A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries
Phase: NA
Conditions: Peripheral Artery Disease
Sponsor: C. R. Bard

 
 
 
A Prospective, Multicenter, LEVANT 2 Continuation 
Registry of the Moxy™ Drug Coated Balloon for Treatment 
of Femoropopliteal Arteries 
 
 
 
LEVANT 2 Continued Access Registry  
Version 1.0 
 
 
Sponsor: 
 
 
 
9409 Science Center Drive 
New Hope, MN 55428 USA 
 
Investigational Device: Moxy™ Drug Coated Balloon 
 
NCT Number: 01628159 (NCT Number added post-approval per CT.gov requirement) 
This study will be conducted in compliance with the protocol and all other applicable regulatory 
requirements including the archiving of essential documents. 
 
 
Confidential Information 
No use or disclosure of this document outside Lutonix, Inc. is permitted without prior written 
authorization from Lutonix. 
 
 
 

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The LEVANT 2 Continued Access Registry Summary 
Title 
A Prospective, Multicenter, Continuation Registry of the Moxy™ Drug Coated 
Balloon for Treatment of Femoropopliteal Arteries  (LEVANT 2 Continued 
Access registry) 
Investigational  
Device 
Lutonix Moxy™ Drug Coated Balloon 
Study Design 
Prospective, Multicenter, Continuation Registry, Safety and Efficacy 
Overview 
The purpose of the LEVANT 2 Continued Access registry is to collect 
additional safety and efficacy data on the Lutonix Moxy Drug Coated Balloon 
in a large population.  The study will enroll the same patient population and 
follow the same medication regimen, follow-up schedule, and definitions as the 
LEVANT 2 randomized protocol.  
 
After successful protocol-defined pre-dilatation, subjects that are determined 
not to require stenting based on the defined angiographic criteria will be treated 
with the Moxy Drug Coated Balloon and followed for 5 years.  Subjects that do 
not meet post-predilatation lesion criteria are excluded (and treated per standard 
practice) and followed for safety for 30 days. 
Purpose 
To collect additional safety and efficacy information on the Moxy Drug Coated 
Balloon for treatment of stenosis or occlusion of the femoral and popliteal 
arteries. 
Objective 
To assess safety and efficacy of use of the Moxy Drug Coated Balloon for 
treatment of stenosis of the femoropopliteal arteries in a large population of 
subjects. 
Treatment 
All subjects meeting protocol-defined post pre-dilatation criteria will be treated 
with the Moxy Drug Coated Balloon. 
Enrollment 
Enrollment will occur at up to 70 global centers, including up to 55 sites 
participating in the LEVANT 2 randomized trial and additional sites outside the 
U.S. For sites participating in the Randomized portion of the trial, enrollment in 
this registry will not start until the full randomized cohort (476 subjects) has 
been enrolled. 
 
Up to 975 subjects are expected to be enrolled in this continuation study to 
ensure approximately 650 subjects treated with the Drug Coated Balloon. 
Subject 
Follow-Up 
Schedule 
The follow up schedule will be the same as in the LEVANT 2 randomized 
protocol, with clinical visits at 6, 12, and 24 months, DUS at 0-30d, 6m, 12m 
and 24 months and telephone follow-up at 1, 36, 48, and 60 months.  
 
Primary 
Endpoint 
Rate of unanticipated device- or drug- related adverse events over time through 
60 months. 
Secondary 
Endpoints 
Safety 
• Composite of freedom from all-cause perioperative (≤30 day) death 
and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 
months: index limb amputation, index limb re-intervention, and 
index-limb-related death. 

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• Freedom at 30 days from all-cause death, index limb amputation 
above the ankle and target vessel revascularization (TVR) (VIVA 
Safety Endpoint)  
The following endpoints will be assessed at 1, 6, 12, 24, 36, 48 and 60 
months: 
• Rate of unexpected device- or drug-related adverse events  
• All-cause death  
• Amputation (above the ankle)-Free Survival (AFS)  
• Target Vessel Revascularization (TVR)  
• Reintervention for treatment of thrombosis of the target vessel or 
embolization to its distal vasculature  
• Major vascular complications 
• Readmission for cardiovascular events  
 
Efficacy 
• Acute Device, Technical and Procedural success  
   
 The following endpoints will be assessed at 6, 12 and 24 Months: 
• Primary and Secondary Patency.  
• Alternative Primary and Secondary Patency based on alternative 
definitions of DUS PSVR <2.0 and <3.0 
• DUS Clinical Patency (DUS PSVR <2.5 without prior Clinically 
Driven TLR) 
• Target Lesion Revascularization (TLR)  
o Clinically-driven 
o Total (clinical and DUS/angiography-driven) 
• Change of Rutherford classification from baseline 
Change of resting Ankle Brachial Index (ABI) from  baseline 
Inclusion 
Criteria 
Inclusion Criteria is the same as in the most recently approved LEVANT 2 
randomized protocol (section 5.3.1). 
Exclusion 
Criteria 
Exclusion Criteria is the same as in the most recently approved LEVANT 2 
randomized protocol (section 5.3.2). 
 
Primary 
Analytical 
Subset 
All subjects treated with a DCB in the LEVANT 2 Randomized protocol and in 
the LEVANT 2 Continued Access registry. 
 
