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14.1 Adverse Events  
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
any untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the medical device. 
NOTE 1: This definition includes events related to the test device or the comparator 
NOTE 2: This definition includes events related to the procedures involved (any procedure 
in the clinical investigation plan). 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
Adverse events will be monitored throughout the study. Investigators must obtain all 
information available to determine the causality and outcome of the AE and to assess 
whether it meets the criteria for classification as a serious adverse device effect requiring 
immediate notification to the sponsor or its designated representative.  
14.2 Adverse Device Effects 
An adverse device effect (ADE) is an AE related to the use of a medical device. 
NOTE 1: This definition includes any adverse events resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, the 
installation, the operation, or any malfunction of the medical device. 
NOTE 2: This definition also includes any event that is a result of a use error or intentional 
abnormal use of the medical device. 
All reported ADEs will be documented on the appropriate CRF and will include the event 
description [diagnosis – only signs or symptoms in case underlying diagnosis is not (yet) 
known], onset, resolution, seriousness, severity, cause and action taken. The investigator 
must assess causality and severity for all ADEs. 
All ADEs will be followed by the Investigator until resolution or until the end of study 
participation. 
14.3 Serious Adverse Events  
An adverse event is defined as serious (SAE), whenever the adverse event  
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient hospitalization or prolongation of existing hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness, or 
5) injury or permanent impairment to a body structure or a body function, 
c) led to fetal distress, fetal death or a congenital abnormality or birth defect 
 

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NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the 
Clinical Investigational Plan, without a serious deterioration in health, is not 
considered a serious adverse event. 
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. 
 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. 
14.4 Serious Adverse Device Effects 
A serious adverse device effect (SADE) is an adverse device effect that has resulted in any 
of the consequences characteristic of a serious adverse event.  
14.5 Unanticipated Serious Adverse Device Effects 
An unanticipated serious adverse device effect (USADE) is a serious adverse device effect 
which by its nature, incidence, severity or outcome has not been identified in the current 
version of the risk analysis report. 
NOTE: Anticipated serious adverse device effect (ASADE) is an effect which by its 
nature, incidence, severity or outcome has been identified in the risk analysis report. 
14.6 Device Deficiency/Malfunction – Device Specific Events 
Device deficiency is the inadequacy of a 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. 
Device malfunction means the failure of a medical device to perform in accordance with its 
intended purpose when used in accordance with the DFU or CIP. 
All device deficiencies (including but not limited to failures, malfunctions, use errors, product 
nonconformities, and labeling errors) will be documented and reported to the sponsor. If 
possible, the device(s) should be returned to the sponsor for analysis. 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. 
Device Deficiencies (DD) (including but not limited to failures, malfunctions, and product 
nonconformities) 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.  

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Device malfunction/failures/deficiencies may or may not result in the subject experiencing 
harmful effect. All AEs/SAEs associated with a device failure are by definition device-related. 
Device deficiencies that did not lead to an AE but could have led to a SAE if: 
 
either suitable action had not been taken, 
 
intervention had not been made, or 
 
circumstances had been less fortunate, 
should be reported per the reporting guidelines in the following section. 
14.7 Adverse and serious adverse events reporting 
Timely, accurate, and complete reporting and analysis of safety information for clinical 
studies are crucial for the protection of subjects. Reporting and analysis of safety data are 
mandated by regulatory authorities worldwide. Since the safety reporting requirements and 
classification systems vary for each Regulatory Authority, requirements from all geographies 
are taken into account for the collection and reporting of safety information. 
Subjects will be carefully monitored during the study for possible adverse events. Any 
adverse event that occurs after the time of enrollment through end of study participation will 
be fully evaluated by the Investigator. Appropriate treatment will be initiated and the study 
follow up will continue as completely as possible. 
 
Causality Assessment 
The Investigator must assess the relationship of the AE to the study device (including the 
medical-surgical procedure) and the occurrence of each adverse event. 

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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; 
- 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. 
 

