Prospective, Non-randomized, Multicenter Clinical Study of the Boston Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and Ranger™ SL (OTW) DCB) in China
Phase: NA
Conditions: Femoropopliteal Artery Lesions
Sponsor: Boston Scientific Corporation

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
 
CLINICAL PROTOCOL 
 
(S6052) 
 
Sponsored By 
BSC International Medical Trading (Shanghai) Co., Ltd, (“BSC China”) 
Part A, 2nd Floor, No.68, Rijing Road, 
WaiGaoQiao Free Trade Zone, 
Shanghai, China 200131 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
                                                                                                                           Page 2 of 78 
 
Contact Information 
Role 
Contact  
Clinical Contact 
Jing Zhou 
Senior Clinical Trial Manager 
BSC China 
31F, No. 763, Mengzi Road  
Huangpu District 
Shanghai 200023 
P.R. China 
Email: Monica.Zhou@bsci.coom 
Phone Mobile:   +86 13072179386  
Author 
Yanfei Yang, MD 
Medical Director of Medical Affairs 
BSC China 
31 Floor, No. 763 Mengzi Road 
Huangpu District 
Shanghai  200023 
P.R. China 
Email:Yanfei.Yang@bsci.com  
Mobile:+86 13810511578 
Tel: +86 10 85742951
Coordinating 
Principal 
Investigator 
Dr. Zhong Chen is the Coordinating Principal Investigator. The 
contact details of the contact are maintained and provided in the 
manual of operations.
Coordinating 
Co-Principal 
Investigator 
Dr. Weiguo Fu is the Coordinating Co-Principal Investigator. The 
contact details of the contact are maintained and provided in the 
manual of operations.
Investigational Sites 
A list of investigational sites is maintained and provided in the 
Manual Of Operations.
Vendors/Labs 
A list of other institutions involved in the trial is maintained and 
provided in the Manual Of Operations.
 
 
 

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
                                                                                                                           Page 3 of 78 
 
Original Release: March 23, 2015 
Current Version: 1 Jul, 2020 
 
Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
AA 
March 23, 
2015 
90702637 
Rev./Ver. AE
None 
None 
Original release 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 2 for 
Contact 
information
Change PM from “Jade Jian Shi” to 
“Yisi Wang” 
PM changed 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 7 in 
Synopsis, 
Page22 for 
Section 
7.1.2 and 
7.2 
Change the assessment of primary 
efficacy endpoint from “DUS” to 
“CTA”; add additional DUS at 30 days 
post index procedure to additional 
endpoints; and delete 30-days and 6-
months DUS assessment in additional 
endpoint 
To reflect the 
changes in study 
endpoints and the 
assessment methods
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 26 for 
Section 
8.4.1 
Add “the diameter ratio of DCB to the 
reference vessel should be 1:1 (no less 
than 1:1), and the recommended length 
of DCB should include the segment of 
vessel treated with the study device 
and the 5 mm proximal and 5 mm 
distal to the treated segment.” 
Clarify the 
requirement of the 
choice of the device 
size 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 9 in 
Synopsis, 
Page27 for 
Section 9.2
Change “Target vessel diameter” 
from” ≥ 4.0 mm and ≤ 6.0 mm“ to
“ ≥ 2.0 mm and ≤ 8.0 mm” 
To accommodate the 
regulatory 
requirements to 
include the use of  all 
sizes of study device
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 10 in 
Synopsis; 
Page 28 for 
Section 9.3 
 
Adjust the exclusion criteria of 
platelet count from “< 100,000 
/ml or > 600,000 /ml” to”< 
80,000 /ml or > 700,000 /ml”; 
 
Add the Angiographic Exclusion 
Criteria: 
   AE1. Subjects with ipsilateral iliac 
inflow lesions , and unsuccessful 
treatment prior to the index procedure 
(i.e., residual stenosis ≥ 30% post 
treatment) 
   AE2. Subjects with no patent 
infrapopliteal artery (i.e., ≥ 50% 
stenosis) to the foot prior to index 
procedure. 
 
Add exclusion criteria 20: 
Subjects who had any major 
procedures (cardiac, aorta, 
peripheral) within 30 days prior 
to the index procedure 
To clarify the 
exclusion criteria and 
adjust the exclusion 
criteria range. 

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
                                                                                                                           Page 4 of 78 
 
 
Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 31 for 
Form 11.1-
1 
Adjust the FU visit time and related 
examinations in form “Data Collection 
Schedule” 
To align with the 
changes in study 
endpoints and the 
assessment methods. 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 9 in 
Synopsis, 
Page 34 for 
Section 
11.5.3 
Change the required length of 
clopidogrel use from “4 weeks” to “3 
months” 
To change the 
required length of 
medication therapy 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 34 for 
Section11.5
Add “Clopidogrel is the first choice, if 
not tolerated, Ticlopidine could be 
used” and “After Surgery: In addition 
to DAPT, the risk of bleeding may be 
increased by subjects with 
anticoagulant therapy. If necessary, 
should choose oral warfarin, and 
disable a new generation of oral 
anticoagulants(like rivaroxaban, 
apixaban or dabigatran” 
Clarify the choice of 
Combined 
medication 
 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 11 in 
Synopsis, 
Page 35 for 
Section 
11.6.1 
 
Delete “Prior to treatment of the 
index lesion, successful (< 30% 
residual stenosis) treatment of 
ipsilateral outflow lesions may 
be performed before or during 
the index procedure.” 
 
Delete “Post Index Procedure: 
Additional interventions should 
not be performed within 30 days 
before or after the index 
procedure.” 
 
Adjust the content 
according to the 
in/exclusion criteria.
 
AB  
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 8 in 
Synopsis, 
Page 33 for 
Section 
11.4, page 
36~37 for 
Section 
11.8~11.11
 
Add CTA assessment in 
screening phase 
 
Allow the 30-day and 6-month 
follow up may be via phone or 
in-person interview.  
 
Delete 6-month DUS assessment
 
Add 3-month DUS assessment 
 
Add 12-month CTA assessment
To align with the 
primary endpoint 
change. 
 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 13 in 
Synopsis, 
Page 42 for 
Section 
13.3 
Change core lab requirement for 
“DUS” to “CTA” 
To align with the 
endpoint change 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 42 for 
Section15 
Add PD Classifications 
To better define the 
PDs 

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
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Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 50 for 
Section 
20.1 
Add clarification for safety reporting 
of Device deficiencies and In-patient 
hospitalization 
To clarify the safety 
reporting 
requirements 
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 53 for 
Section 
20.3(Table 
20.3-1) 
Change SAE reporting timeline from 
within 2 business days to 24 hours 
To align with SAE 
report guideline  
AB 
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 56 for 
Section 
22.2 
Add “Safety Monitoring Process” 
To better monitor the 
safety. 
AB  
November 11, 
2015 
90702637 
Rev./Ver. AE
Page 61 for 
Section 
26.2 
 
Add definitions related to this study 
 
To add relevant 
definitions for the 
study 
 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 8, 
Section 2, 
Primary 
Endpoint; 
Page 25, 
Section 
7.1.2 
To update “The primary efficacy 
endpoint ” from “primary vessel 
patency” to “primary lesion patency”.
To clarify the 
primary efficacy 
endpoint is lesion 
patency not vessel 
patency per 
investigators’ 
requirement.  
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 11, 
Section 2, 
Key 
Inclusion 
Criteria; 
Page 30, 
Section 9.2;
AI1: 
• 
To add “must be overlapped to 
cover targeted lesion(s)” after 
“Lesion length ≥ 20 mm and ≤ 
200 mm, to be covered by one or 
two balloon(s)” 
• 
To add “The lesion length of 
total occluded lesion ≤ 100 mm”
• 
To add “For diffuse lesion or 
multiple tandem lesions (may 
including a total occluded lesion) 
in the same target vessel, the 
total lesion length, including the 
distance between lesions, must 
be ≤ 200 mm, with the 
separation of ≤ 30 mm (3 cm) 
between two adjacent lesions” 
• 
To emphasize 
the overlapping 
requirement of 
two balloons. 
• 
To add one 
specific 
Inclusion 
Criteria of total 
occluded 
lesion. 
• 
To clarify the 
lesion length of 
multiple 
tandem lesion 
to include the 
distance limits 
of two lesions. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 12, 
Section2, 
Key 
Exclusion 
Criteria, 
Page 31, 
Section 9.3
To add “176.8 umol/L” to Exclusion 
Criteria 13. 
• 
To clarify 2.0 
mg/dL serum 
creatinine 
equals to 
176.82 umol/L

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
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Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 12, 
Section 2 
Key 
Exclusion 
Criteria; 
Page 31, 
32 , Section 
9.3 
• 
To add “(even with successfully 
treatment during the procedure, 
these subjects should be 
excluded from enrollment)” in 
AE 2. 
• 
To add AE3 “Failure to 
successfully antegrade cross the 
target lesion with a guidewire 
(successful crossing is defined as 
the tip of crossing device is 
distal to the target lesion in the 
true lumen without flow-limiting 
dissection or perforation as 
evidenced by extravasation of 
contrast media)” 
• 
To combine Exclusion Criteria 
23 “Perforated vessel as 
evidenced by extravasation of 
contrast media” to AE3  
• 
To specify the 
angiographic 
exclusion 
criteria for 
subjects with 
on patent 
infrapopliteal 
artery (i.e., ≥ 
50% stenosis). 
• 
To add AE3 
based on the 
discussion at 
investigator 
meeting for 
total occluded 
lesions.  
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 28, 
Section 8.4
To update the % of residual stenosis 
after pre-dilating the target lesion and 
to add “Incremental pre-dilatation 
technique is recommended, and the 
diameter of last pre-dilation balloon 
catheter should not exceed the 
diameter of DCB catheter.” 
To clarify the pre-
dilatation of the 
target lesion as 
discussed in the 
investigator meeting.
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 28, 
Section 
8.4.2 
To update “minimize balloon overlap 
and the number of balloons used” to 
“the Ranger DCB must overlapped to 
cover targeted lesion(s), and a 1 cm 
overlap is recommended” for the 
lesion required the use of more than 
one balloon. 
To clarify the overlap 
requirement for the 
lesion that need use 
more than one 
balloon as discussed 
in the investigator 
meeting. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 35, 
Section 
11.1 
Page 37, 
Section 
11.4 
To add “(test results within 30 days 
prior to the index procedure are 
acceptable)” for CTA and DUS tests.
To extend the time 
window of CTA and 
DUS tests within the 
acceptable time. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 35, 
Section 
11.1 
To add “in-person clinic visit is 
recommended if subjects have worsen 
symptoms” to 30-day and 6-month 
follow up visit.” 
To add the 
recommendation to 
protect subjects’ 
safety. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 44, 
Section 
13.2 
Updated the duration of “Data 
Retention” for investigator from  
“5years” to “10years”; Update the 
duration of “Data Retention” for BSC 
to “until the product/device is no 
longer in use” . 
To be in compliance 
with China new GCP.

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
                                                                                                                           Page 7 of 78 
 
 
Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
AC 
January, 16, 
2017 
90702637 
Rev./Ver. A 
H 
Page 44, 
Section 
13.2 
Added “Sites are required to inform 
Boston Scientific in writing where 
paper or electronic files are maintained 
in case files are stored off site and are 
not readily available.” Under “Data 
Retention”. 
 
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. A 
H 
Page 45, 
Section 
17.2 
Edited and added some appropriate 
wordings in the section of 
“Investigator Responsibilities” 
according to the new protocol template
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. A 
H 
Page 46, 
Section 
17.2 
Added “and provide analysis report, 
which includes the causality assessed 
by both investigator and BSC and 
decision on study continuance, to 
IRB/EC per local and/or country 
requirements” 
To be in compliance 
with China new GCP.
AC 
January, 16, 
2017 
90702637 
Rev./Ver. A 
H 
Page 46, 
Section 
17.2 
Added the wording of “and potential 
USADE or UADE” to define the 
reportable device deficiency  
To be consistent with 
the latest version of 
BSC global protocol 
template.. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. A 
H 
Page 46, 
Section 
17.2 
Added wording of “provide all 
required source documents related to a 
death event to BSC and the IEC per 
local requirements.” 
To be in compliance 
with China new GCP.
AC 
January, 16, 
2017 
90702637 
Rev./Ver. A 
H 
Page 51-52, 
Section 
20.1 
Editorial revision in the Safety 
“Definitions and Classifications” per 
the new protocol template  
To be consistent with 
BSC global protocol 
template. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page54, 
Section 
20.1 
To add “It is the responsibility of the 
investigator to assess and report to 
BSC any event which occurs in any of 
following categories: 
 
All Serious Adverse Events 
 
All Investigational Device 
Deficiencies  
 
Unanticipated Adverse 
Device 
Effects/Unanticipated 
Serious Adverse Device 
Effects 
 
New findings/updates in 
relation to already reported 
events 
When possible, the medical diagnosis 
should be reported as the Event Term 
instead of individual symptoms. 
To be in consistence 
with the protocol 
template. 

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
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Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
If it is unclear whether or not an event 
fits one of the above categories, or if 
the event cannot be isolated from the 
device or procedure, it should be 
submitted as an adverse event and/or 
device deficiency” 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. A 
H 
Page53-54, 
Section 
20.2 
Combined and revised “Criteria for 
Assessing Relationship of Study 
Device or Procedure to Adverse 
Event”. 
To include the classification of 
“Unlikely Related/ Possibly Related/ 
Probably Related/ Causal 
Relationship”  
To be consistent with 
BSC global protocol 
template. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. A 
H 
Page 57, 
Section 
20.5 
Included the wordings of  “According 
to China local reporting requirements, 
Boston Scientific Corporation will 
report all SAEs  and device 
deficiencies that could lead to SAEs to 
the local Food and Drug 
Administration and the same level 
Commission of Health and Family 
Planning within 5 business days of 
BSC first becoming aware of the 
event, and notify all participating 
investigators/sites and IRBs/Ecs in a 
timely manner.” 
To be in compliance 
with China new GCP 
and latest BSC global 
protocol template. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 59, 
Section 
22.2 
Edited the wordings in the section of 
“Safety Monitoring Process” and  
included the wording of “The BSC 
Medical Safety group includes 
physicians with expertise in vascular 
intervention and with the necessary 
therapeutic and subject matter 
expertise to evaluate and classify the 
events into the categories outlined 
above.” 
To be consistent with 
BSC global protocol 
template. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 60, 
Section 
23.1.1 
Edited the wordings in the section of 
“Possible reasons for premature study 
termination”, and add the wording 
“Note: According to the section 20, 
even if the study is terminated, all the 
Aes, SAEs, SADEs and Device 
Deficiency should be evaluated and 
reported for the subjects who have 
received the treatment of study device. 
(China Medical Device GCP 
requirement: The reasons and criteria 
based on biostatistics of study 
termination are: the statistics method 
of all the data is missing, data is 
missing or error (including withdraw 
To be in compliance 
with China new GCP 
and latest BSC global 
protocol template. 

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
                                                                                                                           Page 9 of 78 
 
 
Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
and termination) and unreasonable 
data handling methods.)” 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page 61, 
Section 
23.4 
To add “According to Section 20, all 
the ongoing Aes should be evaluated 
and reported for the subjects who have 
been treated by study device. And the 
ongoing Aes should be followed up by 
investigators continues, unless BSC 
informed the sites.” 
To be in compliance 
with China new GCP 
and latest BSC global 
protocol template. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Page66-78, 
Section 
26.2 
To edit the wordings in the section of 
“Definition”. 
Editorial revision. 
AC  
January, 16, 
2017 
90702637 
Rev./Ver. AH
Throughout 
the protocol
Minor grammatical, formatting, or 
spelling changes were made. 
Minor errors were 
noted. 
AC 
January, 16, 
2017 
90702637 
Rev./Ver. AH
Header & 
Footer 
Change the Format. 
To be in consistence 
with latest BSC 
protocol template  
AD 
July 21, 2017
90702637 
Rev./Ver. AH
Page 10, 
Section 2 
Protocol 
Synopsis, 
Device 
Sizes; Page 
25, section 
5 Device 
Description
Add new size of Ranger LE DCB 
To include the longer 
sizes of Ranger DCB 
in this study to meet 
the clinical needs of 
treating longer 
lesions. 
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
Page 2 for 
Contact 
information
Change PM from “Yisi Wang” to 
“Jian Wen” 
PM changed 
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
Page 12，
Protocol 
synopsis, 
Planned 
number of 
subjects; 
Page 18, 
Sample size 
parameters; 
P30, Scale 
and 
duration; 
P33, study 
population 
and 
eligibility; 
Page 37, 
Enrollment 
controls; 
Page 46, 
Change sample size from 123 to 139 
 
Adjust the sample 
size according to the 
updated attrition 

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
                                                                                                                           Page 10 of 78 
 
 
Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
Sample 
size.   
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
Page 18, 
Sample size 
parameters; 
Page 45-46, 
Sample 
size;  
Change attrition rate from 15% to 25%
 
Adjust the attrition 
rate according to the 
realistic follow-up 
rate. 
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
Page 37, 
Enrollment 
controls; 
Page 47, 
Number of 
subjects per 
investigativ
e site 
Change the enrollment cap for each 
study site from 25% to 30%, and 
adjust the maximum number of 
patients for each site from 30 to 42 
according to the cap and total sample 
size 
Adjust the enrollment 
cap to give more 
flexibility for site 
which has potential 
to enroll more 
patients. 
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
P52，
Delegation 
of 
responsibilit
y 
Insert “Where there is a sub 
investigator at a site, the sub 
investigator should not be delegated 
the primary supervisory responsibility 
for the site.” 
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
P53, 
Investigator 
responsibilit
ies 
Edited and added some appropriate 
wordings in the section of 
“Investigator Responsibilities” 
according to the new protocol template
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
P53, 
Institutional 
Review 
Board/ 
Ethics 
Committee
Edited and added some appropriate 
wordings in the section of 
“Institutional Review Board/ Ethics 
Committee” according to the new 
protocol template 
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
P53, Role 
of Boston 
scientific 
representati
ves 
Delete “without the approval and 
presence of the HCP” according to the 
new protocol template 
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AE 
December 
7，2018 
90702637 
Rev./Ver. AJ
P55, 
Insurance 
Edited the section of “Insurance” 
according to the new protocol template
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
Home Page; 
Header 
The protocol version was updated 
from AE to AF. 
The protocol template version was 
updated from AJ to AL. 
Update the protocol 
and to be consistent 
with the latest 
version of BSC 
global protocol 
template. 
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P2, Contact 
Information
Project manager was changed from 
Wen Jian to Zhou Jing. 
PM changed. 

