A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
Conditions: Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
Sponsor: C. R. Bard

 
 
 
 
 
CLINICAL PROTOCOL 
 
 
Title:  
A Prospective, Multi-Center, Single-Arm, Real-World Study 
Assessing the Clinical Use of the Bard® UltraScore™ Focused 
Force PTA Balloon 
 
Protocol Number:   BPV-16-001 
 
Study Type: 
Post-Market 
 
Date: 
May 2, 2017 
 
Version: 
1.0 
 
Study Device: 
ULTRASCORETM Focused Force PTA Balloon  
 
Sponsor: 
Bard Peripheral Vascular, Inc. 
 
1625 West 3rd Street 
 
Tempe, AZ 85281 
 
 
 
 
 
 
 
 
 
 
 
This document contains information that is the confidential and proprietary property of C. R. Bard, Inc. Neither this 
document nor the information therein may be reproduced, used or distributed to or for the benefit of any third party 
without the prior written consent of Bard. Shred to dispose of document. 

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Sponsor Contact: 
Project Manager 
Ryan Melloy 
Project Manager, Clinical Affairs 
Bard Peripheral Vascular, Inc. 
1625 West 3rd Street 
Tempe, AZ 85281 
Telephone: (480) 350-6074 
Fax: (480) 449-2542 
E-mail: ryan.melloy@crbard.com  
Medical Monitor: 
Bill Altonaga, M.D.  
Medical Director 
Bard Peripheral Vascular, Inc.  
1625 West 3rd Street 
Tempe, AZ 85281 
 
E-mail: bill.altonaga@crbard.com 
  
Revision History: 
Protocol Version  
Description of Changes 
1.0 
Initial Protocol Version 
 

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1 PROTOCOL SUMMARY 
Title: 
A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing 
the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon 
Sponsor: 
Bard Peripheral Vascular, Inc. 
1625 West 3rd Street 
Tempe, AZ 85281 
Objectives: 
The objective of this study is to assess the clinical use of the Bard® 
UltraScore™ Focused Force PTA balloon in a heterogeneous patient 
population in a real world, on-label clinical application. 
Design & 
Overview: 
This is a prospective, multi-center, single-arm, real-world study to 
assess the clinical use of the Bard® UltraScore™ Focused Force PTA 
balloon for the treatment of stenotic lesions of the superficial femoral 
artery (SFA), popliteal artery, and infra-popliteal arteries (posterior 
tibial, anterior tibial and peroneal arteries). Follow-up for all treated 
subjects will be performed at hospital discharge, 30 days, and 6 and 12 
months post-index procedure. 
Study Device: 
The UltraScore™ Focused Force PTA balloon is a flexible, over the wire 
(OTW) catheter shaft with a semi-compliant balloon fixed at the distal 
end. There are radiopaque markers to aid in visualization of the working 
length of the balloon during fluoroscopy. Two scoring wires, oriented 
180° apart provide focused force upon dilatation. 
The UltraScore™ Focused Force PTA balloon is compatible with .014” 
or .035” guidewires. Shaft sizes are either 130cm (.035”) or 150cm 
(.014”) and include the GeoAlign® Marking System. 
Enrollment: 
A maximum of 350 subjects will be treated in the study. This will allow 
for approximately 175 subjects in an above the knee (ATK) cohort and 
175 subjects in a below the knee (BTK) cohort. Endpoint analysis will 
occur when all subjects have completed the 12 month follow up. All 
subjects will be followed for 12 months post index-procedure. 
Study Sites: 
Up to 35 investigational sites in the United States (US) will participate. 
Study 
Population: 
Male or non-pregnant female ≥ 21 years of age with an expected 
lifespan sufficient to allow for completion of all study procedures. 
Eligible subjects will have a stenotic lesion of the SFA, popliteal, or 
infra-popliteal arteries. ATK subjects will be those that have a lesion of 
the SFA or popliteal artery. BTK subjects will be those that have a 
lesion in the infra-popliteal arteries (posterior tibial, anterior tibial or 
peroneal arteries). 

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Inclusion 
Criteria 
Inclusion Criteria 
1. 
Subject must voluntarily sign and date the Informed Consent Form 
(ICF) prior to collection of study data or performance of study 
procedures. 
2. 
Subject must be either a male or non-pregnant female ≥ 21 years of 
age with an expected lifespan sufficient to allow for completion of 
all study procedures. 
3. 
Subject must be willing to comply with the protocol requirements, 
including the follow-up procedures. 
4. 
Subject must have a target lesion (de novo lesion or prior failed 
treatment) that can be treated with the UltraScore™ Focused Force 
PTA balloon according to the Instructions for Use (IFU). Only a 
target lesion in the SFA, popliteal, or infra-popliteal arteries 
(posterior tibial, anterior tibial, or peroneal arteries) may be treated 
for this study. 
5. 
Subject must have an ATK or BTK target lesion with at least one 
vessel run-off. 
6. 
The target lesion must be able to be crossed using a guidewire (use 
of chronic total occlusion (CTO) or atherectomy is allowed). 

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Exclusion 
Criteria 
Exclusion Criteria 
1. Subjects that are to receive one or more stents as adjunctive 
therapy at the target lesion (bail out stenting is allowed). 
2. The subject has a single target lesion that involves both ATK and 
BTK arteries. 
3. The subject has a target lesion in a previously placed stent or 
stent graft (in-stent restenosis). 
4. The subject has a lesion, which in the opinion of the Investigator, 
would preclude safe use of the UltraScore™ Focused Force PTA 
balloon. 
5. The subject has a flow limiting dissection at the target lesion 
prior to use of the UltraScore™ Focused Force PTA balloon. 
6. The subject has acute limb ischemia. 
7. The subject has been assessed Rutherford category 6. 
8. The subject has a known allergy or sensitivity to contrast media, 
which cannot be adequately pre-medicated.   
9. The subject has another medical condition or is currently 
participating in an investigational drug or another device study 
that, in the opinion of the Investigator, may cause him/her to be 
non-compliant 
with 
the 
protocol, 
confound 
the 
data 
interpretation, or is associated with a life expectancy insufficient 
to allow for the completion of study procedures and follow-up. 
Procedures: 
All subjects will undergo a clinical evaluation at screening (prior to 
index procedure); after consent is voluntarily obtained study subjects 
will be treated with the UltraScore™ Focused Force PTA balloon per the 
site’s standard of care and adhering to the IFU. 
Examinations, evaluations, procedural preparation, angiography, 
treatment and hospital discharge procedures will be conducted per the 
study site’s standard of care. 
Investigators are able to treat 1 (one) lesion per patient in this study. If a 
subject has multiple eligible lesions, the investigator may use his or her 
medical judgment as to which becomes the study target lesion. 
Standard of care treatment of non-target lesions is allowed. 
Subjects with treated ATK lesions will undergo clinical evaluations with 
a Duplex Ultrasound (DUS) performed at 30 days and 6 and 12 months 
post-index procedure. 
Subjects with treated BTK lesions will undergo clinical evaluations 
performed at 30 days and 6 and 12 months post-index procedure. DUS 
is not required for subjects with a treated BTK lesion for this study. 

