A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)
Phase: NA
Conditions: Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
Sponsor: C. R. Bard

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 1 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
 
 
CLINICAL PATIENT REGISTRY PROTOCOL 
Title:  
A Prospective, Multicenter, Single Arm, Real-World Registry 
Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon 
Catheter in Arteries of the Superficial Femoral Artery (SFA) and 
Popliteal Artery (PA) (SAFE-DCB U.S. Registry) 
Protocol Number:   BPV-14-006 
Protocol Type: 
Registry 
 
Date: 
August 19, 2015 
Version: 
2 
Registry Device: 
Lutonix 035 Drug Coated Balloon 
Sponsor: 
Bard Peripheral Vascular, Inc. 
 
1625 West 3rd Street 
 
Tempe, AZ 85281 
Sponsor Contact: 
Sara Scrivano 
Project Manager, Clinical Affairs 
Bard Peripheral Vascular, Inc. 
1625 West 3rd Street 
Tempe, AZ 85281 
Telephone: (480) 379-2856 
E-mail: sara.scrivano@crbard.com  
NCT Number: 02424383 (Number added post-approval per CT.gov requirement) 
 
CONFIDENTIAL 
This document contains information that is the confidential and proprietary property of Bard Peripheral Vascular, Inc. or its affiliates. Neither this 
document nor the information herein may be reproduced, used, or disclosed to or for the benefit of any third party without the prior consent of 
Bard Peripheral Vascular, Inc. Shred to dispose of document. 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 2 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
Revision History: 
 
Protocol Version # Description of Changes 
2 
Protocol Amendment to include additional device sizes and features, 
include additional sites, and increase number of subjects.  
 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 3 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
1. PROTOCOL SUMMARY 
Title: 
A Prospective, Multicenter, Single Arm, Real-World Registry 
Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon 
(DCB) Catheter in Arteries of the Superficial Femoral Artery (SFA) 
and Popliteal Artery (PA) (SAFE-DCB U.S. Registry) 
Sponsor: 
Bard Peripheral Vascular, Inc. 
1625 West 3rd Street 
Tempe, AZ 85281 
Objectives: 
The objective of this patient registry is to assess the clinical use of the 
Lutonix 035 DCB PTA Catheter in a heterogeneous patient 
population in a real world and on-label clinical application.  
Design: 
The registry is a prospective, multicenter, single arm post-market 
real-world registry in the U.S. assessing the clinical use, safety and 
outcomes of the Lutonix 035 DCB Catheter in the Superficial 
Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects 
will be followed for up to three year’s post-index procedure. 
Devices: 
Commercial inventory will be utilized for this patient registry. The 
devices used in this registry will be ordered and purchased by each 
investigational site according to their standard device ordering 
process.  
Enrollment: 
Up to 2,000 registry subjects 
Investigational Sites: 
Up to 100 investigational sites in the United States (U.S.) 
Patient Registry 
Population: 
Male or non-pregnant female ≥ 21 years of age with an expected 
lifespan sufficient to allow for completion of all patient registry 
procedures. Eligible registry subjects will have stenotic or obstructive 
vascular lesions in the SFA/PA. 
Eligibility Criteria 
Inclusion Criteria 
1. The subject provides written informed consent using an 
Informed Consent Form (ICF) that is reviewed and approved 
by the Institutional Review Board (IRB) for the site. 
2. The subject agrees to comply with the protocol-mandated 
follow-up procedures and visits. 
3. The subject is ≥ 21 years old. 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 4 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
4. The subject must have a lesion(s) that can be treated with 
available Lutonix 035 DCB Catheter according to the 
Instructions For Use (IFU).   
 
Exclusion Criteria 
1. The subject is unable or unwilling to provide informed 
consent. 
2. The subject is unable or unwilling to comply with the patient 
registry protocol follow-up procedures and visits. 
3. The subject has another medical condition or is currently 
participating in an investigational drug or an investigational 
device study that, which, in the opinion of the Investigator, 
may cause him/her to be non-compliant with the protocol, 
confounds the data interpretation, or is associated with a life 
expectancy insufficient to allow for the completion of patient 
registry procedures and follow-up. 
Procedures: 
All registry subjects will undergo a clinical evaluation at screening 
(prior to index procedure); after consent is voluntarily obtained 
registry subjects will be treated with the Lutonix 035 DCB per the 
investigational site’s standard of care and adhering to the IFU. 
 
