Prospective, Non-randomized, Multicenter Clinical Study of the JETSTREAM™ Atherectomy System (Jetstream) in Treatment of Occlusive Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries in Chinese Patients
Phase: NA
Conditions: Atherosclerosis
Sponsor: Boston Scientific Corporation

Study Reference S6050                                                         Form/Template 90702637 Rev/Ver AP 
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JETSTREAM CHINA Protocol 
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Page 1 of 86 
 
Prospective, non-randomized, multicenter clinical study of the 
JETSTREAM™ Atherectomy System (Jetstream) in treatment of 
occlusive atherosclerotic lesions in the superficial femoral and/or proximal 
popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
 
CLINICAL PROTOCOL 
 
(S6050) 
National Clinical Trial (NCT) Identified Number: NCT03455855 
 
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 
 
 
 
Date: October 21, 2021 
 
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. 
 
 
 
 
 
 

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Contact Information 
Role 
Contact  
Clinical Contact 
Peng Lv 
Senior Clinical Trial Manager 
BSC China 
16th Floor, South Tower, China Overseas Plaza. No. 8 
Guanghuadongli, 
Chaoyang District 
Beijing 100020 
P.R. China 
Email: Peng.Lv@bsci.com 
Phone Mobile:   +86 18516830968 
Tel: +86 10 85742909 
Author 
Haotian Zhang, MD 
Manager of Medical Affairs 
BSC China 
31 Floor, No. 763 Mengzi Road 
Huangpu District 
Shanghai  200023 
P.R. China 
Email:Haotian.Zhang@bsci.com  
Mobile:+86 17621154031 
Tel: +86 21 80317411 
Coordinating 
Principal Investigator 
Dr. Wei Guo 
Professor, Chief 
Chinese PLA General Hospital 
No.28, Fuxing Road, Haidian District, Beijing 
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. 
 

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Original Release: July 13, 2017 
Current Version: October 21, 2021 
 
Revision History 
Revisio
n 
Number 
Release Date 
Template 
number 
and version 
Section 
Change 
Reason for Change 
AA 
July 13, 2017 
90702637 
Rev./Ver. 
AH 
None 
None 
Original release 
AB 
August 25, 
2017 
90702637 
Rev./Ver. 
AH 
Page 9 in 
Protocol 
Synopsis “Key 
Exclusion 
Criteria” (#22) 
and Page 36 
Section 9.3 
“Exclusion 
Criteria” (#22) 
Add an additional 
exclusion criterion (#22)  
“Presence of outflow 
lesions in the target limb 
requiring intervention 
during the index 
procedure”   
To clearly exclude the 
candidates with outflow 
lesions requiring 
treatment during the 
index procedure in order 
to minimize interference 
in safety endpoints 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
Header;  
Title Page 
Protocol version was 
updated from “AB” to 
“AC”;  
Protocol release date was 
updated from “Aug 25, 
2017” to “Jun 30, 2020”; 
Protocol template version 
was updated from “AH” 
to “AL”. 
Protocol / Protocol 
template update 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
Contact 
Information 
Clinical contact was 
changed from “Jian Wen” 
to “Jing Zhou”, and 
update the contact 
information accordingly. 
Adjust the clinical trial 
manager 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
Protocol 
Synopsis – Key 
Exclusion 
Criteria; 
9.3 Exclusion 
Criteria 
In the eighth criteria, 
remove restrictions on the 
use of drug-coated 
devices 
Adjust based on the new 
clinical evidence on 
drug-coated devices 
especially DCB and the 
current clinical practice, 
to achieve optimal target 
lesion treatment.  
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
Protocol 
Synopsis – 
Multiple 
Interventions 
During Index 
Procedure; 
Remove the restriction on 
the use of drug-eluting 
devices during the 
treatment of non-target 
inflow lesions in the 
target limb 
Adjust based on the new 
clinical evidence on 
drug-coated devices 
especially DCB and the 
current clinical practice, 

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Revision History 
Revisio
n 
Number 
Release Date 
Template 
number 
and version 
Section 
Change 
Reason for Change 
8.3.2 Target 
limb 
to achieve optimal target 
lesion treatment.  
AC 
June 30, 2020 
90702637 
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AL 
Protocol 
Synopsis – 
Primary 
Effectiveness 
Hypothesis; 
12.1.2.1 
Effectiveness 
Hypothesis; 
 
Add the below note in the 
primary effectiveness 
hypothesis: 
“*The expected mean 
acute reduction 
(i.e. %DSbefore Jetstream 
– %DSafter Jetstream) 
was 40%; the primary 
effectiveness hypothesis 
is to demonstrate there is 
a significant acute 
reduction (>0). See 
Statistical Analysis Plan 
for detail.” 
Primary effectiveness 
hypothesis and primary 
effectiveness statistical 
test method are not 
match 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
8.2.2 Target 
Lesion;  
8.5 Treatment; 
11.6.1 
Treatment of 
target lesion 
Delete “no treatment of 
drug-eluting device 
(balloon or stent) in the 
index lesion is allowed 
during the index 
procedure.” 
Remove the restrictions 
on the use of drug-eluting 
devices following 
Jetstream system during 
the index procedure. 
Adjust based on the new 
clinical evidence on 
drug-coated devices 
especially DCB and the 
current clinical practice, 
to achieve optimal target 
lesion treatment.  
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
10 Subject 
Accountability 
Add two sections: 
“10.4 Lost to Follow-up” 
and “10.5 End-of-Study 
Definition” 
To be consistent with 
the newest version of 
BSC global protocol 
template 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
12.3.1 Analysis 
Sets 
Provide the definition for 
ITT and PPS. Also, 
specify that the primary 
and pre-specified 
additional endpoints will 
be analyzed on an ITT 
basis and on a pre-
protocol basis. 
To be consistent with 
the requirements of 
medical device GCP 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
10.3 Control of 
Enrollment; 
12.3.3 Number 
of Subjects per 
Change the number of 
subjects per investigator 
site from “25% of the 
total number (N=18)” to 
Increase enrollment 
flexibility to enable 
potentially enrolled 
centers to enroll more 

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Revision History 
Revisio
n 
Number 
Release Date 
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number 
and version 
Section 
Change 
Reason for Change 
Investigator 
Site 
“35% of the total number 
(N=25)”. 
patients to accelerate 
enrollment 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
12.3 General 
Statistical 
Methods 
Add the section of 12.3.8 
Sensitivity Analysis 
To be consistent with 
the requirements of 
medical device GCP 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
20.6 Reporting 
to Regulatory 
Authorities / 
IRBs /ECs 
/Investigators 
Add the following 
contents: 
“Investigator and 
investigational site are 
responsible for reporting 
all SAEs and device 
deficiencies that could 
lead to SAEs to 
IRBs/ECs, local Food and 
Drug Administration 
within 24 hours of 
investigator becoming 
aware of the event.” 
To be consistent with 
the newest version of 
BSC global protocol 
template 
AC 
June 30, 2020 
90702637 
Rev./Ver. 
AL 
26.2 Definitions 
Modify the definition of 
technical success 
The definition of 
technical success in the 
definition table and in 
the section of 7.2 are not 
matched 
AD 
October 21, 
2021 
90702637 
Rev./Ver. 
AP 
Header;  
Title Page 
Protocol version was 
updated from “AC” to 
“AD”; 
Protocol release date was 
updated from “June 30, 
2020” to “October 21, 
2021”; Protocol template 
version was updated from 
“AL” to “AP”; NCT 
Number was added. 
Protocol/Protocol 
template update 
AD 
October 21, 
2021October 
21, 2021 
90702637 
Rev./Ver. 
AP 
Contact 
Information 
Clinical contact was 
changed from “Jing 
Zhou” to “Peng Lv”; 
Author changed from 
“Yanfei Yang” to 
“Haotian Zhang” and 
update the contact 
information accordingly.  
Adjust the clinical trial 
manager and author 
information. 

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Revision History 
Revisio
n 
Number 
Release Date 
Template 
number 
and version 
Section 
Change 
Reason for Change 
AD 
October 21, 
2021 
90702637 
Rev./Ver. 
AP 
6 Study 
Objectives and 
Endpoints 
Combine Section 6 
“Study Objectives” and 
Section 7 “Study 
Endpoints” to comply 
with the updated Protocol 
Template. Adjust the 
Section number 
accordingly. 
Adjust Section name 
and number according 
to the updated Protocol 
Template. 
AD 
October 21, 
2021October 
21, 2021 
90702637 
Rev./Ver. 
AP 
Protocol 
Synopsis – 
Planned 
Number of 
Subjects; 
Protocol 
Synopsis – 
Sample Size 
Parameters; 
7.1 Scale and 
Duration 
8.1 Study 
Population and 
Eligibility 
9.3 Enrollment 
Controls 
11.1.1 Primary 
Safety Endpoint 
Change the estimated 
sample size from “up to 
72 subjects” to 
“approximately 80 
subjects”, Roll-in subject 
number from “12 
subjects” to “20 subjects”  
Considering the 
additional sites, the 
planned number of roll-
in subjects and overall 
subjects is modified. 
AD 
October 21, 
2021 
90702637 
Rev./Ver. 
AP 
Protocol 
Synopsis – 
Planned 
Number of 
Centers / 
Countries; 
7.1 Scale and 
Duration 
Change the planned site 
number from “up to 6 
clinical sites” to 
“approximately 10 
clinical sites” 
Increase clinical site to 
accelerate enrollment 
AD 
October 21, 
2021 
90702637 
Rev./Ver. 
AP 
Protocol 
Synopsis –
Required 
Medication 
Therapy 
10.5 Required 
concomitant 
Therapy 
Change the term ”After the 
procedure, all subjects will 
be treated with ASA 
(minimum 75 mg per day) 
indefinitely, and with 
Clopidogrel (min 75 mg per 
day) or ticlopidine (200 mg) 
for 6 months” to “Subjects 
shall receive DAPT during a 
period of at least 6 months 
Modify the required 
concomitant medication 
according to the updated 
antithrombotic therapies 
in low extremity artery 
disease to provide 
optimal antithrombotic 
treatment. 

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Revision History 
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Release Date 
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number 
and version 
Section 
Change 
Reason for Change 
post the index procedure, if 
tolerated. After 6 months of 
DAPT post procedure, all 
subjects are suggested to be 
treated with ASA (minimum 
75 mg/d) indefinitely. For 
subjects who are intolerant 
to aspirin, alternative 
antiplatelet medications 
according to investigator’s 
discretion, such as 300mg of 
clopidogrel.” 
Change term “a subject 
could be exempt of 
antiplatelet requirements if 
he/she requires Coumadin or 
other similar anti-coagulant 
due to known comorbidities 
and in the opinion of the 
investigator the combination 
of dual anti-platelet therapy 
(DAPT) and anticoagulation 
could pose an intolerable 
bleeding risk” to “The risk 
of bleeding may be increased
in the subjects who need 
anticoagulation in addition 
to DAPT. If needed, oral 
warfarin and low-dose 
rivaroxaban (2.5mg twice 
per day) can be used, but no 
other new generation of oral 
anticoagulants, such as 
apixaban or dabigatran is 
allowed. subjects receiving 
anticoagulant therapy should 
not receive additional 
antiplatelet therapy if, in the 
opinion of the investigator, 
this could present an 
intolerable bleeding risk.” 
AD 
October 21, 
2021 
90702637 
Rev./Ver. 
AP 
7.1 Scale and 
Duration 
Modify the estimated 
enrollment duration from 
“8 months” to “4 years” 
Modify the estimated 
enrollment duration 
against the actual 
situation. 

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Revision History 
Revisio
n 
Number 
Release Date 
Template 
number 
and version 
Section 
Change 
Reason for Change 
AD 
October 21, 
2021 
90702637 
Rev./Ver. 
AP 
11.3.3 Number 
of Subjects per 
Investigator 
Site 
Change the number of 
subjects per investigator 
site from “35% of the 
total number (N=25)” to 
“35% of the total number 
(N=28)”. 
Increase the number of 
subjects per site 
according to the updated 
subject’s amount. 
AD 
October 21, 
2021 
90702637 
Rev./Ver. 
AP 
11.3.6 Interim 
Analyses 
Change the term “No 
formal interim analyses 
are planned for the 
purpose of stopping this 
study early for declaring 
effectiveness or for 
futility” to “Steering 
Committee can make the 
decision to conduct the  
interim analyses 
accordingly (such as the 
process seriously delayed 
due to epidemic).” 
Modify interim analysis 
information against the 
actual situation. 
AD 
October 21, 
2021 
90702637 
Rev./Ver. 
AP 
23 Study 
Registration 
and Results 
Added “Study 
Registration” and 
“Clinical Investigation 
Report” sections  
according to the protocol 
template update. 
Update the related 
sections per protocol 
template. 
 