Authorized 
Representative 
Bard Limited 
Crawley 
RH11 9BP, UK 

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Table of Contents 
1 
INTRODUCTION ............................................................................................................................... 6 
2 
STUDY OBJECTIVES AND ENDPOINTS ..................................................................................... 6 
2.1 
CONTINUED ACCESS PRIMARY OBJECTIVE ...................................................................... 6 
2.2 
PRIMARY ENDPOINT ................................................................................................................ 6 
2.3 
SECONDARY ENDPOINTS ....................................................................................................... 6 
3 
DEVICE DESCRIPTION .................................................................................................................. 7 
3.1 
INTENDED USE / INDICATIONS FOR USE ............................................................................. 7 
3.2 
ACTIVE PHARMACEUTICAL INGREDIENT (API): PACLITAXEL ..................................... 8 
3.3 
EXCIPIENT (DRUG CARRIER) ..................................................................................................... 8 
3.4 
DEVICE INSTRUCTIONS .......................................................................................................... 8 
3.5 
SUPPLY & SUPPORT OF INVESTIGATIONAL DEVICE ....................................................... 8 
4 
RISK – BENEFIT ANALYSIS .......................................................................................................... 9 
4.1 
EARLY TERMINATION ............................................................................................................. 9 
5 
CLINICAL STUDY DESIGN .......................................................................................................... 10 
5.1 
SCREENING PROCEDURES ................................................................................................... 11 
5.2 
PATIENT SELECTION FOR ENROLLMENT ......................................................................... 11 
5.3 
SUBJECT INCLUSION AND EXCLUSION CRITERIA ......................................................... 11 
6 
STUDY/TREATMENT PROCEDURES ........................................................................................ 12 
6.1 
ENROLLMENT ......................................................................................................................... 12 
6.2 
PRE-DILATATION ................................................................................................................... 12 
6.3 
TREATMENT ............................................................................................................................ 13 
6.4 
POST TREATMENT AND PROVISIONAL (BAILOUT) STENTING PROCEDURES ......... 13 
6.5 
MEDICATIONS ......................................................................................................................... 14 
6.6 
STANDARD TESTS, PROCEDURES, AND FOLLOW-UP .................................................... 15 
7 
ADVERSE EVENTS ........................................................................................................................ 16 
7.1 
ADVERSE EVENT REPORTING ............................................................................................. 16 
8 
SUBJECT WITHDRAWAL CRITERIA ....................................................................................... 16 
9 
DATA COLLECTION AND MONITORING ............................................................................... 16 
9.1 
DATA COLLECTION ................................................................................................................ 16 
9.2 
MONITORING ........................................................................................................................... 17 
9.3 
SOURCE DOCUMENTATION ................................................................................................. 18 
9.4 
RECORD RETENTION ............................................................................................................. 19 
9.5 
STUDY PROCESSING .............................................................................................................. 19 
10 DEVICE ACCOUNTABILITY ....................................................................................................... 20 
11 STUDY MANAGEMENT ................................................................................................................ 20 

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11.1 
SAFETY COMMITTEES ........................................................................................................... 20 
11.2 
IRB/EC APPROVAL .................................................................................................................. 20 
11.3 
INFORMED CONSENT ............................................................................................................ 21 
11.4 
INVESTIGATOR’S RESPONSIBILITIES ................................................................................ 21 
12 PUBLICATIONS .............................................................................................................................. 22 
13 STATISTICAL ANALYSIS PLAN ................................................................................................. 22 
13.1 
OVERVIEW OF STUDY DESIGN ............................................................................................ 22 
13.2 
SAMPLE SIZE JUSTIFICATION .............................................................................................. 22 
13.3 
ANALYSIS ................................................................................................................................. 23 
 
 
Tables 
Table 1: Device Matrix, Moxy Drug Coated Balloon................................................................................... 8 
Table 2: Post Pre-Dilatation Lesion(s) Criteria ........................................................................................... 13 
Table 3: Provisional (Bailout) Criteria........................................................................................................ 14 
Table 4: Follow-Up Schedule and Testing Requirements .......................................................................... 15 
 
 
 
Figures 
Figure 1:  Moxy Drug Coated Balloon ......................................................................................................... 7 
Figure 2 : Chemical Structure of Paclitaxel .................................................................................................. 8 
Figure 3:  Study Flowchart ......................................................................................................................... 10 
 
 
 

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1 INTRODUCTION 
The purpose of the LEVANT 2 Continued Access registry is to collect additional safety and 
efficacy information on the Lutonix Moxy™ Drug Coated Balloon for treatment of stenosis or 
occlusion of the femoropopliteal arteries in a larger patient population.  Enrolled subjects will 
meet the same protocol requirements and undergo the same follow up and testing schedule as 
described in the currently approved LEVANT 2 Randomized protocol. 
 
2 STUDY OBJECTIVES AND ENDPOINTS 
Data from all subjects treated with DCB in the LEVANT 2 Randomized protocol (roll-in and 
randomized to DCB) and in the LEVANT 2 Continued Access registry will be combined and 
analyzed descriptively.  Secondary as-treated, unstented, and per-protocol analyses will also be 
performed. 
 
2.1 CONTINUED ACCESS PRIMARY OBJECTIVE 
The Primary Objective is to assess safety and efficacy of use of the Moxy Drug Coated Balloon 
for treatment of stenosis of the femoropopliteal arteries in a large population of subjects. 
 
2.2 PRIMARY ENDPOINT 
Rate of unanticipated device- or drug- related adverse events over time through 60 months. 
 
2.3 SECONDARY ENDPOINTS 
The following endpoints will be reported using descriptive statistics in the final Study Report.  
 
Safety 
• Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom 
from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, 
index limb re-intervention, and index-limb-related death. 
• Freedom at 30 days from all-cause death, index limb amputation above the ankle and 
target vessel revascularization (TVR) (VIVA Safety Endpoint)  
The following endpoints will be assessed at 1, 6, 12, 24, 36, 48 and 60 months: 
• Rate of unanticipated device- or drug-related adverse events  
• All-cause death  
• Amputation (above the ankle)-Free Survival (AFS)  
• Target Vessel Revascularization (TVR)  
• Reintervention for treatment of thrombosis of the target vessel or embolization to its 
distal vasculature  
• Major vascular complications 
• Readmission for cardiovascular events  
 

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Efficacy 
• Acute Device, Technical and Procedural success  
   