Study Reference Number: S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                               Ranger China Protocol, 91047542 Rev/Ver AF 
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Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P13, 
Indications 
for Use 
Added indications of  the study device 
in the synopsis. 
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P16, 
Participant 
Duration 
Added participant duration in the 
synopsis. 
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P14, 
Planned 
number of 
subjects; 
P21, 
Sample size 
parameters;  
P32, Scale 
and 
Duration; 
P35, Study 
population 
and 
eligibility; 
P38, 
Enrollment 
controls; 
P45, 
Sample size
Sample size was changed from 139 to 
123. 
The new added 16 
subjects can’t get the 
approval by HGRAC, 
so the original 
sample size was used.
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P14, 
Primary 
Endpoint; 
P15, 
Additional 
Endpoints 
Replace “vessel patency” with “Lesion 
patency” in the notes. 
To be consistent with 
the description of 
primary efficacy 
endpoint 
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P15/P31, 
Additional 
Endpoints 
Specify the time point for evaluating 
clinical success and hemodynamic 
success  
To be consistent with 
Table 11.1-1: Data 
Collection Schedule
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P20/P45, 
Primary 
Statistical 
Hypothesis; 
P20/P46, 
Statistical 
Test 
Method; 
P31/P45, 
The 
primary 
efficacy 
endpoint 
Modify the wording of primary 
efficacy endpoint 
To be consistent with 
the description of 
primary efficacy 
endpoint in synopsis

Study Reference Number: S6052 
 
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Revision History 
Revision 
Number
Release Date
Template 
number and 
version 
Section 
Change 
Reason for Change
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P47, 
Subgroup 
Analyses 
The classification of the target lesion 
location was changed from “ 
ATK and BTK” to “distal, mid, 
proximal and ostial” 
Per protocol, all the 
target lesions are in 
the SFA and/or PPA, 
not involved BTK 
artery. 
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P20, 
Sample size 
parameters; 
P38, 
Enrollment 
controls;  
  P45, 
Sample size
The attrition rate was changed from 
25% to 15%. 
Considering that the 
12-month follow-up 
is now nearing 
completion, and the 
last 9 subjects have 
entered the follow-up 
window to be 
followed, the attrition 
rate was adjusted 
according to the 
actual follow-up rate.
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P38, 
Definitions 
of End-of-
study 
Added the definition for end-of-study.
To be consistent with 
the latest version of 
BSC global protocol 
template. 
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P47, 
Number of 
subjects per 
investigator 
site 
The maximum number of subjects per 
site was changed from 42 to 37. 
Updated according to 
the final sample size.
AF 
Apr 30, 2020
90702637 
Rev./Ver. AL
P64, 
Reporting 
to 
Regulatory 
Authorities/
IRBs/ECs/ 
Investigator
s 
Added the following contents in this 
section:” Investigator and 
investigational site is responsible for 
reporting all SAEs and device 
deficiencies that could lead to SAEs to 
IRBs/ECs, local Food and Drug 
Administration and the same level 
Commission of Health within 24 hours 
of investigator becoming aware of the 
event.” 
To be consistent with 
the latest version of 
BSC global protocol 
template. 
 
 
 

Study Reference Number: S6052 
 
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2. Protocol Synopsis 
Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
Study 
Objective(s) 
The primary objective of this study is to demonstrate acceptable safety 
and performance of the Ranger™（Ranger & Ranger LE） and 
Ranger™ SL (OTW) paclitaxel-coated PTA balloon catheter used for 
angioplasty of femoropopliteal artery lesions. 
Indications for 
Use 
The Ranger（Ranger & Ranger LE） and Ranger SL balloon catheters 
are indicated for PTA in the peripheral vasculature, including iliac and 
infrainguinal arteries. 
Test Device 
Boston Scientific Ranger™（Ranger & Ranger LE） and Ranger™ SL 
Paclitaxel-Coated PTA Balloon Catheter (Ranger DCB) 
Control Device 
N/A 
Device Sizes 
The working length is 80cm and 135cm for Ranger DCB catheter and 90 
cm and 150cm for Ranger SL and Ranger LE DCB catheter.  Balloons 
with the following dimensions will be used in this trial: 
 
Diameters of Ranger & Ranger SL & Ranger LE DCB 
Length
2.0 
mm
2.5 
mm
3.0 
mm
3.5 
mm
4.0 
mm
5.0 
mm
6.0 
mm
7.0 
mm
8.0 
mm
30 mm
- 
- 
- 
- 
X 
X 
X 
X 
X 
40 mm
- 
- 
- 
- 
X 
X 
X 
X 
X 
60 mm
- 
- 
- 
- 
X 
X 
X 
X 
X 
80 mm
X 
X 
X 
X 
X 
X 
X 
X 
X 
100 
mm 
X 
X 
X 
X 
X 
X 
X 
X 
- 
120 
mm 
X 
X 
X 
X 
X 
X 
X 
X 
- 
150 
mm 
X 
X 
X 
X 
X 
X 
X 
X 
- 
200 
mm 
- 
- 
- 
- 
X 
X 
X 
X 
- 

Study Reference Number: S6052 
 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
Study Design 
This clinical study is a prospective, non-randomized, multicenter study 
to demonstrate the acceptable safety and performance of angioplasty 
with the Ranger DCB in native femoropopliteal artery lesions.  It is 
intended that all patients with qualifying lesions would be considered for 
enrollment and treated with the Ranger DCB catheter. 
Planned 
Number of 
Subjects 
Approximately 123 patients with femoropopliteal artery lesions will be 
enrolled.  All lesions will be treated with the Ranger DCB. 
Planned 
Number of Sites 
/ Countries 
Up to 15 clinical sites located in China are expected to participate. 
Primary 
Endpoint 
The primary safety endpoint is the rate of following major adverse 
events through 30 days post-procedure: 
 all device and/or procedure related mortality  
 target limb major amputation at  
 Clinically-driven Target Lesion Revascularization (TLR)  
 
The primary efficacy endpoint is primary lesion patency of the treated 
segment(s) as assessed by computed tomography angiography (CTA) at 
12 months post-procedure without clinically-driven TLR. 
 
Notes 
 Lesion patency is defined as freedom from more than 50% diameter 
stenosis  
 All CTA readings will be assessed by an independent core 
laboratory
Additional 
Endpoints 
 Technical success (defined as ability to cross and dilate the lesion to 
achieve residual angiographic stenosis no greater than 30%) 
 Procedural success (defined as technical success with no Major 
Adverse Events (MAEs, including all-cause death, clinically-driven 

Study Reference Number: S6052 
 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
TLR, target limb major amputation or thrombosis at target lesion) 
within 24 hours of the index procedure 
 Target lesion patency assessed by duplex ultrasound sonography 
(DUS) at 3 month post index procedure 
 All-cause death at 30 days, 3, 6 and 12 months 
 Clinically-driven TLR at 3, 6 and 12 months 
 Time to first clinically-driven TLR through 12 months post-
procedure 
 Clinical success (defined as improved Rutherford classification by at 
least +1 class) at pre-discharge, 3 and 12 months, as compared to 
baseline 
 Hemodynamic success (defined as positive change in Ankle-
Brachial Index(ABI)) at pre-discharge, 3 and 12 months, as 
compared to baseline 
 MAEs through 12 months   
 
Notes 
 Lesion patency is defined as freedom from more than 50% stenosis 
based on DUS peak systolic velocity ratio comparing data within the 
treated segment to the proximal normal arterial segment.   
 A systolic velocity ratio > 2.4 suggests > 50% stenosis.
Safety 
Parameters 
The following will be collected and reported at each follow-up interval 
 MAEs including all-cause death, clinically-driven TLR, target limb 
major amputation or thrombosis at target lesion 
 All adverse Events (including but not limited to unanticipated, 
major, serious, device/procedure-related) 
 
Method of 
Assigning 
Patients to 
Treatment 
Once a patient signs the Ethics Committee-approved Informed Consent 
Form, and has met all inclusion criteria and has no exclusion criteria, 
they are eligible to be enrolled in the clinical study.  All eligible 
subjects will receive treatment with the Ranger DCB.  Enrollment 
occurs at the time of advancement of the Ranger DCB into the body. 

Study Reference Number: S6052 
 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
Follow-up 
Schedule 
Follow-up time points include: pre-discharge; 30 days, 3, 6 and 12 
months.   
Tests planned to occur during follow-up visits include the following: 
 CTA assessment before procedure 
 Angiography during the procedure 
 DUS at 3-month follow-up visit  
 CTA at 12-month follow-up visit (evaluated by an independent core 
lab)
Study Duration 
Approximately 1 year of enrollment and 1 year of follow-up 
Participant 
Duration 
The study duration for each subject is expected to be 12 months 
Required 
Medication 
Therapy 
 If patients do not already take acetylsalicylic acid (ASA) (minimum 
75 mg per day) and/or Clopidogrel (75 mg/day)  72 hours at the 
time of index procedure, they will receive recommended peri-
procedural loading doses of 300 mg ASA and/or 300 mg 
Clopidogrel before the balloon angioplasty procedure or no later 
than 2 hours after the index procedure. 
 At the time of the procedure, patients receive an intra-arterial bolus 
of heparin (usually 3000-5000 IU), or alternate anticoagulants as 
substitutes for heparin if justified by individual subject conditions. 
 After the procedure, all patients will be treated with ASA (minimum 
75 mg per day) indefinitely, and with Clopidogrel (minimum 75 mg 
per day) for 3 months.
Key Inclusion 
Criteria 
1. Subjects must be age 18 or older 
2. Subject is willing and able to provide informed consent 
3. Subject is available and willing to attend all required follow-up 
visits 
4. Subject has a clinically significant symptomatic leg ischemia  
5. Subject has a Rutherford clinical category of 2 - 4 
6. If the index lesion is restenotic, the prior PTA must have been > 90 
days prior to treatment in the current study 
7. Only one lesion per limb can be treated under this protocol, which 
means that one index lesion, on one index limb will be “in 
treatment”.  However, both limbs may be treated during either the 
index procedure and/or subsequent procedures

Study Reference Number: S6052 
 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
8. Successful intraluminal wire crossing of the target lesion 
Angiographic Inclusion Criteria: 
AI1. The index lesion is a clinically and hemodynamically de novo 
stenotic or restenotic lesion located in the native nonstented superficial 
femoral artery or proximal popliteal artery between the Hunter’s Canal 
and the popliteal fossa (i.e. within the P1 segment), with the following 
characteristics by visual assessment: 
 Degree of stenosis ≥ 70%  
 Target vessel diameter ≥ 2.0 mm and ≤ 8.0 mm 
 Lesion length ≥ 20 mm and ≤ 200 mm, to be covered by one or 
two balloon(s) (must be overlapped to cover targeted lesion(s) ) 
 The lesion length of total occluded lesion ≤ 100 mm   
 For diffuse lesion or multiple tandem lesions (may including a 
total occluded lesion) in the same target vessel, the total lesion 
length, including the distance between lesions, must be ≤ 200 
mm, with the separation of ≤ 30 mm (3 cm) between two 
adjacent lesions 
AI2. The subject has at least one patent infrapopliteal artery (< 50% 
stenosis) to the foot prior to index procedure  
Key Exclusion 
Criteria 
1. Subjects who have undergone prior vascular surgery of the 
SFA/PPA in the index limb to treat atherosclerotic disease 
2. History of major amputation in the same limb as the target lesion 
3. Presence of aneurysm in the target vessel(s) 
4. Acute ischemia and/or acute thrombosis in any artery of the lower 
limbs 
5. Acute Myocardial Infarction within 30 days before the index 
procedure 
6. History of hemorrhagic stroke within 3 months 
7. History of thrombolysis or unstable angina within 2 weeks of 
enrollment 
8. Persistent, intraluminal thrombus of the proposed target lesion post 
thrombolytic therapy 
9. Known hypersensitivity or contraindication to contrast dye that, in 
the opinion of the investigator, cannot be adequately pre-medicated 
10. Known allergies against Paclitaxel or other components of the used 
medical devices 
11. Intolerance to antiplatelet, anticoagulant, or thrombolytic 
medications that would be administered during the trial

Study Reference Number: S6052 
 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
12. Platelet count < 80,000 mm3 or > 700,000 mm3 
13. Concomitant renal failure with a serum creatinine > 2.0 
mg/dL(176.8 umol/L) 
14. Receiving dialysis or immunosuppressant therapy 
15. Life expectancy of less than one year 
16. Women of child-bearing potential cannot use a reliable method of 
contraception from the time of screening through 12 months after 
the index procedure. 
17. Woman who is pregnant or nursing. (Pregnancy test must be 
performed within 72 hours prior to the index procedure, except for 
women who definitely do not have child-bearing potential). 
18. Previously planned stenting of the index lesion (stents will be 
allowed for bailout situations, such as flow-limiting dissection) 
19. Use of adjunctive therapies (debulking, laser, cryoplasty, re-entry 
devices)  
20. Subjects who had any major procedures (cardiac, aorta, peripheral) 
within 30 days prior to the index procedure 
21. Planned or expected procedures (cardiac, aorta, peripheral) within 
30 days post the index procedure 
22. Presence of outflow lesions requiring intervention within 30 days of 
the index procedure 
23. Heavily calcified target lesions resistant to PTA 
24. Current participation in another drug or device trial that has not 
completed the primary endpoint, including any clinical study using 
drug-coated or drug-eluting technology, that may potentially 
confound the results of this trial, or that would limit the subject’s 
compliance with the follow-up requirements 
25. Current or past intervention using drug-coated/drug-eluting 
technologies in the index limb 
26. Target lesion with in-stent restenosis (any stent or stent-graft) 
Angiographic Exclusion Criteria: 
   AE1. Subjects with ipsilateral iliac inflow lesions, and unsuccessful 
treatment prior to the index procedure (i.e., residual stenosis ≥ 30% post 
treatment 
   AE2. Subjects with no patent infrapopliteal artery (i.e., ≥ 50% 
stenosis) to the foot prior to index procedure (even with successfully 
treatment during the procedure, these subjects should be excluded from 
enrollment)  

Study Reference Number: S6052 
 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
AE3.  Failure to successfully antegrade cross the target lesion with a 
guidewire (successful crossing is defined as the tip of crossing device is 
distal to the target lesion in the true lumen without flow-limiting dissection 
or perforation as evidenced by extravasation of contrast media) 
Multiple 
Interventions  
Prior to or during Index Procedure: 
 Prior to treatment of the index limb, successful (< 30% residual 
stenosis) treatment of ipsilateral iliac inflow lesions may be 
performed 
 Prior to treatment of the index limb, successful treatment of the 
arteries of the non-index limb may be performed 
 Prior to treatment of the index limb, absence of clinical 
complications such as embolism, thrombosis, severe dissection, 
vessel rupture must be confirmed 
 
IMPORTANT NOTE: Use of drug coated devices 
Additional Index Limb Treatment 
 No other Drug Coated Balloon (DCB) or Drug Eluting Stent (DES) 
treatment in the index lesion is allowed throughout the study 
duration 
 DCB or DES treatment in non-index lesions of the index limb is 
allowed after 12 months post procedure 
 
Non-index Limb Treatment 
 
The non-index limb may be treated with DCB or DES before and 
after the index procedure 
Statistical Methods  
Primary 
Statistical 
Hypothesis 
Primary Safety Endpoint:  
The rate of freedom from device and/or procedure-related death, target 
limb major amputation and/or clinically-driven target lesion 
revascularization through 30 days post procedure (i.e. the rate of 
composite MAE-free) exceeds a PG of 88%. 
 
H0: Safety  0.88 
H1: Safety > 0.88 
 
Primary Efficacy Endpoint: 

Study Reference Number: S6052 
 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
The rate of primary lesion patency at 12 months post-procedure without 
clinically-driven TLR exceeds a PG of 53% for femoropopliteal artery 
segments treated with the Ranger DCB. 
 
H0: Patency  0.53 
H1: Patency > 0.53
Statistical Test 
Method 
The primary hypotheses will be tested in a sequential manner to allow 
testing of each of primary safety and efficacy endpoints at the specified 
significance level of 5% without adjustment. The hierarchical testing 
procedure for multiple comparisons with the testing order starting with 
the primary safety endpoint followed by the primary efficacy endpoint. 
That is, the primary efficacy hypothesis will be tested only if the 
primary safety hypothesis is rejected.  
 
