Randomized & Controlled Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB
Phase: NA
Conditions: Peripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery Occlusion
Sponsor: SurModics, Inc.



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SITE INVESTIGATORS SIGNATURE PAGE 
Protocol No. SUR17-001 
I, the undersigned, have read and understood the protocol for the study entitled 
The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical 
Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects with Stenotic 
Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® 
Drug-Coated Balloon: TRANSCEND Study 
Surmodics, Inc. 
The signature below documents the receipt and review of the TRANSCEND clinical study 
protocol and any attachments, and provides the necessary assurances that this study will be 
conducted according to all stipulations of the protocol, including all statements regarding 
confidentiality, and according to the local legal and regulatory requirements and applicable 
United States Federal Regulations, ISO 14155, ICH and GCP guidelines. 
Investigator Name (print or type): 
Investigator’s Signature: 
Date: 
Site Number: 
Site Address: 

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1. Protocol Synopsis
Study Title 
The Randomized And Controlled Noninferiority Trial to Evaluate Safety 
and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the 
Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery 
Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon: 
TRANSCEND Study 
Investigational 
Device 
Surmodics SurVeil™ Drug-Coated Balloon (SurVeil DCB) 
Comparator 
Device 
Medtronic IN.PACT® Admiral® DCB 
Objectives 
To demonstrate the safety and efficacy of the SurVeil DCB for treatment of 
subjects with symptomatic peripheral artery disease (PAD) due to stenosis 
of the femoral and/or popliteal arteries. 
Study Design 
Prospective, multi-center, single-blind, randomized, controlled, 
noninferiority clinical trial 
The trial will randomize approximately 446 subjects with symptomatic 
PAD due to stenoses of the femoral and/or popliteal arteries. Subjects 
meeting eligibility criteria will be randomized 1:1 to treatment with either 
the SurVeil DCB or the IN.PACT Admiral DCB, and followed for 60 
months. 
Subject 
Populations 
Subjects with symptomatic PAD due to a stenotic lesion of the femoral 
and/or popliteal arteries with a reference vessel diameter (RVD) of 4 mm to 
7 mm and a total lesion length ≤180 mm. 
Subjects and 
Sites 
Up to 446 subjects will be randomized at approximately 60 sites in the 
United States and approximately 18 sites outside of the United States. 
Primary Safety 
Endpoint 
The primary safety endpoint is a composite of freedom from device- and 
procedure-related death through 30 days post-index procedure and freedom 
from major target limb amputation (above the ankle) and clinically-driven 
target vessel revascularization (TVR) through 12 months post-index 
procedure. 

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Primary Efficacy 
Endpoint 
The primary efficacy endpoint is primary patency, defined as a composite 
of freedom from clinically-driven target lesion revascularization (TLR) and 
binary restenosis (restenosis defined as duplex ultrasound [DUS] peak 
systolic velocity ratio [PSVR] ≥2.4 or ≥50% stenosis as assessed by 
independent angiographic and DUS core labs) through 12 months post-
index procedure. In cases when there is a discrepancy between 
angiographic and DUS assessment of patency, angiographic assessment 
takes precedence. 
Secondary 
Endpoints 
Acute: 
•
Device Success: defined as successful delivery, balloon inflation,
deflation and retrieval of the intact study device without burst below
rated burst pressure, and achievement of <50% residual stenosis of the
target lesion (by core lab-assessed quantitative angiography [QA])
without flow-limiting arterial dissection using only the study device
•
Technical Success: defined as achievement of a final residual
diameter stenosis of <50% (by core lab-assessed QA) without flow-
limiting arterial dissection at the end of the procedure
•
Procedure Success: defined as evidence of both acute technical
success and absence of Peripheral Academic Research Consortium
major adverse events (PARC MAEs; e.g., death, stroke, myocardial
infarction, acute onset of limb ischemia, index bypass graft or treated
segment thrombosis, and or need for urgent/emergent vascular
surgery) within 72 hours of the index procedure
•
Freedom from all-cause death, major target limb amputation and TVR
through 30 days
Through follow-up: 
•
Primary patency through 24 months (only if both the primary safety
and efficacy hypotheses of noninferiority are met)
•
Target vessel patency, defined as freedom from clinically-driven TVR
and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50%
stenosis as assessed by independent angiographic and DUS core labs),
within 12 and 24 months (In cases when there is a discrepancy
between angiographic and DUS assessment of patency, angiographic
assessment takes precedence.)
•
Sustained clinical improvement, defined as freedom from major target
limb amputation, TVR and worsening target limb Rutherford class,
within 6, 12, and 24 months

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•
Clinically-driven TLR, within 6, 12, 24, 36, 48, and 60 months
•
Historical major adverse events (Historical MAEs), defined as
composite of all-cause death, clinically-driven TLR, major target limb
amputation, or thrombosis at the target lesion, within 6, 12, 24, 36, 48,
and 60 months
•
Major target-limb amputation, within 6, 12, 24, 36, 48, and 60 months
•
Thrombosis at the target lesion, within 6, 12, 24, 36, 48, and 60
months
•
Change in target limb Rutherford class from baseline to 1, 6, 12, and
24 months
•
Change in target limb PARC class from baseline to 1, 6, 12, and 24
months
•
Decrease in target limb resting ankle brachial index (ABI) or toe
brachial index (TBI) ≥0.15 from baseline to 6, 12, and 24 months
•
Change in Walking Impairment Questionnaire (WIQ) score from
baseline to 1, 12, and 24 months
•
Change in 6-minute walk test (6-MWT) from baseline to 12 and 24
months
•
Change in Peripheral Artery Questionnaire (PAQ) score from baseline
to 1, 12, and 24 months
Statistical 
Considerations 
The proposed investigational device exemption (IDE) study will assess 
noninferiority of the 12-month primary patency rate in subjects treated with 
the SurVeil DCB vs. the primary patency rate in subjects treated with the 
IN.PACT Admiral DCB.  
Hypotheses: The efficacy objective will be assessed through testing the 
following hypotheses:  
𝐻𝐻0: 𝑝𝑝𝑆𝑆
Eff – 𝑝𝑝𝑀𝑀
Eff ≤−𝛿𝛿Eff 
𝐻𝐻1: 𝑝𝑝𝑆𝑆
Eff – 𝑝𝑝𝑀𝑀
Eff > −𝛿𝛿Eff 
where 𝑝𝑝𝑆𝑆
Eff and 𝑝𝑝𝑀𝑀
Eff are the 12-month primary patency rates in the SurVeil 
group and comparator IN.PACT Admiral group, respectively, and 𝛿𝛿Eff is 
the noninferiority margin. 
Statistical analyses for the primary endpoint will be conducted using a 
Farrington & Manning test for noninferiority of proportions; the test will be 
a one-sided test at 𝛼𝛼= 0.025 
Sample Size Assumptions: 
•
True 12-month primary patency rate is 82.2% in both treatment groups

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•
1:1 randomization of SurVeil DCB vs IN.PACT Admiral DCB
•
15.0% is the absolute noninferiority margin (50% of the difference in
primary patency rate between IN.PACT Admiral DCB and PTA1)
A sample size of 446 (223 randomized to SurVeil DCB group and 223
randomized to IN.PACT Admiral DCB group) randomized subjects,
accounting for an assumed 10% lost to follow up, will lead to a power
level of 97.5%. If the true primary patency rates are 82.2% in the
IN.PACT Admiral DCB arm, and 80% and 78.3% in the SurVeil DCB
arm, at least 90% and 80% power, respectively, will be preserved at
the planned sample size.
Clinical 
Inclusion 
Criteria 
Subjects must meet all of the following criteria to participate in the trial: 
CI1. Subject is ≥18 years. 
CI2. Subject has target limb Rutherford classification 2, 3 or 4. 
CI3. Subject has provided written informed consent and is willing to 
comply with study follow-up requirements. 
Clinical 
Exclusion 
Criteria 
Subjects will be excluded from the trial if any of the following criteria are 
met: 
CE1. Subject has acute limb ischemia. 
CE2. Subject underwent intervention involving the target vessel within the 
previous 90 days. 
CE3. Subject underwent any lower extremity percutaneous treatment in 
the ipsilateral limb using a paclitaxel-eluting stent or a DCB within 
the previous 90 days. 
CE4. Subject underwent PTA of the target lesion using a DCB within the 
previous 180 days. 
CE5. Subject has had prior vascular intervention in the contralateral limb 
within 14 days before the planned study index procedure or subject 
has planned vascular intervention in the contralateral limb within 30 
days after the index procedure. 
CE6. Women who are pregnant, breast-feeding or intend to become 
pregnant or men who intend to father children during the time of the 
study.  
CE7. Subject has life expectancy less than 2 years. 
CE8. Subject has a known allergy to contrast medium that cannot be 
adequately pre-medicated. 
1 Tepe, Laird, Schneider, et al. Circulation. 2015;131:495-502. 

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CE9. Subject is allergic to ALL antiplatelet treatments. 
CE10. Subject has impaired renal function (i.e. serum creatinine level ≥2.5 
mg/dL). 
CE11. Subject is dialysis dependent. 
CE12. Subject is receiving immunosuppressant therapy. 
CE13. Subject has known or suspected active infection at the time of the 
index procedure. 
CE14. Subject has platelet count <100,000/mm3 or >700,000/mm3. 
CE15. Subject has history of gastrointestinal hemorrhage requiring a 
transfusion within 3 months prior to the study procedure. 
CE16. Subject is diagnosed with coagulopathy that precludes treatment 
with systemic anticoagulation and/or dual antiplatelet therapy 
(DAPT). 
CE17. Subject has history of stroke within the past 90 days. 
CE18. Subject has a history of myocardial infarction within the past 30 
days. 
CE19. Subject is unable to tolerate blood transfusions because of religious 
beliefs or other reasons. 
CE20. Subject is incarcerated, mentally incompetent, or abusing drugs or 
alcohol. 
CE21. Subject is participating in another investigational drug or medical 
device study that has not completed primary endpoint(s) evaluation 
or that clinically interferes with the endpoints from this study, or 
subject is planning to participate in such studies prior to the 
completion of this study. 
CE22. Subject has had any major (e.g. cardiac, peripheral, abdominal) 
surgical procedure or intervention unrelated to this study within 30 
days prior to the index procedure or has planned major surgical 
procedure or intervention within 30 days of the index procedure. 
CE23. Subject had previous bypass surgery of the target lesion.  
CE24. Subject had previous treatment of the target vessel with thrombolysis 
or surgery. 
CE25. Subject is unwilling or unable to comply with procedures specified 
in the protocol or has difficulty or inability to return for follow-up 
visits as specified by the protocol. 
Angiographic 
Inclusion 
The target lesion/vessel must meet all of the following angiographic criteria 
for the subject to participate in the trial: 

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Criteria 
AI1. De novo lesion(s) or non-stented restenotic lesion(s) occurring >90 
days after prior plain old balloon (POBA) angioplasty or >180 days 
after prior DCB treatment.  
AI2. Target lesion location starts ≥10 mm below the common femoral 
bifurcation and terminates distally at or above the end of the P1 
segment of the popliteal artery. 
AI3. Target vessel diameter ≥4 mm and ≤7 mm. 
AI4. Target lesion must have angiographic evidence of ≥70% stenosis by 
operator visual estimate. 
AI5. Chronic total occlusions may be included only after successful, 
uncomplicated wire crossing of target lesion via an anterograde 
approach. Successful crossing of the target lesion occurs when the 
tip of the guide wire is distal to the target lesion without the 
occurrence of flow-limiting dissection or perforation and is judged 
by visual inspection to be within the true lumen. Subintimal 
dissection techniques may be used if re-entry occurs above the knee 
and without the use of re-entry devices. 
AI6. Target lesion must be ≤180 mm in length (one long lesion or 
multiple serial lesions) by operator visual estimate. 
Note: combination lesions must have a total lesion length of ≤180 
mm by visual estimate and be separated by ≤30 mm.  
AI7. Target lesion is located at least 30 mm from any stent if target vessel 
was previously stented. 
AI8. Successful, uncomplicated (without use of a crossing device) wire 
crossing of target lesion. Successful crossing of the target lesion 
occurs when the tip of the guide wire is distal to the target lesion 
without the occurrence of flow-limiting dissection or perforation and 
is judged by visual inspection to be within the true lumen. 
AI9. After pre-dilatation, the target lesion is ≤70% residual stenosis, 
absence of a flow limiting dissection and treatable with available 
device matrix. 
AI10. A patent inflow artery free from significant stenosis (≥50% stenosis) 
as confirmed by angiography. 
AI11. At least one patent native outflow artery to the ankle or foot, free 
from significant stenosis (≥50% stenosis) as confirmed by 
angiography. 

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Angiographic 
Exclusion 
Criteria 
Subjects will be excluded from the trial if the target lesion/vessel meets 
any of the following angiographic criteria: 
AE1. Target lesion has severe calcification (as defined by the PARC 
classification of calcification). 
AE2. Target lesion involves an aneurysm or is adjacent to an aneurysm 
(within 5 mm). 
AE3.  Target lesion requires treatment with alternative therapy such as 
stenting, laser, atherectomy, cryoplasty, brachytherapy, or re-entry 
devices. 
AE4. Significant target vessel tortuosity or other parameters prohibiting 
access to the target lesion. 
AE5. Presence of thrombus in the target vessel.  
AE6. Iliac inflow disease requiring treatment unless the iliac artery disease 
is successfully treated first during the index procedure. Success is 
defined as ≤30% residual diameter stenosis without death or major 
complications.  
AE7. Presence of an aortic, iliac or femoral artificial graft. 
Subject Follow-
up 
All randomized subjects will be followed through 60 months post-index 
procedure with follow-up assessments at 30 days and at 6, 12, 24, 36, 48, 
and 60 months. 

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2. Study Administration and Contacts
Sponsor 
Surmodics, Inc. 
 
9924 West 74th Street 
Eden Prairie, Minnesota, 55344 USA 
 
Principal 
Investigators 
William Gray, MD 
Lankenau Medical Center 
 
 
  
Kenneth Rosenfield, MD 
Massachusetts General Hospital 
 
 
 
Marianne Brodmann, MD 
Medical University Graz, Department of Internal Medicine 
 
Protocol 
Development 
Baim Institute for Clinical Research 
Sammy Elmariah, MD, Medical Director 
Gheorghe Doros, PhD, Statistical Consulting, Biostatistics 
Data 
Coordinating 
Center 
Baim Institute for Clinical Research 
930-W Commonwealth, 3rd Floor
Boston, MA 02215-1212 USA

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Angiographic 
Core Lab 
Yale Angiographic Core Laboratory 
Alexandra Lansky, MD 
One Church Street, Suite 330 
New Haven, CT 06510 USA 
 
Duplex 
Ultrasound Core 
Lab 
VasCore 
Gail Hadley, Technical Director 
1 Bowdoin Square, 10th Floor 
Boston, MA 02114 USA 
 
 
 

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3. Table of Contents 
1. 
PROTOCOL SYNOPSIS .......................................................................................................... 5 
2. 
STUDY ADMINISTRATION AND CONTACTS ....................................................................... 12 
3. 
TABLE OF CONTENTS ........................................................................................................ 14 
TABLE OF FIGURES ................................................................................................................... 20 
TABLE OF TABLES .................................................................................................................... 20 
4. 
INTRODUCTION ................................................................................................................. 21 
4.1 
 ................................................................................... 21 
4.2 
 .................................................................................. 21 
4.3 
 ............................................................................................ 23 
4.4 
 ........................................................................................................... 25 
4.5 
 ...................................................................... 26 
4.6 
Study Rationale ...................................................................................................... 27 
5. 
DEVICE DESCRIPTION/INDICATIONS FOR USE ................................................................. 27 
5.1 
PTA Catheter Description ..................................................................................... 27 
Figure 1. The SurVeil DCB Catheter ............................................................................. 27 
5.2 
Balloon Drug Coating Description ....................................................................... 27 
TABLE 1 PACLITAXEL DESCRIPTION ....................................................................................... 28 
TABLE 2. SURVEIL DEVICE SUPPLY MATRIX AND PACLITAXEL CONTENT (µG) ................... 28 
6. 
TRIAL DESIGN ................................................................................................................... 29 
6.1 
Trial Design ............................................................................................................ 29 
6.2 
Clinical Sites and Subjects .................................................................................... 29 
6.3 
Subject Status Definitions ..................................................................................... 29 
7. 
TRIAL OBJECTIVE AND ENDPOINTS ................................................................................. 30 
7.1 
Trial Objective ........................................................................................................ 30 