 The following endpoints will be assessed at 6, 12 and 24 Months: 
• Primary and Secondary Patency.  Primary Patency is defined as the absence of target 
lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥ 2.5) and 
freedom from target lesion revascularization (TLR). 
• Alternative Primary and Secondary Patency based on alternative definitions of DUS 
PSVR < 2.0 and < 3.0 
• DUS Clinical Patency (DUS PSVR < 2.5 without prior Clinically Driven TLR) 
• Target Lesion Revascularization (TLR) 
o Clinically-driven 
o Total (clinical and DUS/angiography-driven) 
• Change of Rutherford classification from baseline 
• Change of resting Ankle Brachial Index (ABI) from  baseline 
 
3 DEVICE DESCRIPTION  
The Lutonix Moxy Drug Coated Balloon is a standard PTA catheter with a drug coating on the 
balloon portion of the catheter.  The Moxy Drug Coated Balloon is an over-the-wire type design 
with working lengths of 100 and 130 cm and is compatible with 0.035” guidewires.  Marker 
bands are located at the proximal and distal ends of the balloons to assist in delivery and 
placement.  The balloon surface between the marker bands is coated with a specialized 
immediate release non-polymer based coating formulation that includes the anti-proliferative 
drug – paclitaxel - at a surface concentration of 2μg/mm2. 
 
 
FIGURE 1:  MOXY DRUG COATED BALLOON 
 
All devices are provided sterile and for single-use only and are clearly labeled for investigational 
use only.  No more than two devices may be deployed in a single target lesion during a single 
procedure. 
 
3.1 INTENDED USE / INDICATIONS FOR USE 
The Moxy Drug Coated Balloon is indicated for percutaneous transluminal angioplasty of 
obstructive de novo or non-stented restenotic lesions in native femoropopliteal arteries ≤15cm in 
length and >4.0 to <6.0mm in diameter. 
 

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3.2 ACTIVE PHARMACEUTICAL INGREDIENT (API): PACLITAXEL 
Paclitaxel, discovered in 1967 and commercially developed by Bristol-Myers Squibb, is a well 
known mitotic inhibitor indicated for use in the treatment of patients with lung, ovarian, breast, 
head and neck cancers and advanced forms of Kaposi’s sarcoma.  Paclitaxel is also approved for 
the prevention of restenosis.  Various dosages are used depending on target treatment and range 
from multiple 300 mg IV infusions for oncology therapy to a single maximal nominal dose of 
282 µg for devices that treat restenosis, such as coronary stents.  Please refer to Figure 2 and the 
Investigator’s Brochure for a more detailed review of paclitaxel. 
 
 
FIGURE 2 : CHEMICAL STRUCTURE OF PACLITAXEL 
 
3.3 EXCIPIENT (DRUG CARRIER) 
The balloon coating includes small amounts of well known excipients (drug carrier) that are 
approved by the Food and Drug Administration (FDA) as inactive ingredients in drug products 
for intravenous (IV) drug delivery.  
 
3.4 DEVICE INSTRUCTIONS 
A comprehensive set of Instructions for Use (IFU), including warnings and precautions, has been 
created.  Please refer to the most current IFU packaged with the device for complete details on 
preparation and procedural use of the device.  A sample IFU can be found in Appendix G of the 
LEVANT 2 Randomized protocol.  
 
3.5 SUPPLY & SUPPORT OF INVESTIGATIONAL DEVICE  
An investigational device supply of the Moxy Drug Coated Balloon will be made available to all 
activated study sites.  The investigational device matrix that is currently available for this study 
is listed in Table 1.  Always confirm current site inventory supply prior to enrolling subjects into 
the study.  
TABLE 1: DEVICE MATRIX, MOXY DRUG COATED BALLOON 
Balloon 
Diameters 
Balloon Lengths 
40mm 
60 mm 
100 mm 
4 mm 
 
 
 
5 mm 
 
 
 
6 mm 
 
 
 

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Each study site will receive a supply of the Lutonix Moxy Drug Coated Balloons upon 
completion of the protocol requirements for study initiation.  Additional training and support will 
be provided as needed on an ongoing basis.  Any unused devices must be returned to the sponsor 
at the time site enrollment stops or upon sponsor request.  After use, this product may be a 
potential biohazard.  Handle and dispose of in accordance with acceptable medical practices and 
applicable local, state and federal laws and regulations.  For quality control purposes, devices 
may be requested to be returned to the sponsor before or after use, in which case the site should 
return devices by following the Return Material Authorization (RMA) instructions located in the 
study binder. 
 
4 RISK – BENEFIT ANALYSIS 
The potential risks and benefits of participation in this study are clearly identified in the subject 
Informed Consent Form (ICF) and are the same as detailed in the LEVANT 2 Randomized 
protocol, reference section 4.1 – 4.3 of the LEVANT 2 Randomized protocol for complete risk-
benefit analysis. 
 
4.1 EARLY TERMINATION 
Lutonix, Inc. (Sponsor) and the Clinical Events Committee will monitor the progression of the 
continuation access study.  If warranted, the study may be suspended or discontinued if there is 
an observation of serious adverse reactions presenting an unreasonable risk to the study 
population.  
 
The Sponsor may terminate Investigator and site participation in the study for issues including 
but not limited to the following issues: 
• Evidence of an Investigator’s failure to maintain adequate clinical standards  
• Evidence of an Investigator or staff’s failure to comply with the protocol 
• Inaccuracy or late submission of data forms and core lab images 
• Conditions of approval imposed by the reviewing IRB/EC and/or regulatory agencies 
• Evidence of safety concerns or protocol non-compliance 
• Change of staff at site that adversely impacts study conduct   
Any evident pattern of non-compliance with respect to these standards will be cause for the site 
to be put on probation.  If corrective actions are not subsequently undertaken, the clinical site 
will be asked to withdraw from the study and their site may be replaced. 
 
Notification of suspension or termination will occur no later than five (5) working days after the 
Sponsor makes the determination.  In the event of study suspension or termination, the Sponsor 
will send a report outlining the circumstances to the Institutional Review Board (IRB)/Ethics 
Committee (EC), and all Investigators and Regulatory Authorities as required by regulation.  A 

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suspended or terminated study may not be reinitiated without approval of the reviewing IRB/EC 
and Regulatory Authorities, as required by regulation. 
 