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Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
Unanticipated 
Adverse 
Device 
Effect 
/ 
Unanticipated 
Serious 
Adverse Device Effect  
 
Complete AE eCRF page with all 
available 
new 
and 
updated 
information 
 Within 1 business day of first 
becoming 
aware1 
of 
the 
event. 
 Reporting required through 
the end of the study 
Provide 
source 
documentation 
(unidentified) as requested by the 
Sponsor 
 When 
documentation 
is 
available 
Serious 
Adverse 
Device 
Effects 
Complete AE eCRF page with all 
available 
new 
and 
updated 
information 
 Within 2 business days of first 
becoming aware1 of the event 
or 
as 
per 
local/regional 
regulations. 
 Reporting required through 
the end of the study 
Provide 
source 
documentation 
(unidentified) as requested by the 
Sponsor 
 When 
documentation 
is 
available 
Device 
Deficiencies 
(including but not limited to 
failures, malfunctions, and 
product nonconformities) 
Complete Device Deficiency CRF 
with all available new and updated 
information 
 Within 2 business day of first 
becoming aware1 of the event 
and as per local/regional 
regulations 
 Reporting required through 
the end of the study 
Adverse 
Device 
Effect 
(Non-Serious) 
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 
aware1 
of 
the 
information 
1The “become aware date” for an event that requires reporting per the protocol is the date that study personnel listed on the 
Delegation of Authority Log identify or are notified of the event. 
Abbreviations: AE=adverse event; CRF=case report form; eCRF=electronic case report form; UADE=unanticipated adverse 
device effect 
 
Initial reporting may be done by phone, fax, email or by completing the applicable eCRF form 
with as much information as available at that time. In case of urgent questions regarding 
safety reporting, please contact the study contact as indicated in section 5 of this Clinical 
Investigational Plan. 
As additional information becomes available, the Investigator will record all ADEs 
(anticipated and unanticipated) and Device Deficiencies on the appropriate eCRFs. 
In case of Major Adverse Events (MAE), copies of source documentation which contain 
significant information related to the event such as discharge letters, surgery reports, 
consultation letters, ECGs, laboratory results, etc., and, if applicable, angio and/or DUS 
images are required for evaluation of the event. Copies of such documentation shall be 
obtained from the investigator, blinded / de-identified as to the subjects’ identity, and 
provided to the Sponsor or designee. 

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Regarding subject deaths, it is requested that a copy of the death certificate and a copy of 
the autopsy report (if applicable), be sent to the sponsor or designee when available. Any 
other source documents related to the death should also be provided to the sponsor or 
designee. In the event that no source documents are available, the PI is required to describe 
the circumstances of the subject’s death in a letter, e-mail or other written communication. 
UADEs/USADEs have special reporting requirements. The Sponsor will notify the sites, ECs 
and regulatory bodies as per country specific regulations. 
14.8 Annual Safety Report 
In addition to the expedited reporting of SADEs, the sponsor will submit, at a minimum once 
a year throughout the clinical study, an annual safety report to the involved ethics 
committees and competent authorities of the concerned Member States if required. This 
annual safety report can be combined with the annual progress report. 
14.9 Severity  
The investigator will use the following definitions to determine the severity of an adverse 
event:  
- 
Mild: Awareness of a sign or symptom that does not interfere with the subject’s 
usual activity or is transient, resolved without treatment and with no sequelae.  
- 
Moderate: Interferes with the subject’s usual activity and/or requires symptomatic 
treatment.  
- 
Severe: Symptom(s) causing severe discomfort and significant impact of the 
subject’s usual activity and requires treatment.  
14.10 Clinical Events Committee (CEC) 
The CEC is an independent group of individuals with no affiliation with BSC. Committee 
membership will include practitioners of peripheral endovascular procedures, as well as other 
experts with the necessary therapeutic and subject matter expertise to review and adjudicate 
the following endpoints and major adverse events reported by the trial Investigators: 
- 
All Deaths 
- 
Target Lesion Revascularizations 
- 
Target Vessel Revascularizations 
- 
Target limb amputations (major and minor) 
- 
Stent Thrombosis 
Responsibilities, qualifications, membership, and committee procedures are outlined in the 
CEC charter. 
15. POTENTIAL RISKS AND BENEFITS 
15.1 Risks 
Considering the nature and objective of the trial, being a Post-Market Clinical Follow-up 
study with the primary intention to collect additional data regarding the use of the ELUVIA 