As this is a patient registry examinations, evaluations, procedural 
preparation, angiography, treatment, and hospital discharge 
procedures will be conducted per the investigational site’s standard of 
care. 
 
A clinical evaluation with a Duplex Ultrasound (DUS) will be 
performed at 12 months post index-procedure. 
Primary Endpoints: 
Primary Effectiveness:   
Freedom from Target Lesion Revascularization (TLR) at 12 
months. TLR is defined as the first revascularization 
procedure (e.g. PTA, stenting, etc.) of the target lesion after 
the index procedure.   
Primary Safety:   

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 5 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
• Freedom from composite of device and/or procedure related 
perioperative (≤30 day) death, target limb major amputation 
(above the ankle), and target vessel revascularization. 
Secondary 
Endpoints: 
The following secondary endpoints will be also be reported: 
 
• Target Vessel Revascularization (TVR) at -, 6-, 12-, 24-, and 
36-months post-index procedure. TVR is defined as the first 
revascularization procedure (e.g. PTA, stenting, surgical 
bypass, etc.) in the target vessel after the index procedure. 
• TLR at 6 months, 24-, and 36-months post-index procedure. 
• Acute Device and Procedural success defined as lesion 
success defined as attainment of < 30% residual stenosis of 
the target lesion after the index procedure using any 
percutaneous method and/or non-investigational device (i.e., 
post-dilatation) and no peri-procedural complications (death, 
stroke, MI, emergent surgical revascularization, significant 
distal embolization in target limb, and thrombosis of target 
vessel) prior to hospital discharge. 
• Primary Patency at 12 months post index-procedure. Primary 
Patency is defined as the absence of target lesion restenosis 
(defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) 
and freedom from TLR. 
• Freedom from composite of all-cause perioperative (≤30 day) 
death and from the following: index limb amputation, index 
limb reintervention, and index-limb-related death at -, 6-, 12-, 
24-, and 36-months post-index procedure. 
• Freedom from major amputation of the target limb defined as 
above the ankle amputation at -, 6-, 12-, 24-, and 36-months 
post-index procedure. 
Lead Principal 
Investigators: 
Dion Franga, M.D.  
Edward Woo, M.D. 
Medical Monitor: 
Bill Altonaga, M.D. 
Duplex Ultrasound 
Core Lab: 
Michael R. Jaff, D.O., RPVI, FACP, FACC 
VasCore 
62 Staniford Street 
Boston, MA 02114 
Telephone: (617) 726-5552 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 6 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
Principal Investigator’s Responsibility 
Prior to participation in the SAFE-DCB U.S. Patient Registry , 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 Site Initiation. The PI is responsible for training all Sub-Investigators to ensure adequate 
training is obtained prior to performing any data collection or patient registry-related procedures. 
 
The PI must also: 
• Conduct the patient registry in accordance with the patient registry protocol, the signed 
CSA, 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.  
• Ensure that the patient registry 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 patient registry procedure; using the current IRB approved ICF. 
• Provide all required data and reports and agree to source document verification of patient 
registry data with subject’s medical records. 
• Allow Bard personnel or their designee(s), to inspect and copy any documents pertaining 
to the patient registry. 
• Provide appropriate resources to ensure compliance with all patient registry-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 patient registry, including obtaining and documenting the 
Informed Consent process, compliance with the patient registry protocol, obtaining a signed 
CSA, the collection of all required data, and ensuring that all patient registry personnel have 
been properly trained on the protocol and have received other necessary training (if applicable) 
prior to performing any data collection or patient registry-related procedures.

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 7 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
Principal Investigator Protocol Signature Page 
 
 
Site name:  ____________________________________________________________ 
 
 
I have read and understand the contents of the SAFE-DCB U.S. Patient Registry protocol. I agree 
to follow and abide by the requirements set forth in this document. I agree to conduct the patient 
registry in accordance with the patient registry protocol, the signed CSA, the Declaration of 
Helsinki, HIPAA requirements, and GCP including 21 CFR Parts 50, 54, and 56.  
 
I agree to participate in the Bard-sponsored training prior to performing any data collection or 
patient registry-related procedures. 
 