The Investigator must notify the IRB/EC in writing as soon as possible but no later than within 
10 days if the premature termination is related to safety or compliance issues. 
 
5 CLINICAL STUDY DESIGN   
The design of this continuation study will mirror the LEVANT 2 randomized protocol, except 
for the randomized component; all subjects that meet the LEVANT 2 criteria for randomization 
are instead treated with the Moxy Drug Coated Balloon.  After successful protocol-defined pre-
dilatation, subjects that are unlikely to require a stent based on strict angiographic criteria 
(absence of major flow-limiting dissection from the lumen and ≤ 70% residual stenosis or the 
lesion is not appropriate for stenting due to proximity to the knee joint) will be treated with the 
Moxy Drug Coated Balloon. 
 
Subjects that do not meet post-predilatation criteria are excluded (and treated per standard 
practice) and followed for safety only (via telephone or clinical follow up) for 30 days.   
Figure 3 contains an overview of the study.  
 
Post-Predilatation Lesion Criteria
Baseline Angiogram
Dilatation with Moxy 
Drug Coated Balloon
Defined Pre-Dilatation
(Balloon inflated to ~1mm <RVD)/
Enrollment
Defined bailout stenting
(if necessary) with FDA approved Stent. 
Standard Post-Dilatation per physician 
discretion.
Subjects followed for 
Safety through 30 days 
and withdrawn
Recruitment
Major Flow Limiting Dissection
-OR- 
Residual Stenosis >70%
Residual Stenosis ≤70% and Absence of Flow-Limiting 
Dissection
-OR-
Lesion is not appropriate for stenting due to proximity to 
the knee joint
Treat per Standard Practice or
No additional Treatment required
 
FIGURE 3:  STUDY FLOWCHART 
 

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5.1 SCREENING PROCEDURES 
For sites participating in the Randomized portion of the trial, enrollment in this registry will not 
start until the full randomized cohort (476 subjects) has been enrolled. 
All patients admitted for a percutaneous revascularization of a femoropopliteal artery should be 
screened for study eligibility.  If inclusion criteria are met and no exclusion criteria are present at 
the time of screening, the patient should be entered into a study Screening Log.  Once the 
patient’s eligibility has been determined, the Investigator will discuss the study and ask the 
patient to participate.  Prior to enrollment, the patient must sign the LEVANT 2 Continued 
Access informed consent form approved for use by the IRB/EC or other appropriate committee.  
A copy of the signed and dated Informed Consent will be provided to the subject.  Subjects will 
be assured that they may withdraw from the study at any time and for any reason.  The 
background and purpose of the study, participation requirements, as well as the potential benefits 
and risks of the procedure(s) must be explained to the subject. 
 
If not already performed as standard practice, the same assessments and tests must be performed 
as listed in the most recently approved LEVANT 2 randomized protocol after obtaining informed 
consent and prior to the index procedure (within 30 days unless otherwise noted) to verify and 
complete eligibility. 
 
5.2 PATIENT SELECTION FOR ENROLLMENT 
Subjects must meet all the clinical eligibility criteria, agree to participate and comply with study 
protocol requirement and follow-up schedule, and provide informed consent. 
All subjects are expected to remain available (geographically stable) for the duration of the study 
follow-up period.  If any subject moves away, every effort must be made to maintain the follow-
up schedule including having an appropriate physician follow the subject.  The Investigator is 
responsible for ensuring that each follow-up visit occurs at the specified time and that all 
applicable data is reviewed and entered into the electronic case report form system (eCRF) in a 
timely fashion. 
 
5.2.1 CASE PROCTORING REQUIREMENTS 
Each investigator enrolling in the study must undergo formal Moxy procedure proctoring with a 
sponsor representative (or designee) during their initial study Moxy case(s) if it was not 
completed as part of the randomization phase.  The sponsor reserves the right to limit the number 
of investigators performing the study procedure at a site and can expand case proctoring 
requirements as necessary to ensure compliance. 
 
5.3 SUBJECT INCLUSION AND EXCLUSION CRITERIA 
All Inclusion and Exclusion Criteria will be the same as in the most recently approved LEVANT 
2 randomized protocol. 
 

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5.3.1 INCLUSION CRITERIA 
 Reference section 5.3.1 of the LEVANT 2 Randomized protocol. 
 
5.3.2 EXCLUSION CRITERIA 
Reference section 5.3.2 of the LEVANT 2 Randomized protocol. 
 
6 STUDY/TREATMENT PROCEDURES 
 
6.1 ENROLLMENT 
A subject is considered enrolled in the study after both of the following steps have occurred: 
• Baseline angiographic confirmation that the target lesion meets all appropriate 
inclusion/exclusion criteria. 
• Defined pre-dilatation balloon inflation has begun. 
Subjects that do not meet post-predilatation criteria are enrolled but treated per standard practice 
and followed for safety for 30 days via telephone or clinical visit.  Subjects with target lesions 
that, after baseline angiography, do not meet all inclusion/exclusion criteria and are not pre-
dilated per protocol are considered screen failures and will not be enrolled or treated with the 
Moxy Drug Coated Balloon in this study. 
 
6.2 PRE-DILATATION 
Always refer to the current IFU packaged with the Moxy Drug Coated Balloon for complete pre-
dilatation requirements. 
 
Lesion(s) pre-dilatation(s) is required for all patients.  The predilatation balloon should be a 
standard PTA balloon inflated to a diameter approximately 1 mm less than the reference vessel 
diameter (RVD).  Always limit the longitudinal length of the pre-dilatation balloon to avoid 
creating a region of vessel injury that is outside the boundaries of the area to be treated by the 
Moxy Drug Coated Balloon (i.e. geographical miss).  In order to reduce dissections and potential 
subject allocation to the standard practice arm after pre-dilatation, careful and controlled pre-
dilatation(s) inflations should be performed and recorded (on film).  
 