 
 

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2. Protocol Synopsis 
Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
Objective(s) 
To evaluate the safety and effectiveness of JETSTREAM™ Atherectomy 
System (Jetstream) for treating symptomatic Chinese patients  with occlusive 
atherosclerotic lesions in native superficial femoral artery (SFA) and/ or 
proximal popliteal arteries (PPA)during percutaneous peripheral vascular 
intervention 
Planned 
Indication(s) 
for Use  
The Jetstream System is intended for use in atherectomy of the peripheral 
vasculature and to break apart and remove atherosclerotic disease, debris, and 
thrombus from the SFA and/or PPA  
Test Device 
Boston Scientific JETSTREAM™ Atherectomy System (Jetstream system), 
including Atherectomy Console (Jetstream Console) and Atherectomy 
Catheter(Jetstream Catheter) 
Control Device 
N/A 
Device Sizes 
The Jetstream System is a catheter based atherectomy device comprised of 
either a fixed Jetstream SC Catheter or an expandable Jetstream XC Catheter, 
Control Pod and PV Console.    
1. Jetstream Console 
2. Jetstream Catheter 
Model 
Catheter 
Length（
cm） 
Tip 
Diameter（
mm） 
Minimum 
Matched 
Introducer 
Size（F） 
Maximal 
Matched 
Guidewire 
Diameter（
inch） 
Maximum 
Catheter 
Profile（mm
） 
Jetstream XC 
2.1/3.0 
135 
2.1/3.0 
7 
0.014 
2.5 
Jetstream XC 
2.4/3.4 
120 
2.4/3.4 
7 
0.014 
2.45 
Jetstream SC 
1.6 
145 
1.6 
7 
0.014 
2.33 
Jetstream SC 
1.85 
145 
1.85 
7 
0.014 
2.33 
Study Design 
This clinical study is a prospective, non-randomized, multicenter, single-arm 
study to demonstrate the acceptable safety and performance of the 
JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous 
peripheral vascular intervention in patients with occlusive atherosclerotic 
lesions in the native SFA and/or PPA.  It is intended that all patients with 

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Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
qualifying lesions would be considered for enrollment and treated with the 
Jetstream System. 
Planned 
Number of 
Subjects 
Approximately 80 subjects (including roll-in subjects) with symptomatic 
occlusive atherosclerotic lesions in the native SFA and/ or PPA will be 
enrolled. All eligible subjects will be treated with the Jetstream System. 
Planned 
Number of 
Centers / 
Countries 
Approximately 10 clinical sites located in China are expected to participate in 
this study. 
Primary 
Endpoint 
Primary Safety Endpoint: Major Adverse Event (MAE), defined as all-cause 
death, target limb unplanned major amputation and/or target lesion 
revascularization (TLR), within 30 days post index procedure 
 
Primary Effectiveness Endpoint: Acute reduction of percent diameter 
stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when 
compared to its baseline diameter stenosis (absolute mean percentage).  
Additional 
Endpoints 
• Procedural success, defined as  30% residual angiographic stenosis in 2 
near-orthogonal projections by visual assessment, after successfully 
debulking the target lesion and adjunctive interventions (such as 
percutaneous transluminal angioplasty/stenting) without any MAE within 
24 hours post index procedure 
• Primary vessel patency of the treated segment assessed by duplex 
ultrasound sonography (DUS) at 6 and 12 months post-procedure without 
TLR* 
• Clinical success rate (defined as improved Rutherford classification by at 
least +1 class compared to baseline) at 30 days, 6 and 12 months 
• Hemodynamic success rate (defined as positive change in Ankle-Brachial 
Index) at 30 days, 6 and 12 months 
• MAE rate 6 and 12 months post-index procedure  
• All-cause death at 30 days, 6 and 12 months 
• Clinically-driven TLR and TVR rate at 30 days, 6 and 12 months 
• Target limb major amputation at 30 days, 6 and 12 months 
• Rate of peri-procedural complications: 
➢ Perforation at treated segment 
➢ Abrupt closure at treated segment (including dissection and 
thrombosis) 

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Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
➢ Significant dissection (types C – F) at treated segment 
➢ Aneurysm at treated segment 
➢ Distal embolization 
 
 * Vessel 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.  
Method of 
Assigning 
Subjects to 
Treatment 
Once a subject 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 be considered to 
receive treatment with the Jetstream System.  Enrollment occurs at the time of 
advancement of the Jetstream catheter into the introducer sheath. 
Follow-up 
Schedule 
Follow-up time points include: pre-discharge, 30 days, 6 and 12 months. All 
visits will be conducted in a clinic setting. 
Subjects who are enrolled but the Jetstream System is not used will be 
followed through the 30-day follow-up visit only.  
Study Duration 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. 
Required 
Medication 
Therapy 
• If subjects have not already taken acetylsalicylic acid (ASA) (minimum 75 
mg per day) and Clopidogrel (75 mg/day) or ticlopidine (200 mg/day) for 
at least 24 hours prior to the procedure, they will receive loading doses of 
300 mg ASA and 300 mg Clopidogrel before the index procedure. 
• At the time of the procedure, subjects receive an intra-arterial bolus of 
heparin (usually 3000-5000 IU). 
• Subjects shall receive DAPT during a period of at least 6 months post the 
index procedure, if tolerated. 
• After6 months of DAPT post procedure, all subjects are suggested to be 
treated with ASA (minimum 75 mg/d) indefinitely. For subjects who are 
intolerant to aspirin, alternative antiplatelet medications according to 
investigator’s discretion, such as 300mg of clopidogrel. 
Note: The risk of bleeding may be increased in the subjects who need 
anticoagulation in addition to DAPT. If needed, oral warfarin and low-dose 
rivaroxaban (2.5mg twice per day) can be used, but no other new generation of 
oral anticoagulants, such as apixaban or dabigatran is allowed. subjects 

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Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
receiving anticoagulant therapy should not receive additional antiplatelet 
therapy if, in the opinion of the investigator, this could present an intolerable 
bleeding risk. 
Key Inclusion 
Criteria 
1. Subjects age 18 and older  
2. Subject or the subject’s legal representative is willing and able to provide 
consent before any study-specific test or procedure is performed, signs the 
consent form, and agrees to attend all required follow-up visits 
3. Subject has documented chronic, symptomatic lower limb ischemia defined 
as Rutherford categories 2 - 4,  and is eligible for percutaneous peripheral 
vascular intervention 
4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or 
PPA, and meet all of following angiographic criteria by visual assessment: 
a.  Atherosclerotic lesions with diameter stenosis  70%  
b. Guidewire must cross lesion(s) within the true lumen, without a 
sub-intimal course by physicians performed, based on visual 
estimate 
c. Minimum vessel diameter proximal to the lesion ≥ 3 mm and  6 
mm 
d. Lesion length of single or multiple focal stenosis or chronic total 
occlusion (CTO) lesion can be up to 15 cm long  
e. Target lesion located at least 3 cm above the inferior edge of the 
femur  
5. Patent infrapopliteal and popliteal artery, i.e., single distal runoff or better 
with at least one of three vessels patent (< 50% stenosis by visual 
assessment) to the ankle or foot with no planned intervention 
Key Exclusion 
Criteria 
1. Target lesion is located in the iliac artery or above the SFA 
2. Target lesion stenosis < 70% 
3. Target lesion is moderately to severely angulated (> 30°) or torturous at 
treatment segment 
4. Target lesion/vessel previously treated with drug-coated balloon within 12 
months prior to the index procedure 
5. Target lesion/vessel previously treated with atherectomy, laser or other 
debulking devices prior to the index procedure  

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Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
6. Target lesion/vessel with in-stent restenosis  
7. Subjects who have undergone prior surgery or endovascular intervention of 
SFA/PPA in the target limb to treat atherosclerotic disease within 3 months 
prior to the index procedure 
8. Use of laser or any other debulking devices other than Jetstream System 
(such as CTO devices or cutting balloon) in the target limb during the index 
procedure 
9. History of major amputation in the target limb 
10. Documented life expectancy less than 12 months due to other medical co-
morbid condition(s) 
11. Known hypersensitivity or contraindication to contrast dye that, in the 
opinion of the investigator, cannot be adequately pre-medicated 
12. Known history of coagulopathy or hypercoagulable bleeding disorder  
13. Known hypersensitivity/allergy to the investigational devices or protocol 
related therapies (e.g., nitinol, stainless steel or other stent materials, and 
antiplatelet, anticoagulant, thrombolytic medications) 
14. Platelet count < 80,000 mm3 or > 600,000/ mm3 or history of bleeding 
diathesis  
15. Undergoing hemodialysis or concomitant renal failure with a serum 
creatinine > 2.0 mg/dL (176.8umol/L) 
16. History of myocardial infarction (MI), stroke/cerebrovascular accident 
(CVA) or gastrointestinal bleeding within 6 months prior to the enrollment 
17. Unstable angina pectoris at the time of enrollment. 
18. History of severe trauma, fracture, major surgery or biopsy of a 
parenchymal organ within past 14 days 
19. Pregnant, breast feeding, or plan to become pregnant in the next 12 months 
20. Current participation in another investigational drug or device clinical 
study that has not completed the primary endpoint at the time of enrollment 
or that clinically interferes with the current study endpoints (Note: studies 
requiring extended follow-up for products that were investigational, but 
have become commercially available since then are not considered 
investigational studies) 

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Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
21. Septicemia at the time of enrollment 
22. Presence of outflow lesions in the target limb requiring intervention during 
the index procedure 
23. Presence of other hemodynamically significant lesions in the target limb 
requiring intervention within 30 days of enrollment 
24. Acute ischemia and/or acute thrombosis of the target lesion/vessel prior to 
the index procedure  
25. Presence of aneurysm in the target vessel  
26. Perforated vessel as evidenced by extravasation of contrast media prior to 
the enrollment 
Multiple 
Interventions 
During Index 
Procedure 
• 
Contralateral Limb 
Iliac lesion(s) in the contralateral limb may be treated using the same access 
site during the index procedure under the following conditions: 
➢ Treatment with a commercially available device occurs prior to the 
enrollment of the target SFA/PPA lesion, and 
➢ Treatment of the iliac lesion(s) is deemed an angiographic success 
without clinical sequelae (success is measured as < 30% residual 
stenosis by visual estimation) 
➢ If the above criteria are not met, the subject may not be enrolled to the 
study but may be rescreened for eligibility after 30 days.  
• 
Target Limb 
Additional non-target inflow lesions (including iliac lesion and/or common 
femoral lesion proximal to the femoral bifurcation) in the target limb may be 
treated during the index procedure under the following conditions: 
➢ Treatment with a commercially available device occurs prior to the 
enrollment of the target SFA/PPA lesion and 
➢ Treatment of the iliac lesion is deemed an angiographic success 
without clinical sequelae (success is measured as < 30% residual 
stenosis by visual estimation) 

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Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
➢ If the above criteria are not met, the subject may not be enrolled to the 
study but may be rescreened for eligibility after 30 days.  
Statistical Methods  
Primary Safety 
Hypothesis 
The primary safety hypothesis to be tested is that 30-day MAE-free rate in 
subjects treated with Jetstream System exceeds a PG of 88% at one-sided 
significance level of 2.5%. 
Primary Safety 
Statistical Test 
Method 
A normal approximation test will be used to assess the one-sided hypothesis of 
PG: 
H0: Pt  PG (not met) 
H1: Pt > PG (met) 
Where Pt is the 30-day MAE-free rate for the subjects treated with Jetstream 
System and the PG is 88%.*  
*The PG of 88% was estimated on the basis of available literature and is consistent with those describing 
atherectomy outcomes. **  
** Rocha-Singh et al. Performance Goals and Endpoint Assessments for Clinical Trials of 
Femoropopliteal Bare Nitinol Stents in Patients With Symptomatic Peripheral Arterial Disease. 
Catheterization and Cardiovascular Interventions 2007;69:910–919 
Primary 
Effectiveness 
Hypothesis 
The primary effectiveness hypothesis to be tested is that acute reduction of 
percent diameter stenosis (%DS) in subjects treated with Jetstream System 
exceeds 40%* within subject at one-sided significance level of 2.5%. 
*The expected mean acute reduction (i.e. %DSbefore Jetstream – %DSafter Jetstream) was 40%; the 
primary effectiveness hypothesis is to demonstrate there is a significant acute reduction (>0). See 
Statistical Analysis Plan for detail. 
Primary 
Effectiveness 
Statistical Test 
Method 
A paired t-test will be used to assess the one-sided hypothesis of reduction in 
%DS before and after subjects treated with Jetstream System. 
H0: ∆t  0 (not met) 
H1: ∆t > 0 (met) 
where ∆t is the averaged difference in acute reduction of %DS before and after 
the subjects treated with Jetstream System and the within-subject treatment 
effect is 40% with standard deviation of 18% derived by the Pathway PVD 
study, Jetstream Calcium study and JET Registry**. 