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Primary 
Endpoints 
Primary Endpoints 
 
Achieve optimal PTA results (≤30% residual stenosis, without 
major flow limiting dissection). 
 
Achieve technical success of use where the UltraScore™ Focused 
Force PTA balloon is delivered to the target lesion and inflated 
without movement. 
 
Secondary 
Endpoints: 
Secondary Endpoint 
After UltraScore™ Focused Force PTA balloon: 
 Rate of bail-out stenting due to dissection 
Through follow-up (at 30 days and 6 and 12 months): 
 Freedom from Target Lesion Revascularization (TLR) 
 Freedom from major amputation (above the ankle) 
 Improved clinical measures from baseline (ABI, Rutherford) 
 Primary patency for ATK subjects only (as measured by DUS 
core lab; a PSVR ≥2.5 suggests 50% restenosis) 
Other Analyses: 
Other Analyses 
 Target lesion characteristics (e.g. location, type) 
 Procedure details (e.g. duration, inflation times, inflation 
pressures, number of inflations to efface/dilate the target lesion) 
 Adjunctive therapies before and after UltraScore use 
 
Subgroup Analyses 
 Comparison of primary and secondary endpoints between above 
the knee (ATK) and below the knee (BTK) subjects 
 Outcomes based on adjunctive treatments 

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Lead Principal 
Co-
Investigators: 
Craig Walker, M.D. 
Cardiovascular Institute of the South 
225 Dunn Street 
Houma, LA 70360 
Telephone: (985) 876-0300 
 
Robert Beasley, M.D. 
Mount Sinai Medical Center 
4300 Alton Road, Suite 2071 
Miami Beach, FL 33140 
Telephone: (305) 674-2071 
 
Miguel Montero, M.D. 
St. Luke’s Health 
6620 Main Street 
Houston, TX 77030 
Angiographic 
Core Laboratory 
Angiographic Core Lab 
Alexandra J. Lansky, M.D. 
Yale Cardiovascular Research Group 
1 Church Street, Suite 330 
New Haven, CT 06510 
Telephone: (203) 737 – 2142 
 
DUS Core 
Laboratory 
DUS Core Lab 
Ido Weinberg, M.D. 
VasCore 
62 Staniford Street 
Boston, MA 02114 
Telephone: (617) 726-2256 

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Principal Investigator’s Responsibility 
 
Prior to participation in the UltraScore™ Focused Force PTA Balloon Study (the UltraScore 
study), the Principal Investigator (PI) must sign the Clinical Study Agreement (CSA) and 
obtain written approval from his/her Institutional Review Board (IRB). This approval must 
be in the Investigator’s name and a copy sent to Bard along with the IRB approved Informed 
Consent Form (ICF) and the signed CSA, prior to beginning enrollment. The PI must receive 
Bard-sponsored training prior to beginning enrollment. The PI (or designee) is responsible 
for training all Sub-Investigators prior to performing any data collection or study-related 
procedures. 
The PI must also: 
 Conduct the study in accordance with the study protocol, the signed CSA, the 
Declaration of Helsinki, Health Insurance Portability and Accountability Act 
(HIPAA) requirements, Good Clinical Practice (GCP) including 21 CFR Parts 50, 54, 
and 56. 
 Ensure that the study does not commence until IRB approvals have been obtained. 
 Ensure that written informed consent is obtained from each subject prior to the 
conduct of any study procedure; using the current IRB approved ICF. 
 Provide all required data and reports and agree to source document verification of 
study data with subject’s medical records. 
 Allow Bard personnel or their designee(s), as well as FDA representatives, to inspect 
and copy any documents pertaining to the study. 
 Provide appropriate resources to ensure compliance with all study-related procedures 
and prompt submission of all case report forms. 
 Use best efforts to communicate protocol requirements to referring physicians. 
The PI may delegate one or more of the above functions to a Sub-Investigator provided that 
the Sub-Investigator first signs the Sub-Investigator Protocol Signature Page and receives 
appropriate training. However, the Principal Investigator retains overall responsibility for 
IRB approval and proper conduct of the study, including obtaining and documenting the 
Informed Consent process, compliance with the study protocol, obtaining a signed CSA, the 
collection of all required data, and ensuring that all study personnel have been properly 
trained on the protocol and have received other necessary training (if applicable) prior to 
performing any data collection or study-related procedures. 

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Principal Investigator Protocol Signature Page 
 
 
Site name:  ____________________________________________________________ 
 
 
I have read and understand the contents of the UltraScore Study protocol. I agree to follow 
and abide by the requirements set forth in this document. I agree to conduct the study in 
accordance with the study protocol, the signed CSA, the Declaration of Helsinki, HIPAA 
requirements, GCP including 21 CFR Parts 50, 54, and 56.  
I agree to participate in Bard-sponsored training prior to performing any data collection or 
study-related procedures. 
 
_________________________________________ 
Principal Investigator Name (print) 
 
 
_________________________________________ _____________________ 
Principal Investigator Signature 
 
 
Date 

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Sub-Investigator Protocol Signature Page 
 
 
Site name:  ____________________________________________________________ 
 
 
I have read and understand the contents of the UltraScore Study protocol. I agree to follow 
and abide by the requirements set forth in this document. I agree to conduct the study in 
accordance with the study protocol, the signed CSA, the Declaration of Helsinki, HIPAA 
requirements, GCP including 21 CFR Parts 50, 54, and 56.  
I agree to complete training prior to performing any data collection or study-related 
procedures. 
 