See Table 2 for an overview of lesion assessment.  If, after pre-dilatation, the lesion site has a 
major flow-limiting dissection or residual stenosis >70%, the subject will not be treated with the 
Moxy Drug Coated Balloon but is instead treated per institutional standard practice.  Subjects 
excluded from treatment with the Moxy Drug Coated Balloon after pre-dilatation will be 
followed for 30 days for safety and then withdrawn. 
 
 

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TABLE 2: POST PRE-DILATATION LESION(S) CRITERIA 
Angiographic Condition 
Treatment 
Major Flow Limiting Dissection 
-OR- 
Residual Stenosis > 70% 
Excluded, not treated with 
Moxy Drug Coated 
Balloon, and followed for 
safety through 30 days 
Residual Stenosis ≤ 70% and Absence of Flow-Limiting Dissection 
-OR- 
Lesion is not appropriate for stenting due to proximity to the knee joint 
Treat with Moxy Drug 
Coated Balloon 
 
6.3 TREATMENT 
 
6.3.1 LUTONIX MOXY DRUG COATED BALLOON  
Please refer to the current Moxy Drug Coated Balloon IFU for detailed information on device 
use. 
 
The Investigator should determine the appropriate size of the balloon to be used by online QVA 
(if possible) or by visual estimate.  The Moxy Drug Coated Balloon should extend at least 5 mm 
proximally and distally of the pre-dilatation segment.  Care should be taken not to extend the 
entire injury segment unnecessarily. 
 
6.4 POST TREATMENT AND PROVISIONAL (BAILOUT) STENTING 
PROCEDURES 
The rate of provisional (i.e. bailout) stenting in prior SFA clinical trials, including those 
investigating drug coated balloons, has varied considerably.  In particular, a discrepancy has 
been noted in bailout rates between control and treatment arms in previous studies.  This 
discrepancy is likely attributable to investigator bias that the control arm is less likely to succeed 
and thus the threshold for stenting test-device treated subjects is lower.  There is no consensus or 
established objective criteria that are validated regarding the appropriate threshold for 
provisional SFA stenting.  In the absence of an established threshold, the determination to bailout 
has previously been based on criteria that are either subjective or largely left to the discretion of 
the individual operator and his/her judgment. 
 
The current study design is intended to minimize the need for bailout stenting.  Due to the need 
within the medical community to establish validated criteria for provisional stenting, this study 
will utilize more rigorous criteria for bailout stenting.  Specifically, the study will employ the 
additional requirement of a pressure gradient measurement to document an unsatisfactory 
balloon-only outcome (obtained by measuring pressures proximal and distal to the lesion 

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simultaneously).  The minimum pressure gradient threshold for bailout stenting (Table 3) has 
been established by consulting a number of experts who have extensive experience with SFA 
intervention, some of whom utilize pressure gradients routinely in their practices.  Requiring 
confirmation of a baseline pressure gradient prior to stenting establishes objective criteria that 
must be met for bailout stenting (and should reduce the rate in this study).  
 
TABLE 3: PROVISIONAL (BAILOUT) CRITERIA 
Bailout Prevention 
 Treatment requirement prior to bailout stenting: 
• Prolonged (>2 minutes) balloon inflation(s) 
• Vasodilators and/or thrombolytic agents per investigator discretion 
Bailout Criteria 
• Residual stenosis of  >50%  (based on careful in-lab review of angiograms including 
QVA if available)  or  major flow-limiting dissection  (Record angiography in 2 
orthogonal views) 
and 
• Documented translesional pressure gradient of >20mmHg (using ≤4F end-hole catheter) 
or >10mmHg (pressure wire) measured immediately distal to the target lesion 
 
These criteria are set as the minimum baseline pressure gradient requirement for allowing bailout 
stenting; however, bailout stenting is not required for pressures equal to or exceeding these 
thresholds (i.e. presence of a gradient at/above these thresholds does not require that the operator 
place a stent).  Rather, these thresholds are seen as minimum requirements for bailout stenting; 
below these thresholds, bailout stenting is not allowed. 
 
If the criteria for bailout stenting are fulfilled, placement of a bare nitinol stent approved by the 
FDA for use in the SFA is allowed.  The physician should use the shortest stent possible to treat 
only the clinically significant dissection or residual stenosis and not the entire target lesion. 
Antiplatelet therapy should be prescribed per the stent manufacturer’s IFU. 
 
The angiographic core lab and study steering committee will be monitoring cases of bailout 
stenting throughout the course of the study for compliance to provisional (bailout) criteria listed 
in this section. 
 
6.5 MEDICATIONS 
All pre-procedure, Intra-procedure and post-procedure medication requirements will be the same 
as in the most recently approved LEVANT 2 randomized protocol, reference section 7.2 of the 
LEVANT 2 Randomized protocol for the complete details of the pre-procedure, intra-procedure, 
and post-procedure medication regimen. 

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6.6 STANDARD TESTS, PROCEDURES, AND FOLLOW-UP 
All testing, procedures and follow-up requirements will be the same as in the most recently 
approved LEVANT 2 randomized protocol, (reference section 7.3 of the LEVANT 2 
Randomized protocol), with the exception of 
•  Six Minute Walk Test (7.3.1.5)  
• Walking Impairment Questionnaire (7.3.1.6)  
• Quality Of Life Questionnaires (7.3.1.7) 
• Economic Sub-Study (Appendix K)  
• CMP will be replaced with a BMP (without bicarbonate) in order to better correlate with 
lab capabilities in various geographies.  
Pharmacokinetic Testing may be necessary to reach a total of 30 PK sub study subjects if not 
completed as part of the LEVANT 2 randomized protocol. 
TABLE 4: FOLLOW-UP SCHEDULE AND TESTING REQUIREMENTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1  Follow-up can be by telephone or clinical visit, depending on timing of duplex ultrasound (if required) 
2Required if clinical visit occurs 
3Resting ABI is required within 90 days of index procedure.  
4Pre-procedure blood analysis must be performed within 30 days of the procedure 
5Pre-procedure and females of childbearing potential only 
 6PK study in a subset of subjects only 
Event 
Screening  
(pre-consent) 
Pre- 
Procedure 
Procedure 
Post- Procedure 
1 Month1 
6 Month 
12 Month 
24 Month 
36 Month1 
48 Month1 
60 Month1 
Visit Window 
30 
days 
30 
days 
±2  
weeks 
±1  
month 
±1  
month 
±2  
month 
±2  
month 
±2  
mont
h 
±2  
month 
Inclusion/Exclusion Criteria 
√ √ √ 
 