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7.2 
Primary Safety Endpoint ....................................................................................... 30 
7.3 
Primary Efficacy Endpoint ................................................................................... 30 
7.4 
Secondary Endpoints ............................................................................................. 30 
7.4.1 
Acute .......................................................................................................... 30 
7.4.2 
Through Follow-Up ................................................................................... 31 
8. 
TRIAL POPULATION .......................................................................................................... 31 
8.1 
Study Population (Eligibility Criteria) ................................................................. 31 
8.1.1 
Clinical Inclusion Criteria .......................................................................... 32 
8.1.2 
Clinical Exclusion Criteria ........................................................................ 32 
8.1.3 
Angiographic Inclusion Criteria ................................................................ 33 
8.1.4 
Angiographic Exclusion Criteria ............................................................... 34 
9. 
STUDY PROCEDURES ......................................................................................................... 35 
9.1 
Schedule of Events ................................................................................................. 35 
TABLE 3. SCHEDULE OF EVENTS.............................................................................................. 35 
9.2 Informed Consent ...................................................................................................... 37 
9.3 
Enrollment .............................................................................................................. 37 
Figure 2. Subject Status .................................................................................................. 38 
9.4 
Screening/Baseline (Up to 14 Days Prior to Procedure) ..................................... 38 
9.5 
Procedure (Day 1) .................................................................................................. 40 
9.5.1 
Subject Preparation and Baseline Angiography ........................................ 40 
9.5.2 
Inflow Lesion Treatment ........................................................................... 40 
9.5.3 
Target Lesion Pre-Dilatation ..................................................................... 40 
9.5.4 
Randomization ........................................................................................... 41 
9.5.5 
Subjects Not Randomized .......................................................................... 41 
9.5.6 
Treatment with the SurVeil DCB or IN.PACT Admiral DCB .................. 41 
9.5.7 
Bailout Stenting ......................................................................................... 42 
9.5.8 
End of Procedure ....................................................................................... 42 
9.6 
Follow-Up Visits ..................................................................................................... 43 
9.6.1 Exceptions for the 12-month and 24-month Follow-up Visits ........................... 43 

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9.6.2 
1-Month Visit (30 Days, -2 to + 15 Days) ................................................. 43 
9.6.3 
6-Month Visit (180 Days +/- 30 Days) ...................................................... 44 
9.6.4 
12-Month Visit (365 Days +/- 30 Days) .................................................... 44 
9.6.5 
24-Month Visit (730 Days +/- 60 Days) .................................................... 44 
9.6.6 
36-Month Visit (1095 Days +/-60 Days) ................................................... 45 
9.6.7 
48-Month Visit (1460 Days +/-60 Days) ................................................... 45 
9.6.8 
60-Month Visit (1825 Days +/-60 Days) ................................................... 46 
9.7 
Unscheduled Visits ................................................................................................. 46 
9.8 
Medication Regimen .............................................................................................. 47 
TABLE 4. MEDICATION REGIMEN ............................................................................................ 47 
9.9 
Imaging and Other Clinical Assessments ............................................................ 48 
9.9.1 
Angiogram ................................................................................................. 48 
9.9.2 
Duplex Ultrasound (DUS) ......................................................................... 48 
9.9.2.1 Mobile Duplex Ultrasound ........................................................................ 48 
9.9.3 
Target Limb Rutherford and PARC Evaluations ....................................... 49 
9.9.4 
Ankle Brachial Index ................................................................................. 49 
9.9.5 
6-Minute Walk Test, Walking Impairment Questionnaire, and Peripheral 
Artery Questionnaire ................................................................................. 49 
10. BLINDING PLAN ................................................................................................................. 49 
11. SUBJECT ACCOUNTABILITY AND WITHDRAWAL ............................................................. 49 
11.1 Withdrawal ............................................................................................................. 49 
11.2 Loss to Follow-Up ................................................................................................... 50 
12. ADVERSE EVENTS ............................................................................................................. 50 
12.1 Adverse Event Definitions ..................................................................................... 51 
12.1.1 
Adverse Event (AE) ................................................................................... 51 
12.1.2 
Serious Adverse Event (SAE) ................................................................... 51 
12.1.3 
Adverse Device Effect (ADE) ................................................................... 52 
12.1.4 
Anticipated Adverse Event ........................................................................ 52 
12.1.5 
Device Deficiency, Device Malfunction & User Error ............................. 52 

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12.1.6 
Serious Adverse Device Effect (SADE) .................................................... 53 
12.1.7 
Unanticipated Adverse Device Effect (UADE) and Unanticipated Serious 
Adverse Device Effect (USADE) .............................................................. 53 
12.2 Adverse Event Documentation ............................................................................. 53 
12.2.1 
Intensity or Severity ................................................................................... 54 
12.2.2 
Relatedness to Study Device or Procedure ................................................ 54 
TABLE 5. ADVERSE EVENT RELATEDNESS CATEGORIES........................................................ 54 
12.2.3 
Outcome/Event Status ............................................................................... 56 
12.3 Adverse Event Reporting ...................................................................................... 56 
12.3.1 
Serious Adverse Events ............................................................................. 56 
12.3.2 
Unanticipated Adverse Device Effects ...................................................... 56 
12.3.3 
Notification of Events ................................................................................ 57 
TABLE 6. INVESTIGATOR REPORTING RESPONSIBILITIES ...................................................... 57 
TABLE 7. SPONSOR REPORTING RESPONSIBILITIES ............................................................... 58 
13. STUDY COMMITTEES ........................................................................................................ 59 
13.1 Data Monitoring Committee (DMC) .................................................................... 59 
13.2 Clinical Events Committee (CEC) ........................................................................ 59 
13.3 Steering Committee ................................................................................................ 60 
13.4 Publication Committee .......................................................................................... 60 
14. RISK BENEFIT ANALYSIS .................................................................................................. 60 
14.1 Safety Profile........................................................................................................... 60 
14.2 Potential Risks of SurVeil DCB ............................................................................ 61 
14.3 Potential Benefits .................................................................................................... 62 
14.4 Anticipated Adverse Device Effects ...................................................................... 63 
14.5 Residual Risk .......................................................................................................... 63 
14.6 Risks Associated with Participation in the Clinical Trial .................................. 63 
14.7 Possible Interactions with Concomitant Treatments .......................................... 63 
14.8 Risk Mitigation ....................................................................................................... 64 

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14.9 Risk / Benefit Rationale ......................................................................................... 64 
15. DATA COLLECTION AND VERIFICATION .......................................................................... 64 
15.1 Data Collection, Verification and Retention ........................................................ 64 
15.2 Protocol Deviations ................................................................................................ 65 
16. DEVICE SUPPLY AND MANAGEMENT................................................................................ 65 
17. STATISTICAL METHODS .................................................................................................... 66 
17.1 Assessment of Primary Efficacy Endpoint .......................................................... 66 
17.1.1 
Primary Patency Rates and Noninferiority Margin ................................... 67 
17.1.2 
Sample Size Calculations .......................................................................... 67 
17.2 Assessment of the Primary Safety Endpoint ....................................................... 68 
17.2.1 
Primary Safety Endpoint Rates and Noninferiority Margin ...................... 69 
17.2.2 
Sample Size Calculations .......................................................................... 69 
17.3 Handling of Missing Data in the Analysis of Primary Efficacy and Safety 
Endpoints ................................................................................................................ 70 
17.4 Assessment of Secondary Endpoints .................................................................... 70 
17.4.1 
Secondary Endpoints (Acute) .................................................................... 71 
17.4.2 
Secondary Endpoints (Through 60 Months Follow-Up) ........................... 72 
17.5 Study Populations .................................................................................................. 73 
17.6 Subgroup Analysis ................................................................................................. 73 
17.7 Poolability of Data Across Sites and Regions (United States vs. Outside the 
United States) .......................................................................................................... 74 
17.8 Assessment of Adverse Events .............................................................................. 74 
18. REGULATORY COMPLIANCE ............................................................................................ 75 
18.1 Statement of Compliance ....................................................................................... 75 
18.2 Investigator Responsibilities ................................................................................. 75 
18.2.1 
Investigator Delegation of Responsibility ................................................. 75 
18.3 Sponsor Responsibilities ........................................................................................ 75 
18.4 Institutional Review Board/Ethics Committee .................................................... 76 
18.5 Study Amendments ................................................................................................ 76 

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18.6 Informed Consent .................................................................................................. 76 
18.7 Subject Confidentiality .......................................................................................... 77 
18.8 Use of Electronic Signatures ................................................................................. 77 
18.9 Site Monitoring ....................................................................................................... 77 
19 SUSPENSION, TERMINATION, AND CLOSE-OUT ............................................................... 78 
19.1 Procedure for Suspension or Early Termination ................................................ 78 
19.2 Procedure for Resuming the Clinical Investigation After Temporary Suspension
 .................................................................................................................................. 79 
19.3 Routine Close-Out .................................................................................................. 79 
20 PUBLICATION POLICY ....................................................................................................... 80 
21 REFERENCES ..................................................................................................................... 81 
APPENDIX A. ACRONYMS AND ABBREVIATIONS ..................................................................... 84 
APPENDIX B. DEFINITIONS ....................................................................................................... 86 
 
 
 

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Table of Figures 
Figure 1. The SurVeil DCB Catheter ...................................................................................... 27 
Figure 2. Subject Status .......................................................................................................... 38 
 
Table of Tables 
Table 1 Paclitaxel Description ................................................................................................ 28 
Table 2. SurVeil Device Supply Matrix and Paclitaxel Content (µg) .................................... 28 
Table 3. Schedule of Events.................................................................................................... 35 
Table 4. Medication Regimen ................................................................................................. 47 
Table 5. Adverse Event Relatedness Categories ..................................................................... 54 
Table 6. Investigator Reporting Responsibilities .................................................................... 57 
Table 7. Sponsor Reporting Responsibilities .......................................................................... 58 
 

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4. Introduction 
4.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2 
 
 
 
 
 
  
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 

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4.3 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 

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4.6 Study Rationale 
The rationale for the current pivotal study is to further evaluate the safety and efficacy of the 
SurVeil DCB in subjects with symptomatic PAD due to a stenotic lesion of the femoral and/or 
popliteal arteries with a RVD of 4 mm to 7 mm and a total lesion length ≤180 mm. Specifically, 
the SurVeil DCB is being evaluated in terms of its noninferiority to the Medtronic IN.PACT 
Admiral DCB, which is indicated for use in PTA, after successful pre-dilatation, of de novo or 
restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with 
RVDs of 4-7 mm.  
5. Device Description/Indications for Use 
The SurVeil DCB (Figure 1) is indicated for PTA, after pre-dilatation of de novo or restenotic 
lesions (≤180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 
4 mm to 7 mm. 
5.1 PTA Catheter Description 
The SurVeil DCB Catheter (Figure 1) is a standard 0.035” over the wire PTA catheter, 1350 mm 
working length.
 
 
The shaft tubing size is 
5 French and connects the hub to the proximal end of the balloon.
 
 
The shaft of the catheter is coated with Surmodics PhotoLink® lubricious 
 coating. 
The balloon has a cylindrical section, which defines the length of the balloon, with a nominal 
diameter and a nominal length and a cone section at each end. 
 
The catheter 
tip, with an atraumatic design, acts as the transition from the catheter to the guidewire. 
 
Figure 1. The SurVeil DCB Catheter 
5.2 Balloon Drug Coating Description 
The balloon is coated with two proprietary coatings. The first layer is a hydrophilic basecoat 
 
The second layer comprises the drug paclitaxel (See 

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7. Trial Objective and Endpoints  
7.1 Trial Objective  
The objective of the study is to demonstrate the safety and efficacy of the SurVeil DCB for the 
treatment of subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal 
arteries. The study will be deemed a success if at a minimum the hypotheses of inferiority of the 
safety and efficacy of the SurVeil DCB are rejected. 
7.2 Primary Safety Endpoint 
The primary safety endpoint is a composite of freedom from device- and procedure-related death 
through 30 days post-index procedure and freedom from major target limb amputation  (above the 
ankle) and clinically-driven target vessel revascularization (TVR) through 12 months post-index 
procedure. 
7.3 Primary Efficacy Endpoint 
The primary efficacy endpoint is primary patency, defined as a composite of freedom from 
clinically-driven TLR and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak 
systolic velocity ratio [PSVR] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and 
DUS core labs) and through 12 months post-index procedure. In cases when there is a discrepancy 
between angiographic and DUS assessment of patency, angiographic assessment takes precedence. 
7.4 Secondary Endpoints 
7.4.1 Acute  
The following acute secondary endpoints will be assessed: 
• Device Success: defined as successful delivery, balloon inflation, deflation and retrieval of 
the intact study device without burst below rated burst pressure, and achievement of <50% 
residual stenosis of the target lesion (by core lab-assessed quantitative angiography [QA]) 
without flow-limiting arterial dissection, using only the study device. 
• Technical Success: defined as achievement of a final residual diameter stenosis of <50% (by 
core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure. 
• Procedure Success: defined as evidence of both acute technical success and absence of 
Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., 
death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or 
treated segment thrombosis, and or need for urgent/ emergent vascular surgery) within 72 
hours of the index procedure. 
• Freedom from all-cause death, major target limb amputation and TVR through 30 days. 

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7.4.2 Through Follow-Up 
The following endpoints will be assessed through the follow-up period: 
• Primary patency through 24 months (only if both the primary safety and efficacy 
hypotheses of noninferiority are met). 
• Target vessel patency, defined as freedom from clinically-driven TVR and freedom from 
binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by 
independent angiographic and DUS core labs) within 12 and 24 and months (In cases when 
there is a discrepancy between angiographic and DUS assessment of patency, angiographic 
assessment takes precedence.) 
• Sustained clinical improvement, defined as freedom from major target limb amputation, 
TVR and worsening target limb Rutherford class within 6, 12, and 24 months 
• Clinically-driven TLR within 6, 12, 24, 36, 48, and 60 months  
• Historical major adverse events (Historical MAEs), defined as composite of all-cause death, 
clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, 
within 6, 12, 24, 36, 48, and 60 months  
• Major target-limb amputation within 6, 12, 24, 36, 48, and 60 months 
• Thrombosis at the target lesion within 6, 12, 24, 36, 48, and 60 months 
• Change in target limb Rutherford class from baseline to 1, 6, 12, and 24 months 
• Change in target limb Peripheral Academic Research Consortium (PARC) class from 
baseline to 1, 6, 12, and 24 months 
• Decrease in target limb resting ABI or toe brachial index (TBI) ≥0.15 from baseline to 6, 
12, and 24 months 
• Change in Walking Impairment Questionnaire (WIQ) score from baseline to 1, 12, and 24 
months 
• Change in 6-minute walk test (6-MWT) from baseline to 12 and 24 months 
• Change in Peripheral Artery Questionnaire (PAQ) score from baseline to 1, 12, and 24 
months 
8. Trial Population 
8.1 Study Population (Eligibility Criteria) 
Subjects with symptomatic PAD presenting for percutaneous revascularization of stenosed 
femoral and/or popliteal arteries (either de novo lesions or non-stented restenotic lesions >90 days 
from prior POBA angioplasty or >180 days from prior DCB treatment) will be screened according 
to the protocol inclusion and exclusion criteria. Subjects who have signed the approved consent 
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and none of the clinical exclusion criteria will then be screened for angiographic criteria. Once 
angiography is complete and the investigator is satisfied that the subject has met all of the 
remaining study eligibility criteria, the subject may be randomized. Enrolled subjects who were 
not randomized will be considered screen failures and exited from the study. 
8.1.1 Clinical Inclusion Criteria  
Subjects must meet all the following clinical criteria to participate in the trial. 
CI1. Subject is ≥ 18 years of age. 
CI2. Subject has target limb Rutherford classification 2, 3, or 4. 
CI3. Subject has provided written informed consent and is willing to comply with the study 
follow-up requirements. 
8.1.2 Clinical Exclusion Criteria 
Subjects will be excluded from the trial if any of the following clinical criteria are met. 
CE1. Subject has acute limb ischemia. 
CE2. Subject underwent intervention involving the target vessel within the previous 90 days. 
CE3. Subject underwent any lower extremity percutaneous treatment in the ipsilateral limb 
using a paclitaxel-eluting stent or a DCB within the previous 90 days. 
CE4. Subject underwent PTA of the target lesion using a DCB within the previous 180 days. 
CE5. Subject has had prior vascular intervention in the contralateral limb within 14 days 
before the planned index procedure or subject has planned vascular intervention in the 
contralateral limb within 30 days after the index procedure. 
CE6. Women who are pregnant, breast-feeding or intend to become pregnant or men who 
intend to father children during the time of the study.  
CE7. Subject has life expectancy of less than 2 years. 
CE8. Subject has a known allergy to contrast medium that cannot be adequately pre-
medicated. 
CE9. Subject is allergic to ALL antiplatelet treatments. 
CE10. Subject has impaired renal function (i.e. serum creatinine level ≥2.5 mg/dL). 
CE11. Subject is dialysis dependent. 
CE12. Subject is receiving immunosuppressant therapy. 
CE13. Subject has known or suspected active infection at the time of the index procedure. 
CE14. Subject has platelet count <100,000/mm3 or >700,000/mm3.  