 
_________________________________________ 
Principal Investigator Name (print) 
 
 
 
_________________________________________ _____________________ 
Principal Investigator Signature 
 
 
Date 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 8 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
Sub-Investigator Protocol Signature Page 
 
 
Site name:  ____________________________________________________________ 
 
 
I have read and understand the contents of the SAFE-DCB U.S. Patient Registry protocol. I agree 
to follow and abide by the requirements set forth in this document. I agree to conduct the patient 
registry in accordance with the patient registry protocol, the signed CSA, the Declaration of 
Helsinki, HIPAA requirements, and GCP including 21 CFR Parts 50, 54, and 56.  
 
I agree to participate in the Bard-sponsored training prior to performing any data collection or 
patient registry-related procedures. 
 
 
_________________________________________ 
Sub-Investigator Name (print) 
 
 
 
_________________________________________ _____________________ 
Sub-Investigator Signature 
 
 
 
Date 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 9 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
Protocol Abbreviations/Acronyms 
Abbreviation/Acronym  
Definition 
AE 
Adverse Event 
Bard 
Bard Peripheral Vascular, Inc. 
CFR 
Code of Federal Regulations 
CSA 
Clinical Study Agreement 
CV 
Curriculum Vitae 
DCB 
Drug Coated Balloon 
DUS 
Duplex Ultrasound 
(e)CRF 
(electronic) Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practices 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
M.D. 
Medical Doctor 
MDR 
Medical Device Report 
NDA 
Non-Disclosure Agreement 
OTW 
Over-the-Wire 
PA 
Popliteal Artery 
PAD 
Peripheral Arterial Disease 
PI 
Principal Investigator 
PSVR 
Peak Systolic Velocity Ratio 
PTA 
Percutaneous Transluminal Angioplasty 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SFA 
Superficial Femoral Artery 
TLR 
Target Lesion Revascularization 
TVR 
Target Vessel Revascularization 
U.S. 
United States 
 
 
 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 10 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
TABLE OF CONTENTS 
1. PROTOCOL SUMMARY ........................................................................................................ 3 
2. INTRODUCTION ................................................................................................................... 11 
2.1. 
Background ................................................................................................................ 11 
2.2. 
Registry Objective...................................................................................................... 11 
3. DEVICE DESCRIPTION ....................................................................................................... 11 
4. PATIENT REGISTRY DESIGN ............................................................................................ 12 
5. PATIENT REGISTRY ENDPOINTS ..................................................................................... 13 
5.1. 
Primary Endpoints...................................................................................................... 13 
5.2. 
Secondary Endpoints.................................................................................................. 13 
6. INCLUSION AND EXCLUSION CRITERIA ....................................................................... 14 
6.1. 
Inclusion Criteria........................................................................................................ 14 
6.2. 
Exclusion Criteria ...................................................................................................... 14 
7. PATIENT REGISTRY PROCEDURES ................................................................................. 14 
7.1. 
Pre-Treatment Evaluations: ........................................................................................ 14 
7.2. 
Treatment Procedures ................................................................................................ 15 
7.3. 
Follow-Up Visits ........................................................................................................ 15 
8. ADVERSE EVENTS .............................................................................................................. 15 
8.1. 
Definition of Adverse Event ...................................................................................... 16 
8.2. 
Adverse Events Classification ................................................................................... 16 
8.3. 
Definition of Serious Adverse Event ......................................................................... 16 
8.4. 
Relationship of Adverse Event to Device(s)/Procedure ............................................. 17 
8.5. 
Subject Death ............................................................................................................. 18 
9. STATISTICAL PLAN ............................................................................................................ 18 
9.1. 
Patient Registry Hypothesis ....................................................................................... 18 
9.2. 
Data Analysis ............................................................................................................. 19 
10. DATA COLLECTION AND RECORD MAINTENANCE ................................................... 19 
10.1. 
Electronic Data Capture (EDC) ................................................................................. 19 
11. ADMINISTRATIVE REQUIREMENTS ............................................................................... 19 
11.1. 
Investigator Selection ................................................................................................. 19 
11.2. 
Ethical and Regulatory Considerations ...................................................................... 20 
11.3. 
Informed Consent and National Privacy Laws .......................................................... 20 
11.3.1. 
Confidentiality ........................................................................................................ 20 
11.4. 
Deviations from Protocol and Medical Emergencies ................................................. 20 
11.5. 
Required Documents .................................................................................................. 21 
12. MONITORING AND AUDITING ......................................................................................... 21 
12.1. 
Site Initiation Visits ................................................................................................... 21 
12.2. 
Ongoing Monitoring Visits ........................................................................................ 22 
12.3. 
Final Monitoring Visit ............................................................................................... 22 
13. TRAINING .............................................................................................................................. 22 
14. REPORTING REQUIREMENTS ........................................................................................... 22 
15. RECORD RETENTION ......................................................................................................... 23 
16. TERMINATION OF PATIENT REGISTRY ......................................................................... 23 
17. REFERENCES ........................................................................................................................ 24 
 