 
 
 
 
 
 
 
Informed Consent  
 
√ 
 
 
 
 
 
 
 
 
 
Medical History  
√ 
 
 
 
 
 
 
 
 
 
 
Physical Exam 
 
√ 
 
√ 
√2 
√ 
√ 
√ 
 
 
 
Medication Compliance 
 
√ 
 
 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Resting ABI3 
 
√ 
 
 
√2 
√ 
√ 
√ 
 
 
 
Rutherford Classification 
 
√ 
 
 
 
√ 
√ 
√ 
 
 
 
Blood Analysis (CBC with 
differential; BMP, pregnancy5)  
√4  
√ 
√2 
√ 
√ 
 
 
 
 
Angiogram 
 
 
√ 
 
 
 
 
 
 
 
 
Adverse Event Monitoring 
 
 
√ √ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Duplex Ultrasound  
 
 
 
√ 
√ 
√ 
√ 
 
 
 
PK Study6 
 
√ 
 
√ 
√ 
 
 
 
 
 
 

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7 ADVERSE EVENTS 
An adverse event (AE) is defined as any untoward medical occurrence in a subject.  This 
definition does not imply that there is a relationship between the adverse event and the device 
under investigation.  See Appendix A of the LEVANT 2 Randomized protocol for details of all 
the definitions. 
 
7.1 ADVERSE EVENT REPORTING 
All adverse events occurring since the start of the study procedure must be recorded in the eCRF. 
All serious adverse events will be reviewed and adjudicated by the Clinical Events Committee to 
determine whether it is related to the device or procedure.  All adverse events occurring in this 
study will be classified in accordance with the adverse event signs or symptoms.  Any Serious 
Adverse Event must be reported to Lutonix or designee within 24 hours of knowledge.  All 
adverse events will be reported to the IRB/EC per local requirements. 
 
8 SUBJECT WITHDRAWAL CRITERIA 
Subjects can withdraw from the study at any time for any reason; the reason for withdrawal will 
be documented.  All data available at the time of withdrawal (if any) will be used for analysis. 
There will be no further follow-up (per this study protocol) on the subject who has withdrawn.   
If a visit is missed, the site is required to document a minimum of three (3) attempts to contact 
the subject within the follow-up window.  If the subject only misses one protocol required visit, 
the site should repeat the three (3) attempts to contact the subject followed by a certified letter.  
When a subject misses two (2) consecutive follow-up visits with failure of all contact attempts, 
the subject may then be considered lost to follow up and exited from the study. 
 
9 DATA COLLECTION AND MONITORING 
 
9.1 
  DATA COLLECTION 
The Investigator (or designated hospital staff) will assure primary data collection based on 
source-documented hospital chart reviews.  These documents will be completed in an expedited 
fashion. 
 
9.1.1 ELECTRONIC CASE REPORT FORMS (ECRF) 
All required clinical data for this trial will be collected in web-based standardized eCRF.  The 
same electronic data capture system and the same DCB treatment eCRF as in the LEVANT 2 
randomized protocol will be utilized (minus those data points associated with items excluded in 
section 6.3).  Clinical trial data will be collected in accordance with the Guidance for Industry: 
Collection of Race and Ethnicity Data in Clinical Trials.  Subject personal information should be 

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blinded.  Site numbers, subject numbers and initials will be used to track subject information 
throughout the study. 
 
The eCRF is designed to accommodate the specific features of the study design.  Modification of 
the eCRF will only be made if deemed necessary by Lutonix and/or the appropriate regulatory 
body.   
 
9.1.2 ANGIOGRAMS AND DUPLEX ULTRASOUNDS 
All core lab raw data will be sent to the independent Core Lab listed in the study summary.  A 
specific algorithm will be used to analyze each core lab result.  This information will be 
documented on a study form and the data transmitted to Data Management for integration into 
the main study database.   
 
9.2 
  MONITORING 
A formal written Monitoring Plan will be developed in accordance to FDA guidelines 53 CFR 
4723 and the continuation access study protocol by the CROs appointed for this study and 
approved by Lutonix.  Appropriately trained and qualified monitoring personnel will monitor the 
progress of this study.   
 
Each site will have an initiation visit or call performed by a study team member prior to initiation 
of enrollment into the continuation access study.  This visit or call will ensure that the 
investigator understands his/her responsibility for conducting this study at his/her center.  This 
includes, but is not limited to, device accountability, protocol compliance, informed consent 
process, enrolling appropriate subjects, and IRB/EC submissions, approvals, and continuing 
reviews. 
 
Monitoring will be performed on original medical records of all enrolled subjects.  Sites will be 
monitored according to the approved monitoring plan.  Monitoring personnel will monitor for 
accuracy and timely submission of data forms and core lab images, and compliance with the 
study protocol, applicable regulations, the signed Investigator Agreement and any conditions of 
approval imposed by the reviewing IRB/EC and/or regulatory agencies.  Monitoring personnel 
will also confirm documentation of the informed consent process, missing visits or examinations, 
and the reason for any subject failing to complete the study.   
 
Any evident pattern of non-compliance with respect to these standards will be cause for the site 
to be put on probation.  If corrective actions are not subsequently undertaken, the clinical site 
will be asked to stop enrollment and complete outstanding follow-up visits for subjects already 
enrolled at their site.   
 