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Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
**The before-and-after atherectomy in the Pathway PVD shows 79.4%±17.7% and 35.0%±16.1% 
respectively. The before-and-after atherectomy in Jetstream Calcium study shows 86.9%±9.0% and 
37.0%±13.0%. The before-and-after atherectomy in JET Registry shows 91.1%±9.8% and 44.4%±20%, 
and the acute reduction of %DS is 46.7%±20.5%. 
Success 
Criteria for the 
PG Study 
Success Criteria for Primary Safety Endpoint 
Jetstream System will be concluded as meeting PG for device safety if the one-
sided lower 97.5% confidence bound on the observed 30-day MAE-free rate is 
greater than 88%. 
Success Criteria for Primary Effectiveness Endpoint 
Jetstream System will be concluded as meeting endpoint for device 
effectiveness if the one-sided lower 97.5% confidence bound on the difference 
between before and after atherectomy in %DS within subject is greater than 
zero. 
Success Criteria for the Study 
If the primary safety and the primary effectiveness endpoints are both met, the 
study will be considered a success and both device safety and effectiveness 
will be claimed. 
Sample Size 
Parameters 
The overall sample size is consist of the primary cohort and roll-in subjects. 
The sample size of primary cohort is driven by the primary safety endpoint. 
• Power ≥ 90% 
• One-sided overall significance level = 2.5% (alpha) 
• PG for 30-day MAE-free rate = 88% 
• Expected 30-day MAE-free rate = 99%  
• Attrition rate = 15% (loss to follow-up at 30 days) 
• A minimum of 50 subjects to be evaluable at 30 days that will provide 
at least 99% power for the primary safety endpoint 
• A sample size of 60 subjects to be enrolled in the primary cohort at 
baseline 
With additional 2 roll-in subjects per site, the overall subjects to be enrolled are 
approximately 80. 

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Prospective, non-randomized, multicenter clinical study of the JETSTREAM™ 
Atherectomy System (Jetstream) in treatment of occlusive atherosclerotic lesions in the 
superficial femoral and/ or proximal popliteal arteries in Chinese patients 
(JETSTREAM CHINA) 
Core Lab 
All angiographic and DUS readings will be assessed by independent core 
laboratories 
Study 
Committee 
A clinical event committee (CEC) will review and adjudication following pre-
specified CEC events: 
• 
Death 
• 
Target limb major amputation 
• 
Target vessel revascularization (TVR) and target lesion revascularization 
(TLR) 
• 
Distal embolization requiring additional treatment 
• 
Perforation during index procedure that requires additional treatment 
 
 

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3. Table of Contents 
1.    TITLE PAGE……………………………………………………………………………...1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................... 9 
3. 
TABLE OF CONTENTS ........................................................................................................ 18 
3.1. Table of Figures ...................................................................................................... 22 
3.2. Table of Tables ....................................................................................................... 22 
4. 
INTRODUCTION ................................................................................................................. 23 
4.1. Background of development .................................................................................. 23 
4.2. Clinical Study Summary........................................................................................ 23 
4.2.1. 
Pathway PVD clinical study ....................................................................... 23 
4.2.2. 
Jetstream Calcium Study ............................................................................ 26 
5. 
DEVICE DESCRIPTION ....................................................................................................... 28 
5.1. Jetstream Catheter ................................................................................................. 29 
5.2. Jetstream Console .................................................................................................. 30 
5.3. Intended Use ........................................................................................................... 30 
5.4. Device Labeling ...................................................................................................... 30 
6. 
STUDY OBJECTIVES AND ENDPOINTS ............................................................................... 30 
6.1. Study Objectives ..................................................................................................... 30 
6.2. Study Endpoints ..................................................................................................... 31 
6.2.1. 
Primary Endpoints ...................................................................................... 31 
6.2.2. 
Additional Endpoints.................................................................................. 31 
7. 
STUDY DESIGN .................................................................................................................. 32 
7.1. Scale and Duration ................................................................................................. 32 
7.2. Treatment Assignment........................................................................................... 34 
7.2.1. 
Treatment and Control ............................................................................... 34 
7.2.2. 
Target Lesion.............................................................................................. 34 
7.3. Multiple Interventions Using Same Access Site during Index Procedure ........ 34 
7.3.1. 
Contralateral Limb ..................................................................................... 34 
7.3.2. 
Target Limb ................................................................................................ 35 
7.4. Justification for the Study Design ......................................................................... 35 

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7.5. Treatment................................................................................................................ 35 
8. 
SUBJECT SELECTION ......................................................................................................... 36 
8.1. Study Population and Eligibility ........................................................................... 36 
8.2. Inclusion Criteria ................................................................................................... 36 
8.3. Exclusion Criteria .................................................................................................. 37 
9. 
SUBJECT ACCOUNTABILITY .............................................................................................. 39 
9.1. Point of Enrollment ................................................................................................ 39 
9.2. Withdrawal ............................................................................................................. 39 
9.3. Enrollment Controls .............................................................................................. 39 
9.4. Lost to Follow-up ................................................................................................... 39 
9.5. End-of-Study Definition ........................................................................................ 40 
10. STUDY METHODS .............................................................................................................. 40 
10.1. Data Collection ....................................................................................................... 40 
10.2. Study Candidate Screening ................................................................................... 43 
10.3. Informed Consent .................................................................................................. 43 
10.4. Screening (Up to 30 Days Prior to Index procedure).......................................... 43 
10.5. Required Concomitant Medications ..................................................................... 44 
10.5.1. Prior to the index procedure ....................................................................... 44 
10.5.2. In the Catheterization Laboratory .............................................................. 44 
10.5.3. Post-procedure ............................................................................................ 44 
10.6. Enrollment & Index Procedure ............................................................................ 45 
10.6.1. Treatment of target lesion .......................................................................... 45 
10.6.2. Multiple Interventions during index procedure .......................................... 46 
10.6.3. Post-procedure Angiogram ........................................................................ 46 
10.6.4. End of the Index Procedure ........................................................................ 47 
10.7. Post-Procedure / Pre-Discharge ............................................................................ 47 
10.8. 30-Day Follow-up (+/- 7 days) ............................................................................... 47 
10.9. 6-Month Follow-up (+/- 30 days) .......................................................................... 47 
10.10. 
12-Month Follow-up (+/- 30 days) ................................................................... 48 
10.11. 
Study Completion ............................................................................................. 48 
10.12. 
Source Documents ............................................................................................ 48 

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11. STATISTICAL CONSIDERATIONS ....................................................................................... 48 
11.1. Primary Endpoints ................................................................................................. 48 
11.1.1. Primary Safety Endpoint ............................................................................ 49 
11.1.2. Primary Effectiveness Endpoint ................................................................. 50 
11.2. Success Criteria ...................................................................................................... 50 
11.3. General Statistical Methods .................................................................................. 51 
11.3.1. Analysis Sets .............................................................................................. 51 
11.3.2. Control of Systematic Error/Bias ............................................................... 51 
11.3.3. Number of Subjects per Investigative Site ................................................. 51 
11.3.4. Baseline Data Analyses .............................................................................. 51 
11.3.5. Secondary Endpoint Assessments .............................................................. 52 
11.3.6. Interim Analyses ........................................................................................ 52 
11.3.7. Subgroup Analyses ..................................................................................... 52 
11.3.8. Sensitivity Analysis .................................................................................... 52 
11.3.9. Analysis Software ...................................................................................... 52 
11.3.10. Changes to Planned Analyses .................................................................... 53 
12. DATA MANAGEMENT ........................................................................................................ 53 
12.1. Data Collection, Processing, and Review ............................................................. 53 
12.2. Data Retention ........................................................................................................ 53 
12.3. Core Laboratories .................................................................................................. 54 
13. AMENDMENTS ................................................................................................................... 54 
14. DEVIATIONS ...................................................................................................................... 54 
15. DEVICE/EQUIPMENT ACCOUNTABILITY .......................................................................... 55 
16. COMPLIANCE ..................................................................................................................... 55 
16.1. Statement of Compliance ....................................................................................... 55 
16.2. Investigator Responsibilities ................................................................................. 55 
16.2.1. Delegation of Responsibility ...................................................................... 57 
16.3. Institutional Review Board/ Ethics Committee ................................................... 57 
16.4. Sponsor Responsibilities ........................................................................................ 58 
16.5. Insurance ................................................................................................................. 58 
17. MONITORING ..................................................................................................................... 58 

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18. POTENTIAL RISKS AND BENEFITS .................................................................................... 59 
18.1. Risks / Adverse Events Associated with the Study Device and Procedure ....... 59 
18.2. Risks associated with Participation in the Clinical Study .................................. 60 
18.3. Risk Minimization Actions .................................................................................... 60 
18.4. Anticipated Benefits ............................................................................................... 60 
18.5. Risk to Benefit Rationale ....................................................................................... 60 
19. SAFETY REPORTING .......................................................................................................... 60 
19.1. Reportable Events by investigational site to Boston Scientific .......................... 60 
19.2. Definitions and Classification ............................................................................... 61 
19.3. Relationship to Study Device(s) ............................................................................ 63 
19.4. Investigator Reporting Requirements .................................................................. 67 
19.5. Boston Scientific Device Deficiencies .................................................................... 68 
19.6. Reporting to Regulatory Authorities / IRBs / ECs / Investigators .................... 68 
20. INFORMED CONSENT......................................................................................................... 69 
21. COMMITTEES .................................................................................................................... 70 
21.1. Executive Committee ............................................................................................. 70 
21.2. Safety Monitoring Process ..................................................................................... 70 
21.3. Clinical Events Committee .................................................................................... 71 
22. SUSPENSION OR TERMINATION ........................................................................................ 71 
22.1. Premature Termination of the Study ................................................................... 71 
22.1.1 
Criteria for Premature Termination of the Study ....................................... 71 
22.2. Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC Approval .................................................................................................. 72 
22.3. Requirements for Documentation and Subject Follow-up ................................. 72 
22.4. Criteria for Suspending/Terminating a Study Site ............................................. 72 
23. STUDY REGISTRATION AND RESULTS .............................................................................. 73 
23.1. Study Registration .................................................................................................. 73 
23.2. Clinical Investigation Report ................................................................................ 73 
23.3. Publication Policy ................................................................................................... 73 
24. BIBLIOGRAPHY .................................................................................................................. 73 

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25. ABBREVIATIONS AND DEFINITIONS .................................................................................. 75 
25.1. Abbreviations ......................................................................................................... 75 
25.2. Definitions ............................................................................................................... 78 
 
3.1. Table of Figures 
Figure 5.1- 1: JETSTREAM™Atherectomy System ................................................... 28 
Figure 5.1- 2: Jetstream Catheter Tip ........................................................................... 29 
Figure 7.1: JETSTREAM CHINA Study Design ......................................................... 33 
 
 
3.2. Table of Tables 
Table 4.2-1: Major Adverse Events at 30 Days and 6 Months .................................... 24 
Table 4.2-2: Intravascular Ultrasound Findings – 26 Lesions .................................... 26 
Table 4.2-3: Intravascular Ultrasound Findings - 11 Lesions with Adjunctive 
Balloon ....................................................................................................... 27 
Table 5.1-1: Jetstream Catheter Specifications ............................................................ 29 
Table 8.2-1: Inclusion Criteria ....................................................................................... 37 
Table 8.3-1: Exclusion Criteria ........................................................ 错误!未定义书签。 
Table 10.1-1: Data Collection Schedule ......................................................................... 41 
Table 19.2-1: Safety Reporting Definitions ................................................................... 61 
Table 19.3-1: Criteria for Assessing Relationship of Study Device or Procedure 
to Adverse Event ...................................................................................... 64 
Table 19.3-2: Criteria for Assessing Relationship of Antiplatelet Medication to 
Adverse Event ........................................................................................... 66 
Table 19.4-1: Investigator Reporting Requirements .................................................... 67 
Table 25.1-1: Abbreviations ............................................................................................ 75 
Table 25.2-1: Definitions ................................................................................................. 78 
 

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4. Introduction 
4.1. Background of development 
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   For calcified lesions, treatment with PTA may not provide sufficient revascularization and 
stenting is often required.
9  However, inadequate stent expansion is more likely to occur in such 
calcified lesions and there is a concern that the risk of in-stent restenosis and thrombotic events may 
be increased. In order to improve the clinical outcomes, novel technologies of debulking of the 
extensive atheromatous burden has emerged with promising clinical outcomes of atherectomy of 
femoro-popliteal lesions. 9 - 12 
JETSTREAM™Atherectomy System (Jetstream) is one of these atherectomy systems, and was 
approved under 510(K) for the Pathway PV System, a first- generation model, in July 2008, and 
later in April 2013, for the current model. Jetstream Atherectomy System was also granted a CE 
mark in September 2013 and is currently marketed in the United States, Europe, Austria, and 
other regions. 
4.2. Clinical Study Summary 
4.2.1. 
Pathway PVD clinical study 
The Pathway PVD clinical study was a prospective, multicenter, single arm study conducted 
using the Pathway PV System, a first-generation model of Jetstream, in which a total of 172 
subjects were enrolled at 9 investigational sites in Germany, Austria, and Belgium.10 
The primary safety endpoint was the freedom from major adverse events (MAE) including 
clinically driven target lesion revascularization (TLR), any death, target vessel revascularization 
(TVR), myocardial infarction (MI), and index limb amputation at 30 days post procedure. The 
primary effectiveness endpoint was a reduction in mean percent stenosis, with and without 
adjunctive therapy. 