 
_________________________________________ 
Sub-Investigator Name (print) 
 
 
_________________________________________ _____________________ 
Sub-Investigator Signature 
 
 
 
Date 

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TABLE OF CONTENTS 
1  PROTOCOL SUMMARY .........................................................................................................3 
2  INTRODUCTION ...................................................................................................................13 
2.1  Background and Rationale .............................................................................................13 
2.2  Study Rationale ..............................................................................................................13 
2.3  Device Description .........................................................................................................13 
2.3.1  UltraScore™ Focused Force PTA Balloon .........................................................13 
3  STUDY DESIGN.....................................................................................................................14 
4  STUDY ENDPOINTS .............................................................................................................15 
4.1  Primary Endpoint ...........................................................................................................15 
4.1.1  Primary Endpoints ...............................................................................................15 
4.2  Secondary Endpoints ......................................................................................................15 
5  STUDY POPULATION ..........................................................................................................15 
5.1  Inclusion Criteria ............................................................................................................15 
5.2  Exclusion Criteria ...........................................................................................................16 
6  STUDY / TREATMENT PROCEDURES ..............................................................................16 
6.1  Subject Screening and Baseline Evaluations .................................................................16 
6.1.1  Informed Consent ................................................................................................17 
6.1.2  Eligibility .............................................................................................................17 
6.1.3  Baseline Examinations ........................................................................................17 
6.2  Index Procedure ..............................................................................................................17 
6.2.1  Adjunctive Treatment of the Target Lesion ........................................................18 
6.2.2  Angiographic Imaging .........................................................................................18 
6.2.3  Flow Limiting Dissections ..................................................................................19 
6.3  Post-Index Procedure and Discharge .............................................................................20 
6.4  Subject Follow-Up .........................................................................................................20 
6.5  Subject Discontinuation .................................................................................................20 
7  STATISTICAL ANALYSIS PLAN ........................................................................................21 
7.1  Study Hypothesis ............................................................................................................21 
7.2  Sample Size Considerations ...........................................................................................22 
7.3  Data Analysis .................................................................................................................22 
7.4  Evaluation of Primary Endpoints ...................................................................................22 
7.5  Evaluation of Secondary Endpoints ...............................................................................22 
7.6  Other Analyses ...............................................................................................................23 
7.7  Subgroup Analyses .........................................................................................................23 
8  ADVERSE EVENTS AND DEVICE DEFICIENCIES..........................................................23 
8.1  Definitions of Events ......................................................................................................23 
8.1.1  Definition of Adverse Events (AEs) ....................................................................23 
8.1.2  Serious Adverse Events (SAEs) ..........................................................................24 
8.2  Severity of Adverse Events ............................................................................................24 
8.3  Relationship of Adverse Event to Device(s)/Procedure .................................................25 
8.4  Reporting of Events ........................................................................................................25 
8.5  Subject Death .................................................................................................................25 

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8.6  Device Deficiencies ........................................................................................................25 
9  DATA COLLECTION AND RECORD MAINTENANCE ...................................................26 
9.1  Electronic Data Capture (EDC) ......................................................................................26 
9.2  Record Retention ............................................................................................................26 
10  MONITORING AND AUDITING..........................................................................................27 
10.1 Site Initiation Visits ........................................................................................................27 
10.2 Ongoing Monitoring Visits ............................................................................................27 
10.3 Final Monitoring Visit ....................................................................................................27 
11  ADMINISTRATIVE REQUIREMENTS ...............................................................................28 
11.1 Investigator and Site Selection .......................................................................................28 
11.2 Training ..........................................................................................................................28 
11.3 Ethical and Regulatory Considerations ..........................................................................28 
11.4 Informed Consent and National Privacy Laws ..............................................................28 
11.4.1 Confidentiality .....................................................................................................29 
11.5 Deviations from Protocol and Medical Emergencies .....................................................29 
11.6 Required Documents ......................................................................................................29 
11.7 Reporting Requirements .................................................................................................29 
11.8 Publication Policy ..........................................................................................................30 
11.9 Termination of Study .....................................................................................................31 
12  REFERENCES ........................................................................................................................31 
13  APPENDICES .........................................................................................................................32 
13.1 Appendix A – Abbreviations and Acronyms .................................................................32 
13.2 Appendix B – Time and Events Schedule ......................................................................33 
 

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2 INTRODUCTION 
The Bard® UltraScore Study is a prospective, multi-center, single-arm, real-world study 
assessing the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the 
treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and 
infra-popliteal arteries. 
  
This study will be conducted in conformance with the Declaration of Helsinki, Health 
Insurance Portability and Accountability Act (HIPAA) requirements, and Good Clinical 
Practice (GCP) including 21 CFR Parts 50, 54, and 56. 
2.1 Background and Rationale 
Peripheral arterial disease (PAD) occurs when a narrowing, or blockage, develops in the 
arteries; PAD most commonly affects the legs. The primary cause of lower extremity PAD is 
atherosclerosis. Atherosclerosis of the lower extremity arteries results in symptoms ranging 
from intermittent claudication (pain in the buttocks, thighs, or calf which occurs with 
exercise and relieves with rest) to pain at rest, and can ultimately progress to ulceration, 
gangrene and amputation. Percutaneous transluminal angioplasty (PTA) has long been the 
first step of treating a stenosed artery. Other treatments available include atherectomy and 
other vessel preparation, and more recently, treatment with a drug coated balloon with or 
without stenting. 
2.2 Study Rationale 
This study is being done to provide physicians with real world data on the outcomes of use of 
the UltraScore™ Focused Force PTA balloon, including optimal PTA results and long-term 
freedom from clinical target lesion revascularization (TLR), major amputation, and patency. 
For this study, optimal PTA results are those where ≤30% residual stenosis remains after use 
of the UltraScore™ Focused Force PTA balloon. 
2.3 Device Description 
2.3.1 UltraScore™ Focused Force PTA Balloon 
The UltraScore™ Focused Force PTA balloon is a flexible, over the wire (OTW) catheter 
shaft with a semi-compliant balloon fixed at the distal end. There are radiopaque markers to 
aid in visualization of the working length of the balloon during fluoroscopy. Two scoring 
wires, oriented 180° apart provide focused force upon dilatation. 
The UltraScore™ Focused Force PTA balloon is compatible with .014” or .035” guidewires. 
Shaft sizes are either 130cm (.035”) or 150cm (.014”) and include the GeoAlign® Marking 
System.  
 

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Figure 1: UltraScore™ Balloon and GeoAlign® Marking Catheter 
 
 
3 STUDY DESIGN 
 
This study is a prospective, multi-center, single-arm, real-world study in the United States 
assessing the clinical use of the UltraScore™ Focused Force PTA balloon. 
 