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stent system, the additional risk associated with participating in this study, is related to the 
collection of patient data and confidentiality thereof. 
The risks associated with the implantation of the ELUVIA stent, CE-marked and 
commercially available, are described in the current applicable version of the DFU of the 
ELUVIA stent system.  
There may be additional risks linked to the procedure, and follow-up testing which are 
unforeseen at this time. All assessments planned for the follow-up period are standard of 
care, with the exception of the quality of life questionnaires (WIQ and EQ-5D-5L), which do 
not cause any additional risk.  
15.2 Risk Minimization Actions 
In order to mitigate the risk related to loss of data confidentiality, the study is to be performed 
in accordance with all applicable data protection laws. All data and information concerning 
subjects and their participation in this study are considered confidential by the sponsor and 
its designees. Only authorized Investigators and Sponsor or designated personnel will have 
access to confidential records. The Ethics Committee and other regulatory authorities also 
have the right to inspect and copy records pertinent to the study. All public reporting of the 
results of the study will eliminate identifiable references to subjects. 
15.3 Anticipated Benefits 
The subject receives treatment of a narrowed upper leg artery and potential improvement in 
the symptoms of the peripheral artery disease. Furthermore, medical science and future 
patients may benefit from the results of this study.  
15.4 Risk to Benefit Rationale 
The ELUVIA stent is a CE-marked device and has been proven to be suitable for its intended 
purpose. There are no unacceptable residual risks/intolerable risks and all applicable risks 
have been addressed through the provision of the appropriate DFU. Evaluation of the risks 
and benefits that are expected to be associated with the use of the ELUVIA stent 
demonstrate that when used under the conditions intended, the benefits associated with the 
use of the ELUVIA stent should outweigh the risks. 
16. 
STATISTICAL ANALYSIS 
The details of all statistical analyses will be described in the Statistical Analysis Plan. 
16.1 Sample Size  
This study will enroll and treat up to 500 subjects at up to 30 study centers in up to 10 
European countries. 

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16.2 Analysis Population 
The intent-to-treat population (ITT) consists of all subjects enrolled in the study in which the 
ELUVIA stent was implanted. This will be used in the primary analysis of all assessments. 
Additionally, all assessments will be analyzed for the per-protocol population (PP). The PP 
population consists of the subjects enrolled in the study that met all inclusion and exclusion 
criteria and underwent the procedure (ELUVIA stent implantation). 
16.3 Descriptive Statistics 
Descriptive statistics will be presented as mean, standard deviation, median, interquartile 
range (IQR), minimum and maximum for continuous data. 
For categorical data, descriptive statistics will be given as the number and percentage of 
subjects. 
16.4 Assessment Analysis 
The results for all assessments will be given as descriptive statistics and will not be tested 
using formal hypotheses. 
16.5 Missing Data 
All subjects with available data will be used in the statistical analyses. In case of missing 
data, subjects will be excluded from the specific analysis for which no data is available. No 
imputation will be performed for missing data. 
16.6 Subgroup Analysis 
Subgroup analyses may be performed for all assessments for the following subgroups: 
 
Age and gender 
 
Comorbidities (e.g. diabetes, renal insufficiency, etc.) 
 
Peripheral Artery Disease classification (e.g. ABI, Rutherford, etc.) 
 
Lesion location (e.g. proximal, mid, distal SFA, PPA, etc.) 
 
Type of stenosis (e.g. de novo, restenotic, etc.) 
 
Lesion length, degree of stenosis, calcification 
 
TASC classification 
 
Lesion preparation (e.g. scoring balloons, cutting balloons, atherectomy devices, etc.)  
 
Bail out stent implantation (diameter, length, stent size etc.) 
 
Treatment approach (e.g. sub-intimal, intra-luminal, etc.) 
 