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The secondary endpoints included: (1) MAE at 6 months, (2) absence of death or amputation as a 
result of the Pathway PV System during the follow-up period, (3) clinical success defined as ≥ 1 
clinical category improvement of Rutherford scale (or equivalent) from baseline at 6 and 12 
months; (4) hemodynamic success defined as a > 0.1 improvement in the ABI during the period 
from baseline to 30 days post procedure and no deterioration > 0.15 from the maximum early post 
procedure level at 6 and 12 months.  Target lesions had reference vessel diameters ranging from 3 – 
5 mm (visual estimation), total lesion lengths (alone or series of lesions) up to 10 cm for the 
femoropopliteal arteries as well as up to 3 cm for the tibial or peroneal arteries (Rutherford 
categories 1–5 or equivalent).  
The 30-day freedom from MAE was 99% (170/172), with 2 amputations planned prior to the 
intervention being performed (Table 4.2-1). No procedure or device related amputations occurred.   
Table 4.2-1：Major Adverse Events at 30 Days and 6 Months 
 
30 Days (n=172) 
6 Months (n=162) 
 MAE 
2 (1.1%) 
31 (19%) 
 TVR 
0 (0%) 
4 (2.5%) 
 Death* 
  
Sudden Cardiac Arrest (probable) 
 
0 (0%) 
 
1 (0.6%) 
 Amputation 
2 (1.1%) 
2 (1.2%) 
 TLR 
0 (0%) 
25 (15%) 
 Non-Q wave MI 
0 (0%) 
1 (0.6%) 
 
At the 6-month follow-up, 31 subjects had at least 1 MAE.  The freedom from  serious adverse 
device effects (SADEs) and TLR at  6 months post-procedure, was 85% with a 95% lower 
confidence interval of 78%.13 
Success in crossing and debulking the target lesion was achieved in 99% (208/210) of the cases.  
Thirty-three percent of the cases were atherectomy procedures alone, while in 59% of the lesions, 
adjunctive low-pressure angioplasty was also employed.  Stenting was indicated in 7% of the 
subjects.  Mean diameter stenosis was reduced from 79.4% ± 17.7% at baseline to 35.0% ± 16.1% 
after atherectomy.  After adjunctive therapy, the diameter stenosis was further reduced to 21.4% ± 
10.5%.  Interventional success, defined as residual stenosis ≤ 30% by visual estimation, was 
achieved in 209/210 (99%) lesions. 
Clinical success was achieved in 68% (91/133) at 6 months and 70% (75/107) at 12 months, based 
on improvement in Rutherford classification.  Hemodynamic success was achieved in 52% 
(63/121) subjects at 6 months and in 52% (51/98) at 12 months.   
Primary and secondary duplex-documented patency rates at 12 months were 61.8% (76/123 
lesions) and 81.3% (100/123 lesions), respectively.  Clinically driven TLR rates were 15% 
(25/172) at 6 months and 26% (42/162) at 12 months, while TVR rates (including TLR) were 17% 
(29/172) and 30% (49/162), at 6 and 12 months respectively. 

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Additional evaluation of the Pathway PVD Trial dataset was completed by Sixt et al,13 the focus 
of which was to evaluate the changes in Quality of Life (QOL) following atherectomy.  The 
primary endpoint was evaluation of the QOL using the 5-point Walking Impairment Questionnaire 
(WIQ) scale.  The primary safety endpoint was freedom from MAE, including clinically driven 
TLR, any death, TVR, MI, and index limb amputation at 30 days post-procedure, previously 
reported by Zeller et al.10  Secondary endpoints were also previously reported.  The subject cohort 
improved from baseline by an average of 0.94 points in the WIQ at 30-days post procedure, 0.78 
points at the 6 month follow-up and 1.07 points at the 12 month follow-up.  When comparing 
subjects with and without restenosis, a significant improvement in the WIQ was observed at 6 
months, but not at the 12-month follow-up.  Twenty-five (25) procedure-related serious adverse 
events were reported in the 158 subjects at the 6 month follow-up.  These events included 18 
(11%) TLR, 1 (0.6%) TVR, 3 (1.9%) emboli, 1 (0.6%) dissection, 1 (0.6%) abrupt closure, and 1 
(0.6%) re-intervention in the target limb.  All were treated without permanent injury, amputation, 
or death.  An additional serious adverse event was noted at 4 days post-procedure where one 
participant experienced a cerebral infarct and was treated with drug therapy.  The overall 
conclusion is that the Jetstream Atherectomy device for infrainguinal treatment of atherostenotic 
lesions significantly improved the quality of life, as evaluated by the 5 point WIQ.  Additionally, 
the clinical data and analyses support the Jetstream device as safe and effective.    
Additional analysis of data from the Pathway PVD Trial was completed by Sixt et al,14 the goal of 
which was to determine whether the Jetstream Atherectomy system produced different outcomes in 
subjects with and without type 2 diabetes mellitus (DM).  For the 172 subjects enrolled in the 
Pathway PVD Trial, 80 subjects were in the DM group and 92 were in the non-DM group.  Lesion 
characteristics did not differ between the two groups, although the DM group had significantly 
higher body weight (p<0.001) and body mass index (p<0.001).  Procedure related adverse events 
were documented in 49% (39/80) of the DM group and 43% (40/92) of the non-DM group.  At the 
30 day follow-up, the MAE rate for the DM group was 2.5% (2/80) and 0% (0/92) in the non-DM 
group.  At the 6 and 12 month follow-ups, MAE rates were 13.8% (11/80) and 25% (20/80) in the 
DM group compared to 21.7% (20/92) and 31.5% (29/92) in the non-DM group, respectively.  The 
12 month TLR rate was 20% (16/80) in the DM group and 28% (26/92) in the non-DM group.  
During the study period 1 (1.3%) DM subject died, due to probable sudden cardiac arrest, at 
approximately 50 days post-procedure and 1 (1.1%) non-DM subject died due to non-Q wave MI, 
at 5 months post-procedure.  The latter death was noted previously as occurring after the 6-month 
dataset was analyzed.  Other assessments (ABI, Rutherford Class, Walking Impairment) did not 
differ between the DM and non-DM groups.  The overall conclusion was that the Jetstream 
Atherectomy system in complex infrainguinal arteries provides comparable and acceptable 
outcomes in DM and non-DM patients. 
In summary, conclusions from the Pathway PVD Trial support that the Jetstream Atherectomy 
System is safe and effective for treating obstructive lesions with a maximum lesion length of 10 cm 
in infrainguinal arteries with a reference vessel diameter of 3 mm to 5 mm. 

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4.2.2. 
Jetstream Calcium Study 
The Jetstream Calcium Study was a prospective, single-arm, multicenter study to evaluate the 
Jetstream Atherectomy System for severely calcified femoral-popliteal artery lesions, i.e., subjects 
with claudication and lesions with superficial calcium > 90° and > 5 mm in length as determined by 
intravascular ultrasound (IVUS). The 2.1 mm catheter was used in this study without distal 
protection. This study enrolled 26 subjects with eligible lesions in the SFA, popliteal artery, and 
tibial artery.15  
The primary effectiveness endpoint was calcium removal and luminal gain measured by comparing 
pre-intervention to post-atherectomy intravascular ultrasound (IVUS) images. Secondary endpoints 
included  (1) Major adverse events (MAE), defined as death, myocardial infarction, amputation, 
and target lesion or vessel revascularization up to 30 days; (2) adjunctive therapy use; and (3) 
residual diameter stenosis.  
The visually assessed angiographic diameter stenosis improved from 89±9% pre-treatment to 
37±13% post atherectomy and finally to 10±6% post adjunctive treatment. After matching pre- and 
post atherectomy IVUS segments, the treated segment median length measured 36 mm.  The 
segment of superficial calcium with calcium reduction measured 13mm in median length, or 37% 
of the entire treated segment. The IVUS findings from pre to post atherectomy at the lesion level 
showed that the minimum lumen area increased from 5.1±2.8mm2 to 8.3±2.6 mm2 (p<0.0001) and 
area stenosis decreased from 64±17% to 41±18% (p<0.0001). By comparing pre- and post- 
atherectomy IVUS images, the slice with maximum calcium reduction was identified; the lumen 
area in these slices increased from 6.6±3.7mm2 to 10.0±3.6mm2 (p=0.0001). The decrease in 
calcium area, measured as 2.8±1.6mm2, was responsible for 86±23% of the lumen area increase 
(Table 4.2-2).  
Table 4.2-2: Intravascular Ultrasound Findings – 26 Lesions 
 
Pre-treatment 
Post-atherectomy 
p-value 
Proximal reference lumen area (mm2) 
14.6±5.1 
14.5±5.2 
0.91 
Distal reference lumen area (mm2) 
14.8±6.2 
14.7±5.9 
0.97 
Minimum lumen 
area site 
Lumen area(mm2) 
5.1±2.8 
8.3±2.6 
<0.0001 
Minimum lumen diameter(mm) 
2.0±0.4 
2.8±0.4 
<0.0001 
Lumen symmetry index 
0.70±0.13 
0.76±0.14 
0.11 
Area stenosis (%) 
64±17 
41±18 
<0.0001 
Maximum 
calcium ablation 
site 
Lumen area(mm2) 
6.6±3.7 
10.0±3.6 
0.001 
Minimum lumen diameter(mm) 
2.3±0.5 
3.0±0.5 
<0.0001 
Lumen symmetry index 
0.70±0.14 
0.70±0.14 
0.26 
Area stenosis (%) 
53±23 
29±22 
0.0005 
Maximum superficial calcium (˚) 
151±70 
146±71 
0.83 
Decrease of calcium area(mm2) 
NA 
2.8±1.6 
NA 
Calcium reduction (%) 
NA 
86±22 
NA 

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Surface Shape of 
calcium 
Convex 
58% (15) 
27% (7) 
0.02 
Concave 
42% (11) 
73% (19) 
Irregularity of 
superficial 
calcium 
Irregular 
54% (14) 
39% (10) 
0.27 
Smooth 
46% (12) 
61% (16) 
Reverberation 
31% (8) 
39% (10) 
0.58 
Maximum arc of Reverberation (˚) 
23±20 
65±40 
0.006 
Values are mean ± standard deviation or (n). 
 
The Jetstream system removed and modified moderate to severe superficial calcium to achieve 
significant lumen gain, and as shown in Table 4.2-3 adjunctive balloon angioplasty after calcium 
modification showed further lumen increase without major complications. No major adverse events 
occurred up to 30 days post procedure. 
 
Table 4.2-3: Intravascular Ultrasound Findings - 11 Lesions with Adjunctive Balloon 
 
(1) Pre-
treatmen
t 
(2) Post- 
atherectom
y 
(3) Post-
balloo
n 
p-value 
1 vs
. 2 
2 vs
. 3 
Proximal reference lumen area 
(mm2) 
15.1 
14.6 
17.7 
0.15 
0.013 
Distal reference lumen area 
(mm2) 
16.1 
16.4 
18.5 
0.55 
0.083 
Minimum 
lumen 
area site 
Lumen area(mm2) 
4.4 
7.1 
11.9 
<0.001 
<0.001 
Minimum lumen 
diameter(mm) 
2.0 
2.7 
3.4 
<0.001 
<0.001 
Lumen symmetry 
index 
0.74 
0.81 
0.76 
0.13 
0.33 
Area stenosis (%) 
70.9 
51.8 
34.2 
<0.001 
<0.001 
Maximum 
calcium 
ablation 
site 
Lumen area(mm2) 
6.3 
9.3 
13.3 
<0.001 
<0.001 
Minimum lumen 
diameter(mm) 
2.3 
3.0 
3.6 
<0.001 
<0.001 
Lumen symmetry 
index 
0.74 
0.79 
0.76 
0.029 
0.37 
Area stenosis (%) 
59.2 
38.1 
27.8 
<0.001 
0.042 
Maximum 
superficial calcium 
(˚) 
164 
164 
162 
0.99 
0.88 
Decrease of calcium 
area(mm2) 
NA 
2.4 
NA 
NA 
NA 
Calcium reduction 
(%) 
NA 
94 
NA 
NA 
NA 

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Surface 
Shape of 
calcium 
Convex 
55% 
9% 
9% 
0.018 
0.99 
Concave 
46% 
91% 
91% 
Irregulari
ty of 
superficial 
calcium 
Irregular 
55% 
27% 
9% 
0.25 
0.33 
Smooth 
45% 
73% 
9% 
Reverberation 
27% 
73% 
36% 
0.99 
0.99 
Maximum arc of Reverberation 
26˚ 
102˚ 
36˚ 
<0.001 
<0.001 
Dissection  
0% 
27% 
73% 
0.01 
 
 
The study found that the Jetstream Atherectomy System removed and modified superficial calcium 
to achieve significant lumen gain. Adjunctive balloon angioplasty after calcium modification 
showed further lumen increase without major complications. 
5. Device Description 
The test device is intended to be used as adjunctive therapy for percutaneous intervention to 
remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA. 
The JETSTREAM™ Atherectomy System is a rotational atherectomy catheter system designed 
for use in debulking and treating vascular disease in the peripheral vasculature. The catheter 
includes multiple distal ports located at the catheter tip, which are designed to provide 
independent infusion and aspiration functions for the active removal of fluid, excised tissue and 
thrombus from the peripheral treatment site. The Jetstream System consists of two primary 
components that are packaged separately; Atherectomy Catheter (Jetstream Catheter) set and 
Atherectomy Console (Jetstream Console) (Figure5.1-1). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jetstream Catheter Set 
Jetstream Console 
Figure 5.1- 1: JETSTREAM™Atherectomy System 
 