A maximum of 350 subjects will be treated in the study. This will allow for approximately 
175 subjects in an above the knee (ATK) cohort and 175 subjects in a below the knee (BTK) 
cohort. ATK subjects will be those that have a target lesion of the SFA or popliteal artery. 
BTK subjects will be those that have a target lesion in infra-popliteal arteries (posterior tibial, 
anterior tibial, and peroneal arteries). For this study, ATK arteries (SFA and popliteal) will 
end at the takeoff of the first tibial artery. 
 
Treated subjects will be followed for 12 months post-index procedure. Endpoint analysis will 
occur when all subjects have completed the 12 month follow up. No site will be allowed to 
enroll more than 20% of the overall number of subjects to ensure the study be reasonably 
well–balanced. 
 
The UltraScore device has been cleared for use by the F.D.A. The use of UltraScore will be 
done within the indications for use found in the product IFU. A duplex ultrasound (DUS) will 
be done at 30 days and 6 and 12 months post-index procedure for ATK subjects. Otherwise, 
there are no additional treatments or exams that are required to take place within this study. 
There will be minimal patient activities that will be conducted for data collection purposes 
for this study in addition to routine standard of care procedures, including: 
 The subjects (or legally authorized representative) signing an informed consent form 
(ICF); 

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 Subjects with a treated ATK target lesion will undergo clinical evaluations with a 
Duplex Ultrasound (DUS) performed at 30 days and 6 and 12 months post-index 
procedure; 
 Subjects with a treated BTK target lesion will undergo clinical evaluations performed 
at 30 days and 6 and 12 months post-index procedure. DUS is not required for 
subjects with a treated BTK lesion for this study; 
 
4 STUDY ENDPOINTS 
 
4.1 Primary Endpoint 
 
4.1.1 Primary Endpoints 
 
See section 7.4 for primary endpoint analysis discussion. 
 
 Achieve optimal PTA results (≤30% residual stenosis, without major flow limiting 
dissection)  
 
Achieve technical success of use where the UltraScore™ Focused Force PTA balloon 
is delivered to the target lesion and inflated without movement 
 
4.2 Secondary Endpoints 
 
Several secondary endpoints will be analyzed as part of this study. See section 7.5. 
 
After UltraScore™ Focused Force PTA balloon: 
 Rate of bail-out stenting due to dissection 
Through 12 months follow-up: 
 Freedom from TLR 
 Freedom from major amputation (above the ankle) 
 Improved clinical measures from baseline (ABI, Rutherford) 
 Primary patency for ATK subjects only (as measured by DUS core lab; a PSVR 
≥2.5 suggests 50% restenosis) 
 
5 STUDY POPULATION 
 
This study will include a maximum of 350 subjects at up to 35 U.S. sites.  The following 
describe the clinical eligibility (inclusion and exclusion) criteria for this study.  
  
5.1 Inclusion Criteria 
1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to 
collection of study data or performance of study procedures. 

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2. Subject must be either a male or non-pregnant female ≥ 21 years of age with an 
expected lifespan sufficient to allow for completion of all study procedures. 
3. Subject must be willing to comply with the protocol requirements, including the 
follow-up procedures. 
4. Subject must have a target lesion (de novo lesion or prior failed treatment) that 
can be treated with the UltraScore™ Focused Force PTA balloon according to the 
Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-
popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be 
treated for this study. 
5. Subject must have an ATK or BTK target lesion with at least one vessel run-off. 
6. The target lesion must be able to be crossed using a guidewire (use of chronic 
total occlusion (CTO) or atherectomy is allowed). 
 
5.2 Exclusion Criteria 
1. Subjects that are to receive one or more stents as adjunctive therapy at the target 
lesion (bail out stenting is allowed). 
2. The subject has a single target lesion that involves both ATK and BTK arteries. 
3. The subject has a target lesion in a previously placed stent or stent graft (in-stent 
restenosis). 
4. The subject has a lesion, which in the opinion of the Investigator, would preclude 
safe use of the UltraScore™ Focused Force PTA balloon. 
5. The subject has a flow limiting dissection at the target lesion prior to use of the 
UltraScore™ Focused Force PTA balloon. 
6. The subject has acute limb ischemia. 
7. The subject has been assessed Rutherford category 6. 
8. The subject has a known allergy or sensitivity to contrast media, which cannot be 
adequately pre-medicated.   
9. The subject has another medical condition or is currently participating in an 
investigational drug or another device study that, which, in the opinion of the 
Investigator, may cause him/her to be non-compliant with the protocol, confound 
the data interpretation, or is associated with a life expectancy insufficient to allow 
for the completion of study procedures and follow-up. 
 
6 STUDY / TREATMENT PROCEDURES 
 
Appendix B displays the required schedule for subject treatment and evaluation. 
 
6.1 Subject Screening and Baseline Evaluations 
 
During the screening and recruitment process, the Investigator (or authorized designee) 
will be responsible for describing the nature of the study, verifying that the eligibility 
criteria have been met, and obtaining informed consent.  All study procedures will be 
documented in the medical record and/or source document and on study electronic Case 

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Report Forms (eCRFs).  The following specific procedures will be conducted and 
documented.   
 
6.1.1 Informed Consent 
 
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.  
Prior to the conduct of any protocol-specific procedures (including any procedure 
performed to determine subject eligibility); the subject must voluntarily provide 
consent and comply with applicable national and state privacy laws (e.g., HIPAA 
requirements). The ICF templates are standalone documents to facilitate revision(s), 
as necessary, without requiring a protocol amendment. 
6.1.2 Eligibility 
The subject’s eligibility for study enrollment will be reviewed and documented.  
The documentation should indicate that the subject met all study (eligibility) criteria 
at the time of screening and enrollment (see Sections 5.1 and 5.2).  
 