APPENDIX A: Table of Assessments 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 11 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
2. INTRODUCTION 
 
This Patient Registry is a prospective, multi-center, single-arm, patient registry which is intended 
to assess the clinical use in a heterogeneous patient population in a real world clinical 
application. The Lutonix 035 Drug Coated Balloon (DCB) PTA Catheter was approved by 
FDA on October 9, 2014 (PMA P130024) for the indication of percutaneous transluminal 
angioplasty (PTA), after pre-dilatation, of de novo or restenotic lesions up to 150 mm in length 
in native superficial femoral artery (SFA) or popliteal arteries (PA) with reference vessel 
diameters of 4-6 mm.  This is the first approved DCB used to treat stenoses in the SFA and in the 
PA as a result of peripheral arterial diseases (PAD). 
 
This patient registry 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 
PAD occurs when a narrowing, or blockage, develops in the arteries; PAD most commonly 
affects the legs1.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 and gangrene. A number of risk factors can be directly 
correlated with the onset of progressive PAD, including cigarette smoking, diabetes mellitus, 
dyslipidemia, hypertension, hyperhomocysteinemia, and advanced age.1,2 
2.2. Registry Objective 
The objective of this registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter 
in a heterogeneous patient population in a real world, on-label clinical application per the 
Instructions For Use (IFU).  
3. DEVICE DESCRIPTION 
The LUTONIX 035 DCB PTA Catheter is a standard PTA catheter with a drug coating on the 
balloon portion of the catheter.  The LUTONIX Catheter 035 model is an over-the-wire (OTW) 
with working lengths of 75 and 130 cm and is compatible with 0.035” guidewire. 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.  Please refer to the IFU for complete instructions, preparation 
and procedural use of the device.  

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 12 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
Commercial inventory will be utilized for this registry. The devices used in this registry will be 
ordered and purchased by each investigational site according to their standard device ordering 
process.  
 
Figure 1: Lutonix 035 Drug Coated Balloon Catheter  
 
4. PATIENT REGISTRY DESIGN 
The patient registry is a prospective, multicenter, single arm, post-market real-world registry in 
the U.S. assessing the clinical use, safety and outcomes of the LUTONIX  DCB Catheter in the 
SFA and PA. Registry subjects will be enrolled at up to 100 investigational sites and up to 2,000 
registry subjects followed for up to three years post-index procedure.  This registry will be 
performed with marketed devices within the indications for use. There are no additional 
treatments or exams that are required to take place within this registry. There will be minimal 
patient registry activities that will be conducted for data collection for the purpose of this registry 
in addition to routine standard of care procedures; including: 
• The subject (or legally authorized representative) signing an informed consent form 
(ICF);  
• The possibility of performing follow-up visits via the telephone, if these are not routinely 
performed as on-site visits at the requested times, so that the data as detailed in Appendix 
1 can be obtained. 
• The collection and descriptive analysis of collected subject data. 
 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 13 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
5. PATIENT REGISTRY ENDPOINTS 
5.1. Primary Endpoints 
The following primary endpoints will be reported:  
Primary Effectiveness:  
• Freedom from Target Lesion Revascularization (TLR) through 12 months. TLR is 
defined as the first revascularization procedure (e.g. PTA, stenting, etc.) of the target 
lesion after the index procedure.   
 
Primary Safety:   
• Freedom from composite of device and/or procedure related perioperative (≤30 day) 
death, target limb major amputation (above the ankle), and target vessel 
revascularization. 
 