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5.1. Jetstream Catheter 
Jetstream Catheter set is a sterile, single use unit consisting of an electrically driven Catheter and 
Control Pod with detachable Activation Handle. The Catheter utilizes a differentially cutting tip 
and includes both aspiration and infusion capabilities. The Activation Handle provides a user 
interface with keypad controls for device operation. The unit, its electrical connectors, tubing, and 
aspirant collection bag are packaged in a single pouched tray with retention lid, and sterilized with 
ethylene oxide (EO). Note that the tray retention lid is not a sterile barrier. 
The catheter has four types of model based on existence of expandable blade and size of catheter tip 
as shown in Table 5.1-1 and Figure 5.1-2. The Jetstream single cutter (SC) catheters are available in 
1.6mm and 1.85mm sizes and the Jetstream expandable cutter (XC) catheters are available in 
2.1mm (Blade Down)/3.0mm (Blade Up) and 2.4mm (Blade Down)/3.4mm (Blade Up). XC model 
has a mechanism that expandable blade is fold when blade down and expandable blade rises up (i.e. 
Blade Up) when MAX button in the control pod is turned on. 
Table 5.1-1: Jetstream Catheter Specifications 
 
Model 
Catheter 
Length（cm） 
Tip Diameter（
mm） 
Minimum 
Matched 
Introducer Size（
F） 
Maximal Matched 
Guidewire 
Diameter（inch） 
Maximum 
Catheter Profile（
mm） 
Jetstream XC 
2.1/3.0 
135 
2.1/3.0 
7 
0.014 
2.5 
Jetstream XC 
2.4/3.4 
120 
2.4/3.4 
7 
0.014 
2.45 
Jetstream SC 1.6 
145 
1.6 
7 
0.014 
2.33 
Jetstream SC 1.85 
145 
1.85 
7 
0.014 
2.33 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 5.1- 2: Jetstream Catheter Tip 
 
 
Expandable blade 
Saline Inlet 
Cutting Blade 
Aspiration port 
Tip Diameter 
 
Tip Diameter 

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5.2. Jetstream Console 
A reusable PV Console consists of two (2) peristaltic pumps for aspiration and infusion, power 
supply, system controller, keypad interface, and LED indicators for device operational status. 
The PV Console mounts on a standard IV stand and remains outside the sterile field during the 
procedure (Figure 5.1-1). 
5.3. Intended Use 
The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break 
apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA. 
5.4. Device Labeling 
The copies of the Directions for Use (DFU) for the Jetstream System are included in the 
JETSTREAM CHINA Manual of Operations, including the DFU for the Jetstream console and 
DFUs for the Jetstream catheters and control pod. The labeling will include at least the following 
information: 
• Product Name 
• Universal Part Number (UPN) 
• Lot number 
• Project Name, Storage & Shipment condition 
• Expiration (use by) date 
 
The following statements appear on the JETSTREAM 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 and Endpoints 
6.1. Study Objectives 
The primary objective of this study is to evaluate the safety and effectiveness of JETSTREAM™ 
Atherectomy System (Jetstream) for treating symptomatic Chinese patients with occlusive 
atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries 
(PPA) during percutaneous peripheral vascular intervention. 

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6.2. Study Endpoints 
6.2.1. Primary Endpoints 
6.2.1.1. 
The primary safety endpoint:  
The primary safety endpoint is the rate of major adverse event (MAE), defined as all-cause death, 
target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 
days post index procedure. 
6.2.1.2. 
 The primary effectiveness endpoint: 
The primary effectiveness endpoint is the acute reduction of percent diameter stenosis (%DS) post 
atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis 
(absolute mean percentage). 
6.2.2. Additional Endpoints 
• Procedural success, defined as  30% residual angiographic stenosis in 2 near-orthogonal 
projections by visual assessment, after successfully debulking the target lesion and adjunctive 
interventions (such as percutaneous transluminal angioplasty/stenting) without any MAE within 
24 hours post index procedure 
• Primary vessel patency of the treated segment assessed by duplex ultrasound sonography 
(DUS) at 6 and 12 months post-procedure without TLR* 
• Clinical success rate (defined as improved Rutherford classification by at least +1 class 
compared to baseline) at 30 days, 6 and 12 months 
• Hemodynamic success rate (defined as positive change in Ankle-Brachial Index) at 30 days, 6 
and 12 months 
• MAE rate 6 and 12 months post-index procedure  
• All-cause death at 30 days, 6 and 12 months 
• Clinically-driven TLR and TVR rate at 30 days, 6 and 12 months 
• Target limb major amputation at 30 days, 6 and 12 months 
• Rate of peri-procedural complications: 
➢ Perforation at treated segment 
➢ Abrupt closure at treated segment (including dissection and thrombosis) 
➢ Significant dissection (types C – F) at treated segment 
➢ Aneurysm at treated segment 
➢ Distal embolization 
 
Notes 
*Vessel 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.16, 17 

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7. Study Design 
The JETSTREAM CHINA is a prospective, non-randomized, multicenter, single-arm study to 
demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System 
(Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive 
atherosclerotic lesions in the native SFA and/or PPA.  It is intended that all patients with qualifying 
lesions would be considered for enrollment and treated with the Jetstream System. 
7.1. Scale and Duration 
The JETSTREAM CHINA trial will be conducted in approximately 10 sites in Mainland China 
with planned enrollment of approximately 80 subjects, including 20 roll-in subjects with 2 roll-in 
subjects per site. 
The study is planned to have approximately 4 years 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, 30 days, 6 and 12 months post-index procedure. 
 
Subjects who are enrolled but the Jetstream System is not used will be followed through the 30-day 
follow-up visit only. 
 
A schematic of the JETSTREAM CHINA trial design is shown below in Figure 7.1-1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Required Regulatory Documents Obtained 
 
 
 
Site Initiation and Training / Investigational 
Devices Delivered 
 
 
Informed Consent Obtained 
Will subject sign informed 
NO 
consent? 
 
 
 
Inclusion / Exclusion Criteria Confirmed 
 
 
Does subject meet eligibility 
criteria? 
 
Do Not Enroll 
 
NO 
 
 
Guidewire Successfully across target lesion 
NO 
Do Not Enroll 
 
 
 
Atherectomy Performed? 
 
 
PTA performed and/or Stenting 
 
 
 
Pre-discharge Assessments 
 
 
 
Follow-up 
Evaluations30 days, 6 Month, 
12 Month in-office visit                                              
 
 
 
 
 
 
 
 
 
NO 
Pre-discharge Assessments 
Follow-up Evaluation at 
30 days in-office 
visit 
End of Study 
Figure 7.1: JETSTREAM CHINA Study Design 

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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. 
7.2. 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 Jetstream System.  
Enrollment occurs at the time of advancement of the Jetstream catheter into the introducer 
sheath.   
7.2.1. 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 Jetstream System. 
7.2.2. Target Lesion 
A target lesion is a lesion selected by the Investigator for treatment with the investigational 
Jetstream System and a study Jetstream catheter.  Target lesions must meet all the 
angiographic selection criteria.  A diffuse lesion or multiple lesions (including CTO 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 ≤ 150 mm. 
Only one target lesion is allowed in each enrolled subject; and it is decided by physician’s 
discretion in the case that eligible lesions exist in both limbs.   
7.3. Multiple Interventions Using Same Access Site during Index Procedure 
7.3.1. Contralateral Limb 
Iliac Lesion 
 
Using the same access site, iliac lesion(s) in the contralateral limb may be treated 
during the index procedure under the following conditions: 
• 
Treatment with a commercially available device occurs prior to enrollment of the 
target SFA/PPA lesion, and 
 
• 
Treatment of the iliac lesion(s) is deemed an angiographic success without 
clinical sequelae (success is defined as < 30% residual stenosis by visual 
estimation). 
 
If the above criteria are not met, the subject may not be enrolled to the study but 
may be rescreened for eligibility after 30 days. 

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7.3.2. Target Limb 
Inflow Lesion 
 
Using the same access site, additional non-target inflow lesions (including iliac lesion 
and/or common femoral lesion proximal to the femoral bifurcation) in the target limb 
may be treated during the index procedure under the following conditions: 
 
• 
Treatment with a commercially available device occurs prior to enrollment 
of the target SFA/PPA lesion, and 
 
• 
Treatment of the inflow lesion(s) is deemed an angiographic success without clinical 
sequelae (success is measured as < 30% residual stenosis by visual estimation). 
 
• 
If the above criteria are not met, the subject may not be enrolled to the study but 
may be rescreened for eligibility after 30 days. 
7.4. Justification for the Study Design 
Pathway PV system, which is the first generation model of JETSTREAM™ Atherectomy 
System (Jetstream), received 510(K) approval in July 2008, and then, the current generation 
model (Jetstream) in April, 2013. Also, it received CE-Mark certification in September 2013.  
JETSTREAM™ Atherectomy System is now commercially available in the U.S., EU, 
Australia or other foreign areas and its’ effectiveness and safety have been confirmed. 
 
The Jetstream China trial is designed to evaluate the safety and effectiveness of 
JETSTREAM™ Atherectomy System (Jetstream) for treating symptomatic Chinese patients 
with occlusive atherosclerotic lesions in native SFA and/ or PPA, in whom sufficient 
revascularization cannot be expected from the PTA alone during endovascular treatment in 
the opinion of operating physician. The Jetstream China trial is a single arm clinical trial 
compared to the safety performance goal (PG). The PG was set based on published data of 
PTA/stenting outcomes in the recent clinical trial.18 
 
This trial requires at least one roll-in subject per site. 
 
During the trial, dual antiplatelet therapy (DAPT) will be administered for 6 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 Jetstream system treatment will be followed for 12 
month post index procedure.  
7.5. Treatment 
All enrolled subjects will receive treatment with the investigational Jetstream System.  Pre-
dilation of target lesion is prohibited prior to the treatment of Jetstream System.  After target 
lesion is adequately treated by the Jetstream System, PTA and/or stenting with 
commercially-available device(s) are allowed for optimizing treatment. 
 

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The investigator selects the size of Jetstream Catheter according to the proximal and distal 
reference vessel diameters  
Handling Instructions of Study Devices 
It is important for investigators to follow the corresponding DFU for Jetstream system 
treatment and for the study device product matrix. 
8. Subject Selection  
8.1. Study Population and Eligibility  
Approximately 80 patients with symptomatic PAD of the femoropopliteal artery (Rutherford 
clinical category of 2 to 4) receiving percutaneous transluminal balloon angioplasty will be 
screened for enrollment of this study. Clinical and angiographic inclusion and exclusion 
criteria for the JETSTREAM China trial are included in Section 8.2 and Section 8.3 
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. 
8.2. Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 8.2-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 8.3) is 
met.  

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Table 8.2-1: Inclusion Criteria 
Inclusion 
Criteria 
1. Subjects age 18 and older  
2. Subject or the subject’s legal representative is willing and able to provide 
consent before any study-specific test or procedure is performed, signs the 
consent form, and agrees to attend all required follow-up visits 
3. Subject has documented chronic, symptomatic lower limb ischemia defined 
as Rutherford categories 2 - 4,  and is eligible for percutaneous peripheral 
vascular intervention 
4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or 
PPA, and meet all of following angiographic criteria by visual assessment: 
i. 
Atherosclerotic lesion with diameter stenosis  70%  
ii. 
Guidewire must cross lesion(s) within the true lumen, without a 
sub-intimal course by physicians performed, based on visual 
estimate 
iii. 
Minimum vessel diameter proximal to the lesion ≥ 3 mm and  6 
mm 
iv. 
Lesion length of single or multiple focal stenosis or chronic total 
occlusion (CTO) lesion can be up to 15 cm long  
v. 
Target lesion located at least 3 cm above the inferior edge of the 
femur  
5. Patent infrapopliteal and popliteal artery, i.e., single distal runoff or better 
with at least one of three vessels patent (< 50% stenosis by visual 
assessment) to the ankle or foot with no planned intervention 
 
8.3. Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 8.3-1) will be excluded from this 
clinical study. 
Table 8.3-1: Exclusion Criteria 
Exclusion 
Criteria 
1. Target lesion is located in the iliac artery or above the SFA 
2. Target lesion stenosis < 70% 
3. Target lesion is moderately to severely angulated (> 30°) or torturous at 
treatment segment 
4. Target lesion/vessel previously treated with drug-coated balloon within 12 
months prior to the index procedure 
5. Target lesion/vessel previously treated with atherectomy, laser or other 
debulking devices prior to the index procedure  