6.1.3 Baseline Examinations 
 
Each subject will have the following baseline examinations performed prior to the 
index procedure: 
 The subject’s demographic information (e.g., date of birth, sex, etc.) 
 The 
subject’s 
medical 
history, 
including 
antiplatelet/anticoagulation 
medications 
 The subject’s risk factors (e.g., diabetes, hypertension, dyslipidemia, etc.) 
 Rutherford Classification 
 Ankle Brachial Index (ABI) for treated limb only 
6.2 Index Procedure  
This study is collecting data on an F.D.A. cleared medical device, consistent with the 
product IFU. Examinations, evaluations, procedural preparation, angiography, treatment, 
and hospital discharge procedures will be conducted per the investigational site’s 
standard of care. Treatment with the UltraScore™ Focused Force PTA balloon will be 
per the investigational site’s standard of care and adhere to the IFU. For detailed 
information on device use and procedural and medication recommendations, reference 
the IFU. Data collected for this study include: 
 Demographics and procedural information (e.g., target lesion type, TASC 
classification, location and length, degree of calcification, adjunctive treatment(s), 
baseline stenosis, etc.) 

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 Procedural outcomes (e.g., residual stenosis, flow limiting dissections, target 
lesion adjunctive treatments, etc.) 
Investigators are able to treat one (1) target lesion as the study lesion, per patient in this 
study. The investigator may use his or her medical judgment as to which lesion becomes 
the study target lesion if a subject has multiple eligible lesions. 
ATK subjects will be those that have a target lesion of the SFA or the popliteal artery. 
BTK subjects will be those that have a target lesion in the infra-popliteal arteries 
(posterior tibial, anterior tibial, and peroneal arteries). For this study, ATK arteries (SFA 
and popliteal) will end at the takeoff of the first tibial artery. 
Lesions that cross from ATK to BTK may not be treated as the study target lesion. 
Diffuse lesions will be considered separate lesions if there is 2 cm of healthy tissue 
between lesions.  
Standard of care treatment of non-target lesions is allowed. 
See the Instructions for Use for inflation and hold time recommendations. 
Subjects are considered enrolled in the study when the UltraScore balloon is introduced 
into the subject. 
If an angiographically acceptable result cannot be obtained after two inflations of the 
UltraScore™ balloon (>30% residual stenosis), the subject should be considered a 
treatment failure. Subjects will continue to be seen at the protocol specified follow-up 
time points. 
6.2.1 Adjunctive Treatment of the Target Lesion 
Adjunctive treatment of the target lesion before or after use of the UltraScore™ balloon 
as part of standard of care procedures is allowed. All adjunctive treatments of the target 
lesion will be documented on the appropriate eCRF. Care should be taken to limit stent 
usage in the study lesion. Bail out stenting and stenting of non-study lesions is acceptable 
at any time.  
6.2.2 Angiographic Imaging 
Angiographic imaging is required as part of this study. Below is a list of angiographic 
requirements to be completed for each procedure.  
It is required that the following angiographic images of the target lesion are 
captured: 

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 Baseline target lesion (diagnostic); 
 During UltraScore™ Focused Force PTA balloon inflation(s); 
 Post UltraScore™ Focused Force PTA balloon inflation(s); 
 Final run (after adjunctive treatment), with 1 vessel run-off 
All angiography shall be performed using the identical angles, magnification and 
angiographic technique as described in the “Angiography Guidelines” supplied by the 
Angiographic Core Lab.  It is important to use a calibrated measurement ruler so that the 
Angiographic Core Lab may properly assess the target lesion characteristics (e.g., 
location, reference vessel diameter, lesion diameter and length).  Properly labeled 
angiographic-recorded media are to be uploaded or sent to the Angiographic Core Lab for 
evaluation.   
6.2.3 Flow Limiting Dissections 
Major flow limiting dissections are being collected for this study and reporting is 
restricted to grades D, E, and F per the National Heart, Lung, and Blood Institute 
(NHLBI)1. See below. 
Defined as: 
─ 
Type A:  
Radiolucent areas within the artery lumen during contrast 
injection with minimal or no persistence of contrast after the dye has cleared. 
─ 
Type B:  
Parallel tracts, intimal flaps or double lumens separated by a 
radiolucent area during contrast injection with minimal or no persistence of contrast 
after the dye has cleared. 
─ 
Type C:  
Contrast appears angiographically outside the artery lumen 
with persistence of contrast in the area after clearance of dye from the artery lumen. 
─ 
Type D: 
Spiral luminal filling defects. 
─ 
Type E:  
Appearance of new and persistent filling defects with reduced 
flow. 
─ 
Type F:  
Total occlusion without distal flow. 

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6.3 Post-Index Procedure and Discharge 
Medication therapy and medical treatment will be conducted at the discretion of the 
Investigator per the investigational site’s standard of care. Subjects will be treated and 
discharged according to the site’s standard of care.  
 Documentation of Adverse Events (AEs): Documentation of occurrence of AEs since 
the index procedure (see Section 8). 
6.4 Subject Follow-Up 
All study subjects are to be followed according to the investigational site’s standard of 
care practices. In addition to the standard of care visits, study participants will either 
return to the site or be reached by telephone at the following intervals: 
 Follow-up Contact 1: 30 ± 7 days post-procedure;  
 Follow-up Contact 2: 6 months ± 30 days post-procedure;  
 Follow-up Contact 3: 12 months ± 30 days post-procedure. 
Subjects with a treated ATK target lesion will return to the site to undergo a Duplex 
Ultrasound (DUS) performed at 30 days and 6 and 12 months post-index procedure. DUS 
imaging of the target lesion employing the “Ultrasound Guidelines” shall be uploaded or 
sent to the core laboratory for analysis. 
Subjects with a treated BTK target lesion will return to the site for a standard of care 
clinical evaluation at 30 days and 6 and 12 months post-index procedure.  DUS is not 
required for BTK subjects. 
The following will be collected during follow-up and documented in the subject’s 
medical record at the site: 
 
 Documentation of Status: Determine and document whether the subject has 
undergone a TLR or target vessel revascularization (TVR), amputation 
procedure since last contact, and antiplatelet/anticoagulation medications. 
Angiographic imaging of any TLR/TVR must be sent to the angiographic core 
lab for analysis. Measurement of target limb ABI and Rutherford Classification.  
 Documentation of AEs: Documentation of occurrence of AEs since last follow-
up (see Section 8).  
6.5 Subject Discontinuation 
Following the index procedure, subjects should remain in the study until completion of 
required follow-up.  The follow-up period for this study is 12 months (365 ± 30 days). 