QoL (e.g. pain level, WIQ, EQ-5D-5L) 
16.6.1 
Analysis Software 
All statistical analyses will be performed using SPSS, version 23 or later (IBM Corp. 
Released 2014. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp). 

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16.6.2 
Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the primary 
analyses 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. 
17. 
ETHICAL CONSIDERATIONS 
17.1 Regulation/Compliance Statement 
This study will be performed in accordance with the World Medical Association Declaration of 
Helsinki, ISO 14155:2011(E) and all local legal and regulatory requirements. 
In addition to following the governing regulations, any additional requirements of the 
individual study site’s EC and Regulatory Authority will also be followed by the study site(s) 
where applicable. 
EC and where applicable Regulatory Authority approval for the study is required prior to 
beginning the study. A copy of the approvals must be sent to the sponsor prior to enrolling 
the first subject. 
The study will be publicly registered prior to first enrollment in accordance with the 2007 
Food and Drug Administration Amendments Act (FDAAA) and Declaration of Helsinki on 
http://clinicaltrials.gov (PL 110-85, Section 810(a)). 
17.2 Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the Clinical Investigation Plan 
(CIP) / protocol, ISO 14155, ethical principles that have their origin in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing EC, and prevailing local and/or 
country laws and/or regulations, whichever affords the greater protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following:  
 
Prior to beginning the study, sign the Clinical Study Agreement and Protocol Signature 
page documenting his/her agreement to conduct the study in accordance with the CIP. 
 
Provide documentation on his/her qualifications and experience to assume responsibility 
for the proper conduct of the study and that of key members of the center team through 
up-to-date curriculum vitae or other relevant documentation and disclose potential 
conflicts of interest, including financial, that may interfere with the conduct of the clinical 
study or interpretation of results. 
 
Make no changes in or deviate from this CIP, except to protect the life and physical well-
being of a subject in an emergency; document and explain any deviation from the 
approved CIP that occurred during the course of the clinical investigation. 

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 
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 applicable requirements. 
 
Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the eCRFs and in all required reports. 
 
Record, report, and assess (seriousness and relationship to the device/procedure), per 
CIP requirements, every SADE and observed DD. 
 
Report to the sponsor, per the CIP requirements, all SAEs and DD that could have led to 
a SADE and potential USADE or UADE. 
 
Report to the EC any SADEs and DD that could have led to a SADE and 
potential/USADE or UADE, if required by the national regulations or this CIP or by the 
EC, and supply the sponsor with any additional requested information related to the 
safety reporting of a particular event.  
 
Ensure that the device is used only by authorized/designated users and in accordance 
with this protocol and instructions/directions for use. 
 
Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
monitor and respond to questions during monitoring visits or audit(s). 
 
Allow and support regulatory authorities and the EC when performing auditing activities. 
 
Ensure that informed consent is obtained in accordance with applicable laws, this CIP 
and local EC requirements. 
 
Provide adequate medical care to a subject during and after a subject’s participation in 
the clinical study in the case of AEs, as described in the ICF. 
 
Inform the subject of the nature and possible cause of any AEs 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 as needed. 
 
Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
 
Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided with 
some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
 
Inform, with the subject’s approval or when required by national regulations, the subject’s 
personal physician about the subject’s participation in the clinical investigation. 

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 
Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
 
Ensure that an adequate investigational site team and facilities exist and are maintained 
and documented during the clinical investigation. 
 
Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
17.2.1 Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the investigator is responsible for providing appropriate 
training and adequate supervision of those to whom tasks are delegated. The investigator is 
accountable for regulatory violations resulting from failure to adequately supervise the 
conduct of the clinical study. 
17.3 Ethics Committee 
A copy of the written EC, and where appropriate Regulatory Authority approval of the 
protocol (or permission to conduct the study) and ICF, must be received by the sponsor 
before recruitment of subjects into the study. Prior approval must also be obtained for other 
materials related to subject recruitment or which will be provided to the subject. 
Annual EC approval and renewals will be obtained throughout the duration of the study as 
required by local/country or EC requirements. Copies of the Investigator’s reports and the EC 
continuance of approval must be provided to the sponsor. 
17.4 Sponsor Responsibilities 
All information and data sent to the sponsor concerning subjects or their participation in this 
study will be considered confidential by the sponsor. Only authorized sponsor personnel or a 
sponsor representative including Contract Research Organization (CRO) will have access to 
these confidential records. Authorized regulatory personnel have the right to inspect and 
copy all records pertinent to this study. Study data collected during this study may be used 
by the sponsor for the purposes of this study, publication, and to support future research 
and/or other business purposes. All data used in the analysis and reporting of this study will 
be without identifiable reference to specific subject name. 
The sponsor will keep subjects’ health information confidential in accordance with all 
applicable laws and regulations. The sponsor 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. 

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17.4.1 Role of Sponsor Representatives 
Sponsor personnel can provide technical support to the investigator and other Health Care 
Personnel (collectively HCP) as needed during stent implant and testing required by the CIP 
during the index procedure. Support may include HCP training, addressing HCP questions, 
or providing clarifications to HCPs concerning the operation of the test device. 
Sponsor personnel will not do the following:  
 
Practice medicine 
 
Provide medical diagnosis or treatment to subjects 
 
Discuss a subject’s condition or treatment with a subject without the approval and 
presence of the HCP 
 
Independently collect critical study data (defined as study endpoint data) 
 
Enter data in eCRF 
18. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS 
18.1 Subject Reimbursement 
Travel expenses incurred by subjects as a result of participation in the study will be 
reimbursed if requested in accordance with pertinent country laws and regulations and per 
the study site’s regulations. 
18.2 Compensation of Injury  
The sponsor has insurance, in accordance with national regulations, covering the costs of 
treatment of subjects in the event of study related injuries. 
19. ADMINISTRATIVE ASPECTS AND PUBLICATION 
19.1 Handling and Storage of Data and Documents 
The investigators must maintain adequate and accurate records to document the conduct of 
the study and substantiate the study data. These documents include those required by 
applicable regulations, and the subjects’ source documents, as described below.  
Regulatory documents are those documents that individually and collectively permit 
evaluation of the study compliance with applicable regulations and the quality of the data 
produced.  
These documents will be filed in an Investigator Site File (ISF) provided by the sponsor or 
designee. This file shall be used to facilitate and ensure filing of all relevant regulatory 
documents during and after the study. The investigator will be responsible for keeping the 
ISF updated and ensuring that all required documents are filed. The file will be inspected 
during monitoring visits.  
Source documents are original hospital records, clinical charts, screening log, subject 
identification lists, enrollment logs, original laboratory reports, memoranda, pharmacy 
dispensing records, recorded data from automated instruments, transcriptions certified after 

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verification as being accurate, microfiches, photographic negatives, microfilm, magnetic or 
electronic media, x-rays, subject’s files, and records kept at pharmacy, laboratories and 
medico-technical departments involved in the study. The investigator must maintain source 
documents for each subject in the study.  
All information recorded on the eCRFs must be traceable to these source documents. The 
investigator shall arrange for the retention of all study documents and records, including 
subject records, eCRFs, device inventory/accountability logs, signed ICFs and the subject 
identification list, after completion or discontinuation of the study for the minimum period as 
required per local regulation.  
The Principal Investigator or his/her designee will take measures to ensure that these 
essential documents are not accidentally damaged or destroyed. If for any reason the 
Principal Investigator or his/her designee withdraws responsibility for maintaining these 
essential documents, custody must be transferred to an individual who will assume 
responsibility and the sponsor must receive written notification of this custodial change. Sites 
are required to inform the sponsor in writing where paper or electronic files are maintained in 
case files are stored off site and are not readily available. 
19.2 Data Collection and electronic Case Report Forms (eCRFs)  
Clinical data are collected at designated time points throughout the study. Electronic Case 
Report Forms (eCRFs) will be used to collect all patient data during the course of the study. 
All changes made to the clinical data will be captured in an electronic audit trail and available 
for review by the sponsor or its representative or a regulatory authority. eCRFs must be fully 
completed for each subject and electronically signed by the Investigator when complete. 
Data will be stored in a secure, password-protected database which will be backed up 
periodically. Data will be reviewed using programmed and manual data checks. Changes to 
data previously submitted to the sponsor require a new electronic signature by the 
Investigator acknowledging and approving the changes. 
Data queries will be issued to study sites for resolution. Study management reports will be 
generated by the sponsor (or delegate) to monitor data quality and study progress. At the 
end of the study, the data will be frozen and retained by the sponsor for a period of five (5) 
years, or as required by local regulation. 
Good Clinical Practice Guidelines require that Investigators maintain information in the study 
subject’s medical records that corroborate data collected in the eCRFs.  
The Investigator or designated individual shall be responsible for recording all study data on 
the eCRFs provided by the sponsor. The Investigator is required to sign the eCRF on the 
appropriate page(s) to verify that he/she has reviewed and agrees with the recorded data.  
The Investigator will allow the monitor and/or representative of the Sponsor, and any 
regulatory body to review and inspect the study files, subject eCRFs, subject medical records 
and other related study documents as required. Completed eCRFs will be verified by the 
appointed monitor at the investigational site at regular intervals throughout the study. Missing 
or unclear data will be investigated by the monitor and will be retrieved and clarified by study 