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6. Target lesion/vessel with in-stent restenosis  
7. Subjects who have undergone prior surgery or endovascular intervention of 
SFA/PPA in the target limb to treat atherosclerotic disease within 3 months 
prior to the index procedure 
8. Use of laser or any other debulking devices other than Jetstream System 
(such as CTO devices or cutting balloon) in the target limb during the index 
procedure 
9. History of major amputation in the target limb 
10. Documented life expectancy less than 12 months due to other medical co-
morbid condition(s) 
11. Known hypersensitivity or contraindication to contrast dye that, in the 
opinion of the investigator, cannot be adequately pre-medicated 
12. Known history of coagulopathy or hypercoagulable bleeding disorder  
13. Known hypersensitivity/allergy to the investigational devices or protocol 
related therapies (e.g., nitinol, stainless steel or other stent materials, and 
antiplatelet, anticoagulant, thrombolytic medications) 
14. Platelet count < 80,000 mm3 or > 600,000 mm3 or history of bleeding 
diathesis 
15. Undergoing hemodialysis or concomitant renal failure with a serum 
creatinine > 2.0 mg/dL (176.8umol/L)  
16. History of myocardial infarction (MI), stroke/cerebrovascular accident 
(CVA) or gastrointestinal bleeding within 6 months prior to the enrollment 
17. Unstable angina pectoris at the time of enrollment. 
18. History of severe trauma, fracture, major surgery or biopsy of a 
parenchymal organ within past 14 days 
19. Pregnant, breast feeding, or plan to become pregnant in the next 12 months 
20. Current participation in another investigational drug or device clinical study 
that has not completed the primary endpoint at the time of enrollment or 
that clinically interferes with the current study endpoints (Note: studies 
requiring extended follow-up for products that were investigational, but 
have become commercially available since then are not considered 
investigational studies) 
21. Septicemia at the time of enrollment 
22. Presence of outflow lesions in the target limb requiring intervention during 
the index procedure 
23. Presence of other hemodynamically significant lesions in the target limb 
requiring intervention within 30 days of enrollment 

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24. Acute ischemia and/or acute thrombosis of the target lesion/vessel prior to 
the index procedure  
25. Presence of aneurysm in the target vessel  
26. Perforated vessel as evidenced by extravasation of contrast media prior to 
the enrollment 
9. Subject Accountability 
9.1. 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. 
Enrollment occurs at the time of advancement of the Jetstream catheter into the introducer 
sheath. 
9.2. 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.   
9.3. Enrollment Controls 
A minimum of 60 enrolled subjects are needed to adequately assess the primary endpoint at 
30 days, assuming a maximum attrition of 15% for all reasons at 30 days.  With additional 2 
roll-in subjects per site, the overall subjects to be enrolled in the study are approximately 80 
subjects. The enrollment cap for each study site is 35% of total enrolled subjects. 
9.4. Lost to Follow-up 
A subject will be considered lost to follow-up if he or she fails to return for four scheduled 
visits and is unable to be contacted by the study site staff. 
The following action must be taken if a participant fails to return to the clinic for a required 
study visit: 

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• 
The site will attempt to contact the subject and reschedule the missed visit and 
counsel the subject on the importance of maintaining the assigned visit schedule and 
ascertain if the participant wishes to and/or should continue in the study. 
• 
Before a subject is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the subject (where possible, 3 telephone calls and, 
if necessary, a certified letter to the subject’s last known mailing address). These 
contact attempts should be documented in the participant’s medical record or study 
site. 
• 
Should the subject continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
9.5. End-of-Study Definition 
A subject is considered to have completed the study if he or she has completed all phase of 
the study including the last visit or the last scheduled procedure shown in the Data Collection 
Schedule. 
The end of the study is defined as completion of the last visit or procedure shown in the Data 
Collection Schedule in the trial globally. 
10. Study Methods 
10.1. Data Collection 
The data collection schedule is shown in Table 10.1-1.  Please note that the time window for 
30-day follow-up is +/- 7 days, for 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 10.1-1: Data Collection Schedule 
Procedure/Assessment 
Screening 
(≤ 30 days prior to 
index procedure) 
Enrollment 
Index 
Procedure 
Post-
procedure/ 
Pre-hospital 
Discharge 
Follow-up Visitg 
30-day  
(± 7 Days) 
6-month  
(± 30 Days) 
12-month 
(± 30 Days) 
In-person Visit 
X 
X 
X 
X 
X 
X 
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 
Xd 
Xd 
Xd 
Xd 
Xd 
Xd 
Routine Laboratory (including serum 
creatinine, CBC with platelet count tests, and 
pregnancy test within 7 days of index 
procedure for potential child-bearing 
women)a 
X 
 
 
 
 
 
 
DUSb 
O 
 
 
O 
 
X 
X 
ABI 
X 
 
 
 
X 
X 
X 
Rutherford Categories Assessment 
Xc 
 
 
 
X 
X 
X 
Angiographic assessmentb 
 
Xe 
Xf 
 
 
 
 
Procedural assessment (including 
PTA/stenting) 
 
 
Xf 
 
 
 
 
Adverse Events and Device Deficiency 
Assessment 
 
 
X 
X 
X 
X 
X 
X = required; O = optional but recommended 
DUS = Duplex Ultrasound; ABI = Ankle Brachial Index; PTA = Percutaneous Transluminal Angioplasty 
a:  Excluded from the study if serum creatinine > 2.0mg/dL (176.8umol/L), or platelet count < 80.000/mm3, or > 600,000 mm3 , or positive pregnancy test 
(pregnancy test is required within 7 days prior to index procedure for potential child-bearing women) 
b:  Angiographic and DUS recordings will be sent to the respective core labs for analysis. Follow-up angiograms and DUS will not be required for those subjects who 
underwent by-pass surgery of the target lesion during the 12-month follow-up time frame.  
c:  Inclusion criterion: Rutherford category 2 - 4 
d:  Antiplatelet medication assessments 

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e: Adhere to Angiographic Inclusion criteria.   
f:  Procedural (including complications), target lesion, atherectomy, PTA and/or stenting information are collected; angiographic data will be used to localize the 
target lesion 
g:  Follow-up dates will be calculated from the date of the index procedure. All follow-ups will be in-person clinic visits.  The time window for 30-day follow-up 
is +/- 7 days; for 6 or 12-month follow-up is +/- 30 days. 
 
 
 
 
 
 
 

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10.2. 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). 
10.3. 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 9.1 for definition of point of enrollment. 
10.4. Screening (Up to 30 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 30 days prior to the index procedure (unless 
otherwise specified), for all subjects: 
• 
Confirmation of clinical eligibility criteria (inclusion and exclusion criteria) 
• 
Demographics including age, gender, and races others than Han (unless restricted by local laws) 
• 
Physical assessment, including weight and height 
➢ Ankle brachial Index (ABI) 
➢ Rutherford category assessment 
• 
Medical history (including concomitant diseases, concomitant medication and medical 
treatments)  
• 
Routine laboratory tests  
➢ Serum creatinine 
➢ Complete blood count (CBC) with platelets 
➢ Pregnancy test for females of child-bearing potential with analysis per local practice (serum 
and/or urine) is required within 7 days prior to the index procedure 
• 
Current antiplatelet medication usage  
• 
Duplex ultrasound (DUS) – optional (at the discretion of the investigator) 
 

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10.5. 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 practice. 
 
Antiplatelet medications such as P2Y12 inhibitor (Clopidogrel) and acetylsalicylic acid (ASA) are 
administered before the procedure, to minimize thrombotic complications and development of 
restenosis. Clopidogrel is recommended, unless it is not tolerated by the subject, then other 
antiplatelet medications or low-dose rivaroxaban (2.5mg twice per day) can be used. 
 
For subjects who are intolerant to aspirin, alternative antiplatelet medications according to 
investigator’s discretion, such as 300mg of clopidogrel. 
10.5.1. 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  24 hours at the time of index procedure 
should receive appropriate loading doses before the index procedure. Recommended loading 
doses are 300 mg of ASA and 300 mg of clopidogrel. 
10.5.2. In the Catheterization Laboratory 
• 
At the time of the procedure, subjects should receive an intra-arterial bolus of heparin (usually 
3000-5000 IU), or alternate anticoagulants as substitutes for heparin if justified by individual 
subject conditions. 
10.5.3. Post-procedure 
• 
Subjects shall receive DAPT during a period of at least 6 months post the index procedure, if 
tolerated.  The typical recommended DAPT regimen consists of ASA (minimum 75mg/d) and a 
P2Y12 inhibitor, e.g. clopidogrel (minimum 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 subjects 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 subjects with peripheral arterial disease. 
• 
After6 months of DAPT post procedure, all subjects are suggested to be treated with ASA 
(minimum 75 mg/d) indefinitely. For subjects who are intolerant to aspirin, alternative 
antiplatelet medications according to investigator’s discretion, such as 300mg of clopidogrel. 
 
Note: The risk of bleeding may be increased in the subjects who need anticoagulation in 
addition to DAPT. If needed, oral warfarin and low-dose rivaroxaban (2.5mg twice per day) can 

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be used, but no other new generation of oral anticoagulants, such as apixaban or dabigatran is 
allowed. subjects receiving anticoagulant therapy should not receive additional antiplatelet 
therapy if, in the opinion of the investigator, this could present an intolerable bleeding risk. 
10.6. Enrollment & Index Procedure 
Investigators will manage the cardiovascular risk factors and comorbidities for all subjects 
according to standard care.  Investigators should ensure close monitoring of the amount of 
contrast for subjects with elevated serum creatinine levels and consider preventive measures 
(medication and hydration) to reduce the risk of contrast-induced nephropathy (CIN). 
 
Diagnostic angiography of the lower extremities must be performed using standard techniques to 
confirm angiographic eligibility of the target lesion. Visual angiographic assessment may be used 
to determine if criteria are met. 
 
Angiographic images must be sent to the Angiographic Core Laboratory for evaluation. 
10.6.1. Treatment of target lesion 
Procedural information must be reported (specific data fields are noted in the electronic database). 
Refer to the DFU for detailed instructions about preparation and treatment of Jetstream system.  
The start of the index procedure is defined as the time of guide catheter insertion.    
During the procedure, the following procedures and assessments must be completed:  
• Perform angiography according to the Angiographic Core Laboratory procedure guidelines.  
• Confirm angiographic eligibility criteria of the target lesion(s). 
• Cross target lesion using guidewire, after target lesion is crossed by the guidewire within the true 
lumen, without a sub-intimal course based on visual assessment by operating physician, the 
subject will be considered eligible for enrollment. 
• The use of body surface ultrasound will be strongly recommended for lesions such as CTO, 
when the guidewire is difficult to cross the lesion within the true lumen.  
• 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. 
• To evaluate the performance of Jetstream System exactly, pre-dilation of the target lesion prior 
to the treatment with Jetstream system is prohibited. 
• Select an appropriately sized investigational Jetstream Catheter to adequately treat the target 
lesion and record the following information: 
o 
Baseline percent diameter stenosis (%DS) at the target lesion 
o 
Post atherectomy residual %DS at the target lesion 
o 
Information of Jetstream Catheter(s) used 
 

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• After the treatment with Jetstream System, PTA of the target lesions is required to be 
performed with optimally sized balloon(s) (nominal size of artery). Record the following 
information on PTA used: 
 
O Maximum balloon diameter (mm) inflated 
O Maximum pressure (atmospheres) inflated 
O Maximum length of time (seconds) inflated 
 
Procedural recommendations: 
 
• 
Optimal target lesion/vessel treatment is recommended. 
• 
Bailout stenting with a commercially-available stent or by-pass surgery may be performed at 
the discretion of operating physician, if the attempts with PTA have resulted any of the 
following: 
 
o 
Final residual stenosis at the target lesion being > 30% by visual assessment 
o 
Occurrence of Grade C or greater dissection (NHLBI) 
o 
Occurrence of clinically apparent perforation requiring treatments 
o 
Occurrence of any obstructive complication (e.g., recoil) demonstrating a marked decrease 
in the flow in the target vessel 
• 
Angiographic complications, such as distal embolism or no reflow, should also be treated per 
standard practice.  All angiographic complications during procedure should be documented by 
angiography and submitted to the Angiographic Core Laboratory for analysis. 
 
Use of Jetstream System 
 
The DFU for the Jetstream System is provided in the Manual of Operations. Prior to use of the 
device, the treating physician must carefully read and be familiar with the entire DFU. The 
Jetstream system DFU must be followed for performing the device. 
 
Anticoagulant therapy should be consistent with the hospital standard of practice during the 
procedure. 
All clinical sites shall have access to an emergency unit to perform interventions as bypass surgery 
in case of failed PTA. 
10.6.2. Multiple Interventions during index procedure 
Please refer to Section 7.3. Multiple Interventions Using Same Access Site during Index 
Procedure for the treatment of contralateral iliac lesions and the non-target inflow lesions in the 
target limb. 
10.6.3.  Post-procedure Angiogram 
Perform the post-procedure angiography according to the Angiographic Core Laboratory procedure 
guidelines. The final angiogram must be performed and recorded, including distal run-off. 
Angiographic images must be sent to the angiographic core laboratory for evaluation. 