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Monitoring visits will be scheduled based on the enrollment rate at each site, duration of the 
study, compliance, and any suspected inconsistency in data that requires investigation.   
The Study Monitors will maintain personal contact with the Investigator and staff throughout the 
study by phone, mail, and on-site visits.  The Study Monitors will compile and submit to Lutonix 
a monitoring report after each visit which will include any findings, conclusions, and actions 
taken to correct deficiencies.  Specifically, the Study Monitors will review: 
• Screening Procedures 
• Discontinuation of Treatment 
• Source Data 
• Adverse Event/Serious Adverse Event Recording and Reporting 
• Investigational Device Reconciliation 
• Study Data and Core Lab Data Submission 
• Protocol Deviations 
At the close of the study at an investigational site, appropriately trained personnel appointed by 
Lutonix will make a final on-site visit.  The purpose of this visit is to collect all outstanding 
study data documents, ensure that the Investigator's files are accurate and complete, review 
record retention requirements with the Investigator, make a final accounting of all study supplies 
shipped to the Investigator, provide for appropriate disposition of any remaining supplies, and 
ensure that all applicable requirements are met for the study.  The observations and actions made 
at this visit will be documented and communicated to the Investigator. 
 
9.3 
  SOURCE DOCUMENTATION 
Auditors, monitors, medical IRB/ECs, the study Sponsor and regulatory authorities may have 
access to the medical records related to this study.  Original or certified copies of all relevant 
clinical findings, observations, and other activities throughout the clinical investigation must be 
recorded and maintained in the medical file of each enrolled subject.  (No source documentation 
will be recorded directly on a CRF).  At a minimum, the following must be included in each 
subject’s file: 
• Sufficient medical history and current physical condition, including any medication(s) 
the subject is taking at the time of the procedure to assess the subject’s eligibility; 
• The medical file should reveal the subject’s participation in this study, including start 
and expected follow-up time; 
• Dated report of the investigational procedure including medication, material usage, 
and complications, if applicable; 
• Dated reports of the discharge and follow-up assessments; 
• Dated results of required laboratory tests; 
• Any adverse event(s), the resultant action or treatment, and outcome, if applicable; 
and 

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• In the case of withdrawal of subject consent, reason and subject status at time of 
withdrawal.  
The Investigator will permit study–related monitoring, audits, IRB/EC review and authority 
inspections by allowing direct access to the source data.  
In case of electronic source data, access will be allowed or dated print-outs will be available 
prior to the monitoring visits.  Print-outs should not be limited to the vascular data only, but 
should include all available data related to the identified subject(s).  
 
9.4 
   RECORD RETENTION 
The Sponsor and Investigator will maintain the following accurate, complete, and current records 
relating to the conduct of the investigation according to national requirements.  The data for 
some of these records may be available in computerized form from the CRO, but the final 
responsibility for maintaining study records remains with the Investigator.  These include: 
• All correspondence with another Investigator, an IRB/EC, a Core Laboratory, 
Lutonix, a monitor, or regulatory agency, including required reports; 
• Records of receipt, use, or disposition of the investigational device, including receipt 
dates, serial and/or lot numbers, names of all persons who received or used the 
device, why and how many devices were returned to or otherwise disposed of.  
Device reconciliation logs should be kept current and available to Lutonix and 
monitor upon request; 
• Records of each subject's case history, source documents, evidence of informed 
consent, all relevant observations of adverse study device effects, the condition of 
each subject upon entering and during the course of the investigation, relevant 
medical history, the results of all diagnostic testing, and the date of each study 
treatment; 
• Screening log, enrollment log, study personnel visit log; 
• Any other records that the regulations require to be maintained. 
 
9.5 
  STUDY PROCESSING 
 
9.5.1 
 COMMUNICATION 
During the course of the study, regular teleconference calls between Lutonix, the CRO, the Study 
Monitor(s) and each clinical site (if necessary) will be conducted to resolve any problems 
concerning the protocol and data collection.  Every effort will be made to ensure compliance 
with the protocol.  
 
9.5.2 TRAINING 
The training of appropriate clinical site personnel and support staff will be the responsibility of 
Lutonix or their designee.  To ensure proper device usage, uniform data collection and protocol 

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compliance, Lutonix or their designee will present a formal documented training session(s) to 
new study site personnel which will include, but may not be limited to, the following: 
• Techniques for the identification of eligible subjects  
• Protocol 
• Device Training 
• Core lab Instructions 
• Instructions on study and adverse event data collection  
• Schedules for follow-up with the study site coordinators  
• Regulatory requirements  
Detailed feedback regarding completion of forms will be provided by Lutonix or designee, 
through regular site monitoring. 
 
10 DEVICE ACCOUNTABILITY 
All investigational Moxy Drug Coated Balloon must be stored in a locked storage facility to 
which only the Investigator and/or designated study staff will have access.  The Investigator is 
responsible for device accountability at the trial site.  The Investigator may assign the 
responsibility for the device accountability to an appropriate study staff member, but remains the 
final responsible person.  The Investigator must ensure that the device is used only in accordance 
with the protocol and current IFU.  The Investigator must maintain records that document device 
delivery to the trial site, the inventory at the site and administration to each subject.  These 
records must include dates, quantities, batch/serial numbers, expiration dates, and the unique 
code numbers assigned to the trial subjects.  The Investigator must maintain records that 
adequately document which device the subject received according to the protocol and the 
assigned randomization.  In the case where a device has failed, the Investigator must make every 
possible effort to return the device to Lutonix; instructions for this procedure will be provided in 
the Manual of Operating Procedures. 
 
11 STUDY MANAGEMENT 
The Principal Investigators for this study are Kenneth Rosenfield, MD, Boston, MA, USA and 
Dierk Scheinert, MD, Leipzig, Germany. 
 
11.1  SAFETY COMMITTEES 
The Steering Committee (SC)and Clinical Events Committee will continue to function in the 
same manner as in the LEVANT 2 Randomized protocol.   
 