For safety, if the one-sample normal approximation one-sided 95% 
lower confidence bound of the observed 30-day composite MAE-Free 
rate is greater than 0.88, then the Ranger DCB will be considered to 
have acceptable safety performance, and 12-month efficacy performance 
testing will be allowed. 
 
For efficacy, if the one-sample normal approximation one-sided 95% 
lower confidence bound of the observed 12-month lesion patency is 
greater than 0.53, then the Ranger DCB will be considered to have 
acceptable performance. 
Sample Size 
Parameters 
Safety 
 Expected 30-day composite MAE-Free rate for all subjects = 99%   
o Safety Performance Goal = 88%   
 
Test significance level α = 0.05 (one-sided normal approximation) 
 A minimum of 104 evaluable subjects are driven by the efficacy 
endpoint to provide at least 99% power to assess the primary safety 
endpoint at 30 days 
 
Efficacy 
 Expected 12-Month vessel patency = 65% 
o Efficacy Performance Goal = 53% 
 Test significance level α = 0.05 (one-sided normal approximation)

Study Reference Number: S6052 
 
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Prospective, non-randomized, multicenter clinical study of the Boston 
Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and 
Ranger™ SL (OTW) DCB) in China 
RANGER CHINA 
 A minimum of 104 evaluable subjects are required to provide 
adequate power of 80% to assess the primary efficacy endpoint at 12 
months 
 Expected attrition for all reasons at 12 months ≤ 15% 
 Approximately 123 subjects will be enrolled to account for expected 
attrition 
Core Lab 
Computed tomography angiography (CTA) readings will be assessed by 
a blinded core lab. 
 
 
 
 

Study Reference Number: S6052 
 
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3. Table of Contents 
1.    TITLE PAGE……………………………………………………………………………...1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................13 
3. 
TABLE OF CONTENTS .......................................................................................................22 
3.1. Table of Figures .....................................................................................................26 
3.2. Table of Tables ......................................................................................................26 
4. 
INTRODUCTION ................................................................................................................27 
5. 
DEVICE DESCRIPTION ......................................................................................................29 
5.1. Ranger™ DCB Description ..................................................................................29 
5.1.1. 
Drug Component Description ...................................................................29 
5.2. Intended Use ..........................................................................................................30 
5.3. Device Labeling .....................................................................................................30 
6. 
STUDY OBJECTIVES .........................................................................................................30 
7. 
STUDY ENDPOINTS ...........................................................................................................31 
7.1. Primary Endpoints: ..............................................................................................31 
7.1.1. 
The primary safety endpoint: ....................................................................31 
7.1.2. 
The primary efficacy endpoint: ................................................................31 
7.2. Additional Endpoints ............................................................................................31 
8. 
STUDY DESIGN .................................................................................................................32 
8.1. Scale and Duration ................................................................................................32 
8.2. Treatment Assignment..........................................................................................33 
8.2.1. 
Treatment and Control ..............................................................................33 
8.2.2. 
Target and Non-target Lesions .................................................................33 
8.3. Justification for the Study Design ........................................................................33 
8.4. Treatment...............................................................................................................33 
8.4.1. 
Device sizing selection .............................................................................34 
8.4.2. 
Number of device per lesion .....................................................................34 
8.4.3. 
Number of inflation ..................................................................................34 
8.4.4. 
Treatment of dissection .............................................................................34 
8.4.5. 
Role of stenting .........................................................................................35 

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9. 
SUBJECT SELECTION ........................................................................................................35 
9.1. Study Population and Eligibility ..........................................................................35 
9.2. Inclusion Criteria ..................................................................................................35 
9.3. Exclusion Criteria .................................................................................................36 
10. SUBJECT ACCOUNTABILITY .............................................................................................37 
10.1. Point of Enrollment ...............................................................................................37 
10.2. Withdrawal ............................................................................................................38 
10.3. Enrollment Controls .............................................................................................38 
10.4. Definitions of End-of-study ..................................................................................38 
11. STUDY METHODS .............................................................................................................38 
11.1. Data Collection ......................................................................................................38 
11.2. Study Candidate Screening ..................................................................................40 
11.3. Informed Consent .................................................................................................40 
11.4. Screening (Up to 14 Days Prior to Index procedure).........................................40 
11.5. Required Concomitant Medications ....................................................................41 
11.5.1. Prior to the index procedure .....................................................................41 
11.5.2. In the Catheterization Laboratory .............................................................41 
11.5.3. Post-procedure ..........................................................................................41 
11.6. Enrollment & Index Procedure ...........................................................................42 
11.6.1. Multiple Interventions ..............................................................................42 
11.6.2. End of the Index Procedure ......................................................................43 
11.7. Post-Procedure / Pre-Discharge ...........................................................................43 
11.8. 30-Day Follow-up (+/- 7 days) ..............................................................................43 
11.9. 3-Month Follow-up (+/- 30 days) .........................................................................43 
11.10. 6-Month Follow-up (+/- 30 days) ........................................................................44 
11.11. 12-Month Follow-up (+/- 30 days) ......................................................................44 
11.12. Study Completion ................................................................................................44 
11.13. Source Documents ...............................................................................................44 
12. STATISTICAL CONSIDERATIONS ......................................................................................44 
12.1. Endpoints ...............................................................................................................44 
12.1.1. Primary Safety Endpoint ...........................................................................44 
12.1.2. Primary Efficacy Endpoint .......................................................................45 

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12.2. Hypotheses .............................................................................................................45 
12.2.1. Primary Safety Endpoint: .........................................................................45 
12.2.2. Primary Efficacy Endpoint: ......................................................................45 
12.3. Sample Size ............................................................................................................45 
12.4. Statistical Test Methods ........................................................................................46 
12.5. Secondary Endpoints ............................................................................................46 
12.6. General Statistical Methods .................................................................................46 
12.6.1. Analysis Sets .............................................................................................46 
12.6.2. Control of Systematic Error/Bias ..............................................................47 
12.6.3. Number of Subjects per Investigative Site ...............................................47 
12.7. Data Analyses ........................................................................................................47 
12.7.1. Baseline Comparability ............................................................................47 
12.7.2. Post-procedure Endpoints .........................................................................47 
12.7.3. Other Endpoint Measurements .................................................................47 
12.7.4. Interim Analyses .......................................................................................47 
12.7.5. Subgroup Analyses ...................................................................................47 
12.7.6. Changes to Planned Analyses ...................................................................48 
13. DATA MANAGEMENT .......................................................................................................48 
13.1. Data Collection, Processing, and Review ............................................................48 
13.2. Data Retention .......................................................................................................48 
13.3. Core Laboratories .................................................................................................49 
14. AMENDMENTS ..................................................................................................................49 
15. DEVIATIONS .....................................................................................................................49 
16. DEVICE/EQUIPMENT ACCOUNTABILITY .........................................................................50 
17. COMPLIANCE ....................................................................................................................50 
17.1. Statement of Compliance ......................................................................................50 
17.2. Investigator Responsibilities ................................................................................50 
17.2.1. Delegation of Responsibility ....................................................................52 
17.3. Institutional Review Board/ Ethics Committee ..................................................53 
17.4. Sponsor Responsibilities .......................................................................................53 
17.4.1. Role of Boston Scientific Representatives ...............................................53 
17.5. Insurance ................................................................................................................54 

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18. MONITORING ....................................................................................................................55 
19. POTENTIAL RISKS AND BENEFITS ...................................................................................55 
19.1. Risks / Adverse Events Associated with the Study Device ................................55 
19.2. Risks Associated with Paclitaxel ..........................................................................55 
19.3. Risks associated with Participation in the Clinical Study .................................56 
19.4. Risk Minimization Actions ...................................................................................56 
19.5. Anticipated Benefits ..............................................................................................56 
19.6. Risk to Benefit Rationale ......................................................................................56 
20. SAFETY REPORTING .........................................................................................................56 
20.1. Definitions and Classification ..............................................................................56 
20.2. Relationship to Study Device(s) ...........................................................................59 
20.3. Investigator Reporting Requirements .................................................................61 
20.4. Boston Scientific Device Deficiencies ...................................................................62 
20.5. Reporting to Regulatory Authorities / IRBs / ECs / Investigators ...................63 
21. INFORMED CONSENT........................................................................................................63 
22. COMMITTEES ...................................................................................................................65 
22.1. Executive Committee ............................................................................................65 
22.2.  Safety Monitoring Process ............................................................................65 
22.3. Clinical Events Committee ............................................................................65 
23. SUSPENSION OR TERMINATION .......................................................................................65 
23.1 Premature Termination of the Study ..................................................................65 
23.1.1 
Criteria for Premature Termination of the Study ......................................66 
23.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC Approval .................................................................................................66 
23.3 Requirements for Documentation and Subject Follow-up ................................66 
23.4 Criteria for Suspending/Terminating a Study Site ............................................67 
24. PUBLICATION POLICY ......................................................................................................67 
25. BIBLIOGRAPHY .................................................................................................................67 
26. ABBREVIATIONS AND DEFINITIONS .................................................................................69 
26.1. Abbreviations ........................................................................................................69 
26.2. Definitions ..............................................................................................................70 

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3.1. 
Table of Figures 
Figure 8.1-1: Ranger Study Design ...................................................................................... 322 
 
3.2. 
Table of Tables 
Table 9.2-1: Inclusion Criteria ................................................................................................ 35 
Table 9.3-1: Exclusion Criteria ............................................................................................... 36 
Table 11.1-1: Data Collection Schedule ................................................................................. 39 
Table 20.1-1:  Safety Reporting Definitions ........................................................................... 57 
Table 20.2-1: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event .................................................................................................................... 59 
Table 20.2-2: Criteria for Assessing Relationship of Antiplatelet Medication to Adverse 
Event .................................................................................................................... 61 
Table 20.3-1: Investigator Reporting Requirements ............................................................... 61 
Table 26.1-1:  Abbreviations .................................................................................................. 69 
Table 26.2-1: Definitions ........................................................................................................ 70 
 

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4. Introduction 
Peripheral arterial disease (PAD) is a common disease characterized by atherosclerotic 
stenosis and occlusion in peripheral arteries.  Its prevalence is in the range of 3 – 10% with 
increasing with age (about 15 – 20% in people of age over 70-year old).1-3  It most affects 
lower extremities vessels causing claudication, about 5% of the patients eventually develop 
critical limb ischemia (CLI) with a poor prognosis – amputation in 30% and death in 25% of 
those with CLI at 1 year.4, 5 
 
Previous studies show that the prevalence of lower extremity artery disease (LEAD) in China 
is 2.1 – 27.5% in general population.6  But as one of the most rapidly aging nations (the age 
of > 65-year old was 9% of its population in 2011, expecting double by 2020), the prevalence 
will increase remarkably in the near future.   
 
The femoropopliteal artery is the most commonly involved site in patients with PAD.7   
Endovascular therapy, percutaneous transluminal angioplasty (PTA) with optional bailout 
stenting is currently recommended for the majority of symptomatic patients by ACCF/AHA 
and TASC II.5, 8   Although the primary success rate of PTA is high (above 90%), the long 
femoropopliteal lesions have a high rate of restenosis after endovascular treatment, 9, 10 
because of the unique anatomy and biomechanics of femoropopliteal arteries.  Both bare and 
drug-eluting stents were developed to improve the acute and long-term clinical outcomes of 
PTA.  However, the high restenosis rate and stent-based complications (such as stent 
fracture) remain a challenge in the patients with femoropopliteal lesions.  Hence, drug-coated 
balloons (DCB) have been developed to further reduce the restenosis rate and address the 
limitations of stents.  
 
Currently marketed DCBs are coated with Paclitaxel which inhibits the proliferation of 
neointimal vascular smooth muscle cells. This effect has been shown first in a number of 
multicenter randomized clinical trials in the prevention of restenosis following coronary 
angioplasty,11, 12 and in studies in peripheral arteries (e.g. THUNDER trial, Tepe et al.).13 
Restenosis in treated peripheral arteries is caused by an interaction of a variety of mechanical 
and biological processes. These processes involve early vessel recoil causing residual 
stenosis, negative vascular remodeling, and excessive neointimal proliferation.14 - 16 The DCB 
technology adds the benefits of local drug delivery to the mechanical procedure of PTA 
resulting in more effective inhibition of neointimal proliferation and restenosis.  In addition, 
DCB also provides more homogenous drug transfer, rapid release of the drug with little 
impact on long-term healing, absence of a polymer carrier which could decrease chronic 
inflammation, the anatomy of the vessel stays intact, and no overdependence on antiplatelet 
therapy. 11 
 
The safety and performance of DCB in the treatment of peripheral occulusive artery disease 
of the lower extremities has been demonstrated in randomized clinical trials and a series of 
clinical studies. Werk et al. 17 randomly assigned 87 patients with femoropopliteal peripheral 
artery disease to uncoated or paclitaxel-coated balloons (Paclitaxel dose density of 
3 μg/ mm2 balloon surface area). Eligible patients had an occlusion or > 70% diameter 
stenosis of the superficial femoral artery and/or popliteal artery, with clinical Rutherford 

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stage 1 to 5. The primary endpoint of angiographic late lumen loss (LLL) at 6 months was 
significantly reduced in patients treated with DCB when compared to bare PTA control, as 
well as the endpoint of binary restenosis (DCB group, n=6 of 31, 19%; control group, n=16 
of 34, 47%; p=0.035), and the clinical endpoint of improvement in Rutherford class at 6 
months compared to pretreatment (p=0.045). The advantage of paclitaxel-coated balloon 
treatment over PTA with regard to Target Lesion Revascularization (TLR) was maintained 
out to 18 to 24 months after intervention. 
 
Similar results were observed in the THUNDER trial13 which was a prospective, randomized, 
multicentre trial to evaluate the safety and efficacy of a paclitaxel-coated PTA balloon 
(Paccocath; coated with paclitaxel at a dose density of 3 μg/ mm2 balloon surface area) vs. an 
uncoated PTA balloon for the treatment of symptomatic peripheral artery disease 
(Rutherford stages 1 to 5).  All patients had one or more obstructive lesion, either de novo or 
restenotic lesions in the superficial femoral artery, the popliteal artery, or both. The 
angiographic restenosis rate was significantly lower for patients treated with paclitaxel 
coated balloons than for patients in the control group (17% vs. 44%, p=0.01).  The rate of 
target lesion revascularization remains significantly lower for the paclitaxel-coated balloon 
group through 24 months. 
 
The Ranger™ and Ranger™ SL (OTW) Paclitaxel-Coated PTA Balloon Catheters (Ranger 
DCB) are intended to be used in PTA in the peripheral vasculature including iliac and 
infrainguinal arteries. This intended use includes PTA of stenotic and occlusive lesions in the 
femoropopliteal segment (SFA/PPA). 
 
It has been demonstrated that various currently marketed drug-coated balloons are safe and 
effective for the treatment of peripheral artery disease. The core of Ranger DCB technology 
is a proprietary drug and excipient formulation applied to the balloon component of an 
approved, state-of-the-art conventional PTA balloon catheter, with a highly effective 
drug/excipient coating formulation allowing for a reduced drug dose density of 2μg/mm2. 
This coating composition has been shown to be comparably effective to 3μg/mm2 
formulations of other DCB platforms while reducing systemic drug exposure. 
 
Based on a systematic evaluation of device characteristics (risk assessment, design 
verification and validation, biocompatibility, stability, sterility, evaluations of 
pharmacokinetic characteristics and histopathology in a representative preclinical animal 
model) performed by the legal manufacturer and study Sponsor, the study device is 
considered safe for starting clinical evaluations in patients. 
 
The primary objective of this study is to demonstrate acceptable safety and performance of 
the Ranger™ （Ranger & Ranger LE）and Ranger™ SL (OTW) DCBs for angioplasty for 
femoropopliteal artery lesions in Chinese LEAD patient cohort. 

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5. Device Description 
5.1. 
Ranger™ DCB Description 
The Ranger™（Ranger & Ranger LE） and Ranger™ SL Paclitaxel-Coated PTA Balloon 
Catheters (Ranger (Ranger & Ranger LE)and Ranger SL balloon catheters) are Over-the-
Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) balloon catheters with a semi-
compliant balloon coated with a formulation of paclitaxel (drug) and an excipient.  The 
Ranger （Ranger & Ranger LE）and Ranger SL balloon catheters are designed to inhibit 
restenosis by delivering drug to diseased arterial tissue. 
 
The Ranger（Ranger & Ranger LE） and Ranger SL balloon catheters have a coaxial shaft 
design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the 
use of guidewires 0.014 in or 0.018 in (0.36 mm or 0.46 mm) to facilitate advancement of the 
catheter. The balloon is designed to provide an inflatable segment of known diameter and 
length at recommended pressures. The catheter includes a tapered tip to facilitate 
advancement of the catheter to and through the stenosis. 
 
The Ranger（Ranger & Ranger LE） and Ranger SL balloon catheters have two radiopaque 
marker bands (one proximal and one distal) which, in conjunction with fluoroscopy, aid in 
the placement of the balloon. The proximal shaft marks define the length to the distal end of 
the catheter. 
 
The working lengths of the Ranger balloon catheters are 80 cm and 135 cm. The 80 cm 
working length catheter has one mark at 50 cm and two marks at 60 cm. The 135 cm working 
length catheter has one mark at 90 cm and two marks at 100 cm. 
 
The working lengths of the Ranger SL and Ranger LE balloon catheters are 90 cm and 150 
cm. The 90 cm working length catheter has one mark at 50 cm and two marks at 60 cm. The 
150 cm working length catheter has one mark at 90 cm and two marks at 100 cm. 
 