5.2. Secondary Endpoints 
The following secondary endpoints will be reported through 3 years at these timepoints; 30 days, 
6 months, 12 months (1 year), 24 months (2 years), and 36 months (3 years).  
• Target Vessel Revascularization (TVR) at -, 6-, 12-, 24-, and 36-months post-index 
procedure. TVR is defined as the first revascularization procedure (e.g. PTA, stenting, 
surgical bypass, etc.) in the target vessel after the index procedure. 
• TLR at 6-, 24-, and 36-months post-index procedure. 
• Acute Device and Procedural success defined as lesion success defined as attainment of < 
30% residual stenosis of the target lesion after the index procedure using any 
percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-
procedural complications (death, stroke, MI, emergent surgical revascularization, 
significant distal embolization in target limb, and thrombosis of target vessel) prior to 
hospital discharge. 
• Primary Patency at 12 months post index-procedure. Primary Patency is defined as the 
absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) 
≥2.5) and freedom from TLR. 
• Freedom from composite of all-cause perioperative (≤30 day) death and from the 
following: index limb amputation, index limb reintervention, and index-limb-related 
death at -, 6-, 12-, 24-, and 36-months post-index procedure. 
• Freedom from major amputation of the target limb defined as above the ankle amputation 
at -, 6-, 12-, 24-, and 36-months post-index procedure. 
 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 14 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
6. INCLUSION AND EXCLUSION CRITERIA 
All registry subjects consented must meet the inclusion and exclusion criteria. 
 
6.1. Inclusion Criteria 
1. The subject provides written informed consent using an Informed Consent Form (ICF) 
that is reviewed and approved by the Institutional Review Board (IRB) for the site. 
2. The subject agrees to comply with the protocol-mandated follow-up procedures and 
visits. 
3. The subject is ≥ 21 years old. 
4. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB 
Catheter according to IFU. 
 
6.2. Exclusion Criteria 
1. The subject is unable or unwilling to provide informed consent. 
2. The subject is unable or unwilling to comply with the patient registry protocol follow-up 
procedures and visits.  
3. The subject has another medical condition or is currently participating in an 
investigational drug or an investigational device study that, which, in the opinion of the 
Investigator, may cause him/her to be non-compliant with the protocol, confounds the 
data interpretation, or is associated with a life expectancy insufficient to allow for the 
completion of patient registry procedures and follow-up. 
 
7. PATIENT REGISTRY PROCEDURES 
During the screening, the investigator (or designee) will be responsible for describing the nature 
of the patient registry, verifying that the eligibility criteria have been met, and obtaining 
informed consent.  Prior to the conduct of any patient registry procedures, the subject must 
voluntarily sign and date the ICF and HIPAA Authorization.  All patient registry procedures will 
be documented in the medical record and/or source document and on patient registry electronic 
case report forms (eCRF). After consent is obtained the subject must meet all other eligibility 
criteria. 
 
7.1. Pre-Treatment Evaluations: 
After the subject voluntarily signs the ICF and HIPAA Authorization all patient registry 
procedures will be documented in the medical record and/or source document and on patient 
registry eCRF. The subject’s eligibility for patient registry enrollment will be reviewed, and the 
following pre-treatment data points for those registry subjects that are treated will be collected:  

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 15 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
• The subject's demographic information (e.g., Date of Birth, Sex, etc.) 
• The subject’s medical history  
• The subject’s risk factors (e.g., diabetes, HTN, dyslipidemia, etc.)  
7.2. Treatment Procedures 
As this is a registry all examinations, evaluations, procedural preparation, angiography, 
treatment, and hospital discharge procedures will be conducted per the investigational site’s 
standard of care. Treatment with the Lutonix 035 DCB will be per the investigational site’s 
standard of care and adhering to the IFU. For detailed information on device use and procedural 
and medication recommendations reference the IFU.   The treatment characteristics that will be 
collected for this patient registry are: 
 
• Procedural information (e.g., lesion type, treated lesion length and location, CTO, 
calcification, adjunctive treatment, number of run-off vessels, etc.) 
• Device characteristics (adjunctive treatment used to treat the lesion during the procedure)  
 
7.3. Follow-Up Visits 
Registry subjects are to be followed according to the investigational site’s standard of care 
practices.  The only difference from routine clinical practice and this registry is data collection 
and reporting of all AEs to be collected within each follow-up window through 3 years: 30 days 
(±7 days), 6 months (±1 month), 12 months-1 year (±1 month), 24 months-2 year (±1 month), 
and 36 months-3 year (±1 month). Contact may be made either by telephone or by a clinical visit 
for each visit other than the 12 month follow-up visit (clinical visit is not required per protocol). 
A clinical evaluation with a Duplex Ultrasound (DUS) will be performed at 12 months post 
index-procedure. 
 