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CE15. Subject has history of gastrointestinal hemorrhage requiring a transfusion within 90 
days prior to the index procedure.  
CE16. Subject is diagnosed with coagulopathy that precludes treatment with systemic 
anticoagulation and/or DAPT. 
CE17. Subject has history of stroke within the past 90 days. 
CE18. Subject has a history of myocardial infarction within the past 30 days. 
CE19. Subject is unable to tolerate blood transfusions because of religious beliefs or other 
reasons. 
CE20. Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol. 
CE21. Subject is participating in another investigational drug or medical device study that has 
not completed primary endpoint(s) evaluation or that clinically interferes with the 
endpoints from this study, or subject is planning to participate in such studies prior to 
the completion of this study. 
CE22. Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or 
intervention unrelated to this study within 30 days prior to the index procedure or has 
planned major surgical procedure or intervention within 30 days of the index procedure. 
CE23. Subject had previous bypass surgery of the target lesion.  
CE24. Subject had previous treatment of the target vessel with thrombolysis or surgery. 
CE25. Subject is unwilling or unable to comply with procedures specified in the protocol or 
has difficulty or inability to return for follow-up visits as specified by the protocol. 
8.1.3 Angiographic Inclusion Criteria  
The target lesion/vessel must meet all the following angiographic criteria to participate in the 
trial. 
AI1. De novo lesion(s) or non-stented restenotic lesion(s) occurring >90 days after prior 
POBA angioplasty or >180 days after prior DCB treatment. 
AI2. Target lesion location starts ≥10 mm below the common femoral bifurcation and 
terminates distally at or above the end of the P1 segment of the popliteal artery. 
AI3. Target vessel diameter ≥4 mm and ≤7 mm  
AI4. Target lesion must have angiographic evidence of ≥70% stenosis by operator visual 
estimate. 
AI5. Chronic total occlusions may be included only after successful, uncomplicated wire 
crossing of target lesion via an anterograde approach. Successful crossing of the target 
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occurrence of flow-limiting dissection or perforation and is judged by visual inspection 
to be within the true lumen. Subintimal dissection techniques may be used if re-entry 
occurs above the knee and without the use of re-entry devices. 
AI6. Target lesion must be ≤180 mm in length (one long lesion or multiple serial lesions) by 
operator visual estimate. 
Note: combination lesions must have a total lesion length of ≤180 mm by visual estimate and be 
separated by ≤30 mm.  
AI7. Target lesion is located at least 30 mm from any stent, if target vessel was previously 
stented 
AI8. Successful, uncomplicated (without use of a crossing device) wire crossing of target 
lesion. Successful crossing of the target lesion occurs when the tip of the guide wire is 
distal to the target lesion without the occurrence of flow-limiting dissection or 
perforation and is judged by visual inspection to be within the true lumen. 
AI9. After pre-dilatation, the target lesion is ≤70% residual stenosis, absence of a flow 
limiting dissection and treatable with available device matrix. 
AI10. A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by 
angiography. 
AI11. At least one patent native outflow artery to the ankle or foot, free from significant 
stenosis (≥50% stenosis) as confirmed by angiography. 
8.1.4 Angiographic Exclusion Criteria 
Subjects will be excluded from the trial if the target lesion/vessel meets any of the following 
angiographic criteria: 
AE1. Target lesion has severe calcification (as defined by the PARC classification of 
calcification).  
AE2. Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm).  
AE3. Target lesion requires treatment with alternative therapy such as stenting, laser, 
atherectomy, cryoplasty, brachytherapy, or re-entry devices. 
AE4. Significant target vessel tortuosity or other parameters prohibiting access to the target 
lesion.  
AE5. Presence of thrombus in the target vessel.  
AE6. Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully 
treated first during the index procedure. Success is defined as ≤30% residual diameter 
stenosis without death or major complications.  
AE7. Presence of an aortic, iliac or femoral artificial graft.  
 

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9.2 Informed Consent 
Subjects are to be consented prior to initiating any study-specific procedures that are not 
considered routine standard of care. The investigator or site personnel, who has been trained 
on the protocol, will approach individual subjects who are potential candidates for 
participation. She or he will explain the nature and scope of the study, the procedures to be 
performed as part of the study, the potential risks and benefits of participation, and will answer 
questions for the candidate. The study will be explained to the subject in lay terms and adequate 
time will be allowed for the subject to ask questions. Interested subjects will be invited to 
participate in the trial and will be asked to provide written informed consent prior to initiation 
of any trial-related procedure. Subjects will be assured that they may withdraw from the study 
at any time and for any reason, without repercussion. If the subject agrees to participate, the 
informed consent must be signed and dated by the subject or their legally authorized 
representative and by the person who obtained the informed consent. If a participant requires 
a translated consent, the Ethics Committee (EC) or Institutional Review Board (IRB) policies 
will apply to the informed consent process. Any additional persons required to sign the 
informed consent by the local EC/IRB will also do so.  
The informed consent form that is used must be approved by the EC/IRB. A dated and signed 
copy of the informed consent form will be given to the subject or their legally authorized 
representative and a dated and signed copy will be placed in the research folder.  
Failure to obtain a signed and dated informed consent form prior to the procedure constitutes 
a protocol violation, which must be reported in accordance with all applicable regulations. 
9.3 Enrollment 
Eligible subjects will be enrolled consecutively at each investigative site in this study. A 
subject is considered to be enrolled after she or he has signed the informed consent form. 
Enrolled subjects who met all the clinical inclusion criteria and none of the clinical exclusion 
criteria will then be evaluated for angiographic eligibility criteria. If an enrolled subject fails 
any of the clinical or angiographic eligibility criteria, the investigative site research staff will 
enter information into the electronic data capture (EDC) system to document this; the subject 
will be considered a screen failure, will not be randomized, will be exited from the study, and 
will be followed per site standard of care. Subjects who do not fail the angiography eligibility 
criteria may be randomized: once angiography is complete and the investigator is satisfied that 
the subject has met all of the trial eligibility criteria, he/she may then randomize the subject.  
Figure 2 depicts subject status: 
 
 
 

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Figure 2. Subject Status 
 
9.4 Screening/Baseline (Up to 14 Days Prior to Procedure) 
As specified in Section 9.2, signed written informed consent must be obtained for all subjects 
who are potential trial candidates prior to provisional enrollment. Adverse event (AE)/serious 
adverse event (SAE) collection must begin after the subject has signed the consent form.  
Additionally, the following evaluations must be completed for all enrolled subjects prior to the 
procedure, unless otherwise specified: 
Within 14 Days Prior to the Trial Procedure: 
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• Demographics, including date of birth or age at time of procedure, gender, and 
race/ethnicity (as allowed per local regulations) 
• Medical history (general medical, cardiac, peripheral vascular, neurologic and renal 
history), including, but not limited to, the following: 
o Risk factors (e.g. dyslipidemia, hypertension, diabetes mellitus, tobacco use) 
o Cardiovascular history (e.g. prior myocardial infarction, prior percutaneous 
coronary intervention, history of congestive heart failure) 
o History of peripheral vascular disease (e.g. prior interventions, stroke, 
transient ischemic attack) 
• Physical examination, including weight, height, blood pressure, target limb 
examination 
• Target limb Rutherford classification 
• Target limb PARC classification 
• Resting ABI or TBI (see section 9.9.4 for details). Note that resting ABI or TBI may 
be obtained up to 90 days prior to the index procedure, provided there must be no 
significant clinical change in the subject’s status between the ABI/TBI assessment 
and the index procedure. If there is a significant change, defined as a change in 
clinical symptoms, the ABI/TBI must be reassessed. See Appendix B for definition of 
significant clinical change.  
• WIQ  
• 6-MWT 
• PAQ 
• Laboratory tests 
o Complete blood count (CBC); differential is also required if the white blood 
cell count is NOT within normal limits  
o Comprehensive metabolic panel (that includes kidney and liver function tests) 
o Pregnancy test for women of child-bearing potential with analysis per 
standard of care (serum and/or urine) 
• Adverse event (AE)/serious adverse event (SAE) assessment 
• Current medication regimen including anti-platelet/anti-coagulant, and paclitaxel-
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9.5 Procedure (Day 1) 
9.5.1 Subject Preparation and Baseline Angiography 
The subject must have met all clinical inclusion and none of the exclusion criteria, including 
confirmation of all laboratory results, prior to proceeding with the index procedure. Subject 
preparation and percutaneous access should be performed according to the standard hospital 
care unless otherwise specified in this investigational plan. The procedure begins once 
percutaneous access has been established. Standard PTA balloons should be used for pre-
dilatation. Use of embolic capture angioplasty balloons or cutting/scoring balloons and 
atherectomy devices is not allowed. The appropriate size of the balloon to be used should be 
selected by visual assessment.  
Baseline angiography of the vessel(s) will be performed as per the angiographic core laboratory 
procedure guidelines to characterize the target lesion and to confirm angiographic eligibility 
criteria. Because the lesion location must start ≥10 mm below the common femoral bifurcation 
(and terminate distally at or above the end of the P1 segment of the popliteal artery), the 
common femoral artery cannot be treated. Assessment of angiographic eligibility criteria is 
based on a visual assessment of the angiogram and/or QA. All angiograms, either digital 
subtraction angiography or cineangiography, will be submitted to an independent angiographic 
core laboratory for analysis. Angiograms should be captured before and during the index 
procedure, and at any unscheduled interventions. Care should be taken to utilize the same 
angles and views for all angiographic assessments. All angiograms should be submitted as 
soon as possible to the angiographic core laboratory for analysis per the core laboratory 
guidelines. 
9.5.2 Inflow Lesion Treatment 
In order to be randomized, the subject must have a patent inflow artery free from significant 
stenosis (≥50% stenosis) as confirmed by angiography. Subjects can be randomized after 
successful treatment of inflow stenosis per standard practice; there is no limit to the number of 
inflow lesions that can be treated. Successful treatment is defined as ≤30% residual stenosis 
without death or major vascular complications. 
9.5.3 Target Lesion Pre-Dilatation 
Refer to the SurVeil DCB and IN.PACT Admiral DCB Instructions for Use (IFU) for detailed 
pre-dilatation requirements. Pre-dilatation of the target lesion with an uncoated PTA catheter 
is required for both the SurVeil and IN.PACT Admiral DCBs. The uncoated PTA catheters 
should have a diameter that is 1mm less than RVD. The length of the uncoated PTA catheter 
should approximate the length of the lesion. This is in order to limit vessel injury outside the 
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treated area is outside of the DCB treated area. The DCB must be longer than the uncoated 
PTA catheter that was used. 
Successful pre-dilatation is defined as having achieved residual stenosis ≤70% and the absence 
of a flow-limiting dissection. If a subject does not achieve a successful pre-dilatation, the 
subject is not eligible to be randomized, is considered a screen failure, and is treated in 
accordance with standard of care. 
9.5.4 Randomization 
Subjects will be randomized in a 1:1 fashion via the EDC to either the SurVeil DCB or the 
IN.PACT Admiral DCB.   
Prior to randomization, the investigative site should verify that the appropriate sizes of both 
the IN.PACT Admiral and SurVeil products are available for use in the subject. Each subject 
will receive one unique randomization number associated with a randomization assignment 
allocated via EDC. Randomization will be stratified by study center and to prevent bias; the 
blocks and randomization schedules will be pre-defined prior to the first subject being enrolled.   
9.5.5 Subjects Not Randomized 
A subject who was enrolled but not randomized due to not meeting all of the eligibility criteria 
(either clinical or angiographic) will be treated per the investigative site’s standard of care. The 
appropriate electronic case report form (eCRF) should be filled out to indicate that this subject 
has been exited from the study. 
9.5.6 Treatment with the SurVeil DCB or IN.PACT Admiral DCB 
Refer to the appropriate device (SurVeil DCB or IN.PACT Admiral DCB) IFU for detailed 
information on use of the particular device. The investigator should determine the appropriate 
size DCB based on visual estimate and/or QA and plan to use a maximum of 2 SurVeil DCBs. 
DCB sizing must match the RVD and fully cover and extend slightly beyond the lesion length. 
The operator should not plan to use more than two study devices to treat a single target lesion 
during the procedure. The investigator should determine the appropriate size of the balloon(s) 
to be used as follows: 
• 
The nominal DCB diameter must match the RVD distal to the target lesion. 
• 
The nominal DCB length must cover the entire target lesion or area treated by the 
pre-dilatation balloon plus a minimum of 5 mm proximally and 5 mm distally. 
• 
If multiple DCBs are required to treat a lesion, the balloons must overlap by at 
least 10 mm. The additional DCB should be angiographically positioned to ensure 
coverage of at least 5 mm proximally and distally beyond the margins of the pre-
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The balloon to artery ratio must be 1.1:1. 
Use a radiopaque ruler to ensure appropriate placement of the DCB catheter. The device(s) 
should cover the entire lesion. 
Balloon inflation pressure should be at or beyond the nominal pressure. Do not exceed rated 
burst pressure.  
The DCB(s) (SurVeil or IN.PACT Admiral) should be inflated for a minimum of 120 seconds 
to achieve the desired dilatation. If additional dilatation is required, a standard PTA catheter 
should be used. 
If a SurVeil DCB is opened but not used, or if a device deficiency or malfunction occurs during 
its use, it must be returned to Surmodics or its designee in accordance with the packaging and 
shipping instructions. The Sponsor is responsible for device deficiencies reporting of the 
SurVeil DCB to all concerned National Competent Authorities of the EU according to national 
regulations and in line with MEDDEV 2.7/3 revision 3, May 2015. 
9.5.7 Bailout Stenting 
Prior to bailout stenting, the investigator should attempt prolonged balloon inflations (>2 
minutes) in order to limit the amount of bailout stenting required in the study.   
Bailout stenting is allowed if: 
• residual stenosis is ≥50% (based on in-lab review of angiograms with/without QA) 
or  
• major (≥Grade D) flow-limiting dissection confirmed by a peak translesional systolic 
pressure gradient >10 mmHg.   
If bailout stenting is required per either of the above criteria, the investigator should treat the 
patient per standard of care including use of a superficial femoral artery (SFA)-indicated bare 
nitinol stent. The size of the stent should be as short as possible in order to cover the dissection 
or focal area of residual stenosis and not to cover the entire lesion with the bailout stent. During 
angiography, care should be taken to utilize the same angles and views that were used during 
the baseline and DCB procedures. 
All subjects who undergo a bailout procedure, including emergency surgery, are required to be 
followed per the protocol follow-up schedule. These subjects will be included in all study 
analyses. Any complication leading to a bailout procedure is considered an AE in this study, 
or an SAE based on the seriousness of the event (see Section 12.3.1). 
9.5.8 End of Procedure 
Angiography of the vessel(s) must be performed per angiographic core lab guidelines and in 
the same views that were taken at baseline. FDA-approved/CE-marked closure devices are 

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allowed. The end of the procedure is defined as the time the guide catheter is removed from 
the subject. If the subject is returned to the procedure room and a guiding catheter is reinserted 
and a dilatation is performed, this should be considered a repeat intervention. Please see 
Section 9.8 for Medication Regimen information. 
9.6 Follow-Up Visits 
All follow-up visits in the study will be completed per the schedule of events (See Table 3.) 
including the required exams and assessments at the specified timepoints after the index 
procedure. 
9.6.1 Exceptions for the 12-month and 24-month Follow-up Visits 
If travel restrictions and limitations on personal contact with study subjects are due to the 
Coronavirus pandemic (COVID-19), exceptions will be made to the protocol. This includes a 
telephone call to the study subject instead of an in-office visit at the time of the 12-month 
and/or 24-month follow-up visit.  Mobile duplex ultrasound (DUS) examinations will also be 
available during these visits.  However, efforts should continue to obtain an in-office visit to 
perform all of the protocol-required exams and procedures (See Table 3 Schedule of Events) 
at the earliest opportunity for the investigational site and study subject. 
9.6.2 1-Month Visit (30 Days, -2 to + 15 Days) 
Subjects will be evaluated at 1-month post-procedure (30 days -2 to +15 days) by an office 
visit. Evaluations at 1 month include: 
• Physical exam includes an examination of the access site and the target limb.  
• DUS (the clinical status of the subject should be established prior to performing the 
DUS) 
• CBC; differential is also required if the white blood cell count is NOT within normal 
limits  
• Comprehensive metabolic panel (that includes kidney and liver function tests) 
• Target limb Rutherford Classification 
• Target limb PARC classification 
• WIQ  
• PAQ 
• AE/SAE assessment 
• Current medication regimen including anti-platelet/anti-coagulant, and paclitaxel-
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9.6.3 6-Month Visit (180 Days +/- 30 Days) 
Subjects will be evaluated at 6 months post-procedure (180 days ± 30 days) by an office 
visit. Evaluations at 6 months include: 
• Physical exam includes an examination of the target limb  
• Target limb Rutherford classification 
• Target limb PARC classification 
• Target limb resting ABI or TBI (see section 9.9.4 for details) 
• AE/SAE assessment 
• Current medication regimen including anti-platelet/anti-coagulant, and paclitaxel-
related medications 
9.6.4 12-Month Visit (365 Days +/- 30 Days) 
Subjects will be evaluated at 12 months post-procedure (365 days ± 30 Days) by an office or 
telephone call visit. Office visit evaluations at 12 months include: 
• Physical exam includes an examination of the target limb 
• DUS (the clinical status of the subject should be established prior to performing the 
DUS) 
• Target limb Rutherford classification  
• Target limb PARC classification 
• Target limb resting ABI or TBI (see section 9.9.4 for details) 
• WIQ 
• PAQ 
• 6-MWT 
• AE/SAE assessment 
• Current medication regimen including anti-platelet/anti-coagulant, and paclitaxel-
related medications 
Note: For telephone call visit, see Table 3 for Schedule of Events for exams and 
assessments to be performed. 
9.6.5 24-Month Visit (730 Days +/- 60 Days) 
Subjects will be evaluated at 24 months post-procedure (730 days ± 60 days) by an office or 
telephone call visit. Office visit evaluations at 24 months include: 