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However, a subject’s participation may be discontinued. Potential reasons for 
discontinuation may include, but are not limited to the following: 
 Lost to Follow-Up (LTF): A subject may be considered LTF if the site personnel are 
unable to locate the subject despite two documented attempts to notify the subject via 
telephone and a third attempt by certified mail. This does not apply to missed visits, 
where the subject misses one of the follow up contact time points, but completed a 
subsequent one (when a subject misses two consecutive follow-ups with failure of 
contact attempt, the subject may be considered LTF and withdrawn from the study).    
Before the site considers a subject LTF, written agreement should be obtained from 
the Sponsor.   
 Withdrawn Consent: The subject requests to terminate his/her participation in the 
study (the Investigator must attempt to identify and document the reasons for 
termination).  
 Death:  The subject becomes deceased. If known, the cause of death must be 
documented (see Section 8.5).  
 Withdrawal by Investigator: Participation may be immediately terminated by the 
Investigator if, in the opinion of the Investigator, the subject would be exposed to 
inappropriate risk by continuing in the study. Additionally, the Investigator may 
terminate a subject’s participation with prior written approval from the Sponsor if the 
subject is repeatedly noncompliant with study procedures. 
 Study Termination: The study is terminated by the Sponsor (see Section 11.9).  
Additional subjects will not be enrolled to replace those who withdraw from the study. 
 
7 STATISTICAL ANALYSIS PLAN 
 
This section describes the planned statistical analyses for this study. A detailed Statistical 
Analysis Plan (SAP) will be completed and placed on file prior to database lock. The SAP 
will contain a comprehensive explanation of the methodology used in the statistical analyses 
described below. 
 
7.1 Study Hypothesis 
 
There is no formal statistical hypothesis for this study. 
 
 
 
 

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7.2 Sample Size Considerations 
 
This study will enroll up to a maximum 350 subjects at approximately 35 sites. The 
sample size is based on potential adequacy of data to meet the study objectives; it is not 
based on any statistical consideration. 
7.3 Data Analysis 
The analysis population consists of all enrolled subjects who have signed the Informed 
Consent Form and have been treated with the study device. 
Study endpoints will be summarized using descriptive statistics. Summary statistics for 
categorical variables will include frequency counts and percentages and for continuous 
variables mean, standard deviation, minimum, median and maximum. 
Primary endpoints will be reported by rate and with a 95% confidence interval. The 
calculation of rates will be based on available data. Missing data will not be imputed.   
 
7.4 Evaluation of Primary Endpoints 
 
Primary endpoints are: 
 
 Achieve optimal PTA results (≤30% residual stenosis, without flow limiting 
dissection)  
 Achieve technical success of use where the UltraScore™ Focused Force PTA 
balloon is delivered to the target lesion and inflated without movement 
7.5 Evaluation of Secondary Endpoints  
The following secondary endpoints will be reported at the index procedure or through 12 
months at these time points: 30 days, 6 months, and 12 months. 
After UltraScore™ Focused Force PTA balloon: 
 Rate of bail-out stenting due to dissection 
Through follow-up (30 days, 6 and 12 months): 
 Freedom from TLR 
 Freedom from major amputation (above the ankle) 
 Improved clinical measures from baseline (ABI, Rutherford) 
 Primary patency for ATK subjects only (as measured by DUS core lab; a PSVR 
≥2.5 suggests 50% restenosis) 
 
 

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7.6 Other Analyses 
 
 Target lesion characteristics (e.g. location, type) 
 Procedure details (e.g. duration, inflation times, inflation pressures, number of 
inflations to efface/dilate the target lesion) 
 Adjunctive therapies before and after UltraScore use 
 
7.7 Subgroup Analyses 
 
 Primary and secondary endpoints will be explored between above the knee (ATK) 
and below the knee (BTK) subjects 
 Primary and secondary endpoints will be explored between different adjunctive 
treatments 
 
8 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
 
The PI is responsible for the detection, documentation and reporting to the Sponsor of events 
meeting the criteria and definitions set forth in this Section.  Collection and reporting of 
AEs/SAEs will be limited to those events that are device and/or procedure related as outlined 
below and reporting will begin immediately following subject enrollment, during the index 
procedure. 
8.1 Definitions of Events 
8.1.1 Definition of Adverse Events (AEs) 
Collection of AEs will be limited to those that are associated with a localized or 
systemic clinical manifestation that reasonably suggests the involvement of the 
UltraScore device and/or procedure. 
 Device-Related: This category should be restricted to AEs directly attributable 
to the UltraScore™ Focused Force PTA balloon device used as part of the 
procedure. 
 Procedure-Related: This category should be restricted to AEs directly 
attributable to the portion of the procedure when the UltraScore™ Focused 
Force PTA balloon is used, including insertion, inflation, deflation and removal 
of the balloon. AEs that arise from arterial access and adjunctive therapies (pre- 
and post-UltraScore use) should not be reported in this study. 

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8.1.2 Serious Adverse Events (SAEs) 
Each AE will be assessed to determine whether it is serious or non-serious. (NOTE: 
The term serious is not synonymous with severity, which may be used to describe 
the intensity of an event experienced by the subject). A SAE is an AE that: 
1)  
Led to a death; or 
2)  
Led to serious deterioration in the health of the subject, that either resulted in: 
a)  A life-threatening illness or injury; 
b)  A permanent impairment of a body structure or a body function;  
c)  In-patient or prolonged 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)  
Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
Note: Planned hospitalization for a pre-existing conditions or procedures required 
by this study (including subsequent re-interventions assessed in study endpoints), 
without serious deterioration in health, are not considered SAEs. 
To report an SAE, an event must first meet the protocol definition of an AE as 
described in section 8.1. 
8.2 Severity of Adverse Events 
Each AE should be assessed for its severity, or the intensity of an event, experienced by 
the subject according to the criteria below. 
 
 Mild: Awareness of a sign or symptom that does not interfere with the subject’s 
activity or is transient and is resolved without treatment or additional sequelae. 
 Moderate: Interferes with the subject’s usual activity and/or requires additional 
intervention and/or treatment, and may have additional sequelae. 
 Severe: Symptom(s) causing severe discomfort to the subject and/or significant 
impact on the subject’s usual activity. Additional intervention and or treatment are 
necessary. Additional sequelae occur. 