The proximal portion of the Ranger （Ranger & Ranger LE）and Ranger SL balloon 
catheters includes one female 
Luer-lock port connected to the inflation lumen, and one female Luer-lock port for the 
guidewire lumen. In addition, the Ranger（Ranger & Ranger LE） and Ranger SL balloon 
catheters are equipped with a loading tool to help protect the drug coating as it enters the 
hemostatic valve. 
5.1.1. Drug Component Description 
The Ranger（Ranger & Ranger LE） and Ranger SL balloon catheters have a drug coating 
formulation consisting of paclitaxel (the active pharmaceutical ingredient) and an excipient 
(the inactive ingredient). 

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5.1.1.1. 
Paclitaxel 
The active pharmaceutical ingredient in the balloon coating is paclitaxel. It is a white 
powder, isolated from a spectrum of Taxus species and hybrids. The dose of Paclitaxel is 2.0 
μg per mm2 of the balloon surface. The Chemical name of paclitaxel is: Benzenepropanoic 
acid, β -(benzoylamino) α - hydroxy -,6,12b – bis (acetyloxy) - 12- (benzoyloxy) - 
2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11- dihydroxy-4a,8,13,13- tetramethyl-5 
oxo-7,11 methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester, [2aR- [2aα,4β,4aβ,6β,9α 
(αR*,βS*), 11α,12α,12aα,12bα]]. 
Paclitaxel is a diterpenoid with a characteristic taxane skeleton of 20 carbon atoms, a 
molecular weight of 853.91 g/mol and a molecular formula of C47H51NO14. It is highly 
lipophilic, insoluble in water, but freely soluble in methanol, ethanol, chloroform, ethyl 
acetate and dimethyl sulfoxide. 
5.2. 
Intended Use 
The Ranger（Ranger & Ranger LE） and Ranger SL balloon catheters are indicated for PTA 
in the peripheral vasculature, including iliac and infrainguinal arteries. 
5.3. 
Device Labeling 
A copy of the Directions for Use (DFU) for Ranger（Ranger & Ranger LE） and Ranger SL 
DCBs is included in the Ranger China Manual of Operations.  The labeling will include at 
least the following information: 
 Product Name 
 Project Name, Storage & Shipment condition 
 
The following statements appear on the Ranger China product labeling for clinical 
distribution: 
Caution: For Clinical Trial Use Only 
Device labeling will be provided in Chinese per China regulations. 
6. Study Objectives 
The primary objective of this study is to demonstrate acceptable safety and performance of 
the Ranger™（Ranger & Ranger LE） and Ranger™ SL (OTW) paclitaxel-coated PTA 
balloon catheter used for angioplasty of femoropopliteal artery lesions. 

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7. Study Endpoints 
7.1. 
Primary Endpoints: 
7.1.1. The primary safety endpoint:  
The primary safety endpoint is the rate of following major adverse events: 
 All device and/or procedure related mortality through 30 days 
 Target limb major amputation at 30 days 
 Clinically-driven Target Lesion Revascularization (TLR) at 30 days post-procedure 
7.1.2.  The primary efficacy endpoint: 
The primary efficacy endpoint is primary lesion patency of the treated segment as assessed 
by computed tomography angiography (CTA) at 12 months post-procedure without 
clinically-driven TLR. 
 
Notes 
 Lesion patency is defined as freedom from more than 50% diameter stenosis .   
 All CTA readings will be assessed by an independent core laboratory. 
7.2. 
Additional Endpoints 
 Technical success, defined as the ability to cross and dilate the target lesion to achieve 
residual angiographic stenosis no greater than 30% 
 Procedural success, defined as technical success without any Major Adverse Events
（MAEs，including all-cause death, clinically-driven TLR, target limb major 
amputation or thrombosis at target lesion）within 24 hours of the index procedure 
 Target lesion patency assessed by duplex ultrasound sonography (DUS) at 3month post 
index procedure 
 All-cause death at 30 days, 3, 6 and 12 months 
 Clinically-driven TLR at 3, 6 and 12 months 
 Time to first clinically-driven TLR through 12 months post-procedure 
 Clinical success (defined as improved Rutherford Classification by at least +1 class) at 
pre-discharge, 3 and 12 months, as compared to baseline 
 Hemodynamic success (defined as positive change in Ankle-Brachial Index (ABI)) at 
pre-discharge, 3 and 12 months, as compared to baseline 
 MAEs through 12 months  
 
Notes 
 Lesion patency is defined as freedom from more than 50% stenosis based on DUS peak 
systolic velocity ratio comparing data within the treated segment to the proximal normal 
arterial segment.   
 A systolic velocity ratio > 2.4 suggests > 50% stenosis.18, 19 

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8. Study Design 
The Ranger China is a prospective, non-randomized, multicenter clinical study to 
demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB 
catheter in native femoropopliteal artery lesions.  It is intended that all patients with 
qualifying lesions would be considered for enrollment and treated with the Ranger DCB 
catheter. 
8.1. 
Scale and Duration 
The Ranger China trial will be conducted in up to 15 sites in Mainland China with planned 
enrollment of approximately 123 subjects. 
The study is planned to have approximately 1 year of enrollment and 1 year of follow up. 
All subjects will be screened according to the protocol inclusion and exclusion criteria. 
Subjects will be enrolled in a non-randomized process.  Clinical follow-up will be required at 
the following time points: pre-discharge and 30 days, 3, 6 and 12 months post-index 
procedure. 
 
A schematic of the Ranger China trial design is shown below in Figure 8.1-1. 
 
 
 
Figure 8.1-1: Ranger China Study Design 
 
The study will be considered complete after all subjects have completed the 12-month 
follow-up visit, are withdrawn from the trial (due to death or having been lost to follow-up) 
or their follow-up window (i.e., 30 days after a scheduled follow-up visit) has closed. 
123 

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8.2. 
Treatment Assignment 
Patients who sign the Ethics Committee-approved Informed Consent Form (ICF), and have 
met all inclusion criteria and none of the exclusion criteria, are eligible to be enrolled in the 
clinical study.  All eligible subjects will receive treatment with the Ranger DCB catheter.  
Enrollment occurs at the time of advancement of the Ranger DCB catheter into the introducer 
sheath.   
8.2.1. Treatment and Control 
Subjects enrolled in this clinical trial will not be randomized, and there is no control group in 
this study.  All eligible subjects will receive treatment with the Ranger DCB catheter. 
8.2.2. Target and Non-target Lesions 
A target lesion is a lesion selected by the Investigator for treatment with a study DCB 
catheter. Target lesions must meet all the angiographic selection criteria.  A diffuse lesion or 
multiple lesions within the same target vessel segment can be considered as one target lesion 
if the total lesion length (including the distance between lesions) is ≤ 200 mm. 
Only one target lesion is allowed to be treated per limb (Index Limb) under this protocol, i.e., 
one target lesion on one index limb will be “in treatment”.  However, both limbs may be 
treated during either the index procedure and/or subsequent procedures with the 
investigational device (see “Multiple Interventions” in Section11.6.1. 
No other DCB or drug-eluting stent (DES) treatment in the index lesion is allowed 
throughout the study duration.  DCB or DES treatment in non-index lesions of the index limb 
is allowed after 12 months. DCB or DES treatment in the non-index limb is allowed before 
and after the index procedure. 
For non-target lesion procedures, see “Multiple Interventions” in Section 11.6.1. 
8.3. 
Justification for the Study Design 
The Ranger China trial is designed to evaluate the safety and efficacy of the Ranger DCBs 
for the treatment of subjects in China with atherosclerotic lesion(s) in native femoropopliteal 
arteries. 
During the trial, clopidogrel will be administered for 3 months post index procedure and 
aspirin use will be required indefinitely post index procedure.  Ongoing dynamic data safety 
monitoring will be performed throughout the trial to minimize subject risk.  All enrolled 
subjects receiving the Ranger DCB treatment will be followed for 12 month post index 
procedure.  
8.4. 
Treatment 
All enrolled subjects will receive PTA treatment with the Ranger DCB catheter approved for 
this indication.  Before Ranger DCB treatment, the target lesion must be pre-dilated with an 

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uncoated PTA balloon.  All Ranger DCB balloons may be inflated only once.  A second 
Ranger DCB catheter will be used for lesions exceeding the length of the first balloon. 
 
Note: Balloon catheter pre-dilatation is required for all target lesions.  It is recommended to 
always use a smaller diameter balloon dilatation catheter to pre-dilate the target lesion with 
residual stenosis < 50% to facilitate passage of the DCB catheter. Incremental pre-dilatation 
technique is recommended, and the diameter of last pre-dilation balloon catheter should not 
exceed the diameter of DCB catheter.  
8.4.1. Device sizing selection 
The investigator selects the size of Ranger DCB according to the proximal and distal 
reference vessel diameters and lesion length. The diameter ratio of DCB to the reference 
vessel should be 1:1 and not less; and the recommended length of DCB should include the 
segment of vessel treated with the study device and the 5 mm proximal and 5 mm distal to 
the treated segment.  
 
To facilitate passage of the Ranger DCB, it is mandatory to use a smaller diameter balloon (< 
the diameter of reference vessel) dilatation catheter to pre-dilate the target lesion. 
 
The investigators shall follow the instructions in the DFU. 
8.4.2. Number of device per lesion  
Whenever possible, the lesion should be treated with a single balloon that fully covers the 
stenosed or occluded vessel segment.  If the lesion requires the use of more than one balloon, 
the Ranger DCB must be overlapped to cover targeted lesion(s), and a 1 cm overlap is 
recommended.  Typically, a longest properly sized balloon should be used first and followed 
by a second balloon of appropriate dimensions to complete the procedure. 
8.4.3. Number of inflation  
All study devices (Ranger DCB) may be inflated only once, as transfer of therapeutic drug 
levels occurs only during the first inflation.  Repeat inflation of a Ranger DCB at the 
treatment site should be limited to emergency / bail-out situations, e.g. to treat vessel 
perforations or flow-limiting dissections when exchange for an uncoated balloon is deemed 
inappropriate due to safety considerations.  A Ranger DCB may not be re-inflated in a 
segment adjacent to or outside the primarily treated target lesion. 
8.4.4. Treatment of dissection 
Dissections shall be treated at the discretion of the investigator with non-drug-coated 
technology.  If balloon treatment alone is not sufficient to treat a flow-limiting dissection, 
consider the use of a stent. 

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8.4.5. Role of stenting 
Limit stenting to bail-out situations such as flow-limiting dissections that cannot be repaired 
using prolonged balloon inflation alone; or greater than 50% residual stenosis post DCB 
treatment.  In such situations, use bare metal stents of appropriate dimensions, but try to use 
the shortest stent suitable to achieve good flow.  Whenever possible, avoid the use of long 
stents, overlapping stents and stent grafts.  Do not use drug-eluting stents or bio-absorbable 
stents in combination with the Ranger DCB. 
 
Handling Instructions of Study Devices 
It is important for investigators to follow the corresponding DFU for Ranger DCB 
treatment and for the study device product matrix. 
. 
9. Subject Selection  
9.1. 
Study Population and Eligibility  
A total of 123 patients with symptomatic PAD of the femoropopliteal artery (Rutherford 
clinical category of 2 to 4) receiving percutaneous transluminal balloon angioplasty will be 
enrolled into this study. Clinical and angiographic inclusion and exclusion criteria for the 
Ranger China trial are included in Section 9.2 and Section 9.3 respectively.  Prior to 
enrollment in the trial, a subject should meet all of the clinical and angiographic inclusion 
criteria and none of the exclusion criteria. 
9.2. 
Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 9.2-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 9.3) is 
met.  
Table 9.2-1: Inclusion Criteria 
Clinical 
Inclusion 
Criteria 
CI1. Subjects must be age 18 or older 
CI2. Subject is willing and able to provide informed consent 
CI3. Subject is available and willing to attend all required follow-up visits 
CI4. Subject has a clinically significant symptomatic leg ischemia 
CI5. Subject has a Rutherford clinical category of 2 - 4 
CI6. If the index lesion is restenotic, the prior PTA must have been > 90 days 
prior to treatment in the current study 
CI7. Only one lesion per limb can be treated under this protocol, i.e., one index 
lesion on one index limb will be “in treatment”.  However, both limbs may 
be treated during either the index procedure and/or subsequent procedures  
CI8. Successful intraluminal wire crossing of the target lesion 
Angiographic 
Inclusion 
Criteria 
AI1. The index lesion is a clinically and hemodynamically de novo stenotic or 
restenotic lesion located in the native non-stented superficial femoral artery 
and proximal popliteal artery between the Hunter’s Canal and the popliteal 

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(visual 
estimate) 
fossa (i.e. within the P1  segment), with the following characteristics by 
visual assessment: 
 Degree of stenosis ≥ 70%  
 Target vessel diameter ≥ 2.0 mm and ≤ 8.0 mm 
 Lesion length ≥ 20 mm and ≤ 200 mm, to be covered by one or two 
balloon(s) (must be overlapped to cover targeted lesion(s)) 
 The lesion length of total occluded lesion ≤ 100 mm   
For diffuse lesion or multiple tandem lesions (may including a total occluded lesion) in the same 
target vessel, the total lesion length, including the distance between lesions, must be ≤ 200 
mm, with the separation of ≤ 30 mm (3 cm) between two adjacent lesionsAI2. The 
subject has at least one patent infrapopliteal artery (< 50% stenosis) to the 
index foot prior to index procedure 
 
9.3. 
Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 9.3-1) will be excluded from this 
clinical study. 
 
Table 9.3-1: Exclusion Criteria 
Clinical 
Exclusion 
Criteria 
CE1. Subjects who have undergone prior vascular surgery of the SFA/PPA 
         in the index limb to treat atherosclerotic disease 
CE2. History of major amputation in the same limb as the target lesion 
CE3. Presence of aneurysm in the target vessel(s) 
CE4. Acute ischemia and/or acute thrombosis in any artery of the lower 
         limbs 
CE5. Acute Myocardial Infarction within 30 days before the index  
         procedure 
CE6. History of hemorrhagic stroke within 3 months 
CE7. History of thrombolysis or unstable angina within 2 weeks of  
         enrollment 
CE8. Persistent, intraluminal thrombus of the proposed target lesion post  
         thrombolytic therapy 
CE9. Known hypersensitivity or contraindication to contrast dye that, in  
         the opinion of the investigator, cannot be adequately pre-medicated 
CE10. Known allergies against Paclitaxel or other components of the used 
           medical devices 
CE11. Intolerance to antiplatelet, anticoagulant, or thrombolytic  
           medications that would be administered during the trial 
CE12. Platelet count < 80,000 mm3 or > 700,000 mm3 
CE13. Concomitant renal failure with a serum creatinine > 2.0  
           mg/dL(176.8 umol/L) 
CE14. Receiving dialysis or immunosuppressant therapy 
CE15. Life expectancy of less than one year

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CE16. Women of child-bearing potential cannot use a reliable method of  
           contraception from the time of screening through 12 months after  
           the index procedure. 
CE17. Woman who is pregnant or nursing. (Pregnancy test must be  
           performed within 72 hours prior to the index procedure, except for  
           women who definitely do not have child-bearing potential). 
CE18. Previously planned stenting of the index lesion (stents will be  
           allowed for bailout situations, such as flow-limiting dissection) 
CE19. Use of adjunctive therapies (debulking, laser, cryoplasty, re-entry  
           devices) 
CE20. Subjects who had any major procedures (cardiac, aorta, peripheral) 
           within 30 days prior to the index procedure 
CE21. Planned or expected procedures (cardiac, aorta, peripheral) within  
30 ays post the index procedure 
CE22. Presence of outflow lesions requiring intervention within 30 days of 
           the index procedure 
CE23. Heavily calcified target lesions resistant to PTA 
CE24. Current participation in another drug or device trial that has not  
           completed the primary endpoint, including any clinical study of  
           drug-coated or drug-eluting technology, that may potentially  
           confound the results of this trial, or that would limit the subject’s  
           compliance with the follow-up requirements 
CE25. Current or past intervention using drug-coated/drug-eluting  
           technologies in the index limb 
CE26. Target lesion with in-stent restenosis (any stent or stent-graft) 
Angiographic Exclusion Criteria: 
   AE1. Subjects with ipsilateral iliac inflow lesions , and unsuccessful 
treatment prior to the index procedure (i.e., residual stenosis ≥ 30% post 
treatment) 
   AE2. Subjects with no patent infrapopliteal artery (i.e., ≥ 50% stenosis) 
to the foot prior to index procedure (even with successfully treatment 
during the procedure, these subjects should be excluded from enrollment) 
AE3.  Failure to successfully antegrade cross the target lesion with a 
guidewire (successful crossing is defined as the tip of crossing device is distal 
to the target lesion in the true lumen without flow-limiting dissection or 
perforation as evidenced by extravasation of contrast media 
10. Subject Accountability 
10.1. Point of Enrollment 
Subject, who has signed the IRB/IEC-approved study ICF, and has met all inclusion criteria 
and none of the exclusion criteria, will be considered eligible to be enrolled in the trial. 
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10.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented.  While trial withdrawal is 
discouraged, subjects may choose to withdraw from the trial at any time, with or without 
reason and without prejudice to further treatment.  Withdrawn subjects will not undergo any 
additional trial follow-up, nor will they be replaced.  If a subject withdraws from the clinical 
investigation, the reason(s) shall be reported and documented.  If such withdrawal is due to 
problems related to investigational device safety or performance, the investigator shall ask 
for the subject’s permission to follow his/her status/condition outside of the clinical study. 
The Investigator may discontinue a subject from participation in the trial if the Investigator 
feels that the subject can no longer fully comply with the requirements of the trial or if any of 
the trial procedures are deemed potentially harmful to the subject.  Data that have already 
been collected on withdrawn subjects will be retained and used for analysis but no new data 
will be collected after withdrawal.   
10.3. Enrollment Controls 
A minimum of 104 enrolled subjects are needed to adequately assess the primary endpoint at 
12 months.  To account for attrition, the total enrolment shall be about 123 subjects, 
assuming a maximum attrition of 15% for all reasons at 12 months.  The enrollment cap for 
each study site is 30% of total enrolled subjects. 
10.4. Definitions of End-of-study 
A participant is considered to have completed the study if he or she has completed all phases  
of the study including the last visit or the last scheduled procedure shown in the data 
collection schedule. 
11. Study Methods 
11.1. Data Collection 
The data collection schedule is shown in Table 11.1-1.  Please note that the time window for 
30-day follow-up is +/- 7 days, for 3, 6 or 12 months follow-up is +/- 30 days. 
The table below is an overview of all the procedures or tests required per protocol.  If an 
examination/test is required, it is marked with “X”; if it is optional but recommended, it is 
marked with “O”. 