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personnel as necessary throughout the study. The sponsor or their authorized representative 
may request additional documentation from the investigator such as physician procedure 
notes or physician written summaries when adverse events are observed and reported. 
19.3 Deviations 
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 EC 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.  
The sponsor (or delegate) is responsible for analyzing deviations, assessing their 
significance, and identifying any additional corrective and/or preventive actions (e.g. amend 
the CIP, conduct additional training, or terminate the investigation). Repetitive or serious 
investigator compliance issues may result in initiation of a corrective action plan with the 
investigator and site, and in some cases, necessitate suspending enrollment until the 
problem is resolved or ultimately terminating the investigator's participation in the study.  
19.4 CIP Revisions or Amendments  
During the course of the study, a revision or an amendment to the CIP may be necessary. 
Any revision or amendment, including justification for the modification, must be submitted to 
and approved by the study site’s EC and if applicable to the relevant Regulatory Authority 
according to local requirements prior to implementation of the amendment,  
Any revisions or amendment(s) that affect the ICF require a revised, Sponsor and EC 
approved ICF, before changes in study procedures are implemented. These requirements 
should in no way prevent any immediate action from being taken by the Investigator or by the 
Sponsor to preserve the safety of any subjects included in the study, as necessary.  
19.5 Annual Progress Report 
The sponsor/investigator will submit a summary of the progress of the study to the involved 
ECs once a year or according to the national / local requirements.  
Information will be provided on the date of inclusion of the first subject, numbers of subjects 
included and numbers of subjects that have completed the study, SADEs, UADEs, DDs, 
protocol deviations, revisions, and amendments.  
19.6 End of Study Report 
The sponsor (or delegate) will notify the involved ECs and where appropriate the Regulatory 
Authority of the end of the study within a period of 90 days. The end of the study is defined 
as the last subject’s last visit.  

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In case the study is ended prematurely, the sponsor (or delegate) will notify the involved ECs 
and where appropriate the Regulatory Authorities within 15 days, including the reasons for 
the premature termination. 
If required by the national regulations, the investigator/sponsor will submit a final study report 
with the results of the study, including any publications/abstracts of the study, to the involved 
EC and, if applicable, the Regulatory Authority within one year from the end of the study.  
19.7 Public Disclosure and Publication Policy 
In accordance with the sponsor’s Corporate Policy on the Conduct of Human Subject 
Research, the sponsor requires disclosure of its involvement as a sponsor or financial 
supporter in any publication or presentation relating to a sponsor’s study or its results. In 
accordance with the sponsor’s Corporate Policy for the Conduct of Human Subject 
Research, the sponsor will submit study results for publication (regardless of study outcome) 
following the conclusion or termination of the study. The sponsor adheres to the 
Contributorship Criteria set forth in the Uniform Requirements of the International Committee 
of Medical Journal Editors (ICMJE; http://www.icmje.org). In order to ensure the public 
disclosure of study results in a timely manner, while maintaining an unbiased presentation of 
study outcomes, sponsor personnel may assist authors and investigators in publication 
preparation provided the following guidelines are followed: 
 
All authorship and contributorship requirements as described above must be followed. 
 
