LIBERTY 360: Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients With Distal Outflow Peripheral Arterial Disease (PAD)
Conditions: Peripheral Arterial Occlusive Disease
Sponsor: Abbott Medical Devices

NCT 01855412

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Table of Contents
1.
ABBREVIATIONS........................................................................................................ 6
2.
DEFINITIONS............................................................................................................... 7
3.
INTRODUCTION.......................................................................................................... 8
4.
DEVICES USED IN STUDY......................................................................................... 9
5.
STUDY DESIGN AND STATISTICAL METHODOLOGY....................................... 9
5.1. STUDY DESIGN............................................................................................................ 9
5.2. STATISTICAL METHODOLOGY.............................................................................10
6.
SAMPLE SIZE AND SUBJECT ENROLLMENT......................................................10
6.1. SAMPLE SIZE..............................................................................................................10
6.2. SUBJECT ENROLLMENT .........................................................................................10
6.3. SUBJECT SELECTION...............................................................................................10
6.4. INCLUSION CRITERIA .............................................................................................10
6.5. EXCLUSION CRITERIA ............................................................................................11
7.
STUDY OBJECTIVE...................................................................................................11
8.
STUDY ENDPOINTS...................................................................................................11
9.
FOLLOW-UP VISITS..................................................................................................12
11.
ADVERSE EVENTS.....................................................................................................14
11.1.ADVERSE EVENT DEFINITIONS.............................................................................14
11.2.ADVERSE EVENT CLASSIFICATION.....................................................................15
11.3.ADVERSE EVENT REPORTING...............................................................................15
13.
RISKS AND BENEFITS...............................................................................................15
13.1.RISKS............................................................................................................................15
13.2.BENEFITS ....................................................................................................................15
14.
PROTOCOL DEVIATIONS........................................................................................16

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1. ABBREVIATIONS
ABI
Ankle Brachial Index
AE
Adverse Event
AT
Anterior Tibial
BA
Balloon Angioplasty
CFR
Code of Federal Regulations
CLI
Critical Limb Ischemia
CSI
Cardiovascular Systems, Inc.
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
FDA
Food and Drug Administration
HIPAA
Health Insurance Portability and Accountability Act
IC
Intermittent Claudication 
ICF
Informed Consent Form
IFU
Instructions for Use
IRB
Institutional Review Board
MAE
Major Adverse Event
LER
Lower Extremity Revascularization
OAS
Orbital Atherectomy System
PAD
Peripheral Artery Disease
PI
Principal Investigator
POBA
Plain Old Balloon Angioplasty
POP
Popliteal
PPG
Photoplethysmography
PR
Peroneal Tibial
PT
Posterior Tibial
PTA
Percutaneous Transluminal Angioplasty
SFA
Superficial Femoral Artery
TBI
Toe Brachial Index
TLR
Target Lesion Revascularization 
TVR
Target Vessel Revascularization
TPT
Tibial Peroneal Trunk
US 
United States

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11.ADVERSE EVENTS
11.1.
ADVERSE EVENT DEFINITIONS
Adverse events (AEs) collected in this study will be limited to death, serious injury, angiographic 
complications related to the index procedure, revascularizations, amputations of either lower limb,
myocardial infarction and stroke.  For the purposes of this study, pre-planned interventions noted at 
baseline are not considered AEs.

Major adverse events (MAEs) are defined for the purpose of the data analyses of the study 
endpoints and include:
o
Death within 30 days of index procedure
o
Unplanned major (above the ankle) amputation of the target limb
o
Clinically-driven TLR and/or TVR of the target limb
 

Device-related serious injuries, including death, are required by the FDA to be reported as part 
of post market surveillance of medical devices per 21 Code of Federal Regulations (CFR) 803.  
Serious injury means an injury or illness that is device related and includes the following:
o
Is life-threatening,
o
Results in permanent impairment of a body function or permanent damage to a body 
structure, or
o
Necessitates medical or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure.
Device related means related to any interventional device used during index procedure on the 
target limb.
Permanent means irreversible impairment or damage to a body structure or function, excluding 
trivial impairment or damage.
Medical interventions may include hospitalizations or prolonged hospitalizations due to the use of 
the interventional devices used in this study.

Procedural angiographic events that occur during index procedure on the target limb regardless 
of device relatedness that include the following:
o
Dissections of target lesion 
o
Perforations of target lesion 
o
Slow flow/no re-flow 
o
Acute vessel closure 
o
Distal embolization
o
Thrombus formation
o
Other angiographic complications determined reportable by treating physician

Revascularization or amputation of either lower limb that occurs during subject’s
participation in the study

Myocardial Infarction that occurs within 30 days following enrollment

Stroke that occurs within 30 days following enrollment

Death (all causes) throughout study participation

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pre-approve all changes to the ICF prior to initial submission to the IRB.  A copy of the original IRB-
approved ICF must be sent to the Sponsor prior to study start while the original must be retained at 
the study site.  If the ICF is amended by the reviewing IRB, a copy of the approved document must be 
provided to the Sponsor prior to enrollment of subjects in the study.
The Investigator or authorized designee must administer the approved ICF to each prospective study 
subject. Informed consent must be obtained in accordance with the applicable guidelines of 21 CFR 
Part 50 and local laws and regulations, whichever represents the greater protection of the individual.  
This study will be registered on http://www.ClinicalTrials.gov.  The following statement will be 
included in the ICF for the study to notify the prospective subjects for the study:  "A description of 
this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This 
Web site will not include information that can identify you.  At most, the website will include a 
summary of the results.  You can search this website at any time."
19.3.
CONFIDENTIALITY
All information and data sent to the Sponsor concerning subjects or their participation in this study 
will be considered confidential.  All data used in the analysis and reporting of this data will be used in 
a manner without identifiable reference to the subject.  The Investigator consents to visits by the 
Sponsor or designee and authorized governmental body to review the study subjects’ medical records, 
including any test or laboratory data that may have been recorded on diagnostic test media (e.g., 
angiogram).
19.4.
SPONSOR RESPONSIBILITIES
Sponsor responsibilities include but are not limited to:

Selection of Principal Investigators, study sites, and Core Laboratories who participate in the 
study;

Training of participating study sites including the Investigator and staff conducting the study;

Providing financial support to each study site which is fair, reasonable, and equitable to fair 
market value;

Following/promoting all applicable regulatory standards per applicable regulations at each 
study site; and,

Ownership and control of the use of data, including review and approval of study-related 
publications/presentations, etc.
19.5.
INVESTIGATOR RESPONSIBILITIES
The Investigator is responsible for the following:

Protecting the rights, safety, and welfare of subjects.

Conducting the investigation in accordance with the Clinical Trial Agreement with the 
Sponsor, the Protocol, applicable FDA regulations, including 21 CFR Part 50 and 56, and any 
conditions of approval imposed by the IRB.

Delegation of study-related tasks to qualified personnel under their supervision as may be
applicable; however, the Principal Investigator remains responsible for the proper conduct of 
the clinical study.  

Enrollment will commence when the Sponsor has received all required documentation, 
including but not limited to the signed Clinical Trial Agreement and IRB approvals.

At each site, appropriate procedures must be followed to maintain subject confidentiality 
according to the Health Insurance Portability and Accountability Act (HIPAA) regulations.  
Each site may have its own internal procedures or requirements for use and release of subject 
medical information in research studies.  Each Investigator is responsible for obtaining