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Table 11.1-1: Data Collection Schedule 
Procedure/Assessment 
Screening
(≤ 14 days 
prior to 
index 
procedure)
Enrollment
Index 
Procedure 
Post-
procedure/ 
Pre-hospital 
Discharge 
 
Follow-up Visit f 
30-day f 
(± 7 Days) 
3-month 
(± 30 Days)
6-month f 
(± 30 Days)
12-month 
(± 30 Days)
In-person Visit 
X 
X 
X 
X 
O 
X 
O 
X 
Informed Consent process, including 
informed consent signature date 
X 
 
 
 
 
 
 
 
Demographics (including date of birth, 
gender, and race and ethnicity) 
X 
 
 
 
 
 
 
 
Physical Assessment  
X 
 
 
 
 
 
 
 
Medical History (including, concomitant 
diseases, concomitant medication and 
medical treatments)
X 
 
 
 
 
 
 
 
Routine Laboratory (including serum 
creatinine, platelet count and pregnancy 
tests)a 
X 
 
 
 
 
 
 
 
CTAb 
X 
 
 
 
 
 
 
X 
DUSb 
O 
 
 
 
 
X 
 
 
ABI 
X 
 
 
X 
 
X 
 
X 
Rutherford Categories Assessment 
Xc 
 
 
X 
 
X 
 
X 
Angiographic assessment 
 
Xd 
Xe 
 
 
 
 
 
PTA 
 
 
Xe 
 
 
 
 
 
Adverse Events and Device Deficiency 
Assessment 
 
 
X 
X 
X 
X 
X 
X 
 
X = required; O = optional but recommended 
CTA = computed tomography angiography; DUS = Duplex Ultrasound; ABI = Ankle Brachial Index; PTA = Percutaneous Transluminal Angioplasty 
a:  Excluded from the study if serum creatinine > 2mg/dL, or platelet count < 80.000/mm3, or positive pregnancy test (pregnancy test is required within 72 hours prior to index procedure) 
b:  CTA and DUS (test results within 30 days prior to the index procedure are acceptable): primary patency, binary restenosis (> 50%) of the target lesion.   
c:  Inclusion criterion: Rutherford category 2 - 4 
d:  Adhere to Angiographic Inclusion criteria.  Note: calcifications are categorized as mild, moderate, severe; severe calcification of the target lesion is an exclusion criterion. 
e:  Procedural, target lesion, pre-dilatation, and post DCB dilatation information are collected；angiographic data will be used to localize the target lesion(s) 
f:  Follow-up dates will be calculated from the date of the index procedure. The 30-day, and 6-month follow-ups may be via telephone interview (in-person clinic visit is recommended if subjects 
have worsen symptoms ). but 3-month and 12-month follow-ups are in-person clinic visits.  The time window for 30-day follow-up is +/- 7 days; for 3, 6 or 12-month follow-up is +/- 30 days.

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11.2. Study Candidate Screening 
Subjects who are suitable for PTA will be informed about the study and will be asked to sign 
the informed consent form (ICF) before participating in any screening procedure.  After 
signing the ICF, the subject will receive a screening number and will be documented in a 
screening log.  Each clinical investigator must keep a log of all screened subjects, including 
both eligible and non-eligible subjects (screening failures). 
 
11.3. Informed Consent 
Before any study specific tests or procedures are performed, subjects who meet the clinical 
inclusion criteria will be asked to sign the IRB/IEC-approved study ICF.  Subjects must be 
given ample time to review ICF and have questions answered before signing ICF.  
Study personnel should explain to the subject that even if the subject agrees to participate in 
the trial and signs the ICF, vascular angiography may demonstrate that the subject is not a 
suitable candidate for the clinical trial.  
Refer to Section 10.1 for definition of point of enrollment. 
11.4. Screening (Up to 14 Days Prior to Index procedure) 
After a subject has signed the IRB/IEC-approved study ICF, the screening process may 
begin. The screening process will be used to determine the inclusion or exclusion of a subject 
in the study.  This process includes the investigator’s assessment of subject’s medical records 
and diagnosis, and following pre-procedure data must be collected within 14 days prior to the 
index procedure (unless otherwise specified), for all subjects: 
 
Confirmation of clinical eligibility criteria 
 
Demographics including age, gender, and races others than Han (unless restricted by 
local laws) 
 
Physical assessment, including weight and height 
 
Medical history (including concomitant diseases, concomitant medication and medical 
treatments)  
 
Physical assessment 
 
Routine laboratory tests (including pregnancy test) 
 Serum creatinine 
 Complete blood count (CBC) with platelets 
 Pregnancy test for females of childbearing potential with analysis per local practice 
(serum and/or urine) is required within 72 hours prior to the index procedure 
 
Computed tomography angiography (CTA)* – baseline CTA readings will be assessed 
by core laboratory to facilitate the localization of target lesion(s) 
 
Duplex ultrasound (DUS)* – optional (at the discretion of the investigator) 
 
Ankle brachial Index (ABI) 
 
Rutherford category assessment 
 
Current antiplatelet medications 

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* CTA and DUS test results within 30 days prior to the index procedure are acceptable. 
11.5. Required Concomitant Medications 
Protocol-required concomitant medications must be reported in the electronic case report 
form (eCRF) from the time of the pre-procedure visit through the 12 month follow-up. 
Information pertaining to the use of antiplatelet medications including dose changes, 
medication interruptions, and medication cessation, must be documented. Additional 
concomitant medications may be prescribed at the discretion of the investigator based on the 
standard clinical pratice. 
 
Antiplatelet medications such as P2Y12 inhibitor (Clopidogrel) and acetylsalicylic acid 
(ASA) are administered before the procedure, to minimize thrombotic complications and the 
development of restenosis. Clopidogrel is recommended, unless it is not tolerated by the 
subject, Ticlopidine can be used. 
11.5.1. Prior to the index procedure 
 
For subjects who have been taking dual antiplatelet therapy (DAPT) for  72 hours at the 
time of the index procedure, a loading dose is not required. 
 
For subjects who do not already take DAPT drugs for  72 hours at the time of index 
procedure should receive appropriate peri-procedural loading doses before the index 
procedure, or no later than 2 hours after the index procedure. Recommended minimum 
loading doses are 300 mg for ASA and/or 300 mg for clopidogrel. 
11.5.2. In the Catheterization Laboratory 
 
At the time of the procedure, subjects should receive an intra-arterial bolus of heparin 
(usually 3000-5000 I.U.), or alternate anticoagulants as substitutes for heparin if justified 
by individual subject conditions. 
11.5.3. Post-procedure 
 
Subjects shall receive DAPT during a period of at least 3 months post the index 
procedure, if tolerated.  The typical recommended DAPT regimen consists of ASA (min. 
75mg/d) and a P2Y12 inhibitor, e.g. clopidogrel (min. 75mg/d). 
 
Alternate DAPT regimens may be followed if justified by individual subject conditions, 
e.g. if there is documented intolerance to any of these drugs, or the patient is already in a 
different antiplatelet therapy (with at least 2 approved drugs) due to comorbid 
conditions. The investigator shall be guided by the drug manufacturer´s instructions, 
available scientific evidence and medical guidelines applicable to patients with 
peripheral arterial disease. 
 
After 3 months of DAPT post procedure, all subjects will be treated with ASA 
(minimum 75 mg/d) indefinitely. 
 
Note: The risk of bleeding may be increased in the subjects who need anticoagulation in 
addition to DAPT.. If needed, oral warfarin can be used, but no new generation of oral 
anticoagulants, such as rivaroxaban, apixaban or dabigatran is allowed. Patients 

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receiving anticoagulant therapy should not receive additional antiplatelet therapy if, in 
the opinion of the investigator, this could present an intolerable bleeding risk. 
 
11.6. Enrollment & Index Procedure 
During the procedure, the following procedures and assessments must be completed.  
 Perform vascular angiography  
 Confirm angiographic eligibility criteria of lesion(s). 
 Use of radiopaque rulers to document the exact distance of the lesion from a same 
anatomical landmark (such as the patella or the iliac or femoral bifurcation) at baseline 
and during follow-up visits is required. 
 Pre-dilate/pretreat the target lesion(s): before Ranger DCB treatment, pre-dilatation with 
an uncoated PTA balloon (smaller in diameter than the Ranger DCB) is required. 
 Deliver the Ranger DCB treatment to the target lesion(s): all Ranger DCB balloons may 
be inflated only once.  A second Ranger DCB catheter will be used for lesions exceeding 
the length of the first balloon (must be overlapped to cover targeted lesion(s)). 
 
The start of the index procedure is defined as the time of guide catheter insertion.   The 
balloon dilatation procedure, including deployment to the target lesion and balloon inflation, 
deflation and retrieval, is performed under fluoroscopic observation.  Refer to Section 8.4. 
for detailed instructions for index lesion treatment. 
 
After dilation of the entire index lesion, the balloon catheter is withdrawn through the guide 
sheath/introducer sheath, and a post-PTA angiogram is performed to evaluate the technical 
result and possible procedural complications. 
 
All clinical sites shall have access to an emergency unit to perform interventions as bypass 
surgery in case of failed PTA. 
11.6.1. Multiple Interventions 
11.6.1.1. Prior to or during Index Procedure: 
 
Prior to treatment of the index limb, successful (< 30% residual stenosis) treatment of 
ipsilateral iliac inflow lesions may be performed before or during the index procedure. 
 
Prior to treatment of the index limb, successful treatment of the arteries of the non-index 
limb may be performed before or after the index procedure. 
 
Prior to treatment of the index limb, absence of clinical complications such as embolism, 
thrombosis, severe dissection, vessel rupture must be confirmed. 
 
IMPORTANT NOTE: Use of drug coated devices 
Additional Index Limb Treatment 

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 No other drug-coated balloon (DCB) or drug-eluting stent (DES) treatment in the index 
lesion is allowed throughout the study duration 
 DCB or DES treatment in non-index lesions of the index limb is allowed after 12 months 
post procedure 
Non-index Limb Treatment 
 
The non-index limb may be treated with DCB or DES before and after the index 
procedure 
 
11.6.2. End of the Index Procedure 
The end of the index procedure is defined as the time the guiding catheter was removed (post 
final angiography).  The introducer(s) sheaths should be removed per standard local practice. 
The following procedures must be completed:  
 Document procedural, target lesion, pre-dilatation, and study device information on the 
appropriate eCRFs. 
 Record medications 
 Record antithrombotic medications 
 Complete AE assessment and collect source documents as described in Section 20. 
 Finalize angiographic and related required documentation to submit to the Core 
Laboratories per instructions in the Manual of Operations 
11.7. Post-Procedure / Pre-Discharge 
The post-procedure/pre-discharge follow-up is an in-person visit and the following data will 
be collected: 
 
 ABI 
 Rutherford category assessment 
 Adverse events 
11.8.  30-Day Follow-up (+/- 7 days) 
30-day follow-up may be via telephone or in-person interview. The following data will be 
collected: 
 
 
Adverse events 
11.9. 3-Month Follow-up (+/- 30 days) 
The 3-month follow-up is an in-person visit and the following data will be collected: 
 
 
DUS 
 
ABI 
 
Rutherford category assessment 
 
Adverse events 

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11.10. 6-Month Follow-up (+/- 30 days) 
The 6-month follow-up may be via telephone or in-person interview; and the following data 
will be collected: 
 
 
Adverse events 
 
11.11. 12-Month Follow-up (+/- 30 days) 
The 12-month follow-up is an in-person visit and the following data will be collected: 
 
 
CTA 
 
ABI 
 
Rutherford category assessment 
 
Adverse Events (any ongoing adverse events will be managed and treated by treating 
physicians per standard of care.) 
 
Note: Use of rulers to document the exact distance of the lesion from a same anatomical 
landmark (such as the patella or the iliac or femoral bifurcation) at baseline and during 
follow-up visits is required. 
11.12. Study Completion 
Each subject will be followed for 12 months after the index procedure.  For primary endpoint 
evaluation, the data of each subject must be collected until the 12-month follow-up. 
11.13. Source Documents 
Where copies of the original source document as well as printouts of original electronic 
source documents are retained, these shall be signed and dated by a member of the 
investigation center team with a statement that it is a true reproduction of the original source 
document. 
 
12. Statistical Considerations 
12.1. Endpoints 
12.1.1. Primary Safety Endpoint 
The primary safety endpoint is an acceptably low rate of major adverse events defined as: 
 All device and/or procedure related mortality through 30 days post-procedure 
 Target limb major amputation at 30 days post-procedure 
 Clinically-driven TLR at 30 days post-procedure 

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12.1.2. Primary Efficacy Endpoint 
The primary efficacy endpoint is primary lesion patency of the treated segment as assessed 
by computed tomography angiography (CTA) at 12 months post-procedure without 
clinically-driven TLR. 
12.2. Hypotheses 
12.2.1. Primary Safety Endpoint:  
The rate of freedom from device and/or procedure-related death, target limb major 
amputation and/or clinically-driven target lesion revascularization through 30 days post 
procedure (i.e. the rate of composite MAE-free) exceeds a PG of 88%.9 
 
H0: Safety  0.88 
H1: Safety > 0.88 
12.2.2. Primary Efficacy Endpoint:  
The rate of primary lesion patency at 12 months post-procedure without clinically-driven 
TLR exceeds a PG of 53% for femoropopliteal artery segments treated with the Ranger 
DCB.20 
 
H0: Patency  0.53 
H1: Patency > 0.53 
12.3. Sample Size  
The sample size has been estimated based on the following assumptions: 
Safety 
 Expected 30-day composite MAE-Free rate for all subjects = 99%   
o Safety Performance Goal = 88%9   
 
Test significance level α = 0.05 (one-sided normal approximation) 
 A minimum of 104 evaluable subjects are driven by the efficacy endpoint to provide at 
least 99% power to assess the primary safety endpoint at 30 days 
Efficacy 
 Expected 12-Month vessel patency = 65% 
o Efficacy Performance Goal = 53%20 
 Test significance level α = 0.05 (one-sided normal approximation) 
 A minimum of 104 evaluable subjects are required to provide adequate power of 80% to 
assess the primary efficacy endpoint at 12 months 
 Expected attrition for all reasons at 12 months ≤ 15% 
 Approximately 123 subjects will be enrolled to account for expected attrition 

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12.4. Statistical Test Methods 
The primary hypotheses will be tested in a sequential manner to allow testing of each of 
primary safety and efficacy endpoints at the specified significance level of 5% without 
adjustment.  The hierarchical testing procedure for multiple comparisons with the testing 
order will start with the primary safety endpoint followed by the primary efficacy endpoint. 
That is, the primary efficacy hypothesis will be tested only if the primary safety hypothesis is 
rejected.  
 
For safety, if the one-sample normal approximation one-sided 95% lower confidence bound 
of the observed 30-day composite MAE-Free rate is greater than 0.88, then the Ranger DCB 
will be considered to have acceptable safety performance, and 12-month efficacy 
performance testing will be allowed. 
 
For efficacy, if the one-sample normal approximation one-sided 95% lower confidence 
bound of the observed 12-month lesion patency is greater than 0.53, then the Ranger DCB 
will be considered to have acceptable performance. 
12.5. Secondary Endpoints 
The following secondary endpoints are subject of the investigation: 
 Technical success  
 Procedural success  
 Target lesion patency assessed by DUS at 3 months post index procedure 
 All-cause death at 30 days, 3, 6 and 12 months 
 Clinically-driven TLR at 3, 6 and 12 months 
 Time to first clinically-driven TLR through 12 months post-procedure 
 Clinical success (defined as improved Rutherford catergory by at least +1 class) at pre-
discharge, 3 and 12 months, as compared to baseline 
 Hemodynamic success (defined as positive change in ABI) at pre-discharge, 3 and 12 
months, as compared to baseline 
 MAEs through 12 months (including all-cause death, clinically-driven TLR, target limb 
major amputation or thrombosis at target lesion) 
12.6. General Statistical Methods 
12.6.1. Analysis Sets 
The primary and pre-specified additional endpoints will be analyzed on an ITT basis and on a 
per-protocol basis.  For the ITT analysis, all subjects who sign the written ICF and are 
enrolled in the study will be included in the analysis sample, regardless of whether the study 
PTA with the Ranger DCB was performed.  For the per-protocol analysis, Only enrolled 
subjects who are treated with the study device in the target lesion will be included in the 
analysis sample. 