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• Physical exam includes an examination of the target limb  
• DUS (the clinical status of the subject should be established prior to performing the 
DUS)  
• Target limb Rutherford classification  
• Target limb PARC classification 
• Target limb resting ABI or TBI (see section 9.9.4 for details) 
• WIQ 
• PAQ 
• 6-MWT 
• AE/SAE assessment* (All AEs and SAEs will be recorded for the entire study period 
to the extent required by national and/or local requirements. For United States sites 
only: After the 12-month follow-up visit, continuing AEs will be followed through to 
resolution or until event becomes stable, and only new SAEs, including Historical 
MAEs, and clinical study endpoints, will be recorded.) 
• Current medication regimen including anti-platelet/anti-coagulant, and paclitaxel-
related medications 
Note: For telephone call visit, see Table 3 for Schedule of Events for exams and 
assessments to be performed. 
9.6.6 36-Month Visit (1095 Days +/-60 Days) 
The 36-month visit may be performed via a telephone call with the subjects. Evaluations at 
36 months post-procedure (1095 days ± 60 days) include: 
• AE/SAE assessment (All AEs and SAEs will be recorded for the entire study period 
to the extent required by national and/or local requirements. For United States sites 
only: After the 12-month follow-up visit, continuing AEs will be followed through to 
resolution or until event becomes stable, and only new SAEs, including Historical 
MAEs, and clinical study endpoints, will be recorded.) 
• Current medication regimen including anti-platelet/anti-coagulant, and paclitaxel-
related medications 
9.6.7 48-Month Visit (1460 Days +/-60 Days) 
The 48-month visit may be performed via a telephone call with the subjects. Evaluations at 
48 months post-procedure (1460 days ± 60 days) include: 
• AE/SAE assessment (All AEs and SAEs will be recorded for the entire study period 
to the extent required by national and/or local requirements. For United States sites 

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only: After the 12-month follow-up visit, continuing AEs will be followed through to 
resolution or until event becomes stable, and only new SAEs, including Historical 
MAEs, and clinical study endpoints, will be recorded.) 
• Current medication regimen including anti-platelet/anti-coagulant, and paclitaxel-
related medications 
9.6.8 60-Month Visit (1825 Days +/-60 Days) 
The 60-month visit may be performed via a telephone call with the subjects. Evaluations at 
60 months post-procedure (1825 days ± 60 days) include: 
• AE/SAE assessment (All AEs and SAEs will be recorded for the entire study period 
to the extent required by national and/or local requirements. For United States sites 
only: After the 12-month follow-up visit, continuing AEs will be followed through to 
resolution or until event becomes stable, and only new SAEs, including Historical 
MAEs, and clinical study endpoints, will be recorded.) 
• Current medication regimen including anti-platelet/anti-coagulant, and paclitaxel-
related medications 
9.7 Unscheduled Visits 
Any visit that is for an ischemic event of the target limb should be classified as an 
unscheduled visit. 
The following assessments should be performed at unscheduled visits: 
• Physical exam (assessment of the target limb).  
• DUS (the clinical status of the subject should be established prior to performing the 
DUS) per core laboratory guidelines. All images should be submitted to the core 
laboratory as soon as possible. 
• Target limb Rutherford classification 
• Target limb PARC classification 
• Target limb resting ABI or TBI 
• WIQ 
• PAQ 
• 6-MWT 
• AE/SAE assessment (All AEs and SAEs will be recorded for the entire study period 
to the extent required by national and/or local requirements. For United States sites 
only: After the 12-month follow-up visit, continuing AEs will be followed through to 

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Glycoprotein IIb/IIIa 
Inhibitor 
At investigator’s discretion. 
Bivaliruden 
At investigator’s discretion. 
Post-
Procedure1 
Acetylsalicylic acid 
(aspirin) 
75-100 mg daily indefinitely. 
Clopidogrel 
 
or 
Prasugrel/Ticagrelor 
75 mg per day for a minimum of 1 month.  
 
For subjects on chronic prasugrel or ticagrelor therapy, 
post-procedure treatment with the same agent (5 mg or 10 
mg prasugrel daily or 90 mg ticagrelor twice daily) is 
allowed for a minimum of 1 month.  
1 In cases where a stent is placed (bailout stenting), please refer to the stent manufacturer’s 
Instructions for Use for dosing instructions 
9.9 Imaging and Other Clinical Assessments  
9.9.1 Angiogram 
All angiograms will be performed per angiographic core lab guidelines. Care should be taken 
to utilize the same angles and views that were assessed at baseline for all subsequent 
assessments. 
9.9.2 Duplex Ultrasound (DUS) 
All DUS will be performed by personnel who have been trained on the protocol and also on 
the DUS core laboratory guidelines. The quality of the DUS images are critical for assessing 
study endpoints. The DUS core laboratory will be monitoring images closely during the 
duration of the study to ensure DUS images are captured correctly.   
9.9.2.1 Mobile Duplex Ultrasound 
If the investigational site is interested in using mobile duplex ultrasound as an option to obtain 
DUS exams for subjects who are not able to attend an in-office visit, a third party mobile 
diagnostic company has been contracted by the sponsor. (United States sites only).  Subjects 
will be reconsented per local IRB requirements prior to obtaining the mobile DUS exam. 
Mobile DUS technicians will be qualified and trained on the study to perform the DUS exams 
according to the imaging protocol.  The DUS exam images and completed worksheets will be 
provided to the specific investigational site and to the DUS Core Lab.  The DUS core lab will 
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9.9.3 Target Limb Rutherford and PARC Evaluations 
Target limb Rutherford classification and target limb PARC classification can be determined 
with or without a treadmill, but at a minimum, each subject should have the evaluations 
performed in the same manner over the course of the entire study. For example, if a treadmill 
is used for the baseline visit Rutherford and PARC evaluations for a subject, a treadmill should 
then be used for all subsequent Rutherford and PARC evaluations for that same subject. 
Exception: When conducting a telephone visit, Target limb Rutherford Classification without 
the use of treadmill may only be performed.  If a treadmill has been previously used in the 
assessment, it must consistently be used throughout the study and therefore would require an 
office visit. 
9.9.4 Ankle Brachial Index 
A resting ABI should be performed on the target limb per hospital standard practice. If an ABI 
cannot be assessed, a TBI can be used. If a TBI is used, future visits will need to have a TBI 
recorded as well. 
9.9.5 6-Minute Walk Test, Walking Impairment Questionnaire, and Peripheral 
Artery Questionnaire 
The 6-MWT, WIQ, and PAQ will be performed for each subject. 
10. Blinding Plan 
In this single-blind study, all randomized subjects will be blinded.  
All core laboratory personnel (DUS, angiogram), all members of the Clinical Events 
Committee (CEC), and a study statistician will be blinded to the subject’s treatment.  
11.  Subject Accountability and Withdrawal 
11.1 Withdrawal  
Subjects have the right to withdraw from the study at any time and for any reason without 
prejudice to their future medical care by the study personnel or institution. If a subject decides 
to withdraw, they will be asked to participate in a limited capacity by allowing their medical 
status to be followed by telephone contact, medical chart review, or by other agreed upon 
method. If a subject decides not to continue participation in a limited capacity, all study tests 
and procedures will be stopped and an inquiry will be made about the cause of withdrawal; 
however, study data collected prior to their withdrawal may be reviewed and publicly available 
records may be consulted prior to or after withdrawal.  

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The investigative site must account for and document all subjects enrolled in the study, 
including those withdrawn from the study or lost to follow-up. All subjects will be encouraged 
to remain in the trial through 60 months. If a subject withdraws from the clinical investigation, 
the reason(s) shall be reported on the eCRF.  
Reasons for withdrawal include, but are not limited to: 
• Subject does not receive a device 
• Physician discretion 
• Subject choice to withdraw consent 
• Loss to follow-up 
• Death 
Randomized subjects who discontinue participation prematurely will be included in the 
analysis of results (as appropriate) but they will not be replaced in the enrollment of total trial 
subjects. Additional study data may no longer be collected after the point at which a subject 
has been withdrawn from the study or withdraws his/her consent. Data collected up to the point 
of subject withdrawal will be used for analysis. If a subject withdraws due to medical safety 
considerations because of an AE, the AE must be followed by medical attention to satisfactory 
resolution and all study data related to the subject will be reported.  
11.2 Loss to Follow-Up 
A subject will not be considered lost to follow-up unless all efforts to obtain compliance are 
unsuccessful. At a minimum, the effort to obtain follow-up information must include 3 
attempts to make contact with the subject (or their legally authorized representative) via 
telephone and if contact via telephone is not successful, a certified letter from the investigator 
must be sent to the subject’s last known address. Should both telephone and mail efforts to 
contact the subject be unsuccessful, the subject’s primary physician should be contacted. All 
contact efforts to obtain follow-up information must be documented in both the subject’s 
medical records and on the eCRFs. Subjects are not eligible to be exited as lost to follow-up 
until after the 12-month follow-up visit. After the 12-month follow-up visit, if a minimum of 
two consecutive study visits have been missed, after making two attempts by phone and one 
by certified mail at each time point, lost to follow-up may be an acceptable reason for exit. 
12. Adverse Events  
Starting at the time of informed consent signing and at each subsequent evaluation (scheduled 
or unscheduled), the investigator will determine if any AEs have occurred in any subject. 
Subjects are encouraged to report AEs freely or in response to general, non-directed 
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the study. If an AE is determined to have occurred, the investigator should obtain all the 
required information and document findings on the eCRF.   
12.1 Adverse Event Definitions 
12.1.1 Adverse Event (AE) 
An AE is defined as any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs in subjects, users or other persons, whether or not related to the 
investigational medical device. 
NOTE 1: This definition includes events related to the investigational medical device
 
 or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: Abnormal laboratory findings will be considered AEs, only if determined 
by the investigator to be clinically significant  
NOTE 4: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
Any current condition that is recorded as a pre-existing condition in the physical examination 
section, unless there is a change in nature, severity, or degree of incidence, is not an AE. 
All AEs will be followed until the event becomes stable or through to resolution, independent 
of duration or follow-up window. 
12.1.2 Serious Adverse Event (SAE) 
A SAE is an AE that leads to: 
1. Death 
2. A serious deterioration in the health of the subject that either resulted in: 
a. life-threatening illness or injury or 
b. a permanent impairment of a body structure or a body function or 
c. in-patient hospitalization or prolongation of existing hospitalization or 
d. medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function  
3. Fetal distress, fetal death, or congenital abnormality or birth defect.   
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol, without serious deterioration in health, is not considered an SAE. A planned 

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hospitalization is one that is scheduled prior to the subject signing the informed consent for 
the study. 
SAEs include device deficiencies that might have led to an SAE if 
a. suitable action had not been taken or 
b. intervention had not been made or  
c. circumstances had been less fortunate. These are handled under the SAE reporting 
system.  
Please note, any investigational device deficiencies must be reported to Baim Institute for 
Clinical Research. 
  
12.1.3 Adverse Device Effect (ADE) 
An adverse device effect (ADE) is an AE that is related to the investigational medical device. 
NOTE 1: This definition includes AEs resulting from insufficiencies or inadequacies 
in the instructions for use, the deployment, the implantation, the installation, the 
operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event that is a result of a use error or from 
intentional abnormal use of the investigational medical device. 
12.1.4 Anticipated Adverse Event 
Any undesirable health related experience occurring to a subject whether or not considered 
related to the investigational product(s) or drug regimen prescribed as part of the clinical 
protocol, predefined in the clinical protocol and/or IFU that is identified or worsens during a 
clinical study. Anticipated AEs are identified in the IFU and can be found in Section 14.2. 
12.1.5 Device Deficiency, Device Malfunction & User Error 
The investigators are instructed to report all device deficiencies, device malfunctions and user 
errors during the study. The following are the descriptions of each instance: 
Device Failure: A device failure occurs when the device is used in compliance with the IFU, 
but does not perform as described in the IFU and also negatively impacts treatment of the study 
subject 
Device Deficiency (ISO14155:2011): Inadequacy of a medical device related to its identity, 
quality, durability, reliability, safety or performance. This may include malfunctions, use error, 
or inadequate labeling. 

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Device Malfunction (ISO 14155:2011): Failure of an investigational medical device to 
perform in accordance with its intended purpose when used in accordance with the IFU or 
clinical study protocol.  
Use Error: Act or omission of an act that results in a different medical device response than 
intended by the manufacturer or expected by the user. 
NOTE 1: Use error includes slips, lapses, and mistakes. 
NOTE 2: An unexpected physiological response of the subject does not in itself constitute 
a use error. 
12.1.6 Serious Adverse Device Effect (SADE) 
An SADE is an ADE that has resulted in any of the consequences characteristic of an SAE.   
12.1.7 Unanticipated Adverse Device Effect (UADE) and Unanticipated Serious 
Adverse Device Effect (USADE) 
12.1.7.1 
UADE per the United States Code of Federal Regulations (CFR) 
Pertinent to investigative sites conducting this study within the United States: An unanticipated 
adverse device effect (UADE) is defined in 21 CFR 812.3(s) as “any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a device, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects.”  
12.1.7.2 
USADE per the International Organization for Standardization (ISO) 
Pertinent to investigative sites conducting this study outside the United States: An 
unanticipated serious adverse device effect (USADE) is defined in ISO14155:2011 3.42 as 
“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. 
12.2 Adverse Event Documentation 
All AEs must be documented on the appropriate eCRF and will be characterized by the 
following criteria: 
• Seriousness 
• Intensity or Severity 

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• Relatedness to device and procedure 
• Outcome 
• Treatment or action taken 
All AEs (serious and non-serious) will be reported for the entire study period to the extent 
required by national and/or local requirements. For United States investigative sites only: After 
the 12-month follow-up visit, continuing AEs will be followed through to resolution or until 
event becomes stable, and only SAEs, including Historical MAEs, and clinical study 
endpoints, will be recorded.  
12.2.1 Intensity or Severity 
The intensity or severity or each AE, as assessed by the investigator, will be recorded using 
the following definitions: 
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 a subject’s usual activity, but the subject is still able to 
function  
Severe 
Events that interrupt a subject’s usual daily activity and generally require a 
systemic drug therapy or other treatment 
12.2.2 Relatedness to Study Device or Procedure  
The investigator will evaluate if the AE or SAE is related to the investigational device or study 
procedure.  The investigator will use the following definitions for this assessment: 
Table 5. Adverse Event Relatedness Categories 
Not Related Relationship to the device or procedures 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 investigational device 
or the procedures; 
• 
the serious 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 serious event; 
• 
 the event involves a body site or an organ not expected to be affected by the 
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• 
the serious 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 investigational 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 serious event. 
Unlikely 
Related 
The relationship with the use of the device 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 investigational device 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. 
Probable 
The relationship with the use of the investigational device seems relevant and/or the 
event cannot reasonably explained by another cause, but additional information may 
be obtained. 
Causal 
Relationship 
The serious event is associated with the investigational device or with procedures 
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 investigational device 
use/application or procedures; 
• 
the event involves a body-site or organ that- 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
• 
the serious 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 serious 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 investigational device used 
for diagnosis, when applicable; 
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 serious event. 

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12.2.3 Outcome/Event Status 
The clinical outcome of the AE or SAE at the time of the last observation will be characterized 
as follows: 
• Recovered/resolved 
• Recovered/resolved with sequelae 
• Ongoing 
• Death 
12.3 Adverse Event Reporting 
12.3.1 Serious Adverse Events 
Reporting of SAEs includes reporting of any SAE, any investigational medical device 
deficiency that might have led to an SAE and any new finding/update in relation to already 
reported events.  
It is the responsibility of each investigator to report all SAEs to the sponsor or its designee 
within 24 hours using the appropriate eCRF, and in accordance with applicable national 
regulations. Report of a subject death must be submitted using the eCRF along with a brief 
statement of the pertinent details, and the death records/certificate or autopsy report, if 
available/performed. Every effort should be made to report the SAEs leading to the subject 
death using the eCRF.  
The Sponsor or its designee will evaluate the SAE for UADE and perform analysis of the event. 
The Sponsor or its designee will prepare the safety documentation to be submitted to 
investigators, National/local regulatory authorities, and IRB/ECs according to national/local 
regulations and IRB/EC requirements.  
12.3.2 Unanticipated Adverse Device Effects 
If a complication occurs that the site investigator believes may be a potential UADE, the site 
should immediately contact the sponsor or its authorized representative to determine reporting 
requirements. In addition, when there is a reason to believe a device may have malfunctioned, 
causing potential harm to a subject, the site should immediately notify the sponsor.  
The site investigator shall submit to the sponsor or its authorized representative a report of any 
UADE occurring during an investigation as soon as possible, but in no event later than 24 hours 
after the Investigator first learns of the effect. All UADEs must be documented by the site 
investigator including the date of onset, a complete description of the event, causality 
assessment, possible reason(s) for the event, severity, duration, actions taken, and outcome. 