The following information to be collected is: 
• Occurrence of device and/or procedure related AEs or SAEs since discharge 
• TLR/TVR evaluation 
At the 12 month follow-up visit, the DUS of Target Limb images will be submitted to DUS Core 
Laboratory for evaluation.  Reference the “Ultrasound Guidelines” for Imaging and 
upload/submission guidelines which is found external from this protocol. 
 
8. ADVERSE EVENTS 
The Principal Investigator (PI) is responsible for the detection and documentation of events 
meeting the criteria and definition of an AE or SAE, as provided in this protocol.  Collection and 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 16 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
reporting of AEs/SAEs will be limited to those events that are device and/or procedure related 
and reporting will begin immediately following subject enrollment, during the index procedure. 
 
8.1. Definition of Adverse Event 
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 patient registry device(s) and/or 
procedure.    
 
− Device(s)-Related: This category should be restricted to AEs directly attributable to the 
Lutonix® DCB Catheter device(s) used as part of the procedure. 
− Procedure-Related:  A procedure includes any activity performed during a patient 
registry-related procedure. 
  
8.2. Adverse Events Classification 
Each AE should be assessed for its severity, or the intensity of an event, experienced by the 
subject. 
 
─ 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 sequelae. 
─ Moderate:  May interfere with the subject’s activity and require additional intervention 
and/or treatment, and may have additional sequelae. 
− Severe: Significant discomfort to the subject and/or interferes with the subject’s activity.  
Additional intervention and or treatment are necessary.  Additional sequelae occur.   
 
8.3. Definition of Serious Adverse Event 
Each device and/or procedure related 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.).  
 
An SAE is an AE that: 
1. led to a death 
2. led to a serious deterioration in the health of the subject that: 
a. resulted in a life-threatening illness or injury 
b. resulted in a permanent impairment of a body structure or a body function 
c. required in-patient hospitalization or prolongation of existing hospitalization 
d. resulted in medical or surgical intervention to prevent impairment to body structure 
or a body function 
3. led to fetal distress, fetal death, or a congenital abnormality or birth defect 
 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 17 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
Note: Planned hospitalization for pre-existing conditions or procedures (including subsequent 
TLR/TVRs- assessed in the patient registry endpoints), without serious deterioration in health are 
not considered SAEs. 
8.4. Relationship of Adverse Event to Device(s)/Procedure 
Each AE/SAE should be assessed for its relationship to the device or procedure as follows: 
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 a peripheral balloon dilatation procedure 
include: 
• Additional intervention 
• Allergic reaction to drugs, excipients or contrast medium 
• Amputation/loss of limb 
• Aneurysm or pseudoaneurysm 
• Arrhythmias 
• Embolization 
• Hematoma 
• Hemorrhage, including bleeding at the puncture site 
• Hypotension/hypertension 
• Inflammation 
• Occlusion 
• Pain or tenderness 
• Pneumothorax or hemothorax 
• Sepsis/infection 
• Shock 
• Stroke 
• Thrombosis 
• Vessel dissection, perforation, rupture, or spasm 
Although systemic effects are not anticipated, refer to the Physicians’ Desk Reference for more 
information on the potential adverse events observed with paclitaxel. 
 
Potential adverse events, not described above, which may be unique to the paclitaxel drug 
coating include: 
• Allergic/immunologic reaction to the drug coating (paclitaxel) 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 18 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
• Alopecia 
• Anemia 
• Blood product transfusion 
• Gastrointestinal symptoms 
• Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) 
• Hepatic enzyme changes 
• Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis 
• Myalgia/Arthralgia 
• Myelosuppression 
• Peripheral neuropathy 
 
Any AE report that may be considered a potential Medical Device Report (MDR) (21 CFR 
803(e)) should be handled according to the Bard MDR Reporting Procedure, which complies 
with 21 CRF 803(e). 
 
8.5. Subject Death 
Subject death, for any reason during the patient registry from time of consent through discharge, 
must be reported to Bard within 1 business day of the investigational site becoming aware of the 
event.  
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.  
 