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12.6.2. Control of Systematic Error/Bias 
Selection of subjects will be made from the investigators’ general or professional referral 
population. All subjects meeting the inclusion/exclusion criteria that have signed the 
protocol-specific ICF will be eligible for enrollment in the trial. Consecutively eligible 
subjects should be enrolled into the study to minimize selection bias. In determining subject 
eligibility for the study, the investigator’s assessment of imaging will be used. The 
effectiveness endpoint data obtained from the core laboratory and the safety adjudicated data 
from independent Clinical Event Committee (CEC) will be used for the primary analyses. 
12.6.3. Number of Subjects per Investigative Site 
A maximum of 37 patients (30% of total enrolled subjects) will be recruited from any site to 
avoid treatment center bias and ensure homogeneous study results. 
12.7. Data Analyses 
12.7.1. Baseline Comparability 
Subject demographics, clinical history, risk factors, and pre-procedure lesion characteristics 
will be summarized using descriptive statistics (e.g., mean, standard deviation, n, minimum, 
maximum) for continuous variables and frequency tables for discrete variables.  No formal 
statistical testing will be done since this is a single-arm trial. 
12.7.2. Post-procedure Endpoints 
Post-procedure information will be collected at 30-day, 6-month and 12-month scheduled 
follow-up assessment as detailed in the clinical trial schedule and will be summarized using 
descriptive statistics for continuous variables (e.g., mean, standard deviation, n, minimum, 
maximum) and frequency tables or proportions for discrete variables.  No formal statistical 
testing will be done in this single-arm trial. 
12.7.3. Other Endpoint Measurements  
Clinical event rates will be presented as proportions and continuous data will be summarized 
by presenting sample sizes, means, standard deviations, minimums, and maximums.  Point 
estimates and 95% confidence intervals will be provided.  No statistical testing will be 
performed for the additional endpoints. 
12.7.4. Interim Analyses  
No formal interim analyses are planned for the purpose of stopping this study early for 
declaring effectiveness or for futility. 
12.7.5. Subgroup Analyses 
Primary and pre-specified additional endpoints will be summarized by the following subgroups 
of subjects. 

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 Location of the target lesions, such as distal, mid, proximal, and ostial. 
12.7.6. Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analysis will be 
documented in an amended Statistical Analysis Plan approved prior to performing the 
analysis.  Changes from the planned statistical methods after performing the analysis will be 
documented in the clinical study report along with a reason for the deviation. 
13. Data Management 
13.1. Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by EDC System. All changes 
made to the clinical data will be captured in an electronic audit trail and available for review 
by Boston Scientific Corporation (BSC) or its representative. The associated RAVE software 
and database have been designed to meet regulatory compliance for deployment as part of a 
validated system compliant with laws and regulations applicable to the conduct of clinical 
studies pertaining to the use of electronic records and signatures. Database backups are 
performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the EDC system and will 
be issued to the site for appropriate response. Site staff will be responsible for resolving all 
queries in the database. 
 
13.2. Data Retention 
The Principal Investigator or Investigational site will maintain, at the investigative 
site, in original format all essential study documents and source documentation that 
support the data collected on the study subjects in compliance with ICH/GCP 
guidelines.  Documents must be retained for  10years after the formal discontinuation 
of the clinical investigation of the product. These documents will be retained by BSC 
until the product/device is no longer in use in compliance with local regulations. The 
Principal Investigator or his/her designee will take measures to ensure that these 
essential documents are not accidentally damaged or destroyed. If for any reason the 
Principal Investigator or his/her designee withdraws responsibility for maintaining 

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these essential documents, custody must be transferred to an individual who will 
assume responsibility and BSC must receive written notification of this custodial 
change. Sites are required to inform Boston Scientific in writing where paper or 
electronic files are maintained in case files are stored off site and are not readily 
available. 
 
13.3. Core Laboratories 
Computed tomography angiography (CTA)data from Ranger China trial will be assessed by a 
blinded core lab.  All centers have to send the de-identified data records of baseline CTA and 
the CTA performed at the12-month follow-up visit for blinded assessment to the core lab.   
 
 
Contact information for Core Laboratories is provided in the study Manual of Operations. 
14. Amendments  
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals from 
IRB/EC of the revised protocol must be obtained prior to implementation. 
15. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC of any deviation from the investigational plan to protect 
the life or physical well-being of a subject in an emergency, and those deviations which 
affect the scientific integrity of the clinical investigation. Such notice shall be given as soon 
as possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days.  
All protocol deviations (PDs) are classified to “major” and “minor”defined as below:  
 A major PD is a protocol deviation that directly or potentially disrupts the study 
progress (i.e., the study design, study data and results can be compromised), OR a 
protocol deviation that compromises the safety and welfare of study participants. 
 A minor PD is a protocol deviation that does not disrupt study progress (i.e., the study 
design, study data and results will not be compromised), AND does not compromise 
the safety and welfare of study participants. 
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using EDC.  Sites may also be 
required to report deviations to the IRB/EC, per local guidelines and government regulations.  

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Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, site re-training, or site 
discontinuation/termination) will be put into place by the sponsor. 
16. Device/Equipment Accountability 
The investigational devices shall be securely maintained, controlled, and used only in this 
clinical study.  
Boston Scientific Corporation shall keep records to document the physical location of all 
investigational devices from shipment of investigational devices from BSC or designated 
facility to the investigation sites until return or disposal. 
The Principal Investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the investigational devices, which shall include the 
following: 
 Date of receipt, quantity and specific specifications of received devices 
 Internal handover records for device in investigation sites, as applicable 
 Identification of each investigational device (batch number or unique code) 
 Expiry date, as applicable 
 Date or dates of use 
 Subject identification 
 Date and quantity on which the investigational device was returned, if applicable 
 Date and quantity of return (and number) of unused, expired, or malfunctioning 
investigational devices, if applicable. 
17. Compliance 
17.1. Statement of Compliance 
This study will be conducted in accordance with ISO 14155:2011 (2nd Edition; 2011-02-01) 
Clinical Investigation of Medical Devices for Human Subjects- GCP, or the relevant parts of 
the ICH Guidelines for GCP, ethical principles that have their origins in the Declaration of 
Helsinki, and pertinent China’s laws and regulations. The study shall not begin until the 
required approval/favorable opinion from the IRB/IEC and/or regulatory authority has been 
obtained, if appropriate. Any additional requirements imposed by the IRB/IEC or regulatory 
authority shall be followed, if appropriate. 
17.2. Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigational 
plan/protocol, ISO 14155, ethical principles that have their origins in the Declaration of 

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Helsinki, any conditions of approval imposed by the reviewing IRB/EC, and prevailing local 
and/or country laws and/or regulations, whichever affords the greater protection to the 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
 Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement. 
 Prior to beginning the study, sign the Investigator Brochure Signature Page and Protocol 
Signature page documenting his/her agreement to conduct the study in accordance with 
the protocol. 
 Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
 Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
 Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
 Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
 Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event and observed device deficiency; and provide analysis report, which 
includes the causality assessed by both investigator and BSC and decision on study 
continuance, to IRB/EC per local and/or country requirements. 
 Report all SAEs and device deficiencies that could have led to a SAE and 
potential/USADE or UADE to BSC by written documents, per the protocol requirements. 
 Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
could have led to a SADE and potential/USADE or UADE, if required by the national 
regulations or this protocol or by the IRB/EC, and supply BSC with any additional 
requested information related to the safety reporting of a particular event; provide all 
required source documents related to a death event to BSC and the IEC per local 
requirements. 
 Maintain the device accountability records and control of the device, ensuring that the 
investigational device is used only by authorized/designated users and in accordance with 
this protocol and instructions/directions for use. 
 Allow the sponsor and sponsor represtentatives to perform monitoring and auditing 
activities, and be accessible to the clinical research monitor or auditor and respond to 
questions during monitoring visits. 

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 Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
 Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC requirements. 
 Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
 Inform the subject of the nature and possible cause of any adverse events experienced. 
 As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the investigational device when it is used/operated by the subject. 
 Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
 Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed. 
 Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
 Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
 Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
 Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
 Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
 Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
17.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal investigator is responsible for providing 
appropriate training and adequate supervision of those to whom tasks are delegated. Where 
there is a sub investigator at a site, the sub investigator should not be delegated the primary 
supervisory responsibility for the site. The investigator is accountable for regulatory 
violations resulting from failure to adequately supervise the conduct of the clinical study.  

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17.3. Institutional Review Board/ Ethics Committee 
The investigational site will obtain the written and dated approval/favorable opinion of the 
IRB/EC/REB for the clinical investigation before recruiting subjects and implementing all 
subsequent amendments, if required.  
A copy of the written IRB/EC and/or competent authority approval of the protocol (or 
permission to conduct the study) and ICF, must be received by the sponsor before 
recruitment of subjects into the study and shipment of investigational product/equipment. 
Prior approval must also be obtained for other materials related to subject recruitment or 
which will be provided to the subject. 
Any amendment to the protocol will require review and approval by the IRB/EC/REB before 
the changes are implemented to the study.  All changes to the ICF will be IRB/EC/REB 
approved; a determination will be made regarding whether a new ICF needs to be obtained 
from participants who provided consent, using a previously approved ICF. Annual 
IRB/EC/REB approval and renewals will be obtained throughout the duration of the study as 
required by applicable local/country laws or regulations or IRB/EC/REB requirements. 
Copies of the study reports and the IRB/EC/REB continuance of approval must be provided 
to the sponsor.  
17.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC and will be kept confidential in accordance with all 
applicable laws and regulations..  Only authorized BSC personnel and/ or a BSC 
representative including Contract Research Organization (CRO) will have access to these 
confidential records.  Authorized regulatory personnel have the right to inspect and copy all 
records pertinent to this study.  Study data collected during this study may be used by BSC 
for the purposes of this study, publication, and to support future research and/or other 
business purposes, such as overseeing and improving the performance of its device, new 
medical research and proposals for developing new medical products and procedures.  All 
data used in the analysis and reporting of this study or shared with a third-party researcher 
will be without identifiable reference to specific subjects. 
Information received during the study will not be used to market to subjects; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes.  
17.4.1. Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed during implant, testing required by the protocol, 
and follow-ups. Support may include HCP training, addressing HCP questions, or providing 
clarifications to HCPs concerning the operation of BSC equipment/devices (including 
programmers, analyzers, and other support equipment). 
At the request of the investigator and while under investigator supervision, BSC personnel 
may operate equipment during implant or follow-up, assist with the conduct of testing 

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specified in the protocol, and interact with the subject to accomplish requested activities. 
Typical tasks may include the following. 
 Interrogating the device or programming device parameters to investigator-requested 
settings as well as operating investigational equipment 
 Performing lead diagnostic testing using a Pacing System Analyzer or programmer to 
obtain pacing and sensing thresholds and impedance measurements 
 Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel 
 Assisting with the collection of study data from Pacing System Analyzers, programmers, 
and other equipment 
 Entering technical data on technical source form as long as the responsible investigator 
verifies and signs the completed form  
 Print out programming reports directly from the  programmer and provide original reports 
to clinical site as source documentation 
 Provide technical expertise/support to subjects during office visits and/or during 
teleconference calls/electronic communications with the principal investigator or their 
delegated site staff and the subject.  
 
In addition, BSC personnel may perform certain activities to ensure study quality. These 
activities may include the following. 
 Observing testing or medical procedures to provide information relevant to protocol 
compliance 
 Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following.  
 Practice medicine 
 Provide medical diagnosis or treatment to subjects 
 Discuss a subject’s condition or treatment with a subject 
 Independently collect critical study data (defined as primary or secondary endpoint data) 
 Enter data in electronic data capture systems or on paper case report forms 
17.5. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained.  

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18. Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations.  In addition, the clinical research monitor verifies that 
study records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively.  The Principal 
Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, and appropriate regulatory authorities. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Principal Investigator 
and relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
19. Potential Risks and Benefits 
19.1. Risks / Adverse Events Associated with the Study Device  
The following anticipated adverse events (AE) have been identified for this study, including, 
but are not limited to, the following: 
• Allergic reaction (device, contrast medium, medications) 
• Arrhythmias 
• Arteriovenous fistula 
• Death 
• Hematoma 
• Hemodynamic instability 
• Hemorrhage 
• Pseudo-aneurysm 
• Sepsis/infection 
• Thromboembolic episodes 
• Vascular thrombosis 
• Vessel injury (e.g., dissection, perforation, rupture) 
• Vessel occlusion 
• Vessel spasm 
19.2. Risks Associated with Paclitaxel  
Potential adverse events not captured above, that may be due to systemic administration of 
paclitaxel, include, but are not limited to, the following: 
 
• Allergic/immunologic reaction to drug (paclitaxel or structurally-related compounds) or 
coating or its individual components 
• Alopecia 
• Anemia 
• Blood product transfusion 

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• Gastrointestinal symptoms 
• Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) 
• Hepatic enzyme changes 
• Histologic changes in vessel wall, including inflammation, cellular damage or necrosis 
• Myalgia/Arthralgia 
• Peripheral neuropathy 
There may be other potential adverse events that are unforeseen at this time. 
19.3. Risks associated with Participation in the Clinical Study 
In addition to the aforementioned risks associated with the PTA with Ranger DCB and the 
use of paclitaxel, the use of prolonged dual antiplatelet therapy after DCB treatment may 
increase the risk of bleeding.  There may be additional risks linked to the procedure, which 
are unforeseen at this time 
19.4. Risk Minimization Actions 
Additional risks may exist.  Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
19.5. Anticipated Benefits 
Anticipated benefits include the effective treatment of atherosclerotic stenosis and occlusion 
in the peripheral arteries, and improvement in the symptoms of peripheral artery disease. 
19.6. Risk to Benefit Rationale 
The Ranger DCB is expected to be suitable for its intended purpose.  There are no unacceptable 
residual risks/intolerable risks and all applicable risks have been addressed through the 
provision of appropriate Directions for Use (DFU).  Evaluation of the risks and benefits that 
are expected to be associated with use of the Ranger DCB catheters demonstrate that when 
used under the conditions intended, the benefits associated with use of the Ranger DCB 
catheters should outweigh the risks.  
 
 
20. Safety Reporting 
20.1. Definitions and Classification 
Safety definitions are provided in Error! Reference source not found..  Administrative 
edits were made to combine definitions from ISO 14155-2011 and MEDDEV 2.7/3 12/2010. 
 

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Table 20.1-1:  Safety Reporting Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, whether or not related to the 
investigational medical device.  
NOTE 1: This includes events related to the investigational medical 
device or comparator. 
NOTE 2: This definition includes events related to the procedures 
involved (any procedure in the clinical investigation plan). 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the investigational medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155-2011 
 
 
Adverse event related to the use of an investigational medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies 
or inadequacies in the instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or 
intentional abnormal use of the investigational medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
 
 
Adverse event that: 
 Led to death, 
 Led to  serious deterioration in the health of the subject, that either 
resulted in: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolongation of existing hospitalization 
of existing hospitalization, or 
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function 
 Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155-2011 
 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Unanticipated Adverse Device 
Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects.   

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Term 
Definition 
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Ref: ISO 14155-2011 
 
 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the risk analysis 
report. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect 
which by its nature, incidence, severity or outcome has been identified in 
the risk analysis report. 
Device Deficiency 
 
Ref: ISO 14155-2011 
 
 
Inadequacy of a medical device related to its identity, quality, durability, 
reliability, safety or performance. This may include malfunctions, use 
error, or inadequacy in the information supplied by the manufacturer. 
NOTE 1:  All device deficiencies that could have led to a SADE if a) 
suitable action had not been taken or b) if intervention had not been made or 
c) if circumstances had been less fortunate shall be reported as required by 
the local IRB/EC, national regulations, or the protocol. 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 
 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
 All Serious Adverse Events 
 All Investigational Device Deficiencies  
 Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
 New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the investigation.   
Death should not be recorded as an AE, but should only be reflected as an outcome of a 
specific SAE (see Error! Reference source not found. for AE definitions).  
Any AE experienced by the study subject after informed consent, whether during or 
subsequent to the procedure, must be recorded in the eCRF. 
Refer to Section 19 for the known risks associated with the study device(s). 
Device deficiencies and other device issues should not be reported as AEs. Instead, they should 
be reported on the appropriate eCRF per the study CRF Completion Guidelines. If an AE 
results from a device deficiency or other device issue, the AE should be reported on the 
appropriate eCRF. 
In-patient hospitalization is defined as the subjects being admitted to the hospital, with the 
following exceptions. 