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13. Study Committees 
13.1 
Data Monitoring Committee (DMC) 
 
 The Committee will include a biostatistician and physicians 
independent from the trial with expertise in vascular surgery and vascular intervention. 
The DMC will be responsible for monitoring the trial performance and the safety of enrolled 
subjects. Prior to the start of subject enrollment, the Committee will approve a DMC Charter 
and Standard Operating Procedures (SOPs). The Committee will meet on a schedule and with 
a frequency necessary to support the DMC’s safety review function and will review trial 
performance and safety data on a regular schedule and on an as-needed basis if necessary, and 
make any recommendations it thinks appropriate to the Sponsor and to the Steering Committee 
regarding modification or early termination of the trial. All final decisions, however, regarding 
trial modifications, rest with Surmodics, as advised by the Steering Committee. No formal 
statistical rule for stopping the trial will be defined in this trial and no formal interim analysis 
is planned. Meeting outcomes will be documented in the resulting letter of recommendation 
from the DMC, and noted in the IDE annual progress reports. 
13.2 
 Clinical Events Committee (CEC) 
CEC members are chosen based on their clinical expertise and have no association with any 
trial for which they adjudicate events. As appropriate, the CEC is blinded to treatment 
assignment during all deliberations. Three voting members comprise a quorum. This 
committee is comprised of 3-5 physicians with experience in clinical trial event adjudication, 
including physicians with expertise in vascular surgery and/or vascular intervention. 
Committee physicians meet regularly throughout the study to adjudicate events in an ongoing 
fashion. 
 
 CEC review of events will be planned as events 
become available for adjudication. Adjudication results will be available electronically after 
the adjudication is complete. 
As documentation of the CEC meeting and each event under review, the Baim Institute for 
Clinical Research will provide to Surmodics relevant supporting documentation and/or 
adjudication results. 
The CEC will be responsible for adjudicating MAEs (PARC and Historical), specified clinical 
endpoints and determining their device- and procedure-relatedness. Prior to the start of subject 
enrollment, the CEC will approve a charter and criteria for event evaluation. Explicit rules 
outlining the minimum amount of data required, and the algorithm followed to classify study 
endpoint–related clinical events will be established and provided in the charter. 

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13.3 
Steering Committee 
A steering committee will be composed of the study principal investigators, the steering 
committee chairperson, representatives of the sponsor, and may also include other experts. The 
Steering Committee participates in sponsor-requested meetings to review study progress and 
conduct, and to provide feedback to the sponsor on an ad hoc basis. 
13.4 
 Publication Committee 
The publication committee will be defined during the course of the study. Committee 
membership will include representatives of the steering committee. The goal of the committee 
is to ensure that the study results are published. The publication committee is responsible for 
reviewing proposals for publication, overseeing the development of manuscripts and abstracts, 
and identifying and appointing author(s)/writer(s). 
14. Risk Benefit Analysis  
14.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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14.2 
 Potential Risks of SurVeil DCB 
Risks associated with the SurVeil DCB include risks associated with a standard peripheral 
balloon dilatation catheterization procedure. These risks may include, but are not limited to, 
the following: 
Puncture related: 
• Arterio-venous fistula 
• Bleeding 
• Femoral nerve compression with associated neuropathy 
• Groin area bruising and discomfort 
• Local hematoma 
• Local hemorrhage 
• Local infections 
• Local or distal thromboembolic episodes 
• Pseudoaneurysm 
• Total occlusion or thrombosis 
Dilatation related: 
• Acute re-occlusion necessitating surgical intervention 
• Aneurysm or rupture of the artery 
• Dissection in the dilated artery wall 
• Perforation of the artery wall 
• Prolonged spasms 
• Restenosis of the dilated artery 
Angiography related: 
• Allergic reaction to contrast solution 
• Arrhythmias 
• Death 
• Drug reactions 
• Endocarditis 

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• Kidney failure 
• Low blood pressure 
• Pain and tenderness 
• Pyrogenic reaction 
• Respiratory failure 
• Sepsis/infection 
• Short-term hemodynamic deterioration 
• Stroke 
• Systemic embolization 
Potential risks that may be unique to the SurVeil DCB catheter: 
• Allergic/immunologic reaction 
• Alopecia 
• Anemia 
• Gastrointestinal symptoms 
• Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) 
• Hepatic enzyme changes 
• Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis 
• Myalgia/arthralgia 
• Myelosuppression 
• Peripheral neuropathy 
There may be other potential risks that are unforeseen at this time. The occurrence of the above-
listed risks may lead to the need for a repeat procedure, emergency blood vessel surgery, 
amputation or death.  
For more detailed information on the risks of treatment with the SurVeil DCB, including a 
complete list of warnings, precautions and potential AEs, please refer to the IFU, which is 
provided with the product. 
14.3 
 Potential Benefits 
There are no guaranteed benefits from participation in this trial; however, it is possible that 
treatment with the SurVeil DCB may reduce the potential for restenosis of the treated lesion, 
thereby reducing the need for repeat interventions. 

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Moreover, in this clinical investigation all subjects will have a more intense medical follow-
up compared to standard practice, which can be beneficial to the long-term clinical outcome 
of study subjects. 
Additionally, information gained from the conduct of this study may be of benefit to others 
with the same medical condition. Efficacy and safety data collected on the SurVeil DCB will 
contribute to expanding the knowledge of use of DCBs in peripheral interventions. Surmodics 
believes the risk for significant injury or death is low and the potential benefits of decreased 
restenosis and need for re-intervention are likely, but these potential risks and benefits have 
yet to be quantified. 
14.4 
Anticipated Adverse Device Effects 
The anticipated adverse device effects are listed in Section 14.2. These events are typical for 
other commercially available peripheral balloon dilatation devices. 
14.5 
Residual Risk 
There were no intolerable risks remaining in the risk analysis. The remaining risks have been 
mitigated as far as reasonably practicable. 
14.6 
Risks Associated with Participation in the Clinical Trial 
The risks associated with participation in this study will be similar to those associated with use 
of commercially available peripheral balloon dilatation devices. The risks of participation in 
this study will be minimized by careful subject and site selection, as well as by implementing 
monitoring procedures to ensure proper conduct and management of the study. 
Meta-analyses of randomized controlled trials of paclitaxel-coated balloons and paclitaxel-
eluting stents used to treat peripheral arterial disease in the femoropopliteal arteries have 
identified an increased risk of late mortality at 2 years and beyond. The magnitude and 
mechanism for the increased risk in mortality is currently unclear. The analyses also 
demonstrated reduced revascularization rates with the drug-containing products. The impact 
of future device exposure is unknown as is the impact of other drug-containing devices. 
Physicians should discuss the benefits and risks of all available treatment options with 
patients. 
 
14.7 
Possible Interactions with Concomitant Treatments 
Concomitant treatment with this device has not been investigated. Therefore the interaction of 
this device with concomitant treatments remains unknown. 

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14.8 
 Risk Mitigation 
To minimize the potential risks associated with study procedures, all efforts will be made to 
select investigators who are experienced and skilled in using peripheral interventional devices. 
Additionally, at study initiation all investigators will be trained on the SurVeil IFU and the 
protocol. All enrolling investigators will be instructed on appropriate subject selection in an 
effort to minimize the risk of recruiting ineligible subjects to the study. 
Subjects will be monitored closely throughout the study duration and will be evaluated at pre-
specified time points to assess their clinical status. 
14.9 
Risk / Benefit Rationale 
The conclusions from the risk analyses performed on the SurVeil DCB are:  
• The device is appropriate for the intended use. 
• The potential benefits of the device outweigh the risks. 
• All applicable risks have been addressed through appropriate testing and any residual 
risks are acceptable when weighed against the potential benefits to the subject. 
• The use of the device is designed to protect the health and safety of the subject, user, 
and environment.  
15.  Data Collection and Verification 
15.1 
Data Collection, Verification and Retention 
All required data for this trial will be collected on standardized eCRFs. The investigator or 
investigational site will maintain, at the investigative site, in original format, all essential study 
documents and source documentation that support the data collected on the study subjects in 
compliance with International Conference on Harmonization (ICH)/Good Clinical Practice 
(GCP), ISO14155:2011, and any local regulatory guidelines. Sites that are able to send 
complete source documents to the Baim Institute will be encouraged to do so: the EDC system 
allows a direct upload of documentation, which mitigates the site burden and reduces delays. 
This will not replace monitoring visits on site, but can be used to accelerate the review of the 
subject data. 
Documents must be retained for at least 2 years after the last approval of a marketing 
application or until at least 2 years have elapsed since the formal completion of or 
discontinuation of the clinical investigation of the product. These documents will be retained 
for a longer period of time by agreement with Surmodics or in compliance with other local 
regulations. To avoid error, the investigator should contact Surmodics before the destruction 
of any records and reports pertaining to the trial to ensure they no longer need to be retained. 
In addition, Surmodics should be contacted if the investigator plans to leave the investigational 
site so arrangements can be made for the transfer of records. 

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15.2 
Protocol Deviations  
A protocol deviation is defined as any instance during the conduct of the study in which the 
investigator or other site personnel changed or failed to adhere to the study design or 
procedures specified by the protocol. Examples of protocol deviations may include:  
a. enrollment of a study subject who does not meet all of the 
inclusion/exclusion criteria specified in the protocol;  
b. failure to obtain a key safety procedure or lab test; or  
c. enrollment of a patient during a lapse in IRB/EC approval of the study.  
All relevant protocol deviations should be submitted by the site on the applicable eCRF, and 
will be reviewed and assessed for their impact on subject safety by Surmodics or its designee.  
Investigative sites are expected to comply with the study protocol except where necessary to 
protect the life or physical well-being of a subject in an emergency (in cases of medical 
emergency, the Baim Institute for Clinical Research should be notified within 24 hours of the 
occurrence of the event). 
All protocol deviations will be tracked and entered into the EDC system. Surmodics or its 
designee is responsible for assuring the site investigator is aware of all protocol deviations at 
their site, reporting to regulatory agencies as appropriate, and for determining if the trial needs 
to be terminated at a particular site due to the number or type of protocol deviations. 
Investigative sites should report deviations to their IRBs/ECs per their procedures. 
Protocol deviations for inability to perform office visits, exams or procedures due to COVID-
19 pandemic should be completed and a notation of “COVID-19” in the CRF for each 
deviation. 
16. Device Supply and Management 
Tracking of the investigational product used in this study will be consistent with 21 CFR Part 
821 and ISO 14155:2011, and in accordance with location-specific requirements. Devices must 
be stored in a locked location at the investigative site. 
Surmodics will provide the investigational device (SurVeil DCB) to all participating sites. 
Control devices (IN.PACT Admiral DCBs) will not be provided by the study; sites should use 
their own inventory in this case. 
Device management will be captured through EDC and on the device accountability log. The 
site will record device usage in the EDC as soon as possible after opening any DCB (both test 
and control devices) used in this study, including the description and the dimensions of the 
device. If a SurVeil DCB is opened but not used, or if a device deficiency or malfunction 
occurs during its use, it must be returned to Surmodics or its designee in accordance with the 
packaging and shipping instructions.  

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Based on pre-specified thresholds, resupply of study device will be triggered electronically.    
17.  Statistical Methods 
The proposed study is a prospective, multi-center, randomized, controlled trial designed to 
assess the noninferiority of the SurVeil DCB in the treatment of subjects with stenotic lesions 
of the femoropopliteal artery, compared to the IN.PACT Admiral DCB, with respect to the 
primary efficacy endpoint of 12-month primary patency, defined as freedom from clinically-
driven TLR and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as 
assessed by independent angiographic and DUS core labs), and with respect to the primary 
safety endpoint, defined as a composite of freedom from device- and procedure-related death 
through 30 days post-index procedure and freedom from major target limb amputation (above 
the ankle) and clinically-driven TVR through 12 months post-index procedure.  The study will 
be deemed a success if at a minimum the hypotheses of inferiority of the safety and efficacy 
of the SurVeil DCB are rejected. The proportions of subjects meeting the primary efficacy and 
safety endpoints at 12-months post-index procedure and the confidence intervals of these rates 
in each group will be reported. 
The main analysis of primary efficacy and safety endpoints will be based on multiple 
imputation.  Details on the imputation model will be included in the Statistical Analysis Plan 
(SAP). 
17.1 
Assessment of Primary Efficacy Endpoint 
The primary efficacy endpoint is primary patency, defined as a composite of freedom from 
clinically-driven TLR and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% 
stenosis as assessed by independent angiographic and DUS core labs) and through 12 months 
post-index procedure. In cases when there is a discrepancy between angiographic and DUS 
assessment of patency, angiographic assessment takes precedence. The primary efficacy 
objective will be assessed through testing the following hypotheses: 
𝑯𝑯𝟎𝟎: The proportion of subjects who meet the efficacy endpoint in the SurVeil DCB group 
through 12 months post-index procedure is clinically inferior to the proportion of subjects who 
meet the efficacy endpoint in the IN.PACT Admiral DCB group  
𝐻𝐻0: 𝑝𝑝𝑆𝑆
Eff – 𝑝𝑝𝑀𝑀
Eff ≤−𝛿𝛿Eff  
𝑯𝑯𝟏𝟏: The proportion of subjects who meet the efficacy endpoint in the SurVeil DCB group 
through 12 months post-index procedure is clinically noninferior to the proportion of subjects 
who meet the efficacy endpoint in the IN.PACT Admiral DCB group 
𝐻𝐻1: 𝑝𝑝𝑆𝑆
Eff – 𝑝𝑝𝑀𝑀
Eff > −𝛿𝛿Eff 
where 𝑝𝑝𝑆𝑆
Effand 𝑝𝑝𝑀𝑀
Effare the 12-month primary patency rates in the SurVeil DCB group and 
comparator IN.PACT Admiral DCB group, respectively, and 𝛿𝛿Eff is the noninferiority margin. 

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Statistical analyses for the primary efficacy endpoint will be conducted using a Farrington & 
Manning test for noninferiority of proportions. The SurVeil DCB will be declared noninferior 
to IN.PACT Admiral DCB with respect to the efficacy endpoint if the null hypothesis of 
inferiority is rejected at a one-sided significance level of 2.5%. Subsequently, if the null 
hypothesis of inferiority is rejected, a statistical test for superiority  
𝐻𝐻0: 𝑝𝑝𝑆𝑆
Eff – 𝑝𝑝𝑀𝑀
Eff ≤0 
𝐻𝐻1: 𝑝𝑝𝑆𝑆
Eff – 𝑝𝑝𝑀𝑀
Eff > 0 
at the one-sided 2.5% will be conducted. If the superiority hypothesis is also met, the Surveil 
DCB will be declared superior to IN.PACT Admiral DCB with respect to the efficacy endpoint. 
The main analysis will be carried out using the Intention-To-Treat (ITT) analysis set. In 
addition to the main ITT analysis, supportive analyses will also be carried out using the As 
Treated (AT) and Per-Protocol (PP) analysis sets. 
17.1.1 Primary Patency Rates and Noninferiority Margin  
The FDA-approved/CE marked Medtronic IN.PACT Admiral DCB will be used as the 
comparator for the SurVeil DCB. In the Medtronic Premarket Approval (PMA) study, the 12-
month primary patency rates were 82.2% and 52.4% in the IN.PACT Admiral DCB and PTA 
groups,40 respectively. The observed difference in the 12-month primary patency rates between 
the IN.PACT Admiral DCB and PTA groups was 29.8%. Based on 50% of the difference in 
primary patency between IN.PACT Admiral DCB and PTA, a noninferiority margin of 15.0% 
is clinically justified as it preserves the 50% of the treatment effect between DCB and PTA.  
17.1.2 Sample Size Calculations 
The assumptions for this analysis are: 
• True 12-month primary patency rate is 82.2% in both treatment groups 
• 1:1 randomization of SurVeil DCB vs. IN.PACT Admiral DCB  
• 15.0% is the absolute noninferiority margin (50% of the difference in primary 
patency rate between IN.PACT Admiral DCB and PTA)  
• Statistical analysis will be conducted using a Farrington & Manning test for 
noninferiority of proportions; the test will be a one-sided test at 𝛼𝛼=0.025  
• Sample Size: N=400 (200 in the SurVeil DCB group and 200 in the IN.PACT 
Admiral DCB group) evaluable subjects or 446 (223 in the SurVeil DCB group and 
223 in the IN.PACT Admiral DCB group) randomized subjects to account for an 
assumed 10% loss to follow-up 
Under these assumptions, the power is at least 97.5%. If the true primary patency rates are 
82.2% in the IN.PACT Admiral DCB group and 78.3% or higher in the SurVeil DCB group, 

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at least 80% power will still be preserved at the planned sample size. Power calculations were 
performed with SAS software, version 9.3 (SAS Institute, Cary, NC). 
 