9. STATISTICAL PLAN 
This section describes the planned statistical analyses for this patient registry. 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.  
9.1. Patient Registry Hypothesis 
There is no formal statistical hypothesis for this patient registry.  
Sample Size Considerations 
This patient registry is projected to enroll up to 2000 registry subjects at approximately 100 sites. 
The sample size is based on potential adequacy of data to meet the patient registry objectives. It 
is not based on any statistical consideration. 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 19 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
9.2. Data Analysis 
The analysis population consists of all enrolled registry subjects who have signed the Informed 
Consent Form and have been treated with the patient registry device. 
The patient registry 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. 
The key patient registry endpoints of freedom from TLR and TVR rates as well as primary 
patency rate will be reported by time point along with their 95% confidence intervals. The 
calculation of rates at each time point will be based on available data at the time point. Missing 
data will not be imputed. Additionally, a Kaplan-Meier curve across the whole duration of the 
patient registry for TLR and TVR and Patency may be created. The rates at each time point 
derived from the Kaplan-Meier curve take into account of information from registry subjects 
who discontinue from the registry prematurely and cause missing data.  
10. DATA COLLECTION AND RECORD MAINTENANCE 
The Investigator is responsible for ensuring the complete and accurate recording of patient 
registry data in the appropriate sections of the source documentation and eCRFs are 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. 
 
10.1. 
Electronic Data Capture (EDC) 
The Investigator is responsible for ensuring the accuracy and completeness of all patient registry 
documentation. All clinical patient registry data will be recorded in the eCRFs provided to the 
investigational site.  
 
11. ADMINISTRATIVE REQUIREMENTS 
 
11.1. 
Investigator 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 registry subjects. Other site personnel must have appropriate research 
experience and infrastructure to ensure adherence to this protocol and enrollment of sufficient 
numbers of evaluable registry subjects. The curriculum vitae (CV) of the 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) 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 20 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
and/or the investigational 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 patient registry as per the Clinical Study Agreement (CSA).  
 
11.2. 
Ethical and Regulatory Considerations  
The Investigator must provide Bard with written documentation of IRB approval prior to the 
patient registry being initiated. The IRB must give written renewal of the original approval at 
least annually to continue the patient registry. A copy of each written renewal must be provided 
to Bard. 
 
11.3. 
Informed Consent and National Privacy Laws 
Prior to any patient registry procedure, the Investigator (or designee) must explain to each 
subject  in layman’s terms, the nature of the patient registry, its purpose, expected duration, and 
the risks and benefits of patient registry participation. Also, registry 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 in 
this patient registry. The registry subjects must be informed of their right to withdraw from the 
patient registry 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 patient registry will not 
jeopardize their future medical care. After this explanation and before any patient registry 
procedure is conducted, and before entering the patient registry, the subject must voluntarily 
provide consent. The subject will receive a copy of his/her signed ICF. 
 
11.3.1. Confidentiality 
All information and data sent to Bard or Bard designees concerning registry subjects or their 
participation in this patient registry will be considered confidential. All data used in the analysis 
and reporting of this patient registry 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. 
 
11.4. 
Deviations from Protocol and Medical Emergencies 
The patient registry 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 interests of the subject. Bard and the investigational site’s IRB must be 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 21 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
notified immediately if this occurs followed by written confirmation that describes the 
emergency action and outcomes.  
 
11.5. 
Required Documents 
An Investigator may not screen or enroll registry subjects until authorized to do so by Bard. At a 
minimum, the following documentation must be received by Bard prior to patient registry 
commencement:  
• Signed and executed Non-disclosure Agreement (NDA) by PI and appropriate party at 
Bard; 
• Signed CSA by PI (or designee);  
• CVs, signed within 2 years of patient registry start, and for the PI; 
• CVs for Study Coordinator(s); 
• Signed Protocol Signature Page by PI; 
• Signed Financial Disclosure Statement by PI; 
• Written approval from the IRB of both the protocol and ICF  
 
12. MONITORING AND AUDITING 
The patient registry monitor(s) are designated as agents of Bard and are assigned to oversee the 
conduct and progress of the patient registry and to be the principal communication link between 
Bard and the Investigator. The patient registry monitor(s) will assist in pre-qualifying potential 
investigational sites. The patient registry monitor(s) will periodically conduct on-site inspection 
and monitoring of investigational sites and records, to ensure continued compliance with this 
protocol and adequacy of the Investigator and the investigational site to carry out the patient 
registry.  
 
The investigational 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. 
 