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 A hospitalization that is uncomplicated and elective/planned (i.e., planned prior to 
enrollment) does not have to be reported as an SAE. 
 If complications or AEs occur during an elective/planned (i.e., planned prior to enrollment) 
hospitalization after enrollment, the complications and AEs must be reported as AEs or 
SAEs if they meet the protocol-specified definitions. However, the original 
elective/planned hospitalization(s) itself should not be reported as an SAE. 
20.2. Relationship to Study Device(s) 
The Investigator must assess the relationship of the AE to the study device or procedure.  See 
criteria inError! Reference source not found. 
Table 20.2-1: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 

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Classification 
Description 
Not Related 
 
Relationship to the device or procedures can be excluded when: 
- the event is not a known side effect of the product category the device belongs 
to or of similar devices and procedures; 
- the event has no temporal relationship with the use of the investigational device 
or the procedures; 
- the serious event does not follow a known response pattern to the medical 
device (if the response pattern is previously known) and is biologically 
implausible; 
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ not expected to be affected by the 
device or procedure; the serious event can be attributed to another cause (e.g. an 
underlying 
or concurrent illness/ clinical condition, an effect of another device, drug, 
treatment or other risk factors); 
- the event does not depend on a false result given by the investigational device 
used for diagnosis, when applicable; harms to the subject are not clearly due to 
use error; 
- In order to establish the non-relatedness, not all the criteria listed above might 
be met at the same time, depending on the type of device/procedures and the 
serious event.
Unlikely Related 
The relationship with the use of the device seems not relevant and/or the event can 
be reasonably explained by another cause, but additional information may be 
obtained. 
Possibly Related 
The relationship with the use of the investigational device is weak but cannot be 
ruled out completely. Alternative causes are also possible (e.g. an underlying or 
concurrent illness/ clinical condition or/and an effect of another device, drug or 
treatment). Cases were relatedness cannot be assessed or no information has been 
obtained should also be classified as possible. 
Probably Related
The relationship with the use of the investigational device seems relevant and/or 
the event cannot reasonably explained by another cause, but additional information 
may be obtained. 

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Classification 
Description 
Causal 
Relationship 
The serious event is associated with the investigational device or with procedures 
beyond reasonable doubt when: 
- the event is a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- the event has a temporal relationship with investigational device use/application 
or procedures; 
- the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the investigational device used for 
diagnosis, when applicable; 
- In order to establish the relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the serious event.
 
The Investigator must assess the relationship of the AE to the antiplatelet medication using 
the following categories and definitions (Table 20.2-2). 
Table 20.2-2: Criteria for Assessing Relationship of Antiplatelet Medication to Adverse 
Event 
Classification 
Description 
Unrelated 
The adverse event is determined to be due to a concurrent illness or effect of a 
device/drug and is not determined to be potentially related to the antiplatelet 
medication. 
Related 
The adverse event is determined to be potentially related to the antiplatelet 
medication, and an alternative etiology is equally or less likely compared to the 
potential relationship to antiplatelet medication. 
 
20.3. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Error! Reference 
source not found.. 
Table 20.3-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
Unanticipated Adverse Device 
Effect / Unanticipated Serious 
Complete AE eCRF page with all 
available new and updated information.  
 Within 24 hours of first 
becoming aware of the event. 

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Event Classification 
Communication Method  
Communication Timeline  
Adverse Device Effect 
(UADE/USADE)  
 
 Terminating at the end of the 
study 
Serious Adverse Event 
including Serious Adverse 
Device Effects(SADE) 
Complete AE eCRF page with all 
available new and updated information.  
 Within 24 hours of first 
becoming aware of the event  
 Reporting required through the 
end of the study 
Provide all relevant source documentation 
(unidentified) for reported event 
 When documentation is 
available 
Device Deficiencies (including 
but not limited to failures, 
malfunctions, and product 
nonconformities) 
Note:  Any Investigational 
Device Deficiency that might 
have led to a serious adverse 
event if: a) suitable action had 
not been taken or b) 
intervention had not been 
made or c) if circumstances 
had been less fortunate is 
considered a reportable event.
Complete Device Deficiency eCRF with 
all available new and updated information. 
 Within 24 hours of first 
becoming aware of the event. 
 Reporting required through the 
end of the study 
Adverse Event including 
Adverse Device Effects 
Complete AE eCRF page, which contains 
such information as date of AE, treatment 
of AE resolution, assessment of 
seriousness and relationship to the device. 
 In a timely manner  but no later 
than10 business days after 
becoming aware of the 
information 
 Reporting required through the 
end of the study  
Abbreviations: AE = adverse event; CRF = case report form; IDE = Investigational Device Exemption; UADE = 
unanticipated adverse device effect 
20.4. Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and inadequacy in the information supplied by the manufacturer) 
will be documented and reported to BSC. If possible, the device(s) should be returned to 
BSC for analysis.  Instructions for returning the investigational device(s) will be provided in 
Device Management Plan.  If it is not possible to return the device, the investigator should 
document why the device was not returned and the final disposition of the device.  Device 
failures and malfunctions should also be documented in the subject’s medical record. 
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not to be reported as adverse events. However, if there is an adverse 
event that results from a device failure or malfunction, that specific event would be recorded 
on the appropriate eCRF. 
And, any Investigational Device Deficiency that might have led to a serious adverse event if 
a) suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate is considered a reportable event. 

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20.5. Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
BSC is responsible for reporting adverse event information and device deficiencies 
information to all participating Principal Investigators and regulatory authorities, as 
applicable.  
The Principal Investigator is responsible for informing the IRB/EC, and regulatory 
authorities of UADE and SAE as required by local/regional regulations. 
According to China local reporting requirements, Boston Scientific Corporation will report 
all SAEs  and device deficiencies that could lead to SAEs to the local regulatory authorities 
within 5 business days of BSC first becoming aware of the event, and notify all participating 
investigators/sites and IRBs/ECs in a timely manner.  
Investigator and investigational site is responsible for reporting all SAEs and device 
deficiencies that could lead to SAEs to IRBs/ECs, local Food and Drug Administration and 
the same level Commission of Health within 24 hours of investigator becoming aware of the 
event. 
BSC shall notify all participating Chinese study centers if SAEs/SADEs or Device 
Deficiencies occur which imply a possible increase in the anticipated risk of the procedure or 
use of the device or if the occurrence of certain SAEs/SADEs demands changes to the 
protocol or the conduct of the study in order to further minimize the unanticipated risks. 
Boston Scientific Corporation, Investigator, or Site must notify the EC of UADEs, USADEs, 
SADEs, SAEs, Device Deficiencies and/or other CEC events as applicable according to local 
reporting requirements. A copy of the Investigator’s reports and other relevant reports (if 
applicable) to the IRB/IEC must be provided to BSC in accordance with local requirements. 
  
21. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
each subject or his/her legally authorized representative.  The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable.  The ICF must be 
approved by BSC or its delegate (e.g. CRO), the site’s IRB/EC, or central IRB, if applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study.  The ICF template may be modified to meet the requirements of 
the investigative site’s IRB/EC.  Any modification requires acceptance from BSC prior to 
use of the form.  The ICF must be in a language understandable to the subject and if needed, 
BSC will assist the site in obtaining a written consent translation.  Translated consent forms 
must also have IRB/EC approval prior to their use.  Privacy language shall be included in the 
body of the form or as a separate form as applicable.   

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The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
 be conducted by the Principal Investigator or designee authorized to conduct the process,  
 include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
 avoid any coercion of or undue influence of subjects to participate, 
 not waive or appear to waive subject’s legal rights, 
 use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
 provide ample time for the subject to consider participation and ask questions if 
necessary, 
 ensure important new information is provided to new and existing subjects throughout the 
clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the site and a copy of the signed and dated document and any 
other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements (e.g., FDA requirement is within 5 working days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Acceptance by Boston Scientific is required if changes to the revised ICF are 
requested by the site’s IRB/EC. The IRB/EC will determine the subject population to be re-
consented. 
Study personnel should explain to the subject that even if the subject agrees to participate in 
the trial and signs the ICF, vascular angiography may demonstrate that the subject is not a 
suitable candidate for the trial.  A Screening Log will be maintained to document select 
information about candidates who fail to meet the Ranger China trial eligibility criteria, 
including, but not limited to, the reason for screen failure. 

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22. Committees 
22.1. Executive Committee 
An Executive Committee composed of BSC Clinical Management, study Principal 
Investigator will be convened.  This committee will be responsible for the overall conduct of 
the study which will include protocol development, study progress, subject safety, overall 
data quality and integrity, and timely dissemination of study results through appropriate 
scientific sessions and publications.  As appropriate the Executive Committee may request 
participation of Ranger China Investigators on the Committee. 
22.2.  Safety Monitoring Process 
To promote early detection of safety issues, the BSC Safety team and its delegated CRO 
Safety team will provide review, process, monitor and evaluation of the safety events 
defined in the study-specific safety plan. Success of this program requires dynamic 
collection of unmonitored data as soon as the event is reported. During regularly scheduled 
monitoring activities, clinical research monitors will support the dynamic reporting process 
through their review of source document and other data information. The BSC Medical 
Safety group includes physicians with expertise in vascular intervention and with the necessary 
therapeutic and subject matter expertise to evaluate and classify the events into the categories 
outlined above. 
 
22.3. Clinical Events Committee 
The Clinical Events Committee (CEC) is an independent group of individuals with pertinent 
expertise who review and adjudicate important clinical endpoints and relevant AEs reported 
by study Investigators. 
The CEC will review a safety event dossier, which may include copies of subject source 
documents provided by study sites, for all reported cases of clinically-driven TVR, target 
limb major amputation, thrombosis at target lesion, and death.  
Committee membership will include practitioners of vascular interventional therapy, as well 
as other experts with the necessary therapeutic and subject matter expertise to adjudicate the 
event categories outlined above.  Responsibilities, qualifications, membership, and 
committee procedures are outlined in the CEC charter.  
23. Suspension or Termination 
23.1 Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of subjects.  Investigators, associated IRBs/ECs, and regulatory 
authorities, as applicable, will be notified in writing in the event of study termination. 

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23.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
 Any new important information that affects the study to continue (eg. safety or properties 
of product ), 
 A decision of regulatory authorities to discontinue the study. 
 An enrollment rate far below expectation that prejudices the conclusion of the study.  
 A decision on the part of Boston Scientific to suspend or discontinue development of the 
device. 
Note: According to the section 20, even if the study is terminated, all the AEs, SAEs, SADEs 
and Device Deficiency should be evaluated and reported for the subjects who have received 
the treatment of study device.  
(China Medical Device GCP requirement: The reasons and criteria based on biostatistics of 
study termination are: the statistics method of all the data is missing, data is missing or error 
(including withdraw and termination) and unreasonable data handling methods.) 
23.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval 
Any investigator, or IRB/ EC in the Ranger China Study may discontinue participation in the 
study or withdrawal approval of the study, respectively, with suitable written notice to 
Boston Scientific.  Investigators, associated IRBs/ECs, and regulatory authorities, as 
applicable, will be notified in writing in the event of these occurrences. 
23.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating centers by Boston Scientific. 
The IRB/EC and regulatory authorities, as applicable, will be notified.  Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB or EC terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by Boston Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible.  In the event there are no opportunities 
to transfer Principal Investigator responsibility; detailed information on how enrolled 
subjects will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and 
investigational product to Boston Scientific, unless this action would jeopardize the rights, 
safety, or welfare of the subjects. 

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23.4 Criteria for Suspending/Terminating a Study Site 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
site at any time after the study initiation visit if no subjects have been enrolled beyond 6 
months after site initiation; or if enrollment is significantly slower than expected; or if the 
center has multiple or severe protocol violations/noncompliance without justification and/or 
fails to follow remedial actions. 
In the event of termination of investigator participation, all study devices and testing 
equipment, as applicable, will be returned to BSC unless this action would jeopardize the 
rights, safety or well-being of the subjects.  The IRB/EC and regulatory authorities, as 
applicable, will be notified.  All subjects enrolled in the study at the site will continue to be 
followed through the end of the study. The Principal Investigator at the site must make 
provision for these follow-up visits unless BSC notifies the investigational site otherwise. 
According to Section 20, all the ongoing AEs should be evaluated and reported for the 
subjects who have been treated by study device. And the ongoing AEs should be followed 
up by investigators continues, unless BSC informed the sites.  
24. Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. BSC will submit study 
results for publication (regardless of study outcome) following the conclusion or termination 
of the study. Boston Scientific Corporation adheres to the Contributorship Criteria set forth in 
the Uniform Requirements of the International Committee of Medical Journal Editors 
(ICMJE; http://www.icmje.org). In order to ensure the public disclosure of study results in a 
timely manner, while maintaining an unbiased presentation of study outcomes, BSC 
personnel may assist authors and investigators in publication preparation provided the 
following guidelines are followed. 
 All authorship and contributorship requirements as described above must be followed. 
 BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
 The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
25. Bibliography 
1. 
Criqui MH, Fronek A, Barrett-Connor E, Klauber MR, Gabriel S, Goodman D.  The prevalence 
of peripheral arterial disease in a defined population.  Circulation 1985;71(3):510e551. 
2. 
Hiatt WR, Hoag S, Hamman RF.  Effect of diagnostic criteria on the prevalence of peripheral 
arterial disease. The San Luis Valley Diabetes Study.  Circulation 1995;91(5):1472e1479. 
3. 
Selvin E, Erlinger TP.  Prevalence of and risk factors for peripheral arterial disease in the United 
States: results from the National Health and Nutrition Examination Survey, 1999 - 2000.  
Circulation 2004;110(6):738e743. 

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4. 
Garcia LA.  Epidemiology and Pathophysiology of Lower Extremity Peripheral Arterial Disease.  
J Endovasc Ther 2006;13(Suppl II):II-3–II-9. 
5. 
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al.  Inter-Society 
Consensus for the Management of Peripheral Arterial Disease (TASC II).  Eur J Vasc Endovasc 
Surg 2007;33(Suppl. 1):S1-S75. 
6. 
《老年人四肢动脉粥样硬化性疾病诊治中国专家建议2012)>写作组,中华医学会老年医学分会,中华医学会外
科学分会血管外科专业组,中华老年医学杂志编辑委员会: 老年人四肢动脉粥样硬化性疾病诊治中国专家建
议(2 0 1 2). Chin J Geriatr 2013;32:121-131. 
7. 
Kasapis C, Gurm HS.  Current approach to the diagnosis and treatment of femoral-popliteal 
arterial disease: a systematic review.  Curr Cardiol Rev 2009;5:296-311. 
8. 
Rooke TW, Hirsch AT,Misra S, Sidawy AN, Beckman JA, Findeiss LK, et al.  2011 
ACCF/AHA focused update of the guideline for the management of patients with peripheral 
artery disease (updating the 2005 guideline): a report of the American College of Cardiology 
Foundation/American Heart Association Task Force on Practice Guidelines: developed in 
collaboration with the Society for Cardiovascular Angiography and Interventions, Society of 
Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery.  J 
Vasc Surg 2011;54:e32-58. 
9. 
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G.  Performance goals and endpoint 
assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic 
peripheral arterial disease.  Catheter Cardiovasc Interv 2007;69:910-919. 
10. Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, 
Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR.  Nitinol stent implantation versus balloon 
angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-
month results from the RESILIENT randomized trial.  Circ Cardiovasc Interv 2010;3:267-276. 
11. Waksman R & Pakala R.  Drug-eluting balloon: the comeback kid?  Circ Cardiovasc Interv 
2009;2:352-358. 
12. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, 
DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME.  Comparison of a polymer-based paclitaxel-
eluting stent with a bare metal stent in patients with complex coronary artery disease: a 
randomized controlled trial.  JAMA 2005;294:1215-1223. 
13. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder U, Beregi J, Claussen CD, Oldenburg A, 
Scheller B & Speck U.  Local delivery of paclitaxel to inhibit restenosis during angioplasty of 
the leg.  N Engl J Med 2008;358:689-699. 
14. Tenaglia AN, Fortin DF, Califf RM, Frid DJ, Nelson CL, Gardner L, Miller M, Navetta FI, 
Smith JE, Tcheng JE & et al.  Predicting the risk of abrupt vessel closure after angioplasty in an 
individual patient.  J Am Coll Cardiol 1994;24:1004-1011. 
15. Lincoff AM, Popma JJ, Ellis SG, Hacker JA & Topol EJ.  Abrupt vessel closure complicating 
coronary angioplasty: clinical, angiographic and therapeutic profile.  J Am Coll Cardiol 
1992;19:926-935. 
16. Post MJ, Borst C & Kuntz RE.  The relative importance of arterial remodeling compared with 
intimal hyperplasia in lumen renarrowing after balloon angioplasty. A study in the normal rabbit 
and the hypercholesterolemic Yucatan micropig.  Circulation 1994;89:2816-2821. 
17. Werk M, Langner S, Reinkensmeier B, Boettcher H, Tepe G, Dietz U, Hosten N, Hamm B, 
Speck U & Ricke J.  Inhibition of restenosis in femoropopliteal arteries: paclitaxelcoated versus 
uncoated balloon: femoral paclitaxel randomized pilot trial.  Circulation 2008;118:1358-1365. 
18. Leiner T, et al.  “Peripheral Arterial Disease: Comparison of Color Duplex US and 
Contrast-enhanced MR Angiography for Diagnosis".  Radiology 2005;235:699-708. 
19. Klein W, et al.  “Dutch Iliac Stent Trial: Long-Term Results in Patients Randomized to 
Primary or Selective Stent Placement.”  Radiology 2006;238:734-44. 
20. Lutonix 2014 Panel Presentation Summary of Safety and Effectiveness Data (SSED) 

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http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medica
ldevices/medicaldevicesadvisorycommittee/circulatorysystemdevicespanel/ucm400421.p
df. 
21. Cutlip DE, Windecker S, Mehran R, et al. Clinical endpoints in coronary stent trials: a 
case for standardized definitions. Circulation 2007;115:2344–51. 
 
