A Prospective, Multi-center, Non-Randomized Controled Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions In Chinese Population--FAST CTO China
Conditions: CAD
Sponsor: Boston Scientific Corporation

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A Prospective,  Multi-center,  Non-Randomized Controled Trial for A Novel 
Facilitated Antegrade Steering Technique in Revascularization of Coronary 
Chronic Total Occlusions In Chinese Population 
(FAST-CTO China) 
 
CLINICAL PROTOCOL 
S2362 
 
 
 
Sponsored By 
BSC International Medical Trading (Shanghai) Co.,  Ltd,  (“BSC China”) 
Part A,  2nd Floor,  No.68,  Rijing Road, 
WaiGaoQiao Free Trade Zone, 
Shanghai,  China 200131 
 
 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their designated 
representatives participating in this clinical investigation. The protocol should be held confidential 
and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 
 
 

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Contact Information 
Role 
Contact  
Clinical Contact 
Chenchen Fan 
Clinical Trial Manager 
BSC China 
12F, Building 2, 16 Tianze Road  
Beijing 100125 
P.R.China 
Email: Chenchen.Fan@bsci.com 
Tel: +86 10 85216427 
 
Cuifen Li 
 
Medical Affairs Manager 
Boston Scientific Corporation 
12F, Building 2, 16 Tianze Road  
Beijing 100125 
P.R.China 
Email:  cuifen.li@bsci.com 
Mobile: 86 10 87542962 
Coordinating Principal 
Investigator 
Dr. Yuejin Yang is the Coordinating Principal Investigator. The contact 
details of the contact are maintained and provided in the manual of 
operations. 
Coordinating 
Co-Principal 
Investigator 
TBD 
 
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 AA:22 Aug 2016 
Current Version AC: 12 Nov 2019 
Revision History 
 
Revision 
Number 
Protocol 
Date 
Template 
number and 
version 
 Protocol 
Section 
Modifiied 
Summary of Change 
Justification for 
Modification 
AB 
10 Jun 
2019 
92120219_Rev/Ver 
C 
Inclusion 
Criteria 
1, ‘Lesion length < 
20mm’ change to 
‘Lesion length < 40mm’ 
2, delete CTO must be 
“Verified” (aka 
“Refractory”)  
From 
Investigator’s 
suggestion. 
(currently, 
most patients’ 
lesion length> 
20mm) 
AB 
10 Jun 
2019 
92120219_Rev/Ver 
C 
Objective(s) 
‘To assess the safety and 
efficacy of the 
BridgePoint CTO system 
in recanalization of  CTO 
lesions which are 
resistant to a 
conventional wire 
approach in a multicenter 
study in Chinese 
population’ change to 
‘To assess the safety and 
efficacy of the 
BridgePoint CTO system 
in recanalization of  CTO 
lesions in a multicenter 
study in Chinese 
population’ 
According to 
current 
guidelines/ 
consensus’s 
suggestion.  
AB 
10 Jun 
2019 
92120219_Rev/Ver 
C 
Primary 
Effectiveness 
Endpoint 
Delete “in those cases 
that were otherwise 
refractory to treatment 
with a currently 
marketed guidewire” in 
the definition of 
Technical Success 
According to 
the inclusion 
criteria and 
objective 
AC 
12 Nov 
2019 
92120219_Rev/Ver 
C 
Device Sizes 
Delete device sizes 
Device Sizes 
information in 
the device 
registration 
certificate 
AC 
12 Nov 
2019 
92120219_Rev/Ver 
C 
Test Device 
“Stingray   
Catheter”change to 
“Stingray  LP Catheter” 
According to 
the device 
registration 
certificate 

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Revision History 
 
Revision 
Number 
Protocol 
Date 
Template 
number and 
version 
 Protocol 
Section 
Modifiied 
Summary of Change 
Justification for 
Modification 
AC 
12 Nov 
2019 
92120219_Rev/Ver 
C 
Contact 
information 
Change PM from 
“Guangwei Yang” to 
“Chenchen Fan” 
PM changed 
AC 
12 Nov 
2019 
92120219_Rev/Ver 
C 
Contact 
information 
Delete“Coordinating 
Co Principal Investigator
” 
There was no 
coordinating co 
principal 
investigator 
AC 
12 Nov 
2019 
92120219_Rev/Ver 
C 
Risks 
Related to 
Study 
Device 
Cardiac tamponade 
Recurrence of angina  
According to 
the device 
Directions for 
Use 
AC 
12 Nov 
2019 
92120219_Rev/Ver 
C 
Background 
Change” These two 
products have been 
approved by CFDA and 
launch in China in 
2014 .”to “These two 
products have been 
approved by CFDA and 
launch in China in 2014 
and 2017.” 
Stingray  LP 
Catheter have 
been approved 
by CFDA and 
launch in China 
in 2017 
 