11.2  IRB/EC APPROVAL 
Investigators must submit the study protocol to their IRB/EC and obtain written approval before 
being allowed to conduct and participate in the continued access study.  Annual re-approval must 
also be obtained.  The Investigator is also responsible for fulfilling any conditions of approval 

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imposed by the IRB/EC, such as regular safety reporting, study timing, etc.  The Investigator will 
provide Lutonix or designee with copies of such approvals and reports. 
 
Any amendments to the protocol, as well as possible associated information and consent form 
changes, will be submitted to the IRB/EC and written approval obtained prior to implementation.  
 
11.3   INFORMED CONSENT 
Part of the IRB/EC approval must include approval of an Informed Consent Form (ICF) that is 
specific to the continued access study and approved by the FDA and any other relevant 
regulatory bodies.  The Investigator must administer this approved ICF to each prospective study 
subject, and obtain the subject's signature on the ICF prior to enrollment in the study.  The ICF 
may be modified to suit the requirements of the individual site.  The Investigator will provide 
Lutonix or designee with a copy of the approved ICF for his/her site.  Lutonix or designee must 
pre-approve each ICF prior to initial submission to the IRB/EC; major changes must be approved 
by the FDA. 
 
The study must be explained in a language that is understandable to the subject and he/she must 
be allowed sufficient time to decide whether to participate.  All subjects will be assured that they 
have the right to withdraw from the study at any time during the course of the protocol and this 
decision will not influence his/her relationship with the Investigator (treating physician) and/or 
study staff.  
 
11.4   INVESTIGATOR’S RESPONSIBILITIES 
Each Investigator is responsible for ensuring the investigation is conducted according to all 
signed agreements, the Investigational Plan and applicable laws and regulations.  The site 
Principal Investigator will select qualified co-investigators at each site and will maintain 
responsibility for oversight of all procedures and data collection.  All co-investigators must be 
trained on all aspects of the protocol prior to enrolling and performing procedures.  All 
interventionalists performing procedures must be trained as co-investigators in the study. 
The Investigator may not begin enrollment in the continued access study until Lutonix or 
designee receives appropriate IRB/EC approval and any other applicable document (revised 
investigator agreement, etc.) 
 
11.4.1 STUDY COORDINATOR 
To ensure proper execution of the Investigational Plan, each Investigator must identify a Study 
Coordinator for the site.  Working with and under the authority of the Investigator, the Study 
Coordinator helps ensure that all study requirements are fulfilled, and is the contact person at the 
site for all aspects of study administration.  The Investigator has the ultimate responsibility of all 
study requirements. 
 

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11.4.2 REPORTS 
Report requirements will be the same as listed in the most current LEVANT 2 Randomized 
protocol.  
 
12 PUBLICATIONS 
The publication policy will be the same as listed in the most current LEVANT 2 Randomized protocol. 
13 STATISTICAL ANALYSIS PLAN  
 
13.1   OVERVIEW OF STUDY DESIGN 
The purpose of the LEVANT 2 Continued Access registry is to collect additional safety and 
efficacy information of the Lutonix Moxy Drug Coated Balloon for treatment of stenosis or 
occlusion of the femoral and popliteal arteries in a large population of subjects.  The LEVANT2 
Continued Access Study is an open-label registry study of the Drug Coated Balloon.  
 
Approximately 975 subjects will be enrolled in order to include a total of 650 subjects treated 
with the Moxy Drug Coated Balloon after successful predilatation.  Subjects are considered 
enrolled in the study after being consented and the defined pre-dilatation balloon inflation has 
begun.  Based on angiographic results after predilatation, up to 1/3 of predilated subjects are not 
expected to meet criteria for enrollment and will be treated per standard of care.  Enrollment will 
continue only until a sample size of 650 DCB-treated subjects is achieved. 
 
The Primary Endpoint is the rate of unanticipated device- or drug- related adverse events over 
time through 60 months.  Secondary endpoints include the rate at 1, 6, 24, 36, 48, and 60 months 
and the primary and majority of the secondary endpoints of the LEVANT 2 Randomized Study. 
 
13.2   SAMPLE SIZE JUSTIFICATION 
Taken together with the LEVANT 2 Randomized Study, the 650 additional DCB subjects 
enrolled in the LEVANT 2 Continued Access registry will provide a safety dataset on 1022 
subjects treated with the Drug Coated Balloon, since the LEVANT 2 Randomized Protocol 
includes approximately 55 roll-ins and 317 test subjects randomized to drug coated balloon.  
Allowing for up to 15% loss-to-follow-up, an evaluable sample size of 869 test subjects is 
expected.  If the observed rare adverse event rate is 1%, then the upper limit of the 95% 
Confidence Interval is 1.8% (PASS2008: Exact Clopper-Pearson).  Assuming an expected 1% 
incidence rate, Power is > 95% to observe at least 4 unexpected SAEs (PASS2008: Post-
Marketing Surveillance).  Similarly, if the observed rate is 2%, then the upper limit of the 95% 
Confidence Interval is 3.0%.  Assuming an expected 2% incidence rate, Power is > 95% to 
observe at least 11 unexpected SAEs.  This study provides the ability to detect and describe the 
rate of rare unanticipated adverse events with some precision.  
 

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US and non-US enrollment will be contemporaneously monitored throughout the study to ensure 
adequate sampling of both US and non-US subjects. 
 
13.3   ANALYSIS  
Data from all the subjects treated with DCB in the LEVANT 2 Randomized protocol (roll-in and 
randomized to DCB) and in the LEVANT 2 Continued Access registry will be combined and 
analyzed using descriptive statistics.  To assess the consistency of results under different 
analyses, secondary as-treated (AT) and per-protocol (PP) analyses will be performed for the 
primary and secondary endpoints.  An additional supportive analysis of patients with and without 
bailout stenting will also be performed based on descriptive statistics, and data will further be 
presented for PP analysis of subjects with and without bailout stenting.  Poolability by geography 
and by test group (LEVANT2 roll-ins, randomized subjects, and continued access subjects) will 
also be evaluated. 
 
In addition to the primary endpoint, all secondary endpoints will also be analyzed using 
descriptive statistics.