Sample Size Calculation Assuming a One-sided 2.5% Type I Error Bound 
Comparator 
Non-
inferiority 
Margin 
Sample Size 
Patency Rate 
Power 
Evaluable 
Enrolled* 
SurVeil 
IN.PACT 
Total SurVeil IN.PACT Total SurVeil IN.PACT 
IN.PACT 
Admiral,  
1:1 
Randomiza-
tion 
15.0% ** 
400 
200 
200 
446 
223 
223 
82.2% 
82.2% 
97.5% 
80.0% 
82.2% 
90.0% 
78.3% 
82.2% 
80.0% 
* Enrolled sample size assumes 10% loss to follow-up at 12 months.  
** The 15.0% margin is 50% of the difference between Medtronic IN.PACT Admiral DCB and PTA patency 
rates. 
17.2 
Assessment of the Primary Safety Endpoint 
The primary safety endpoint is a composite of freedom from device- and procedure-related 
death through 30 days post-index procedure and freedom from major target limb amputation 
and clinically-driven TVR through 12 months post-index procedure.  
The primary safety objective will be assessed through testing the following hypotheses: 
𝑯𝑯𝟎𝟎: The proportion of subjects who meet the safety endpoint in the SurVeil DCB group 
through 12 months post-index procedure is inferior to the proportion of subjects who meet the 
safety endpoint in the IN.PACT Admiral DCB group  
𝐻𝐻0: 𝑝𝑝𝑆𝑆
Saf – 𝑝𝑝𝑀𝑀
Saf ≤−𝛿𝛿Saf 
𝑯𝑯𝟏𝟏: The proportion of subjects who meet the safety endpoint in the SurVeil DCB group 
through 12 months post-index procedure is clinically noninferior to the proportion of subjects 
who meet the safety endpoint in the IN.PACT Admiral DCB group 
𝐻𝐻1: 𝑝𝑝𝑆𝑆
Saf – 𝑝𝑝𝑀𝑀
Saf > −𝛿𝛿Saf 
where 𝑝𝑝𝑆𝑆
Saf and 𝑝𝑝𝑀𝑀
Saf are the 12-month primary safety rates in the SurVeil DCB group and 
comparator IN.PACT Admiral DCB group, respectively, and 𝛿𝛿Saf is the noninferiority margin. 
Statistical analyses for the primary safety endpoint will be conducted using a Farrington & 
Manning test for noninferiority of proportions. The SurVeil DCB will be declared noninferior 
to IN.PACT Admiral DCB with respect to safety endpoint if the null hypothesis of inferiority 
is rejected at a one sided significance level of 2.5%.  
Subsequently, if the null hypothesis of inferiority is rejected, a statistical test for superiority  
𝐻𝐻0: 𝑝𝑝𝑆𝑆
Saf – 𝑝𝑝𝑀𝑀
Saf ≤0 

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𝐻𝐻1: 𝑝𝑝𝑆𝑆
Saf – 𝑝𝑝𝑀𝑀
Saf > 0 
at the one-sided 2.5% will be conducted. If the superiority hypothesis is also met, the Surveil 
DCB will be declared superior to IN.PACT Admiral DCB with respect to the safety endpoint. 
The main analysis will be carried out using the ITT analysis set. In addition to the main ITT 
analysis, supportive analyses will also be carried out using the AT and PP analysis sets. 
17.2.1 Primary Safety Endpoint Rates and Noninferiority Margin 
The FDA-approved/CE marked Medtronic IN.PACT Admiral DCB will be used as the 
comparator for the SurVeil DCB. In the primary publication of the IN.PACT SFA trial, the 
primary safety rates were 95.7% and 76.6% in the IN.PACT Admiral DCB and PTA groups, 
respectively.40 The observed difference in primary safety endpoint rates between the IN.PACT 
Admiral DCB and PTA groups was 19.1%. Based on 50% of the difference in primary safety 
endpoint between IN.PACT Admiral DCB and PTA, a noninferiority margin of 10.0% is 
clinically justified, as it preserves the 50% of the treatment effect between the DCB and PTA. 
This is the same noninferiority margin utilized in the IN.PACT SFA study.  
17.2.2 Sample Size Calculations 
The assumptions for this analysis are: 
• True 12-month primary safety endpoint rate is 95.7% in both treatment groups 
• 1:1 randomization of SurVeil DCB vs. IN.PACT Admiral DCB  
• 10.0% is the absolute noninferiority margin (50% of the difference in primary safety 
endpoint rate between IN.PACT Admiral DCB and PTA)  
• Statistical analysis will be conducted using a Farrington & Manning test for 
noninferiority of proportions; the test will be a one-sided test at 𝛼𝛼=0.025  
• Sample Size: N=400 (200 in the SurVeil DCB group and 200 in the IN.PACT 
Admiral DCB group) evaluable subjects or 446 (223 in the SurVeil DCB group and 
223 in the IN.PACT Admiral DCB group) randomized subjects to account for an 
assumed 10% loss to follow-up 
Under these assumptions, the power is at > 99%. If the true primary safety endpoint rates are 
95.7% in the IN.PACT Admiral DCB group and 92.7% or higher in the SurVeil DCB group, 
at least 80% power will be preserved at the planned sample size. Power calculations were 
performed with SAS software, version 9.3 (SAS Institute, Cary, NC). 
Sample Size Calculation Assuming a One-Sided 2.5% Type I Error Bound 
Comparator 
Non-
Inferiority 
Margin 
Sample Size 
Primary Safety Rate Power 
Evaluable 
Enrolled* 
SurVeil 
IN.PACT 
Total SurVeil IN.PACT Total SurVeil IN.PACT 
IN.PACT 
Admiral,  
10.0% ** 
400 
200 
200 
446 
223 
223 
95.7% 
95.7% 
99.5% 
93.6% 
95.7% 
90.0% 

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1:1 
Randomiza-
tion 
92.7% 
95.7% 
80.0% 
* Enrolled sample size assumes 10% loss to follow-up at 12 months.  
** The 10.0% margin is 50% of the difference between Medtronic IN.PACT Admiral DCB and PTA primary 
safety endpoint rates. 
17.3 
Handling of Missing Data in the Analysis of Primary Efficacy and Safety 
Endpoints 
Every effort will be undertaken to limit premature discontinuations and ascertain completeness 
of data collection. The reasons for missing data will be described in detail and evaluated for 
assessment of possible bias. The missing data is expected to be <10% at 12 months.  
 To assess the effect of missing data on the results of the primary efficacy and safety endpoints, 
a series of sensitivity analyses will be carried out.   
First, a tipping point analysis will be carried out. For the primary efficacy endpoint, it is 
assumed that for all IN.PACT Admiral DCB subjects with missing primary patency status, the 
loss of primary patency did not occur. For SurVeil DCB subjects with missing data, it will be 
first assumed that the loss of primary patency occurred for exactly one such subject; then the 
primary analyses will be re-run to assess if noninferiority is met under this assumption. Then 
it will be assumed the primary patency loss occurred for exactly two SurVeil DCB subjects 
with missing data, and the primary noninferiority analysis will be rerun. The process will 
continue sequentially in this manner until all SurVeil DCB subjects with missing data are 
considered to have lost primary patency. Of interest is the “tipping point”, or i.e., the number 
of imputed SurVeil DCB subjects not meeting primary patency where noninferiority is not met 
in this analysis. A similar analysis will be carried out for the primary safety endpoint. 
Second, a sensitivity analysis of the primary efficacy and safety endpoints will be carried out 
using Cox regression. In this analyses, study discontinuation before an event will be treated as 
a censored observation at the time of dropout. 
17.4 
Assessment of Secondary Endpoints 
The main analysis of the secondary endpoints will be carried out using the ITT analysis set. In 
addition to the main ITT analysis, supportive analyses will also be carried out using the AT 
and PP analysis sets. 
Primary patency through 24 months will be compared between treatments only if both the 
primary safety and efficacy hypotheses of noninferiority are met. This hierarchical testing 
scheme ensures that the study-wide Type I error rate is 0.025 (one-sided) when the key 
secondary endpoint is tested at one-sided α=0.025. 
The objective is to assess whether the primary patency rate of subjects in the SurVeil DCB 
group is noninferior to that of the IN.PACT DCB group: 

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𝑯𝑯𝟎𝟎: The proportion of subjects with primary patency in the SurVeil DCB group through 24 
months is clinically inferior to that of the IN.PACT DCB group. 
𝑯𝑯𝟏𝟏: The proportion of subjects with primary patency in the SurVeil DCB group through 24 
months is clinically noninferior to that of the IN.PACT DCB group. 
The Farrington and Manning test for noninferiority of proportions at a one-sided significance 
level of α=0.025 will be used to test the hypothesis. The primary patency rate at 24 months, 
along with the 95% confidence intervals of these rates in each group, will be reported. If 
noninferiority is demonstrated for the 24-month patency rates between the SurVeil DCB and 
IN.PACT Admiral DCB groups, a test of superiority of the SurVeil DCB compared to the 
IN.PACT Admiral DCB will be conducted. 
In the Medtronic Premarket Approval (PMA) study, the 24-month primary patency rates were 
78.9% and 50.1% in the IN.PACT Admiral DCB and PTA groups,41 respectively, with an 
observed difference of 28.8%. Thus, a noninferiority margin of 15.0% is clinically justified, as 
it preserves ~50% of the treatment effect between DCB and PTA at 2 years.   
Descriptive analysis of the following additional Secondary Endpoints will be performed, 
comparing the two treatment groups. 
17.4.1 Secondary Endpoints (Acute) 
• Device Success: defined as successful delivery, balloon inflation, deflation and retrieval 
of the intact study device without burst below rated burst pressure, and achievement of 
<50% residual stenosis of the target lesion (by core lab-assessed QA) without flow-
limiting arterial dissection, using only the study device. 
• Technical Success: defined as achievement of a final residual diameter stenosis of <50% 
without flow-limiting arterial dissection at the end of the procedure. 
• Procedure Success: defined as evidence of both acute technical success and absence of 
PARC MAEs (e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, 
index bypass graft or treated segment thrombosis, and or need for urgent/ emergent 
vascular surgery) within 72 hours of the index procedure. 
• Freedom from all-cause death, major target limb amputation and TVR through 30 days. 
The incidence estimates for each endpoint above will be reported along with a 95% confidence 
interval for the SurVeil and the IN.PACT Admiral groups. Fisher’s exact test at a two-sided 
significance level of 0.05 will be used to compare the results between the SurVeil and 
IN.PACT Admiral groups. 

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17.4.2 Secondary Endpoints (Through 60 Months Follow-Up) 
In addition to primary patency through 24 months, as listed above, other secondary endpoints 
through follow-up include: 
• Target vessel patency, defined as freedom from clinically-driven TVR and freedom 
from binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as 
assessed by independent angiographic and DUS core labs), within 12 and 24 months (In 
cases when there is a discrepancy between angiographic and DUS assessment of 
patency, angiographic assessment takes precedence.) 
• Sustained clinical improvement, defined as freedom from major target limb amputation, 
TVR and worsening target limb Rutherford class, within 6, 12, and 24 months 
• Clinically-driven TLR, within 6, 12, 24, 36, 48, and 60 months 
• Historical MAEs, defined as composite of all-cause death, clinically-driven TLR, major 
target limb amputation, or thrombosis at the target lesion, within 6, 12, 24, 36, 48, and 
60 months 
• Major target-limb amputation, within 6, 12, 24, 36, 48, and 60 months 
• Thrombosis at the target lesion, within 6, 12, 24, 36, 48, and 60 months 
The incidence estimates for each endpoint above will be reported along with a 95% 
confidence interval for the SurVeil and the IN.PACT Admiral groups at the specified time 
points. Fisher’s exact test at a two-sided significance level of 0.05 will be used to compare 
the incidence of each endpoint between the SurVeil and IN.PACT Admiral groups at each 
specified time point. In addition, Kaplan-Meier estimates will be provided at 6, 12, and 24 
months, unless otherwise indicated: 
• Change in target limb Rutherford class from baseline to 1, 6, 12, and 24 months 
• Change in target limb PARC class from baseline to 1, 6, 12, and 24 months 
• Decrease in resting target limb ABI or TBI ≥0.15 from baseline to 6, 12, and 24 months 
• Change in WIQ score from baseline to 1, 12, and 24 months 
• Change in 6-MWT from baseline to 12 and 24 months 
• Change in PAQ from baseline to 1, 12, and 24 months 
Descriptive statistics (means, standard deviations and 95% confidence intervals) for each of 
the above endpoints will be reported in each treatment group and at the specified time points. 
The differences between the Surveil DCB and the IN.PACT Admiral DCB in the above 
endpoints at the specified time points will be evaluated using a two-sample t-test or the 
nonparametric Wilcoxon rank-sum test at a two-sided significance level of 0.05. 

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17.5 
Study Populations 
The study will use the following analysis data sets: 
Screen Failure Analysis Population 
The Screen Failure analysis set is defined as all subjects who were enrolled but not randomized.  
Intention-to-Treat (ITT) Analysis Population 
The ITT analysis set will comprise all subjects who were randomized. Subjects will be 
analyzed according to their randomized group assignment. The ITT analysis set will be used 
for the primary efficacy and safety analyses.  
As Treated (AT) Analysis Population 
The AT analysis set will include only those subjects treated with either an investigational or 
control device, and the comparison will be based on the actual device used, not the randomized 
assignment. The AT analysis set will be used for sensitivity and supporting analyses for the 
primary safety and efficacy analyses.  
Per-Protocol (PP) Population 
The PP analysis set is defined as all randomized subjects who were treated with the assigned 
study balloon, who have sufficient follow-up data (at least 335 days of follow-up or 
experienced the primary endpoint), and who had no major protocol eligibility violations (i.e. 
inclusion/exclusion criteria violations that could impact the primary endpoint). Subjects will 
be compared based on the actual device used. The PP analysis set will be used for sensitivity 
and supporting analyses for the primary safety and efficacy analyses.   
17.6 
Subgroup Analysis 
The following subgroups will be analyzed, in order to assess for heterogeneity of clinical 
endpoints: 
• 
Age 
• 
Smokers vs. non-smokers 
• 
Females vs. males 
• 
Subjects with diabetes mellitus vs. subjects without diabetes mellitus 
• 
Lesion length ≤90 mm vs. >90 mm in length  
• 
Calcified vs. non-calcified lesions 
• 
De novo vs. restenotic lesions 
• 
Subjects with bailout stenting vs. subjects without bailout stenting 
The treatment group difference (SurVeil DCB vs. IN.PACT Admiral DCB) in the primary 
endpoint rate and the two-sided 95% confidence interval of the difference will be presented 
within each subgroup. A test of interaction on the primary endpoint will be performed using 
logistic regression models with the effects of subgroup, randomized treatment, and randomized 

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treatment-by-subgroup interaction to formally assess heterogeneity of treatment effect on the 
primary endpoint across subgroups. An interaction p-value <0.15 will indicate a potential 
differential effect of treatment across the subgroup; the nature of any such effect (e.g., 
quantitative vs. qualitative) will further be investigated by inspecting the treatment differences 
within the relevant subgroups. The purpose of this analysis is not to formally assess 
noninferiority within each subgroup, but simply to assess consistency of results across the 
various subgroups.  Subjects with an event or with appropriate follow-up will be included in 
this analysis. 
17.7 
Poolability of Data Across Sites and Regions (United States vs. Outside the United 
States)  
In evaluating the center treatment effect heterogeneity, centers with 9 or fewer subjects  
randomized will be combined by geographic region into aggregate sites, not to exceed 20 
subjects per aggregate site. Logistic regression will be employed, with treatment, site, and the 
interaction of treatment and site as covariates. Statistical significance (0.15 level) of the 
interaction term will indicate that the observed effects are not homogeneous across sites.  
Since the study plans to recruit patients from the United States as well as from outside the 
United States, a poolability analysis will be conducted to determine if data from these two 
regions are poolable. For both the primary and safety endpoints, a logistic regression with 
treatment, region (United States vs. non- United States) and their interaction as covariates will 
be employed. Statistical significance (0.15 level) of the interaction term will indicate that the 
observed effects are not homogeneous between the two regions and may potentially negate 
poolability of the two regions for the primary analysis or may require assessment of the 
endpoint rate adjusting for region variability. In that case, further inspection of the “by-region” 
primary endpoint rates and possible discussion with the FDA will determine if regions may 
still be pooled for the primary analysis and if adjustment for region variability is required (for 
example, if it is agreed between the sponsor and the FDA that the statistically significant region 
effect is not clinically meaningful, it is possible that the regions may still be pooled for the 
primary endpoint analysis, and without adjustment for region variability). 
17.8 
Assessment of Adverse Events 
Descriptive statistics will be used to identify the frequencies and 95% confidence intervals of 
AEs in each treatment group. Fisher’s exact tests at a two-sided significance level of 0.05 will 
be used to compare the AEs proportions. 