Sponsor involvement in the publication preparation and the sponsor Publication Policy 
should be discussed with the Coordinating Principal Investigator(s) and/or Executive 
Committee at the onset of the project. 
 
The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission. 
Publication status will be posted to the pertinent study listing on clinicaltrials.gov. 
20. MONITORING  
Monitoring will be performed during the study according to the study Monitoring Plan. 
The Investigator/institution guarantees direct access to original source documents by 
sponsor 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. 
It is the responsibility of the Sponsor to ensure proper monitoring of this clinical study per 
regulations. Trained Sponsor personnel or delegates appointed by the Sponsor may perform 
study monitoring at the study site in order to ensure that the study is conducted in 
accordance with the CIP, the Clinical Study Agreement, and applicable regulatory and local 
requirements. The Sponsor, or delegates, must therefore be allowed access to the subjects’ 
case histories (clinic and hospital records, and other source data/ documentation) upon 

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request as per the ICF, Research Authorization (where applicable) and Clinical Study 
Agreement. The principal investigator should also be available during monitoring visits. 
20.1 Monitoring Visits 
Monitoring visits may be conducted periodically to assess site study progress, the 
investigator’s adherence to the CIP, regulatory compliance, maintenance of study records 
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, oversight, and facilities to conduct the study safely and effectively, and 
review of source documents against subject eCRFs. Monitors review site regulatory and 
study compliance by identifying findings of non-compliance and communicating those 
findings along with recommendations for preventative/corrective actions to site personnel. 
Monitors may work with study personnel to determine appropriate corrective action 
recommendations and to identify and correct non-compliance trends within the study or at a 
particular site. 
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, 
study compliance, number of AEs, number and type of deviations, findings from previous 
monitoring visits and any suspected inconsistency in data that requires investigation. 
Regulatory documents may be reviewed at each study site.  
 
 

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21. ABBREVIATIONS AND DEFINITIONS 
21.1 Abbreviations 
Abbreviation 
Terminology 
ABI 
Ankle Brachial Index 
ACC/AHA 
American College of Cardiology/American Heart Association 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ASADE 
Anticipated Serious Adverse Device Effect 
BSC 
Boston Scientific Corporation 
CE 
Conformité Européenne (meaning European Conformity) 
CEC 
Clinical Events Committee 
CIN 
Contrast-Induced Nephropathy 
CIP 
Clinical Investigational Plan 
CRF 
Case Report Form 
CVA 
Cerebrovascular Accident 
DD 
Device Deficiency 
DES 
Drug Eluting Stent 
DFU 
Directions For Use 
DUS 
Duplex Ultrasound 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDAAA 
Food and Drug Administration Amendments Act 
ICF 
Informed Consent Form 
ITT 
Intent to Treat 

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Abbreviation 
Terminology 
MAE 
Major Adverse Event 
PI 
Principal Investigator 
PPA 
Proximal Popliteal Artery 
PSVR 
Peak Systolic Velocity Ratio 
PTA 
Percutaneous Transluminal Angioplasty 
QA 
Quantitative Angiography 
RCC 
Rutherford-Becker clinical classification 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SDS 
Stent Delivery System 
SFA 
Superficial Femoral Artery 
TBI 
Tibial Brachial Index 
TLR 
Target Lesion Revascularization 
TVR 
Target Vessel Revascularization 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
VIVA 
Vascular InterVentional Advances 
WIQ 
Walking Impairment Questionnaire 
 
 