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8.3 Relationship of Adverse Event to Device(s)/Procedure 
Investigators will assess each AE for its relationship to the device or procedure. The 
following categories should be used for assigning the certainty of the relatedness: 
 
 Definitely Related: An AE is definitely related if it is obvious, certain or 
there is little doubt regarding the relationship. 
 Possibly Related: An AE is possibly related if it is capable of being related 
but relatively unlikely. 
 Not Related: An AE is not related if it is determined that there is no 
plausible association. 
Potential adverse events which may be associated with peripheral balloon dilatation with 
the UltraScore balloon are found in the IFU. 
8.4 Reporting of Events 
All AEs determined to be related to the device/procedure, should be recorded on the 
appropriate eCRF. 
It is the responsibility of the Investigator to notify the IRB of applicable AEs in 
accordance with the governing IRB requirements.  
See section 11.7 for all study reporting requirements. 
8.5 Subject Death 
Subject death, for any reason during the study, must be reported to the Sponsor within 
one (1) working day of the investigational site becoming aware of the event. Notification 
of a subject death should be done by email, telephone call, or fax.  
Notification of death must include a brief statement of the pertinent details. All available 
medical records related to the subject’s death must be maintained.  
8.6 Device Deficiencies 
The Investigator will record any device deficiencies on the appropriate eCRF.  A device 
deficiency has occurred if a study device used in the study procedure failed to meet its 
performance specifications whether due to mechanical failure, malfunction, or defect. 
Device deficiencies also include errors and inadequate labeling. 
 
This applies to:  

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 Study devices used in the subject; or 
 Study devices in which the catheter package was opened, but the device was not used 
for catheterizing the subject; or  
 Study devices with which insertion attempts were made, but the study device was not 
used in the subject. 
All mechanical failures, malfunctions, and defects of the study devices will be recorded 
on the appropriate eCRF page and will be promptly reported to the Sponsor. The 
device(s) should be returned to the Sponsor as outlined in the sites regulatory 
binder. 
If the device deficiency was associated with an AE, the reporting provisions for AEs 
apply. 
Any device deficiency that did not lead to an AE but could have led to one, if suitable 
action had not been taken, if intervention had not been made or if circumstances had been 
less fortunate must be reported to the Sponsor within one (1) working day of the event 
per Section 8.4. 
It is the responsibility of the Investigator to notify the IRB of such device deficiencies in 
accordance with the IRB and/or the Competent Authority’s local regulations. 
 
9 DATA COLLECTION AND RECORD MAINTENANCE 
 
The Investigator is responsible for ensuring the complete and accurate recording of patient 
study data in the appropriate sections of the source documentation and eCRFs provided. The 
monitor will ensure the accuracy of data recording at each investigational site by comparing 
recorded data to supporting source documents during periodic site visits. Adherence to 
proper recording of information as well as ensuring that corrections are being made will also 
be addressed during these periodic visits. 
9.1 Electronic Data Capture (EDC) 
The Investigator is responsible for ensuring the completeness and accuracy of all study 
documentation. All Clinical study data will be recorded in eCRFs provided to the site.   
9.2 Record Retention 
The Investigator shall retain all study records for a period of two years after the later of 
the following two dates: the date on which the study is terminated or is completed. 
 

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10 MONITORING AND AUDITING 
 
The study monitors are designated as agents of Bard and are assigned to oversee the conduct 
and progress of the study and to be the principal communication link between Bard and the 
Investigator.  The study monitors may assist in pre-qualifying potential investigational sites.  
The study monitors will periodically conduct on-site inspection and monitoring of sites and 
records, to ensure continued compliance with this protocol and adequacy of the Investigator 
and the site to conduct the study.  
 
Sites may also be subject to quality assurance audit by personnel of Bard (and its affiliates).  
It is important that the Investigator(s) and the relevant investigational site personnel are 
available during the monitoring visits and possible audits and that sufficient time is devoted 
to the process. 
10.1 Site Initiation Visits 
Before the study begins, the study monitors may visit the investigational site or conduct 
an online meeting (e.g., WebEx) to review with the Investigator(s) and staff the 
provisions and proper conduct of this study. This visit will include a detailed review of 
this protocol, verification that all necessary documents are on file at the investigational 
site and confirmation of IRB approvals.  
10.2 Ongoing Monitoring Visits  
The study monitor will conduct periodic on-site or remote inspection and monitoring of 
the investigational site and records to ensure compliance with this protocol. 
 
The study monitor will maintain personal contact with the Investigator and staff 
throughout the study by telephone, e-mail, fax, mail and on-site visits. The study monitor 
will confirm that the ICF to be used is the version approved by the IRB and verify that all 
necessary documents are on file at the investigational site. 
10.3 Final Monitoring Visit 
At the completion of the study, the study monitor will conduct a final visit. The purpose 
of this visit is to collect all outstanding study data documents, confirm that the 
Investigator’s files are accurate and complete, review the record retention requirements 
with the Investigator, and ensure that all applicable requirements for closure of the study 
are met. The actions and observations made at this visit will be recorded and filed.  
 

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11 ADMINISTRATIVE REQUIREMENTS 
11.1 Investigator and Site Selection 
The Investigator must be of good standing as an Investigator and knowledgeable in 
relevant areas of clinical research to ensure adherence to the requirements of this 
protocol, including the protection of human subjects.  Other site personnel must have 
appropriate research experience and infrastructure to ensure adherence to this protocol 
and enrollment of sufficient numbers of evaluable study subjects.  The curriculum vitae 
(CV) of the Investigator(s), Sub-Investigator(s) and Study Coordinator(s) will be 
maintained in Bard’s files as documentation of qualification by training and experience. 
Federal databases will be searched to ensure that the Investigator(s) and/or the site are not 
prohibited from engaging in federally-sponsored clinical research.   
The Principal Investigator and Sub-Investigator(s) will sign the signature pages of this 
protocol, agreeing to comply with all applicable government regulations and the 
requirements of this study as per the Clinical Study Agreement (CSA).  
11.2 Training 
Each investigator and appropriate site personnel will be trained on this protocol and study 
procedures. All training will be documented and filed at the investigational site and with 
Bard. The Investigators participating in this study will have had substantial experience 
previously performing endovascular procedures with scoring balloons (including 
VascuTrak), standard PTA, and other adjunctive endovascular procedures (e.g., DCB 
PTA, atherectomy, stent and stent graft procedures). Specific training on the 
UltraScore™ Focused Force PTA balloon will be completed during the initiation visit. 
11.3 Ethical and Regulatory Considerations 
The Investigator must provide Bard with written documentation of IRB approval prior to 
the study being initiated. The IRB must give written renewal of the original approval at 
least annually to continue the study. A copy of each written renewal must be provided to 
Bard. 
11.4 Informed Consent and National Privacy Laws 
Prior to any study procedure, the Investigator (or designee) must explain to each subject 
in layman’s terms, the nature of the study, its purpose, expected duration, and the risks 
and benefits of participation.  Also, subjects will be informed of uses and disclosures of 
their medical information for research purposes, and their rights to access information 
about them.  All applicable national privacy laws (e.g., HIPAA) will be followed.  The 
subjects must be informed of their right to withdraw from the study at any time and for 
any reason without sanction, penalty, or loss of benefits to which they are otherwise 
entitled, and that withdrawal from the study will not jeopardize their future medical care.  