12.1. 
Site Initiation Visits 
Before the patient registry begins, the patient registry monitor(s) 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 patient registry. 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.  
 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 22 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
12.2. 
Ongoing Monitoring Visits  
The patient registry monitor will conduct limited and periodic on-site inspection and monitoring 
of the investigational site and records, to ensure compliance with this protocol. 
 
The patient registry monitor will maintain personal contact with the Investigator and staff 
throughout the patient registry by telephone, e-mail, fax, mail and on-site visits. The patient 
registry monitor will confirm that the ICF to be used is the version approved by the IRB, verify 
that all necessary documents are on file at the investigational site. This monitoring will oversee 
IRB acceptance of the patient registry.  
 
12.3. 
Final Monitoring Visit 
At the completion of the patient registry, the patient registry monitor will conduct a final on-site 
visit. The purpose of this visit is to collect all outstanding patient registry 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 
patient registry are met. The actions and observations made at this visit will be recorded and 
filed. 
 
13. TRAINING 
Each Investigator and appropriate site personnel being trained on this protocol and patient 
registry procedures. All training will be documented and filed at the investigational site and with 
Bard. The Investigators participating in this patient registry will have had substantial experience 
previously performing endovascular procedures with DCB PTA, standard PTA, and other 
adjunctive endovascular procedures (e.g., stent and stent graft procedures) and therefore device 
training is not required. 
 
14. 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: 
Event:  
Notification to:  Time to Notification: 
Device-related 
AEs, SAEs, or death 
Bard and IRB (if 
applicable) 
As soon as possible, but no later than one 
(1) business day after investigator 
awareness (see Section 7) 
Withdrawal of IRB Approval Bard 
Within 5 business days 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 23 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
Patient Registry Progress 
Bard and IRB 
At least yearly 
 
15. RECORD RETENTION 
The Investigator shall retain all patient registry records for a period of two years after the later of 
the following two dates: the date on which the patient registry is terminated or is completed.  
 
16. TERMINATION OF PATIENT REGISTRY  
Bard reserves the right to suspend enrollment or terminate the patient registry at any time as set 
forth in the Clinical Study Agreement. Written notice will be provided in advance of such 
termination. Bard may suspend enrollment or terminate the patient registry 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. 
 
 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 24 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
17. REFERENCES 
1  
Weitz, J.I., Byrne, J., Clagett, G.P., Farkouh, M.E., Porter, J.M., Sackett, D.L., 
Strandness, D.E., & Taylor, L.M.  (1996). Diagnosis and Treatment of Chronic 
Arterial Insufficiency of the Lower Extremities: A Critical Review.  Circulation, 94, 
3026-3049. 
 
2  
Hirsch AT, et al. (2006). ACC/AHA 2005 practice guidelines for the management of 
patients with peripheral arterial disease (lower extremity, renal, mesenteric, and 
abdominal aortic): A collaborative report from the American Association for Vascular 
Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and 
Interventions, Society for Vascular Medicine and Biology, Society of Interventional 
Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing 
Committee to Develop Guidelines for the Management of Patients With Peripheral 
Arterial Disease): Endorsed by the American Association of Cardiovascular and 
Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for 
Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease 
Foundation. Circulation, 113(11): e463–e654. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify Bard Peripheral Vascular, Inc. Before Releasing this Document. 
Bard Peripheral Vascular, Inc. 
 
 
Lutonix 035 Drug Coated Balloon  
SAFE-DCB U.S. Registry (BPV-14-006) Version 2  
Page 25 of 25 
 
    
 
 Bard Peripheral Vascular, Inc. 
 
Appendix 1: Time and Events Schedule 
Procedure 
Screening 
Index 
Procedure 
Hospital 
Discharge 
30 days 
(± 7d) 
6 months 
(±1 month) 
12 months-1 year 
(±1 month) 
24 months-2 year 
(±1 month) 
36 months-3 year 
(±1 month) 
Informed Consent 
✓ 
 
 
 
 
 
 
 
Eligibility Criteria 
✓ 
✓ 
 
 
 
 
 
 
Demographics 
✓ 
 
 
 
 
 
 
 
Medical History / 
Risk factors 
✓ 
 
 
 
 
 
 
 
Treatment Procedural 
Information 
 
✓ 
 
 
 
 
 
 
Adverse Event 
Assessment 
 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
TLR/TVR 
Assessment 
 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
DUS Evaluation /  
DUS image 
submission to Core 
Lab 
 
 
 
 
 
 
✓