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

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Term 
Definition 
DEATH 
All deaths are considered cardiac unless an unequivocal non-cardiac 
cause can be established. Specifically, an unexpected death in 
subjects with coexisting potentially fatal non-cardiac diseases (e.g. 
Cancer, infection) should be classified as cardiac. 
All death events will be submitted to CEC and will be categorized as: 
Cardiac death: any death due to immediate cardiac cause (e.g. MI, 
low-output failure, fatal arrhythmia). Unwitnessed death and death of 
unknown cause will be classified as cardiac death. This includes all 
procedure related deaths including those related to concomitant 
treatment. 
Vascular death: death due to cerebrovascular disease, pulmonary 
embolism, ruptured aortic aneurysm, dissecting aneurysm, or other 
vascular cause. 
Non-cardiovascular death: any death not covered by the above 
definitions, including death due to infection, sepsis, pulmonary 
causes, accident, suicide, or trauma. 
DIAMETER 
STENOSIS 
The maximal narrowing of the target lesion relative to the reference 
vessel diameter. 
DISSECTION- 
NHLBI GRADE 
TYPES 
Type A- Small radiolucent area within the lumen of the vessel 
disappearing with the passage of the contrast material. 
Type B- Appearance of contrast medium parallel to the lumen of the 
vessel disappearing within a few cardiac cycles. 
Type C- Dissection protruding outside the lumen of the vessel 
persisting after passage of the contrast material. 
Type D- Spiral shaped filling defect with or without delayed run-off of 
the contrast material in the antegrade flow. 
Type E- Persistent luminal filling defect with delayed run-off of the 
contrast material in the distal lumen. 
Type F- Filling defect accompanied by total vessel occlusion. 
DISTAL 
EMBOLIZATION 
Migration of a filling defect, or thrombus, to distally occlude the target 
vessel or one of its branches. 

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

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

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Term 
Definition 
RUTHERFORD / 
BECKER 
CLASSIFICATION 
Categor
y 
Clinical Description 
Objective Criteria 
0 
Asymptomatic 
Normal Treadmill /stress test 
1 
Mild claudication 
Completes 
treadmill 
exercise; 
ankle 
pressure 
(AP) 
after 
exercise <50mm Hg, but >25 mm 
Hg less than BP 
2 
Moderate claudication 
Between categories 1 and 3 
3 
Severe claudication 
Cannot 
complete 
treadmill 
exercise and AP after exercise 
<50 mm Hg 
4 
Ischemic rest pain 
Resting AP <40 mm Hg, flat or 
barely 
pulsatile 
ankle 
or 
metatarsal 
pulse 
volume 
recording (PVR); toe pressure 
(TP) <30 mm Hg 
5 
Minor 
tissue 
loss 
– 
nonhealing ulcer, focal 
gangrene 
with 
diffuse 
pedal edema 
Resting AP <60 mm Hg, ankle or 
metatarsal (MT) PVR flat or 
barely pulsatile; TP <40 mm Hg  
6 
Major 
tissue 
loss 
– 
extending above 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 
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 
REVASCULARIZATI
ON (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. 

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Term 
Definition 
TARGET VESSEL 
REVASCULARIZATI
ON (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.) 
TRANSATLANTIC 
INTER-SOCIETAL 
CONSENSUS 
(TASC) LESION 
GUIDELINES 
Type A lesion: 
 
Single stenosis  10 cm in length. 
 
Single occlusion  5 cm in length. 
 
Type B lesion: 
 
Multiple lesions (stenoses or occlusions), each  5cm 
 
Single stenosis or occlusion  15cm not involving the infra 
geniculate popliteal artery 
 
Single or multiple lesions in the absence of continuous tibial 
vessels to improve inflow for a distal bypass 
 
Heavily calcified occlusion  5cm in length 
 
Single popliteal stenosis 
 
Type C lesion: 
 
Multiple stenoses or occlusions totaling > 15cm with or without 
heavy calcification 
 
Recurrent stenoses or occlusions that need treatment after two 
endovascular interventions 
 
Type D lesion: 
 
Chronic total occlusions of the CFA or SFA (>20cm, involving the 
popliteal artery) 
 
Chronic total occlusion of the popliteal artery and proximal 
trifurcation vessels 

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Term 
Definition 
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. 
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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