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After this explanation and before any study procedure is conducted, and before entering 
the study, the subject must voluntarily provide consent. The subject will receive a copy of 
his/her signed ICF. 
11.4.1 
Confidentiality 
All information and data sent to the Sponsor or its designees that constitutes 
protected health information of study subjects will be considered confidential.  All 
data used in the analysis and reporting of this study will be used in a manner 
without identifiable reference to the subject.  The Investigator consents to visits by 
personnel of Bard and its affiliates or designees. 
11.5 Deviations from Protocol and Medical Emergencies 
The study will be conducted as described in this protocol. Any deviations from this 
protocol must be documented by the Investigator. If an emergency situation arises in 
which the safety and welfare of a subject may require immediate alternative intervention, 
the Investigator should act in the best interest of the subject. Bard and the site’s IRB must 
be notified immediately if this occurs followed by written confirmation that describes the 
emergency action and outcomes.  
11.6 Required Documents 
An Investigator may not screen or enroll subjects until authorized to do so by Bard. At a 
minimum, the following documentation must be received by Bard prior to the 
commencement of study activities:  
 Signed and executed Non-Disclosure Agreement (NDA) by PI and appropriate party 
at Bard; 
 CVs, signed and dated within 2 years of study start for the PI; 
 CVs for Study Coordinator(s); 
 Signed Clinical Study Agreement (CSA) by PI (or designee);  
 Signed “Protocol Signature Page” by PI; 
 Signed “Financial Disclosure Statement” by PI; 
 Written approval from the IRB of both the protocol and ICF. 
11.7 Reporting Requirements 
The Investigator must promptly report to Bard all progress and final reports and any 
withdrawal of IRB approval at the investigational site. At a minimum, the Investigator 
shall inform Bard of the following events according to the notification timelines below: 
 

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Table 3:  Reports and Notifications Required from Clinical Investigators 
Event/Report 
Type:  
Notification to:  
Time to Notification: 
Device-related 
AEs/SAEs 
Bard and IRB  
(as applicable) 
As soon as possible, but no later than one (1) 
working day after investigator awareness and per 
local IRB requirements.   
Procedure-related 
AEs / SAEs 
Bard and IRB (as 
applicable) 
As soon as possible and per local IRB 
requirements. 
Subject Death 
Bard and IRB 
As soon as possible, but no later than one (1) 
working day after investigator awareness and per 
local IRB requirements. Relevant documentation 
to be submitted to the Sponsor no later than three 
(3) working days (See Section 8.5).   
Device 
Deficiencies 
Bard and IRB (as 
applicable) 
As soon as possible.  The device(s) should be 
returned to Bard.    
Any device deficiency that did not lead to an AE 
but could have led to an SADE, if suitable action 
had not been taken, if intervention had not been 
made or if circumstances had been less fortunate 
must be reported to the Sponsor within one (1) 
working day of the event. 
Protocol deviations 
(major*) 
Bard and IRB 
As soon as possible, but in no event later than five 
(5) working days after emergency occurs (see 
Section 11.5). 
Withdrawal of IRB 
approval 
Bard 
Immediately by telephone followed by a copy of 
the notification within five (5) working days. 
Study progress 
report 
Bard and IRB 
At regular intervals or annually 
Failure to obtain 
ICF 
Bard 
Within five (5) working days. 
Final report 
Bard  
Within three (3) months of study completion 
*Major protocol deviations are defined as those that occur to protect the life or physical well-being of a 
subject in an emergency, or those that may affect the scientific soundness of the study, or the rights, safety 
or welfare of human subjects. 
11.8 Publication Policy 
At the conclusion of this study, an article may be prepared for publication in a reputable 
scientific journal. The publication of the principal results from any single-center 
experience within the study is not allowed until the preparation and publication of the 

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multicenter 
results. 
A 
description 
of 
this 
study 
will 
be 
available 
on 
http://www.clinicaltrials.gov, as required by U.S. law. 
11.9 Termination of Study 
Bard reserves the right to suspend enrollment or terminate the study at any time as set 
forth in the CSA. Written notice will be provided in advance of such termination. Bard 
may suspend enrollment or terminate the patient study at a specific investigational site for 
reasons including, but not limited to, inadequate data collection, low subject enrollment 
rate, achievement of the total enrollment, or non-compliance with this protocol or other 
clinical research requirements. 
12 REFERENCES 
1 Coronary Artery angiographic changes after PTCA: Manual of Operations NHBLI PTCA 
Registry 1985; 6:9. 
 

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13 APPENDICES 
13.1 Appendix A – Abbreviations and Acronyms 
Abbreviation/Acronym  
Definition 
AE 
Adverse Event 
ASA 
Aspirin 
CFR 
Code of Federal Regulations 
CSA 
Clinical Study Agreement 
CTO 
Chronic Total Occlusion 
CV 
Curriculum Vitae 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practices 
HIPAA 
The Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
LTF 
Lost to Follow-up 
MM 
Medical Monitor 
NDA 
Non-Disclosure Agreement 
PI 
Principal Investigator 
PTA 
Percutaneous Transluminal Angioplasty 
SAE 
Serious Adverse Event 
US 
United States 
 
 
 

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13.2 Appendix B – Time and Events Schedule 
 
Screening / Index 
Procedure / Discharge 
30 Days (±7 days) 
6 Months (±30 days) 
12 Months (±30 days) 
Informed Consent 
 
 
 
 
Demographics / Medical History 
 
 
 
 
Physical Examination 
 
 
 
 
Rutherford (Category and Grade) 
 
 
 
 
Resting ABI (Treated Limb only) 
 
 
 
 
Anticoagulation/Anti-platelets 
 
 
 
 
Eligibility Criteria 
 
 
 
 
Angiographic Image Collection 
 
 
 
 
Duplex Ultrasound§ 
 
 
 
 
TLR Assessment 
 
 
 
 
Adverse Event Assessment 
 
 
 
 
 
§ATK subjects only