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10.6.4. 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, device information (Catheter/Console), PTA/stenting 
information on the appropriate eCRFs 
• Record medications 
• Record antithrombotic medications 
• Complete AE assessment and collect source documents as described in Section 19. 
• Finalize angiographic and related required documentation to submit to the Core Laboratories per 
instructions in the Manual of Operations 
10.7. Post-Procedure / Pre-Discharge 
The subject may be discharged from the hospital when clinically stable at the Investigator’s 
discretion. The post-procedure/pre-discharge follow-up is an in-person visit and the following data 
will be collected prior to hospital discharge: 
 
• 
Medication assessment 
• 
AE assessment (any ongoing adverse events will be managed and treated by treating physicians 
per standard of care.) 
• 
Duplex ultrasound (DUS) – optional (at the discretion of the investigator) 
10.8.  30-Day Follow-up (+/- 7 days) 
30-day follow-up is an in-person interview. The following data will be collected: 
 
• 
ABI measurements 
• 
Rutherford category assessment 
• 
Medication assessment 
• 
Adverse events (any ongoing adverse events will be managed and treated by treating physicians 
per standard of care.) 
10.9. 6-Month Follow-up (+/- 30 days) 
The 6-month follow-up is an in-person interview; and the following data will be collected: 
 
• 
DUS of target lesion performed according to the DUS Core Laboratory procedure guidelines 
• 
ABI measurements 
• 
Rutherford category assessment 
• 
Medication assessment 
• 
Adverse events (any ongoing adverse events will be managed and treated by treating physicians 

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per standard of care.) 
10.10. 12-Month Follow-up (+/- 30 days) 
The 12-month follow-up is an in-person visit and the following data will be collected: 
 
• 
DUS of target lesion performed according to the DUS Core Laboratory procedure guidelines 
• 
ABI measurements 
• 
Rutherford category assessment 
• 
Medication 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. 
10.11. Study Completion 
Each subject received atherectomy by Jetstream system will be followed for 12 months after the 
index procedure.  For primary endpoint evaluation, the data of each such subject must be collected 
until the 12-month follow-up. 
10.12. 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. 
11. Statistical Considerations 
The sample size justification and the power analysis described here are associated with the primary 
hypotheses. Roll-in subjects will be analyzed separately for observational purpose. The details of all 
statistical analyses will be described in the Statistical Analysis Plan. 
11.1. Primary Endpoints 
The overall sample size is consist of the primary cohort and roll-in subjects. The sample size of the 
primary cohort is justified by hypothesis parameters and driven by the primary safety 30-day 
endpoint to preserve adequate statistical testing power for both primary effectiveness and safety 
endpoints. 

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11.1.1. Primary Safety Endpoint 
The primary safety endpoint is the rate of major adverse event (MAE), defined as all-cause death, 
target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days 
post index procedure. 
11.1.1.1. Safety Hypotheses  
The primary safety hypothesis to be tested is that 30-day MAE-free rate in subjects treated with 
Jetstream System exceeds a PG of 88% at one-sided significance level of 2.5%.  
The null hypothesis (H0) states that the PG is not met as opposed to the alternative hypothesis (H1) 
which states that the PG is met. The hypotheses inequalities are shown below: 
H0: Pt  PG (not met) 
H1: Pt > PG (met) 
where Pt is the 30-day MAE-free rate for the subjects treated with Jetstream System and the PG is 
88%.9 
The PG of 88% was estimated on the basis of available literature and is consistent with those 
described atherectomy outcomes. 18 
11.1.1.2. Safety Sample Size 
The overall sample size is consist of the primary cohort and roll-in subjects. The primary cohort is 
driven by the primary safety endpoint. 
• Power ≥ 90% 
• One-sided overall significance level = 2.5% (alpha) 
• PG for 30-day MAE-free rate = 88% 
• Expected 30-day MAE-free rate = 99%  
• Attrition rate = 15% (loss to follow-up at 30 days) 
• A minimum of 50 subjects to be evaluable at 30 days that will provide at least 99% power 
for the primary safety endpoint 
• A sample size of 60 subjects to be enrolled in the primary cohort at baseline 
With additional 2 roll-in subjects per site, the overall subjects to be enrolled are approximately 80. 
11.1.1.3. Safety Statistical Test Method 
A normal approximation test (e.g. Chi-Square Test) will be used to assess the one-sided hypothesis 
of PG. 

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11.1.2. Primary Effectiveness Endpoint 
The primary effectiveness endpoint is the acute reduction of percent diameter stenosis (%DS) post 
atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis 
(absolute mean percentage). 
11.1.2.1. Effectiveness Hypotheses 
The primary effectiveness hypothesis to be tested is that acute reduction of percent diameter stenosis 
(%DS) in subjects treated with Jetstream System exceeds 40%* within subject at one-sided 
significance level of 2.5%. 
*The expected mean acute reduction (i.e. %DSbefore Jetstream – %DSafter Jetstream) was 40%; the primary effectiveness hypothesis is to 
demonstrate there is a significant acute reduction (>0). See Statistical Analysis Plan for detail. 
The null hypothesis (H0) states that there is no treatment effect before and after subjects treated with 
Jetstream System as opposed to the alternative hypothesis (H1) states that there is a treatment effect. 
The hypotheses inequalities are shown below: 
H0: ∆t  0 (not met) 
H1: ∆t > 0 (met) 
where ∆t is the averaged difference in acute reduction of %DS before and after the subjects treated 
with Jetstream System and the within-subject treatment effect is 40% with standard deviation of 
18% derived by the Pathway PVD study, Jetstream Calcium study and JET Registry**. 
**The before-and-after atherectomy in the Pathway PVD shows 79.4%±17.7% and 35.0%±16.1% respectively. The before-and-after 
atherectomy in Jetstream Calcium study shows 86.9%±9.0% and 37.0%±13.0%. The before-and-after atherectomy in JET Registry 
shows 91.1%±9.8% and 44.4%±20%, and the acute reduction of %DS is 46.7%±20.5%. 
11.1.2.2. Effectiveness Sample Size/Power Analysis 
The power analysis for the primary effectiveness endpoint is based on the following assumptions. 
• One-sided significance level (alpha) = 2.5% 
• Expected acute reduction of percent diameter = 40% with the common standard deviation 
estimated to be within the range of historical data 
The sample size is driven by the primary safety endpoint to provide at least 99% power to assess the 
primary effectiveness endpoint. 
11.1.2.3. Effectiveness Statistical Method 
A paired t-test will be used to assess the one-sided hypothesis of reduction in %DS before and after 
subjects treated with Jetstream System. 
11.2. Success Criteria 
Success Criteria for Primary Safety Endpoint 

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Jetstream System will be concluded as meeting PG for device safety if the one-sided lower 97.5% 
confidence bound on the observed 30-day MAE-free rate is greater than 88%. 
Success Criteria for Primary Effectiveness Endpoint 
Jetstream System will be concluded as meeting endpoint for device effectiveness if the one-sided 
lower 97.5% confidence bound on the difference between before and after atherectomy in %DS 
within subject is greater than zero. 
Success Criteria for the Study 
If the primary safety and the primary effectiveness endpoints are both met, the study will be 
considered a success and both device safety and effectiveness will be claimed.  
11.3. General Statistical Methods 
11.3.1. Analysis Sets 
The primary and pre-specified additional endpoints will be analyzed on an ITT basis and on a pre-
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 subject used the Jetstream 
System. For the pre-protocol analysis, only enrolled subjects who are treated with the study device 
in the target lesion will be included in the analysis sample. 
Roll-in subjects will be analyzed separately for observational purpose. 
11.3.2. 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. 
11.3.3. Number of Subjects per Investigative Site 
No study sites will be allowed to enroll more than 35% (N=28) of the total number of enrolled 
subjects to avoid treatment center bias and ensure homogeneous study results. 
11.3.4. Baseline Data Analyses 
Subject demographics, and clinical characteristics, site-reported and core lab reported lesion 
characteristics, procedure assessment, device information, and medication compliance will be 
summarized using descriptive statistics. The analysis level may be (but will not be limited to) by 
subject, lesion, procedure, or device. 

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For continuous and/or ordinal variables, the descriptive statistics will include mean, standard 
deviation, number evaluated, minimum and maximum. Some specific variables may also include 
additional statistics such as median and confidence intervals. For binary or categorical variables, the 
descriptive statistics will include percentage, numerator, denominator, and number evaluated. Some 
variables may include confidence intervals as needed. 
11.3.5. Secondary Endpoint Assessments 
Secondary assessments may refer to (but not limited to) peri-procedural complications, 
clinical/procedural/hemodynamic success, safety/effectiveness endpoints, any type of AE rates at 
time points that data is collected (details refer to Section 6.2.2.). All additional assessments are 
observational. 
11.3.6. Interim Analyses  
Steering Committee can make the decision to conduct the  interim analyses accordingly (such as the 
process seriously delayed due to epidemic). 
11.3.7. Subgroup Analyses 
Primary endpoints and/or additional assessments will be summarized by the following categories (but 
not limit to): 
 
•    Lesion location (distal, mid, proximal, ostial ) 
 
•    Sex (male, female) 
 
•    Age (-64, 65-74, 75-) 
 
•    Lesion Characteristics (lesion length -50, 50-100, 100-150, 150- mm) 
 
•    Jetstream Catheter size (SC1.6, SC1.85, XC 2.1/3.0, XC 2.4/3.4) 
 
•    Diabetes (medically treated, non-medically treated) 
All subgroup analyses are observational. 
11.3.8.  Sensitivity Analysis 
Sensitivity analyses for the primary effectiveness and/or safety endpoints assessment will be 
conducted to assess the impact of missing data on the result’s robustness. 
11.3.9. Analysis Software 
All statistical analyses will be performed using the Statistical Analysis Software (SAS), version 9.2 
or later (Copyright © 2002-2010 by SAS Institute Inc., Cary, North Carolina 27513, USA. All rights 
reserved). 

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11.3.10. Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the primary endpoint 
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. 
12. Data Management 
12.1. 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. 
12.2. 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 10 years 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 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. 

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12.3. Core Laboratories 
Angiographic and DUS data from Jetstream China trial will be assessed by independent core labs.  
All centers have to send the de-identified data records of baseline angiograms and the DUS 
recordings performed at the 6&12-month follow-up visits for blinded assessment to the core lab.   
 
Contact information for Core Laboratories is provided in the study Manual of Operations. 
13. 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. 
14. 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.  
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. 

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15. 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. 
16. Compliance 
16.1. 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. 
16.2. 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 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.  

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• 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 representatives to perform monitoring and auditing activities, and 
be accessible to the clinical research monitor or auditor and respond to questions during 
monitoring visits. 
• 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. 

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• 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. 
16.2.1. 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. The investigator is accountable for 
regulatory violations resulting from failure to adequately supervise the conduct of the clinical study.  
16.3. Institutional Review Board/ Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational site will provide to the sponsor 
documentation verifying that their IRB/EC is registered or that registration has been submitted to the 
appropriate agency, as applicable according to national/regulatory requirements.   
A copy of the written IRB/EC and/or competent authority approval of the protocol (or permission to 
conduct the study) and Informed Consent Form, must be received by the sponsor before recruitment 

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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. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the study as 
required by local/country or IRB/EC requirements.  Copies of the Investigator’s reports and the 
IRB/EC continuance of approval must be provided to the sponsor.  
16.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study will be 
considered confidential by BSC.  Only authorized BSC personnel 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.  All data used in the analysis and reporting 
of this study will be without identifiable reference to specific subject name. 
Boston Scientific will keep subjects’ identifiable health information confidential in accordance with 
all applicable laws and regulations.  Boston Scientific may use subjects’ health information to 
conduct this research, as well as for additional purposes, such as overseeing and improving the 
performance of its device, new medical research and proposals for developing new medical products 
or procedures, and other business purposes.  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.  
16.5. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC for 
subjects in the study will be obtained.  If any study related health injury occurs and a site is held 
responsible for its compensation, where required, BSC will assume the responsibility, except in the 
case that damages are incurred due to violation of the protocol, intentional or serious negligence at 
the site. 
17. 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 

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relevant study personnel are available during on-site monitoring visits or audits and that sufficient 
time is devoted to the process. 
18. Potential Risks and Benefits 
18.1. Risks / Adverse Events Associated with the Study Device and Procedure 
Potential anticipated adverse events associated with the use of study device and other interventional 
catheters in this study and the PTA procedure include, but are not limited to the following 
(alphabetical order): 
• Abrupt or sub-acute closure 
• Allergic reaction (device, contrast medium, medications) 
• Amputation 
• Arrhythmias 
• Arteriovenous fistula 
• Bleeding/hemorrhage (access site and/or non-access site) 
• Death 
• Dissection 
• Embolization (air, plaque, thrombus, device, tissue or other) 
• Extremity ischemia which may require urgent intervention or surgery 
• Fever 
• Hematoma 
• Hemodynamic instability (hypotensive/hypertensive episodes) 
• Infection/sepsis 
• Minor burn 
• Pain 
• Perforation  
• Pseudo-aneurysm 
• Restenosis of the treated segment 
• Renal insufficiency or failure 
• Vascular complications which may require surgical repair (e.g., dissection, perforation, rupture) 
• Vasospasm  

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• Vessel occlusion  
• Stroke/transient cerebral ischemic attack 
• Thrombosis/thromboembolism  
18.2. Risks associated with Participation in the Clinical Study 
In addition to the aforementioned risks associated with the use of Jetstream System and PTA 
procedure, the use of prolonged dual antiplatelet therapy after atherectomy and PTA may increase 
the risk of bleeding.  There may be additional risks linked to the procedure, which are unforeseen at 
this time 
18.3. 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. 
18.4. Anticipated Benefits 
Potential anticipated benefits include the improvement of procedural success of atherosclerotic 
SFA/PPA lesions with improvement in the symptoms of disease. However, the Jetstream system is 
an investigational device and these potential benefits may or may not actually be present. 
18.5. Risk to Benefit Rationale 
The Jetstream System 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 Jetstream System demonstrate that when used under the conditions intended, 
the benefits associated with use of the Jetstream System should outweigh the risks.  
19. Safety Reporting 
19.1. Reportable Events by investigational site to Boston Scientific 
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 

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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. 
Any AE event required by the protocol, experienced by the study subject after informed consent and 
once considered enrolled in the study (as defined in study subject classification section), whether 
during or subsequent to the procedure, must be recorded in the eCRF. 
Underlying diseases are not reported as AEs unless there is an increase in severity of frequency 
during the course of the investigation. For centers in Austria cancer must always be reported as a 
Serious Adverse Event. Death should not be recorded as an AE, but should only be reflected as an 
outcome of ONE (1) specific SAE (see Table 19.2-1 for AE definitions). 
Refer to Section 18 for the known risks associated with the study device(s). 
In-patient hospitalization is defined as the subjects being admitted to the hospital, with the following 
exceptions. 
• 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. 
19.2. Definitions and Classification 
Safety definitions are provided in Table 19.2-1,with reference from ISO 14155-2011 and MEDDEV 
2.7/3 12/2010. 
 