26. Abbreviations and Definitions  
26.1. Abbreviations 
Abbreviations are shown in Error! Reference source not found..   
Table 26.1-1:  Abbreviations 
Abbreviation/Acronym 
Term 
ASA 
ABI 
ADE 
AE 
AP 
ASADE 
BMS 
BRR 
CA 
CAD 
CEC 
CIP 
Core lab 
CRF 
DCB 
DES 
DFU 
DUS 
EC 
EDC 
eCRF 
HCP 
ICF 
ISF 
LLL 
MAE 
MAX 
MI 
MIN 
MLD 
OTW 
PAD 
PPA 
PSVR 
Acetylsalicylic Acid 
Ankle Brachial Index 
Adverse Device Defect 
Adverse Event 
Ankle Pressure 
Anticipated Serious Adverse Device Effect 
Bare Metal Stent 
Binary Restenosis Rate 
Competent Authority 
Coronary Artery Disease 
Clinical Event Committee 
Clinical Investigation Plan 
Core Laboratory 
Case Report Form 
Drug-coated Balloon 
Drug Eluting Stent 
Directions for Use 
Duplex Ultrasound Sonography 
Ethics Committee 
Electronic Data Capturing 
Electronic Case Report Form 
Health Care Personnel 
Informed Consent Form 
Investigator Site File 
Late Lumen Loss 
Major Adverse Events 
Maximum 
Myocardial Infarction 
Minimum 
Minimal Lumen Diameter 
Over The Wire 
Peripheral Artery Disease 
Proximal Popliteal Artery 
Peak Systolic Velocity Ratio 

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Abbreviation/Acronym 
Term 
PTA 
PVR 
QoL 
QVA 
SADE 
SAE 
SFA 
StDev 
TLR 
TM 
TP 
TVR 
USADE
Percutaneous Transluminal Angioplasty 
Pulse Volume Recording 
Quality of Life 
Quantitative Vascular Angiography 
Serious Adverse Device Effect 
Serious Adverse Event 
Superficial Femoral Artery 
Standard Deviation 
Target Lesion Revascularization 
Transmetatarsal 
Toe Pressure 
Target Vessel Revascularization 
Unanticipated Serious Adverse Device Effect
26.2. Definitions 
Table 26.2-1: Definitions 
Term 
Definition 
AMPUTATION 
• 
Major Amputation: amputation of the lower limb at the ankle 
level or above; and can be further specified as below-the-knee and 
above-the-knee amputations, as well as planned and unplanned 
amputations. 
• 
Minor Amputation: amputation of the lower limb below the ankle 
level, i.e. forefoot or toes. 
ANKLE-BRACHIAL 
INDEX (ABI) 
The ratio between the systolic pressure measured at the ankle and the 
systolic pressure measured in the arm as follows:  
• 
Ankle: The systolic pressure will be measured in the target limb at 
the arteria dorsalis pedis and/or the arteria tibialis posterior. If 
both pressures are measured, the highest pressures will be used for 
the ABI calculation.  
• 
Brachial: The systolic pressure will be measured in both arms, and 
the highest of both pressures will be used for the ABI calculation. 
An ABI <0.9 indicates the presence of peripheral arterial disease in 
symptomatic patients as well as in asymptomatic patients. In addition, 
an ABI <0.9 reflects the presence of generalized asymptomatic or 
symptomatic atherosclerotic disease, and its associated increased 
cardiovascular risk.
ARRHYTHMIA 
Any variation from the normal rhythm of the heartbeat, including but 
not limited to, sinus arrhythmia, premature beats, heart block, 
ventricular or atrial fibrillation, ventricular tachycardia, or atrial 
flutter.

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Term 
Definition 
ASSISTED PRIMARY 
PATENCY 
Percentage (%) of lesions without clinically-driven TLR and those 
with clinically-driven TLR (not due to complete occlusion or by-pass) 
that reach endpoint without restenosis.
BLEEDING 
COMPLICATION 
Includes, but is not limited to, intracranial hemorrhage, GI bleeding, 
hematoma, bleeding at percutaneous catheterization site, and/or 
retroperitoneal bleeding. Bleeding that requires surgery qualifies as an 
SAE.
CALCIFICATION 
Readily apparent densities seen within the artery wall and site of 
lesion as an x-ray-absorbing mass.
CEREBRO-VASCULAR 
ACCIDENT (CVA) 
CEREBRO-VASCULAR ACCIDENT / STROKE 
An acute symptomatic episode of neurological dysfunction attributed 
to a vascular cause lasting more than 24 hours or lasting 24 hours or 
less with a brain imaging study or autopsy showing infarction. 
CLINICAL Success 
Clinical success defined as improved Rutherford classification by at 
least +1 class compared to baseline.
COMPLETE BLOOD 
COUNT (CBC) 
A blood test used to measure several components and features of 
blood, including:  Red Blood Cells, White Blood Cells, Hemoglobin, 
Hematocrit and Platelets.
COMPLICATION 
An undesirable clinical event that results in death, injury, or invasive 
intervention. Complications may include, but are not limited to 
perforation, occlusion, intimal flap, dissection, loss of side branch, 
distal embolization, hypotension, hematoma, arrhythmias, etc. 
Complications may or may not be related to the investigational 
product(s).

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Term 
Definition 
DEATH 
All deaths are considered cardiac unless an unequivocal non-cardiac 
cause can be established. Specifically, an unexpected death in subjects 
with coexisting potentially fatal non-cardiac diseases (e.g. Cancer, 
infection) should be classified as cardiac. 
All death events will be submitted to CEC and will be categorized as: 
Cardiac death: any death due to immediate cardiac cause (e.g. MI, 
low-output failure, fatal arrhythmia). Unwitnessed death and death of 
unknown cause will be classified as cardiac death. This includes all 
procedure related deaths including those related to concomitant 
treatment. 
Vascular death: death due to cerebrovascular disease, pulmonary 
embolism, ruptured aortic aneurysm, dissecting aneurysm, or other 
vascular cause. 
Non-cardiovascular death:  any death not covered by the above 
definitions, including death due to infection, sepsis, pulmonary 
causes, accident, suicide, or trauma. 
Index Limb-Related Death: In the Ranger China Trial, all death will 
also be adjudicated by the Clinical Event Committee (CEC) as “likely 
related” to a complication of the index limb. 
Perioperative Death is the death within 30 days of the index 
procedure.
DIAMETER STENOSIS 
The maximal narrowing of the target lesion relative to the reference 
vessel diameter. 
DISSECTION- NHLBI 
GRADE TYPES 
Type A- Small radiolucent area within the lumen of the vessel 
disappearing with the passage of the contrast material. 
Type B- Appearance of contrast medium parallel to the lumen of the 
vessel disappearing within a few cardiac cycles. 
Type C- Dissection protruding outside the lumen of the vessel 
persisting after passage of the contrast material. 
Type D- Spiral shaped filling defect with or without delayed run-off 
of the contrast material in the antegrade flow. 
Type E- Persistent luminal filling defect with delayed run-off of the 
contrast material in the distal lumen. 
Type F- Filling defect accompanied by total vessel occlusion. 
DISTAL 
EMBOLIZATION 
Migration of a filling defect, or thrombus, to distally occlude the 
target vessel or one of its branches. 
HEMATOMA 
A localized swelling filled with blood resulting from a break in a 
blood vessel. 

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Term 
Definition 
HEMODYNAMIC 
IMPROVEMENT 
Improvement of ABI by ≥ 0.1 or to an ABI ≥ 0.90 as compared to the 
pre-procedure value without the need for repeat revascularization. 
HEMODYNAMIC 
SUCCESS 
Hemodynamic success is defined as a positive change in Ankle-
Brachial Index compared to baseline.
HYPOTENSION 
Systolic blood pressure < 80 mmHg lasting more than 30 minutes or 
requiring intervention (e.g. pacing, IABP, intra venous vasopressors 
to sustain systolic blood pressure). This excludes transient 
hypotension or vagal reactions, which are self-limited or readily 
reversible. 
INTIMAL FLAP 
An extension of the vessel wall into the arterial lumen. 
LESION LENGTH 
Measured as the distance from the proximal shoulder to the distal 
shoulder of the lesion, in the view that demonstrates the stenosis in its 
most elongated projection. 
MAJOR ADVERSE 
EVENTS (MAEs) 
In the Ranger China Trial, Major Adverse Events (MAEs) include all-
cause death, clinically-driven TLR, target limb major amputation or 
thrombosis at target lesion.
MINIMAL LUMEN 
DIAMETER 
The vessel diameter as measured at the most narrow point of the 
lesion.
PERFORATION 
Perforations are classified as follows: 
Angiographic perforation: perforation detected by the clinical site or 
Angiographic Core Laboratory at any point during the procedure. 
Clinical perforation: perforation requiring additional treatment 
(including efforts to seal the perforation), or resulting in significant 
hemodynamic compromise, abrupt closure, or death.
PRIMARY PATENCY 
 
In Ranger China, vessel patency is defined as freedom from more 
than 50% diameter stenosis.  
 
 
Primary patency is the absence of more than 50% stenosis assessed 
by either CTA or DUS (peak systolic velocity ratio ≤ 2.4), without 
clinically-driven target lesion revascularization post the index 
procedure. 
PRIMARY SUSTAINED 
CLINICAL 
IMPROVEMENT 
Improvement in Rutherford classification of one or more categories as 
compared to pre-procedure without the need for repeat TLR. 

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Term 
Definition 
PROCEDURAL SUCCESS
Technical success with no MAEs noted within 24 hours of the index 
procedure. 
PSEUDO-ANEURYSM 
An encapsulated hematoma in communication with an artery. 
PRODUCT NON-
CONFORMITY 
A departure of a quality characteristic from its intended level or state 
that occurs with a severity sufficient to cause an associated product or 
service not to meet a specification requirement. 
REPEAT 
INTERVENTION 
(PERCUTANOUS 
AND/OR SURGERY)
Either repeat percutaneous transluminal angioplasty (PTA) or artery 
bypass surgery, performed subsequently to the subject leaving the 
cath lab after the index procedure.  
REFERENCE VESSEL 
DIAMETER (RVD) OF 
NORMAL ARTERY 
SEGMENT 
Angiographic measurement of the artery proximal and/or distal to the 
lesion intended for treatment. 
RESTENOSIS 
Diameter stenosis > 50% assessed by angiography, CTA or DUS 
(peak systolic velocity ratio > 2.4) 
RUTHERFORD / 
BECKER 
CLASSIFICATION 
Category
Clinical Description 
Objective Criteria 
0 
Asymptomatic 
Normal Treadmill /stress test 
1 
Mild claudication 
Completes treadmill exercise; ankle 
pressure (AP) after exercise < 50 mm 
Hg, but > 25 mm Hg less than BP
2 
Moderate claudication 
Between categories 1 and 3 
3 
Severe claudication 
Cannot complete treadmill exercise and 
AP after exercise < 50 mm Hg
4 
Ischemic rest pain 
Resting AP < 40 mm Hg, flat or barely 
pulsatile ankle or metatarsal pulse 
volume recording (PVR); toe pressure 
(TP) < 30 mm Hg
5 
Minor tissue loss – nonhealing 
ulcer, focal gangrene with 
diffuse pedal edema
Resting AP < 60 mm Hg, ankle or 
metatarsal (MT) PVR flat or barely 
pulsatile; TP < 40 mm Hg 
6 
Major tissue loss – extending 
above MT level
Same as Category 5 
SECONDARY 
SUSTAINED CLINICAL 
IMPROVEMENT 
Improvement in Rutherford classification of one or more categories as 
compared to pre-procedure including those subjects with repeat TLR. 

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Term 
Definition 
SOURCE DATA 
All information in original records and certified copies of original 
records of clinical findings, observations, or other activities in a 
clinical investigation, necessary for the reconstruction and evaluation 
of the trial. Source data are contained in the source documents 
(original records or certified copies).
SOURCE DOCUMENT 
Original documents, data or records. 
Examples:  Hospital records, laboratory notes, device accountability 
records, photographic negatives, radiographs, records kept at the 
investigation site, at the laboratories and at the medico-technical 
departments involved in the clinical investigation.
TARGET LESION 
Target lesion is the lesion selected by the investigator for treatment 
with the study device (Ranger DCB), the length of the target lesion is 
inclusive of the section of vessel treated with the study device and the 
5 mm proximal and 5 mm distal to the treated section. 
TARGET LESION 
REVASCULARIZATION 
(TLR) 
Target lesion revascularization (TLR) is a repeat revascularization procedure 
(percutaneous or surgical) within 5 
mm proximal or distal to the originally treated target lesion segment. A TLR will be 
considered as clinically driven 
if the culprit lesion diameter stenosis is > 50% determined by DUS, CTA or 
angiography AND the subject has 
either clinical and/or functional recurrent ischemia (e.g., recurrent/progressive 
intermittent claudication, ≥ 1 change in Rutherford Category associated with the 
target limb, or associated with decreased ABI/TBI of ≥ 20% or ≥ 0.15 in the 
treated segment. TBI allowed in cases of incompressible vessels). 
 
A target lesion revascularization for an in-lesion diameter stenosis less than 50% 
might also be considered a major adverse event (MAE) by the CEC if the subject 
has recurrent symptoms (≥ 1 change in Rutherford Classification or associated  
with decreased ABI/TBI of ≥ 20% or ≥ 0.15 in the treated segment. TBI allowed 
in cases of incompressible vessels).Non-Target Lesion Revascularization 
Non-target lesion revascularization is any (de novo or repeat) vascular 
intervention or bypass surgery of a non-target lesion in a target vessel 
or a non-target vessel. This includes revascularization at the time of 
an index (study) vascular intervention of a separate target lesion and 
subsequent revascularization after the index (study) vascular 
intervention.

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Term 
Definition 
TARGET VESSEL 
 
Target vessel is defined as the vessel containing the target 
lesion(s).  If the target lesion is entirely within the right superficial 
femoral artery, then the target vessel is the right superficial femoral 
artery.  If the target lesion extends from the right superficial femoral 
artery into the right proximal popliteal artery, then both the right 
superficial femoral artery and right proximal popliteal artery would be 
considered part of the target vessel. 
TARGET VESSEL 
REVASCULARIZATION 
(TVR) 
 
Target vessel revascularization (TVR) is any repeat intervention or 
surgical bypass of any 
segment of a target vessel. In the Ranger China Trial, TVR includes 
target lesion 
revascularization (TLR) or a non-target lesion revascularization (see 
definitions below) in the 
same target vessel. 
A TVR will be considered clinically-driven if the culprit lesion diameter stenosis 
is > 50% by DUS, CTA or 
angiography AND the subject has either clinical and/or functional recurrent 
ischemia (e.g., recurrent/progressive 
intermittent claudication, ≥ 1 change in Rutherford Category associated with the 
target limb, or associated with 
decreased ABI/TBI of ≥ 20% or ≥ 0.15 in the treated segment. TBI allowed in 
cases of incompressible vessels). 
A target vessel revascularization for a culprit lesion diameter stenosis 
less than 50% might also 
be considered a MAE by the CEC if the subject has recurrent 
symptoms (≥ 1 change in 
Rutherford Classification or associated with decreased ABI/TBI of ≥ 
20% or ≥ 0.15 in the 
 treated segment. TBI allowed in cases of incompressible vessels).

Study Reference Number：S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                                Ranger China Protocol, 91047542 Rev/Ver AF 
                                                                                                                           Page 77 of 78 
 
 
Term 
Definition 
TRANSATLANTIC 
INTER-SOCIETAL 
CONSENSUS (TASC) 
LESION GUIDELINES 
Type A lesion: 
 Single stenosis  10 cm in length. 
 Single occlusion  5 cm in length. 
 
Type B lesion: 
 Multiple lesions (stenoses or occlusions), each  5 cm 
 Single stenosis or occlusion  15cm not involving the infra 
geniculate popliteal artery 
 Single or multiple lesions in the absence of continuous tibial 
vessels to improve inflow for a distal bypass 
 Heavily calcified occlusion  5cm in length 
 Single popliteal stenosis 
 
Type C lesion: 
 Multiple stenoses or occlusions totaling > 15 cm with or without 
heavy calcification 
 Recurrent stenoses or occlusions that need treatment after two 
endovascular interventions 
 
Type D lesion: 
 Chronic total occlusions of the CFA or SFA (> 20 cm, involving 
the popliteal artery) 
 Chronic total occlusion of the popliteal artery and proximal 
trifurcation vessels 
TECHNICAL SUCCESS 
Technical success is defined as the ability to cross and dilate the 
lesion to achieve residual angiographic stenosis no greater than 30% 
(by visual estimate in 2 near-orthogonal projections) without balloon 
rupture, or inflation/deflation abnormalities.
THROMBUS 
(ANGIOGRAPHIC) 
Discrete, mobile intraluminal filling with defined borders 
with/without associated contrast straining; these are classified as 
either absent or present. 
TOTAL OCCLUSION 
Lesion with no flow; implies 100% diameter stenosis.
VASCULAR 
COMPLICATION 
An occurrence of hematoma > 5 cm, pseudoaneurysm, arteriovenous 
(AV) fistula, or need for vascular surgical repair. 
VESSEL PATENCY 
 
Vessel patency is defined as freedom from more than 50% diameter 
stenosis assessed by angiography, CTA or DUS (with peak systolic 
velocity ratio > 2.4). 
 

Study Reference Number：S6052 
 
Form/Template 90702637 Rev/Ver AL 
Confidential                                                Ranger China Protocol, 91047542 Rev/Ver AF 
                                                                                                                           Page 78 of 78 
 
 
Term 
Definition 
Abbreviations are defined in Table 26.1-1. 
 
 
 
Investigator Statement（See Chinese version protocol）