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18.  Regulatory Compliance  
18.1 
Statement of Compliance  
This study will be conducted in accordance with applicable regulations and/or guidance per 
country or region including ISO 14155:2011 Clinical Investigation of Medical Devices for 
Human Subjects, Good Clinical Practice, the relevant parts of the ICH Guidelines for GCP, 
ethical principles that have their origins in the Declaration of Helsinki, and pertinent individual 
country laws and regulations. The study shall not begin until the required approval/favorable 
opinion from the IRB/EC and/or regulatory authority has been obtained, if appropriate. Any 
additional requirements imposed by the IRB/EC or regulatory authority shall be followed, if 
appropriate. 
18.2 
Investigator Responsibilities 
The role of the site investigator is to implement and manage the day-to-day conduct of the 
clinical investigation as well as ensure data integrity and the rights, safety and well-being of 
the subjects involved in the clinical investigation. The principal investigator of an 
investigational site is responsible for ensuring that the study is conducted in accordance with 
the Clinical Study Agreement, the investigational plan/protocol, ISO 14155:2011, ethical 
principles that have their origins in the Declaration of Helsinki, any conditions of approval 
imposed by the reviewing IRB/EC, and prevailing local and/or country laws and/or regulations, 
whichever affords the greater protection to the subject. 
18.2.1 Investigator 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.  
18.3 
Sponsor Responsibilities 
Surmodics, the sponsor, has the overall responsibility for the conduct of the study, including 
assurance that the study meets and is conducted within the regulatory requirements specified 
by each reviewing regulatory authority. In this study, the Surmodics will have certain direct 
responsibilities and will delegate other responsibilities to designees such as the Baim Institute 
for Clinical Research and core laboratories. Surmodics and its designees will ensure adherence 
to requirements regarding sponsor general duties, selection of investigators, monitoring, 
supplemental applications, maintaining records and submitting reports.  

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18.4 
Institutional Review Board/Ethics Committee 
The investigational site will provide to the sponsor documentation verifying that their IRB/EC 
is registered or that registration has been submitted to the appropriate agency, as applicable 
according to national/regulatory requirements.   
A copy of the written IRB/EC and/or competent authority approval of the protocol and 
informed consent form, must be received by the sponsor before recruitment of subjects into 
the study and shipment of investigational product/equipment. Prior approval must also be 
obtained for other materials related to subject recruitment or which will be provided to the 
subject. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the study 
as required by local/country or IRB/EC requirements. Copies of the investigator’s reports and 
the IRB/EC continuance of approval must be provided to the sponsor.  
18.5 
Study Amendments 
All changes to the protocol must be documented in the format of an amendment with 
justification statements. All amendments must be submitted to the IRB/EC and regulatory 
authority for review and approval. Following approval, the protocol amendment will be 
distributed to all protocol recipients at the study site. 
18.6 
Informed Consent 
Written informed consent is required from all subjects or their legally authorized 
representative. The investigator is responsible for ensuring that informed consent is obtained 
prior to the use of any investigational devices or study-required procedures and/or testing that 
is outside of standard of care. A copy of the consent form must be forwarded to Surmodics or 
their designee for review and approval prior to submitting to the IRB/EC.   
The obtaining and documentation of informed consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155:2011, any applicable national regulations, 
and local EC and/or Regulatory authority body, as applicable. The informed consent must be 
approved by Surmodics or its designee, the investigative site’s IRB/EC, or central IRB, if 
applicable, prior to study use. 
Failure to obtain subject consent will be reported to the applicable regulatory body per their 
requirements (e.g., FDA requirement is within 5 business days of learning of such an event). 
Any violations of the informed consent process must be reported as deviations to the sponsor 
and national/local regulatory authorities (e.g. IRB/EC), as appropriate. 

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18.7 
Subject Confidentiality 
Subject confidentiality will be maintained throughout the study in a way that assures that data 
can always be tracked back to the source data. For this purpose, a unique subject identification 
code (identification number and subject name code) will be used that allows identification of 
all data reported for each subject. 
Data relating to the study might be made available to third parties (for example in case of an 
audit performed by regulatory authorities) provided the data are treated as confidential and that 
the subject’s privacy is guaranteed. 
For investigative sites within the United States, “Protected Health Information” will be treated 
and maintained in compliance with the Health Insurance Portability and Accountability Act of 
1996 (HIPAA) Privacy rule. For investigative sites within the European Union, data protection 
for individuals will be maintained in compliance with the Directive 95/46/EC, and as of 
25MAY2018, in compliance with the General Data Protection Regulation (Regulation 
2016/679), with regard to the processing of personal data and on the free movement of such 
data. 
The duration of storage time of personal data at the investigational sites will be in accordance 
with national regulations (see Section 15.1). 
18.8 
Use of Electronic Signatures 
The Sponsor will be responsible for certification to the FDA that electronic signatures in their 
system are intended to be the legally binding equivalent of traditional handwritten signatures, 
as specified in 21 CFR, Part 11.100 (c). 
18.9 
Site Monitoring 
Qualified monitors from Surmodics or designee will conduct on-site and remote monitoring 
visits to ensure that all investigators conduct the study in compliance with the protocol and the 
investigators’ agreements. The site will receive notification prior to each monitoring visit 
during the course of the study. The investigator and/or sub-investigator and other appropriately 
trained study staff are expected to be available on the day of the visit in case any questions 
might arise.  
The progress of the study will be monitored by:  
• Ensuring the completed eCRF matches source documents, and resolution of any 
discrepancies. Direct access to complete source documents and medical records, 
including electronic medical records, must be made available during monitoring visits 
for verification of eCRF data. Source documents will be reviewed to verify the data 
recorded on the eCRF, including AE data, based on the study-specific monitoring 
plan.  

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• Periodic on-site visits and remote monitoring of data will be done based on the study-
specific monitoring plan. 
• Frequent telephone or email communications between the investigator/site and the 
assigned site monitors.  
Periodic on-site and remote monitoring visits will be made in accordance with the approved 
monitoring plan at all active study sites throughout the clinical study to assure that the 
investigator’s obligations are fulfilled and all applicable regulations and guidelines are being 
followed. These visits will ensure that the facilities are still acceptable, the protocol and 
investigational plan are being followed, the IRB/EC has been notified of approved protocol 
changes as required, complete records are being maintained, appropriate and timely reports 
have been made to the sponsor and the IRB, device and device inventory are controlled, and 
the investigator is properly executing all agreed activities. Additional detail will be provided 
in the study Monitoring Plan.   
Surmodics and designee will evaluate circumstances where an investigator deviates from the 
clinical protocol. Surmodics or its designees retain the right to remove either the investigator 
or the investigational site from the study for issues of non-compliance with the protocol or 
regulatory requirements. Surmodics or designee will perform the monitoring responsibilities 
per their SOPs.  
On one or more occasions, the investigative site may be inspected or audited by Surmodics, its 
designee, or a third party such as a regulatory agency. The investigator will be informed in 
advance of this visit.  
A representative or designee of Surmodics may accompany the monitor to the site. 
19 Suspension, Termination, and Close-Out 
19.1 
Procedure for Suspension or Early Termination 
The sponsor may suspend or prematurely terminate either this clinical investigation in an 
individual investigation site or the entire clinical investigation. 
A site investigator, IRB/EC, or regulatory authority may suspend or prematurely terminate 
participation in this clinical investigation at the investigational sites for which they are 
responsible. 
If suspicion of an unacceptable risk to subjects arises during the clinical investigation, or when 
so instructed by the EC or regulatory authorities, the sponsor will suspend the clinical 
investigation while the risk is assessed. The sponsor will terminate the clinical investigation if 
an unacceptable risk is confirmed. 

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The sponsor will consider terminating or suspending the participation of a particular 
investigational site or investigator if monitoring or auditing identifies serious or repeated 
deviations on the part of an investigator. 
If suspension or premature termination occurs, the terminating party will justify its decision in 
writing and promptly inform the other parties with whom they are in direct communication.  
If suspension or premature termination occurs: 
• The sponsor will remain responsible for providing resources to fulfill the 
obligations from this protocol and existing agreements for following the subjects 
enrolled in the clinical investigation, and 
• The site investigator or authorized designee will promptly inform the enrolled 
subjects at his/her investigation site 
If the trial is terminated, Surmodics must comply with all applicable government regulations 
and the protocol-required subject follow-up. Should discontinuation of the study occur, the 
investigator must return all clinical study materials (including devices) to the Sponsor, and 
provide a written statement to the IRB/EC explaining the reasons for the premature 
termination. All applicable clinical investigation documents shall be subject to the same 
retention policies, as detailed in Section 15.1. 
19.2 
Procedure for Resuming the Clinical Investigation After Temporary Suspension 
When the sponsor concludes an analysis of the reason(s) for the suspension, implements the 
necessary corrective actions, and decides to lift the temporary suspension, the sponsor will 
inform the relevant parties of the rationale and provide them with the relevant data supporting 
this decision. 
Concurrence will be obtained from the IRBs/ECs and, where appropriate, regulatory 
authorities before the clinical investigation resumes. 
If subjects have been informed of the suspension, the site investigator or authorized designee 
will inform them of the reasons for resumption. 
19.3 
Routine Close-Out 
Routine close-out activities will be conducted to ensure that the site investigator's records are 
complete, all documents needed for the sponsor's files are retrieved, remaining clinical 
investigation materials are disposed of, previously identified issues have been resolved, and all 
parties are notified. 

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20 Publication Policy 
The Sponsor acknowledges the importance of publication of information collected or generated 
by the trial. Publications will be in accordance with international recognized scientific and 
ethical standards concerning publications and authorship, including the Uniform Requirements 
for Manuscripts Submitted to Biomedical Journals, established by the International Committee 
of Medical Journal Editors (ICMJE).  
The Sponsor will establish a publication committee (as described in Section 13.4) and the 
committee membership may include the Principal Investigator, other Investigators from the 
study, and representatives of Surmodics, Inc. (e.g. statistician, clinical research specialist, etc.). 
The committee will establish a publication strategy.  
 

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21 References  
1. 
Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice Guidelines for the 
management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, 
and abdominal aortic): a collaborative report from the American Association for Vascular 
Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and 
Interventions, Society for Vascular Medicine and Biology, Society of Interventional 
Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to 
Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): 
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National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-
Society Consensus; and Vascular Disease Foundation. Circulation 2006;113:e463-654. 
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Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics--2013 
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Murabito JM, Evans JC, D'Agostino RB, Sr., Wilson PW, Kannel WB. Temporal 
trends in the incidence of intermittent claudication from 1950 to 1999. Am J Epidemiol 
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Murabito JM, D'Agostino RB, Silbershatz H, Wilson WF. Intermittent claudication. 
A risk profile from The Framingham Heart Study. Circulation 1997;96:44-9. 
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Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter-
Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc 
Surg 2007;45 Suppl S:S5-67. 
6. 
Murphy TP, Ariaratnam NS, Carney WI, Jr., et al. Aortoiliac insufficiency: long-term 
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McDermott MM, Guralnik JM, Ferrucci L, et al. Asymptomatic peripheral arterial 
disease is associated with more adverse lower extremity characteristics than intermittent 
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8. 
Bradbury A. In: BASIL Investigators’ Meeting Vascular Society. 
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Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe 
ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 
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Conte MS. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) and 
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Slovut DP, Lipsitz EC. Surgical technique and peripheral artery disease. Circulation 
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Nicoloff AD, Taylor LM, McLafferty RB, Moneta GL, Porter JM. Patient recovery 
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2011 ACCF/AHA Focused Update of the Guideline for the Management of patients 
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15. 
Tendera M, Aboyans V, Bartelink ML, et al. ESC Guidelines on the diagnosis and 
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extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the 
Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European 
Society of Cardiology (ESC). Eur Heart J 2011;32:2851-906. 
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Sarode K, Spelber DA, Bhatt DL, et al. Drug delivering technology for endovascular 
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Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G, Viva Physicians I. 
Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol 
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Zeller T. Drug coated balloons: hope or hype? Available at: 
http://evtoday.com/2012/08/drug-coated-balloons-hope-or-hype/. Accessed October 13, 
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Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents 
in patients with stenosis in native coronary artery. N Engl J Med 2003;349:1315-23  
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Stone GW, Ellis SG, Cannon L, et al. Comparison of a polymer-based paclitaxel-
eluting stent with a bare metal stent in patients with complex coronary artery disease: a 
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Dake MD, Ansel GM, Jaff MR, et al. Durable Clinical Effectiveness With Paclitaxel-
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Trial. Circulation 2016;133:1472-83; discussion 83. 
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Loh JP, Barbash IM, Waksman R. The current status of drug-coated balloons in 
percutaneous coronary and peripheral interventions. EuroIntervention 2013;9:979-88. 
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Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures 
after femoropopliteal stenting. J Am Coll Cardiol 2005;45:312-5. 
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Laird JD. Limitations of percutaneous transluminal angioplasty and stenting for the 
treatment of disease of the superficial femoral and popliteal arteries. J Endovasc Ther 
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Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc 
Interv 2009;2:352-8. 
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Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed 
healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193-202. 
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Finn AV, Joner M, Nakazawa G, et al. Pathological correlates of late drug-eluting 
stent thrombosis: strut coverage as a marker of endothelialization. Circulation 
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Kayssi A, Al-Atassi T, Oreopoulos G, Roche-Nagle G, Tan KT, Rajan DK. Drug-
eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial 
disease of the lower limbs. Cochrane Database Syst Rev 2016:CD011319. 
30. 
Seedial SM, Ghosh S, Saunders RS, et al. Local drug delivery to prevent restenosis. J 
Vasc Surg 2013;57:1403-14. 
31. 
Fanelli F, Cannavale A, Boatta E, et al. Lower limb multilevel treatment with drug-
eluting balloons: 6-month results from the DEBELLUM randomized trial. J Endovasc Ther 
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32. 
Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis 
after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ 
Cardiovasc Interv 2012;5:831-40. 
33. 
Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis 
during angioplasty of the leg. N Engl J Med 2008;358:689-99. 
34. 
Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in 
femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel 
randomized pilot trial. Circulation 2008;118:1358-65. 
35. 
Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated 
balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal 
revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus 
uncoated balloon angioplasty. JACC Cardiovasc Interv 2014;7:10-9. 
36. 
Byrne RA, Joner M, Alfonso F, Kastrati A. Drug-coated balloon therapy in coronary 
and peripheral artery disease. Nat Rev Cardiol 2014;11:13-23. 
37. 
Freyhardt P, Zeller T, Kroncke TJ, et al. Plasma levels following application of 
paclitaxel-coated balloon catheters in patients with stenotic or occluded femoropopliteal 
arteries. Rofo 2011;183:448-55. 
38. 
Micari A, Cioppa A, Vadala G, et al. Clinical evaluation of a paclitaxel-eluting 
balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter 
Italian registry. JACC Cardiovasc Interv 2012;5:331-8. 
39. 
Micari A, Cioppa A, Vadala G, et al. 2-year results of paclitaxel-eluting balloons for 
femoropopliteal artery disease: evidence from a multicenter registry. JACC Cardiovasc 
Interv 2013;6:282-9. 
40. 
Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous 
transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral 
artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation 
2015;131:495-502. 
41. 
Laird JR, Schneider PA, Tepe G, et al. Durability of Treatment Effect Using a Drug-
Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll 
Cardiol 2015;66:2329-38. 
42. 
Lutonix I, October 10, 2014. (Accessed February 27, 2017, at 
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418455.htm) 
43. 
Jaff MR, Rosenfield K, Scheinert D, et al. Drug-coated balloons to improve 
femoropopliteal artery patency: Rationale and design of the LEVANT 2 trial. Am Heart J 
2015;169:479-85. 
44. 
Rosenfield K, Jaff MR, White CJ, et al. Trial of a Paclitaxel-Coated Balloon for 
Femoropopliteal Artery Disease. N Engl J Med 2015;373:145-53. 
45. 
Lyden, S. ILLUMENATE Pivotal Stellarex DCB IDE Study 12-Month Results. In: 
Transcatheter Cardiovascular Therapeutics, 2016. 
46. 
Metzger C. US Trial Update: Levant 2. In: Transcatheter Cardiovascular 
Therapeutics. San Francisco, CA; 2013. 
47. 
Cassese S, Byrne RA, Ott I, et al. Paclitaxel-coated versus uncoated balloon 
angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial 
disease: a meta-analysis of randomized trials. Circ Cardiovasc Interv 2012;5:582-9. 
 