Table 19.2-1: Safety Reporting Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
Ref: MEDDEV2.7/3 12/2010 
 
 
 
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) 
 
Adverse event related to the use of an investigational medical device 

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Table 19.2-1: Safety Reporting Definitions 
Term 
Definition 
Ref: ISO 14155-2011 
Ref: MEDDEV2.7/3 12/2010 
 
 
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 
 
Ref: MEDDEV2.7/3 12/2010 
 
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 
 
Ref: MEDDEV2.7/3 12/2010 
 
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.   
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV2.7/3 12/2010 
 
 
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. 

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Table 19.2-1: Safety Reporting Definitions 
Term 
Definition 
Device Deficiency 
 
Ref: ISO 14155-2011 
Ref: MEDDEV2.7/3 12/2010 
 
 
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 
 
19.3. Relationship to Study Device(s) 
The Investigator must assess the relationship of the AE to the study device or procedure.  See criteria 
in Table 19.3-1:  

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Table 19.3-1: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event 
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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Table 19.3-1: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event 
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 19.3-2). 
 
 

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Table 19.3-2: Criteria for Assessing Relationship of Antiplatelet Medication to Adverse 
Event 
Classification 
Description 
Not Related 
Relationship to the antiplatelet medication can be excluded when: 
- the event is not a known side effect of the medication category the antiplatelet 
medication belongs to or of similar medication; 
- the event has no temporal relationship with the use of the antiplatelet medication; 
- the serious event does not follow a known response pattern to the antiplatelet 
medication (if the response pattern is previously known) and is biologically implausible; 
- the discontinuation of antiplatelet medication use or the reduction of the dose of 
antiplatelet medication - when clinically feasible – and reintroduction of its use (or 
increase of the dose of antiplatelet medication), do not impact on the serious event; 
- the event involves a body-site or an organ not expected to be affected by the 
antiplatelet medication; 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 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 antiplatelet medication and the serious 
event. 
Unlikely Related 
The relationship with the use of the antiplatelet medication 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 antiplatelet medication 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 antiplatelet medication seems relevant and/or the 
event cannot reasonably explained by another cause, but additional information may be 
obtained.  

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Table 19.3-2: Criteria for Assessing Relationship of Antiplatelet Medication to Adverse 
Event 
Classification 
Description 
Causal 
Relationship 
The serious event is associated with the antiplatelet medication beyond reasonable doubt 
when: 
- the event is a known side effect of the medication category the antiplatelet medication 
belongs to or of similar medication; 
- the event has a temporal relationship with antiplatelet medication use; 
- the event involves a body-site or organ that 
o the antiplatelet medication are applied to; 
o the antiplatelet medication have an effect on; 
- the serious event follows a known response pattern to the antiplatelet medication (if the 
response pattern is previously known);  
- the discontinuation of antiplatelet medication use (or reduction of the dose of 
medication) and reintroduction of its use (or increase of the dose of medication), 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; 
 
- In order to establish the relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of antiplatelet medication and the serious event. 
19.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 19.4-1. 
Table 19.4-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
Unanticipated Adverse Device 
Effect / Unanticipated Serious 
Adverse Device Effect 
(UADE/USADE)  
Complete AE eCRF page with all 
available new and updated information.  
 
• Within 24 hours of first 
becoming aware of the event. 
• 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) 
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 

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Table 19.4-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
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. 
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 
19.5. 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. 
19.6. 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 according to China 
local reporting requirements.  
The Principal Investigator is responsible for informing the IRB/EC, and regulatory authorities of 
UADE and SAE as required by local/regional regulations. 

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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.  
Investigator and investigational site are responsible for reporting all SAEs and device deficiencies 
that could lead to SAEs to IRBs/ECs, local Food and Drug Administration within 24 hours of 
investigator becoming aware of the event. 
BSC shall notify all participating Chinese study centers if SAEs/SADEs 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. 
20. 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.   
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, 

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• 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 Jetstream China trial eligibility criteria, including, but not limited to, the reason 
for screen failure. 
21. Committees 
21.1. 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 Jetstream China Investigators on 
the Committee. 
21.2. 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 

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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. 
21.3. 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 following reported events: 
• 
Death 
• 
Target limb major amputation 
• 
Target vessel revascularization (TVR) and target lesion revascularization (TLR) 
• 
Distal embolization requiring additional treatment 
• 
Perforation during index procedure that requires additional treatment 
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.  
22. Suspension or Termination 
22.1. 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. 
22.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the following. 
• The occurrence of unanticipated adverse device effects that present a significant or unreasonable 
risk to subjects enrolled in 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. 

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22.2. Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC Approval 
Any investigator, or IRB/ EC in the Jetstream 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. 
22.3. 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. 
22.4. 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. 

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23. Study Registration and Results 
23.1. Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly accessible 
database. 
23.2. Clinical Investigation Report 
Study results will be made available in accordance with the legal requirements and the recognized 
ethical principles, in accordance with the Boston Scientific Policy. A Clinical Investigation Report 
will be made available to all investigators, IRB/EC/REB and regulatory authorities, as applicable in 
accordance with the Boston Scientific Policy and local requirements.  As applicable an abbreviated 
Clinical Investigation Report will be made available on a publicly accessible database. 
23.3. 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.  
24. 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. 
4. Garcia LA.  Epidemiology and Pathophysiology of Lower Extremity Peripheral Arterial 
Disease.  J Endovasc Ther 2006;13(Suppl II):II-3–II-9. 

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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. Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW, Clair D.  
Effective Endovascular Treatment of Calcified Femoropopliteal Disease With Directional 
Atherectomy and Distal Embolic Protection: Final Results of the DEFINITIVE Ca++ Trial.  
Catheterization and Cardiovascular Interventions 2014;84:236–244. . 
10. Zeller T, Krankenberg H, Steinkamp H, Rastan A, Sixt S, Schmidt A, Sievert H, Minar E, 
Bosiers M, Peeters P, Balzer JO, Gray W, Tubler T, Wissgott C, Schwarzwalder U, Scheinert D. 
One-Year Outcome of Percutaneous Rotational Atherectomy With Aspiration in Infrainguinal 
Peripheral Arterial Occlusive Disease: The Multicenter Pathway PVD Trial.  J ENDOVASC 
THER 2009;16:653–662.  
11. Singh T, Koul D, Szpunar S, Torey J, Dhabuwala J, Saigh L, Pires LA, Davis T.  Tissue 
Removal by Ultrasound Evaluation (The TRUE Study): The Jetstream G2 System Post-Market 
Peripheral Vascular IVUS Study.  J INVASIVE CARDIOL 2011;23:269–273.  
12. McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA.  Lower Extremity 
Revascularization Using Directional Atherectomy: 12-Month Prospective Results of the 
DEFINITIVE LE Study.  J Am Coll Cardiol Intv 2014;7:923–33.  
13. Sixt S, Rastan A, Scheinert D, Krankenberg H, Steinkamp H, Schmidt A, Sievert H, Minar E, 
Bosiers M, Peeters P, Balzer JO, Tubler T, Wissgott C, Cancino OGC, Schwarzwalder U, 
Thomas Zeller T.  The 1-Year Clinical Impact of Rotational Aspiration Atherectomy of 
Infrainguinal Lesions.  Angiology 2011;62(8):645-656.  
14. Sixt S, Scheinert D, Rastan A, Krankenberg H, Steinkamp H, Schmidt A, Sievert H, Minar E, 
Bosiers M, Peeters P, Balzer JO, Tubler T, Wissgott C, Nielsen C, Schwarzwalder U, Zeller T. 
One-Year Outcome After Percutaneous Rotational and Aspiration Atherectomy in Infrainguinal 
Arteries in Patient With and Without Type 2 Diabetes Mellitus.  Ann Vasc Surg 2011; 25: 520-
529. 
15. Maehara A, Mintz GS, Shimshak TM, Ricotta JJ, Ramaiah V, Foster MT, Davis TP, Gray WA. 
Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial 
calcium in peripheral arteries.  EuroIntervention 2015;11:96-103.  
16. Leiner T, et al.  “Peripheral Arterial Disease: Comparison of Color Duplex US and Contrast-
enhanced MR Angiography for Diagnosis".  Radiology 2005;235:699-708. 

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17. 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. 
18. 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
25. Abbreviations and Definitions  
25.1. Abbreviations 
Abbreviations are shown in Table 25.1-1.   
 
Table 25.1-1: Abbreviations 
 
Abbreviation 
Terminology 
ABI 
Ankle Brachial Index 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BSC 
Boston Scientific Corporation 
CE 
Conformité Européenne (meaning European Conformity) 
CEC 
Clinical Event Committee 
CIN 
Contrast-Induced Nephropathy 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
 

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Table 25.1-2: Abbreviations 
 
Abbreviation 
Terminology 
CVA 
Cerebrovascular Accident 
DFU 
Directions for Use 
DUS 
Duplex Ultrasound 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EVT 
Endovascular Therapy 
GCP 
Good Clinical Practice 
HCP 
Health Care Professional 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
ICH 
International Conference on Harmonization 
IMR 
Independent Medical Reviewer 
ITT 
Intent to Treat 
IRB 
Institutional Review Board 
IVUS 
Intravascular Ultrasound 
MAE 
Major Adverse Event 
OPC 
Objective Performance Criteria 
PAD 
Peripheral arterial disease 
PG 
Performance Goal 
PPA 
Proximal Popliteal Artery 
PSVR 
Peak Systolic Velocity Ratio 
PTA 
Percutaneous Transluminal Angioplasty 

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Table 25.1-3: Abbreviations 
 
Abbreviation 
Terminology 
QA 
Quantitative Angiography 
QOL 
Quality of Life 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SC 
Single Cutter 
SFA 
Superficial Femoral Artery 
TASC 
Transatlantic Inter-Societal Consensus 
TBI 
Tibial Brachial Index 
TLR 
Target Lesion Revascularization 
TVR 
Target Vessel Revascularization 
USADE 
Unanticipated Serious Adverse Device Effect 
UPN 
Universal Product Number 
XC 
Expandable Cutter 
 

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25.2. Definitions 
Table 25.2-1: 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. 
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. 

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Table 25.2-1: Definitions 
Term 
Definition 
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). 
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: 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. 

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Table 25.2-1: Definitions 
Term 
Definition 
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. 
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) 
Major Adverse Events (MAEs) include all-cause death, target limb 
unplanned major amputation and/or target lesion revascularization 
(TLR). 

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Table 25.2-1: Definitions 
Term 
Definition 
MINIMAL LUMEN 
DIAMETER 
The vessel diameter as measured at the narrowest 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 
Vessel patency is defined as freedom from more than 50% diameter 
stenosis.  
 
Primary patency is the absence of more than 50% stenosis assessed 
by angiography, CTA or DUS (i.e., peak systolic velocity ratio must 
≤2.4), without clinically-driven target lesion revascularization (TLR) 
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. 
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) 

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Table 25.2-1: Definitions 
Term 
Definition 
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. 
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. 

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Table 25.2-1: Definitions 
Term 
Definition 
TARGET LESION 
Target lesion is the lesion selected by the investigator for treatment 
with the study device, 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 5mm 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. 
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. 

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Table 25.2-1: Definitions 
Term 
Definition 
TARGET VESSEL 
REVASCULARIZATION 
(TVR) 
 
Target vessel revascularization (TVR) is any repeat intervention or 
surgical bypass of any segment of a target vessel. 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). 

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Table 25.2-1: Definitions 
Term 
Definition 
TRANSATLANTIC 
INTER-SOCIETAL 
CONSENSUS (TASC) 
LESION GUIDELINES 
FOR 
FEMOROPOPLITEAL 
LESIONS 
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  30% residual angiographic stenosis 
in 2 near-orthogonal projections by visual assessment, after 
successfully debulking the target lesion and adjunctive interventions 
(such as percutaneous transluminal angioplasty/stenting). 
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. 

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Table 25.2-1: Definitions 
Term 
Definition 
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). 
Abbreviations are defined in Table 25.1-1. 
 
 
 
 
 
Investigator Statement （See Chinese version protocol）