 

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Appendix A. Acronyms and Abbreviations 
Abbreviation/Acronym Complete Term 
6-MWT 
6-Minute walk test 
ABI 
Ankle brachial index 
ADE 
Adverse device event 
AE 
Adverse event 
AR 
Adverse reaction 
BARC 
Bleeding Academic Research Consortium 
BASIL 
Bypass Surgery versus Angioplasty in Severe Ischemia of the 
Leg 
BMS 
Bare metal stent 
CBC 
CEC 
Complete blood count 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CLI 
Critical limb ischemia 
CRO 
Clinical research organization 
DAPT 
Dual antiplatelet therapy 
DCB 
Drug-coated balloon 
DCC 
Data coordinating center 
DES 
Drug-eluting stent 
DMC 
Data monitoring committee 
DUS 
Duplex ultrasound 
EC 
Ethics committee 
EDC 
Electronic data capture 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EFS 
Early feasibility study 
FDA 
Food and Drug Administration 
FEP 
Fluorinated ethylene propylene 
GCP 
Good clinical practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonization 
IDE 
Investigational device exemption 
IFU 
Instructions for use 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LLL 
Late lumen loss 
MAE 
Major adverse event 
MI 
Myocardial infarction 
PAD 
Peripheral artery disease 

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Abbreviation/Acronym Complete Term 
PAQ 
Peripheral Artery Questionnaire 
PARC 
Peripheral Academic Research Consortium 
PEB 
Paclitaxel-eluting balloon 
POBA 
Plain old balloon angioplasty 
PSVR 
Peak systolic velocity ratio 
PTA 
Percutaneous transluminal angioplasty 
QA 
Quantitative angiography 
RVD 
Reference vessel diameter 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SFA 
Superficial femoral artery 
SOP 
Standard operating procedure 
SUSAR 
Suspected unexpected serious adverse reaction 
TASC 
TransAtlantic Inter-Society Consensus Classification 
TBI 
Toe brachial index 
TLR 
Target lesion revascularization 
TVR 
Target vessel revascularization 
UADE 
Unanticipated adverse device effect 
US 
United States 
USADE 
Unanticipated serious adverse device effect 
WBC 
White blood cell 
WIQ 
Walking Impairment Questionnaire 
 
 
 

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Appendix B. Definitions 
ADVERSE DEVICE EFFECT 
An ADE is defined as any AE that is related to the use of the investigational medical device. 
NOTE 1: This definition includes AEs resulting from insufficiencies or inadequacies 
in the instructions for use, the deployment, the implantation, the installation, the 
operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event that is a result of a use error or from 
intentional abnormal use of the investigational medical device. 
ADVERSE EVENT 
An AE is defined as any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs in subjects, users or other persons, whether or not related to the 
investigational medical device. 
NOTE 1: This definition includes events related to the investigational medical device
 
 or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: Abnormal laboratory findings will be considered AEs, only if determined 
by the investigator to be clinically significant.  
NOTE 4: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
ANKLE BRACHIAL INDEX 
Ankle systolic pressure/brachial systolic pressure (ABI), measured by constructing a ratio from 
the peak systolic pressure measured during the deflation of the ankle cuffs during DUS 
detection to the systolic brachial pressure. 
ANTICIPATED ADVERSE EVENT 
Any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other 
medical event) occurring to a subject, whether or not considered related to the investigational 
product(s) or drug regimen prescribed as part of the clinical protocol, predefined in the clinical 
protocol and/or IFU, and/or product label that is identified or worsens during a clinical study. 

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ARTERIAL THROMBOSIS OF THE TREATED SEGMENT ON ANGIOGRAPHY 
A total occlusion documented by DUS and/or angiography at the treatment site with or without 
symptoms. Thrombosis may be categorized as acute (<1 day), subacute (1-30 days) and late 
(>30 days). The presence of thrombus at the target lesion must be noted as an AE in the eCRF. 
BLEEDING ACADEMIC RESEARCH CONSORTIUM (BARC)1 DEFINITION FOR 
BLEEDING 
Bleeding complications are defined according to the BARC classification of bleeding events 
Type 0: no bleeding 
Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled 
performance of studies, hospitalization, or treatment by a healthcare professional; may include 
episodes leading to self-discontinuation of medical therapy by the patient without consulting a 
healthcare professional 
Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected 
for a clinical circumstance, including bleeding found by imaging alone) that does not fit the 
criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring 
nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization 
or increased level of care, or (3) prompting evaluation 
Type 3 
Type 3a 
Overt bleeding plus hemoglobin drop of 3 to <5 g/dL (provided hemoglobin drop is 
related to bleed) 
Any transfusion with overt bleeding 
Type 3b 
Overt bleeding plus hemoglobin drop ≥5 g/dL (provided hemoglobin drop is related to 
bleed) 
Cardiac tamponade 
Bleeding 
requiring 
surgical 
intervention 
for 
control 
(excluding 
dental/nasal/skin/hemorrhoid) 
Bleeding requiring intravenous vasoactive agents 
Type 3c 
Intracranial hemorrhage (does not include microbleeds or hemorrhagic 
transformation, does include intraspinal) 
Subcategories confirmed by autopsy or imaging or lumbar puncture 
Intraocular bleed compromising vision 
Type 4: CABG-related bleeding 
 
1 Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a 
consensus report from the Bleeding Academic Research Consortium. Circulation 2011;123:2736-47. 

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Perioperative intracranial bleeding within 48 h 
Reoperation after closure of sternotomy for the purpose of controlling bleeding 
Transfusion of ≥5 U whole blood or packed red blood cells within a 48-h period 
Chest tube output ≥2L within a 24-h period 
Type 5: fatal bleeding 
Type 5a 
Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious 
Type 5b 
Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation 
CLINICALLY-DRIVEN TARGET LESION REVASCULARIZATION 
Clinically-driven TLR is any repeat intervention of the target lesion (plus 10 mm proximal and 
distal to the index device) or surgical bypass of the target lesion performed due to target lesion 
diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., 
recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to 
medical therapy, critical limb ischemia) or recurrence of the clinical syndrome for which the 
initial procedure was performed. If the target lesion is occluded and bypass is done to another 
artery below the knee, this should be considered TLR. 
CLINICALLY-DRIVEN TARGET VESSEL REVASCULARIZATION 
Clinically-driven TVR is any repeat intervention of the target vessel or surgical bypass of the 
target vessel performed due to target vessel diameter stenosis ≥50% and either evidence of 
clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent 
claudication, claudication unresponsive to medical therapy, critical limb ischemia) or 
recurrence of the clinical syndrome for which the initial procedure was performed. If the target 
vessel is occluded and bypass is done to another artery below the knee, this should be 
considered TVR. 
DEATH 
All-cause mortality. 
DEVICE DEFICIENCY (ISO14155:2011) 
Inadequacy of a medical device related to its identity, quality, durability, reliability, safety, or 
performance. This may include malfunctions, use error, or inadequate labeling. 
DEVICE FAILURE 
A device failure occurs when the device is used in compliance with the IFU, but does not 
perform as described in the IFU and also negatively impacts treatment of the study subject.  

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DEVICE MALFUNCTION (ISO 14155:2011) 
Failure of an investigational medical device to perform in accordance with its intended 
purpose when used in accordance with the IFU or clinical study protocol.   
DEVICE SUCCESS 
Successful delivery, balloon inflation, deflation and retrieval of the intact study device without 
burst below rated burst pressure, and achievement of <50% residual stenosis of the target lesion 
(by core lab-assessed quantitative angiography [QA]) without flow-limiting arterial dissection, 
using only the study device. 
DISSECTION, NHLBI (National Heart, Lung, and Blood Institute) CLASSIFICATION2 
Grade A: 
Small radiolucent area within the lumen of the vessel disappearing with the 
passage of the contrast material. 
Grade B: 
Appearance of contrast medium parallel to the lumen of the vessel 
disappearing within a few cardiac cycles. 
Grade C: 
Dissection protruding outside the lumen of the vessel persisting after passage 
of the contrast material. 
Grade D: 
Spiral shaped filling defect with or without delayed run-off of the contrast 
material in the antegrade flow. 
Grade E: 
Persistent luminal filling defect with delayed run-off of the contrast material 
in the distal lumen. 
Grade F: 
Filling defect accompanied by total coronary occlusion. 
EMBOLIC EVENTS OF TARGET LIMB 
Embolism with concomitant suggestive clinical signs and symptoms, located separate from 
and distal to the target lesion. Classified by probability: 
• Definite: Angiographic evidence of distal embolization with a new intraluminal filling defect 
and/or abrupt occlusion of a run-off vessel distal to a lesion that is clearly not attributable to 
wire trauma or dissection, irrespective of the time from the index procedure. 
• Probable: Suggestive clinical signs and symptoms of distal embolization occurring ≤30 days 
after the index procedure, in the absence of angiographic evidence. 
 
2 Detre, K., R. Holubkov, S. Kelsey, M. Bourassa, D. Williams, D. Holmes, Jr., G. Dorros, D. Faxon, R. Myler, 
K. Kent, et al. One-year follow-up results of the 1985-1986 National Heart, Lung, and Blood Institute's 
Percutaneous Transluminal Coronary Angioplasty Registry. Circulation. 1989;80(3):421-8. 
 

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• Possible: Suggestive clinical signs and symptoms of distal embolization occurring >30 days 
after the index procedure in the absence of angiographic evidence. 
INDEX PROCEDURE 
The index procedure is the randomized study procedure occurring on day 1, in which subjects 
are randomly assigned to receive either a SurVeil DCB or an IN.PACT Admiral DCB. 
MAJOR ADVERSE EVENT, PARC3 
A PARC MAE is death, stroke, myocardial infarction, acute onset of limb ischemia, index 
bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery. 
MAJOR ADVERSE EVENT, HISTORICAL 
A historical MAE is all-cause death, clinically-driven TLR, major target limb amputation 
(above the ankle), or thrombosis at the target lesion. 
MAJOR LIMB AMPUTATION 
Above the ankle amputation. 
MAJOR VASCULAR COMPLICATIONS  
Major vascular complications include the following: 
• Hematoma at access site >100 mm 
• False aneurysm requiring surgical or percutaneous intervention 
• Arterio-venous fistula requiring surgical or percutaneous intervention 
• Retroperitoneal bleed associated with significant hemodynamic and/or clinical 
sequelae 
• Any transfusion (any transfusion required will be reported as a vascular complication 
unless the clinical indication is clearly something other than a catheterization 
complication) 
• Vascular surgical repair of the vascular access site 
 
3 Patel MR, Conte MS, Cutlip DE, et al. Evaluation and treatment of patients with lower extremity peripheral 
artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC).J Am Coll 
Cardiol. 2015;65(9):931-41. 

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PARC4 CALCIFICATION CLASSIFICATION 
Focal: <180˚ (1 side of vessel) and less than one-half of the total lesion length 
Mild: <180˚ and greater than one-half of the total lesion length 
Moderate: ≥180˚ (both sides of the vessel at same location) and less than one-half of the total 
lesion length 
Severe: >180˚ (both sides of the vessel at same location) and greater than one-half of the total 
lesion length 
PARC CLINCAL SYMPTOM CLASSIFICATION 
• Asymptomatic 
• Mild claudication/limb symptoms (no limitation in walking) 
• Moderate claudication/limb symptoms (able to walk without stopping >2 blocks or 
200 meters or 4 minutes) 
• Severe claudication/limb symptoms (only able to walk without stopping <2 blocks or 
200 meters or 4 minutes) 
• Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial 
perfusion) 
• Ischemic ulcers on distal leg 
• Ischemic gangrene 
PATENT RUN-OFF 
At least one patent native outflow artery from the popliteal to the ankle, free from significant 
(≥50%) stenosis as confirmed by angiography or ultrasound that has not previously been 
revascularized. 
PRIMARY PATENCY 
Defined as a composite of freedom from clinically-driven TLR and binary restenosis 
(restenosis defined as DUS PSVR ≥2.4 or by ≥50% stenosis as assessed by independent 
angiographic and DUS core labs) and through 12 months post-index procedure. In cases when 
there is a discrepancy between angiographic and DUS assessment of patency, angiographic 
assessment takes precedence. 
PROCEDURE SUCCESS 
 
4 Patel MR, Conte MS, Cutlip DE, et al. Evaluation and treatment of patients with lower extremity peripheral 
artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC).J Am Coll 
Cardiol. 2015;65(9):931-41. 

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Evidence of both acute technical success and absence of major adverse events (e.g., death, 
stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated 
segment thrombosis, and or need for urgent/ emergent vascular surgery) within 72 hours of the 
index procedure.  
REFERENCE VESSEL DIAMETER 
RVD is defined as the average of normal segments within 10 mm proximal and distal to the 
target lesion from two orthogonal views using QA.  
RESTENOSIS 
Defined as DUS PSVR ≥2.4 or by ≥50% stenosis as assessed by independent angiographic and 
DUS core labs. PSVR is a ratio of the peak systolic velocity (PSV) at the lesion relative to the 
PSV of a normal segment in a proximal reference vessel. The PSVR consequently cannot be 
calculated in the presence of an abnormal proximal PSV, as can occur in the setting of inflow 
disease, cardiac disease, or cardiac arrhythmias. In the presence of abnormal reference PSV, 
the core lab uses the following additional secondary criteria to identify restenosis of the target 
lesion (≥50% in severity): 
• Focal increase in the absolute PSV at the area of visible plaque 
• Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in 
velocity distal to the stenosis 
• Review of the B-mode images 
RUTHERFORD CLASSIFICATION 
0: 
Asymptomatic, no hemodynamically significant occlusive disease 
1: 
Mild Claudication 
2: 
Moderate Claudication 
3: 
Severe Claudication 
4: 
Ischemic rest pain 
5: 
Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia 
6: 
Major tissue loss, extending above transmetatarsal level, functional foot no longer 
salvageable 
SERIOUS ADVERSE DEVICE EFFECT 
An ADE that results in any of the consequences characteristic of a SAE is considered a SADE. 
SERIOUS ADVERSE EVENT 
A SAE is an AE that leads to: 

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1. Death, 
2. Serious deterioration in the health of the subject that either resulted in: 
a. Life-threatening illness or injury, or 
b. Permanent impairment of a body structure or a body function, or 
c. In-patient hospitalization, or prolongation of existing hospitalization, or 
d. Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
3. Fetal distress, fetal death or a congenital abnormality or birth defect. 
NOTE 1: This includes device deficiencies that might have led to an SAE if a) suitable 
action had not been taken or b) intervention had not been made or c) if circumstances 
had been less fortunate. These are handled under the SAE reporting system. 
NOTE 2: Planned hospitalization for pre-existing condition, or a procedure required 
by the clinical study plan, without a serious deterioration in health, is not considered to 
be an SAE. A planned hospitalization is one that is scheduled prior to the patient signing 
the informed consent for the study. 
SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION 
A SUSAR is an AR that is both serious and unexpected. 
TARGET LESION 
A lesion that is to be treated during the index procedure. 
TARGET LESION REVASCULARIZATION 
TLR is any repeat intervention of the target lesion (plus 10 mm proximal and distal to the index 
device) or surgical bypass of the target lesion performed for restenosis or other complication 
involving the target lesion. If the target lesion is occluded and bypass is done to another artery 
below the knee, this should be considered TLR. In the assessment of TLR, angiograms should 
be assessed by the angiographic core laboratory and made available to the clinical endpoints 
committee for review. 
TARGET LIMB AMPUTATIONS 
All amputations at the target limb including both above the ankle (Major) amputations and 
below the ankle (Minor) amputations. 
TARGET VESSEL REVASCULARIZATION 
TVR is any repeat intervention of the target vessel or surgical bypass of the target vessel 
performed for restenosis or other complication involving the target vessel. If the target vessel 

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is occluded and bypass is done to another artery below the knee, this should be considered 
TVR. In the assessment of TVR, angiograms should be assessed by the angiographic core 
laboratory and made available to the clinical endpoints committee for review. 
TARGET VESSEL   
Superficial femoral and popliteal arteries, defined as the arterial segment from the bifurcation 
between the superficial and profunda femoris arteries (proximal anatomical landmark) to the 
distal segment of the popliteal artery at the origin of anterior tibial artery (distal anatomical 
landmark). 
TECHNICAL SUCCESS 
Achievement of a final residual diameter stenosis of <50% (by core lab-assessed QA) without 
flow-limiting arterial dissection at the end of the procedure. 
THROMBOSIS 
A total occlusion documented by DUS and/or angiography at the treatment site with or without 
symptoms. Thrombosis may be categorized as acute (<1 day), subacute (1-30 days) and late 
(>30 days). The presence of thrombus at the target lesion must be noted as an AE in the eCRF. 
UNANTICIPATED ADVERSE DEVICE EFFECT 
An UADE is defined in 21 CFR 812.3(s) as any serious adverse effect on health or safety or 
any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem or death was not previously identified in nature, severity or degree of incidence in the 
protocol, or any other unanticipated serious problem associated with a device that relates to the 
rights, safety or welfare of a subject. 
UNEXPECTED AE 
Any AE that is not consistent in specificity or severity with the current investigator’s 
brochure/protocol, including all amendments, is considered unexpected. 
UNSCHEDULED VISIT 
An unscheduled visit is any visit that is for an index procedure-related AE or for 
revascularization of the target limb. 
USE ERROR 
An act or omission of an act that results in a different medical device response than intended 
by the manufacturer or expected by the user. (Note 1: Use error includes slips, lapses and 
mistakes. Note 2: An unexpected physiological response of the subject does not in itself 
constitute a use error.) 
WALKING IMPAIRMENT QUESTIONNAIRE     

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Instrument to measure walking distance, walking speed, and stair-climbing limitations in 
patients with PAD in the outpatient setting.5 
WOMAN OF CHILDBEARING POTENTIAL 
A woman of childbearing potential is any postmenarchal female who has not undergone 
surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. 
Menopause is defined as 12 months of amenorrhea in a woman >45 years old in the absence 
of other biological or physiological causes. In women <55 years old, menopause must be 
confirmed by a serum follicle-stimulating hormone level of >40 mIU/mL.   
WORSENING OF ANKLE BRACHIAL INDEX 
A deterioration in the ABI by ≥0.15 from baseline. 
WORSENING RUTHERFORD CLINICAL CATEGORY 
A deterioration (an increase) in the Rutherford Category by more than 1 category from the 
earliest post-procedural measurement. 
 
 
 
5 Jain, A., K. Liu, L. Ferrucci, M. Criqui, L. Tian, J. Guralnik, H. Tao, and M. McDermott. 2012. The Walking 
Impairment Questionnaire stair-climbing score predicts mortality in men and women with peripheral arterial 
disease. J Vasc Surg 55:1662-73.