 

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2. Protocol Synopsis 
A Prospective,  Multi-center,  Non-Randomized Controled Trial for A Novel Facilitated 
Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions In 
China Population 
(FAST-CTO China) 
Objective(s) 
To assess the safety and efficacy of the BridgePoint CTO system in 
recanalization of  CTO lesions in a multicenter study in Chinese 
population 
Planned Indication(s) for 
Use  
All subjects who are candidates for percutaneous coronary 
intervention (PCI),  signed the informed consent form and had 
chronic total coronary occlusion (CTO) lesion will be evaluated for 
enrollment in this study. 
Test Device 
BridgePoint CTO System: 
• 
CrossBoss Catheter 
• 
Stingray  LP Catheter 
• 
Stingray Guidewire and Extension Wire 
Control Device 
NA 
Study Design 
Prospective,  multicenter,  single-arm,  observational study 
Planned 
Number 
of 
Subjects 
At least 100 subjects will be enrolled. Each site will be allowed to 
enroll up to a maximum of 25subjects. 
Planned 
Number 
of 
Centers / Countries 
Up to 5 -10 investigational sites in China 
Primary Safety Endpoint:  30-day MACE rate for CTO cases in which the BridgePoint Medical 
System was used. 
MACE is defined as the composite of cardiac death,  Q-wave and 
non-Q-wave myocardial infarction(MI),  and any ischemia-driven 
target lesion revascularization(TLR). 
Primary 
Effectiveness 
Endpoint: 
Technical Success: the ability of the BridgePoint Medical System to 
successfully facilitate placement of a guidewire beyond a CTO lesion 
in the true vessel lumen/within the collaterals 
Additional Endpoints 
• 
Procedural success is a mean lesion diameter stenosis <50% in 2 
near-orthogonal projections with TIMI 2-3 flow, as visually 
assessed by the physician, without the occurrence of in-hospital Q 
wave MI, TLR, or cardiac death. 
• 
Total procedure time 
• 
Total Fluoroscopy time and dose (mSv)  
• 
Total  contrast dose 
• 
rate of MACE at 30 days,  6 months and 12 months 
• 
rate of stent thrombosis (ST) at 30 days,  6 months and 12 
months 
• 
rate of cardiac tamponade through hospital discharge after the 
index procedure 
• 
rate of kidney failure caused by contrast through hospital 
discharge after the index procedure 

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Method 
of 
Assigning 
Patients to Treatment 
NA 
Follow-up Schedule 
Subject follow up will occur via telephone contact or clinic visit at 30 
days,  6and 12 months post index procedure,  for all enrolled 
subjects. 
Study Duration 
About 2 years. 
Required 
Medication 
Therapy 
Based on the American College of Cardiology (ACC)/American 
Heart Association (AHA)/Society for Cardiovascular Angiography 
and Interventions (SCAI) guidelinesab, and supported by the 
European Society of Cardiology (ESC) guidelinesc, dual antiplatelet 
therapy with aspirin and a clopidogrel is prescribed as follows to 
reduce the risk of thrombosis. 
Aspirin: 
• 
For subjects who have been taking aspirin for ≥ 72 hours at the 
time of the procedure, a loading dose is not required. But a 75-
325 mg aspirin is recommended prior to the index procedure. 
• 
For subjects who have not been taking aspirin for ≥ 72 hours at 
the time of the procedure, a loading dose is recommended 24 
hours prior to the index procedure, where the loading dose shall 
be decided by the investigator. 
• 
Subjects shall take aspirin indefinitely after the index procedure.  
Thienopyridine 
• 
For subjects who have been taking clopidogrel for 72 hours at 
the time of the index procedure, a loading dose is not required. 
• 
For subjects who have not been taking clopidogrel for 72 hours 
at the time of the index procedure, a loading dose is required. It 
is recommended that the loading dose be administered prior to 
the index procedure. However, in all cases, the loading dose is 
required to be administered not more than2 hours after the index 
procedure. 
The following loading doses are recommended:  
o 
Clopidogrel: A peri-procedural loading dose of 600 mg is 
recommended.  
Subjects must be treated with clopidogrel for at least 6 months 
following the index procedure. In subjects not at high risk of 
bleeding, clopidogrel treatment should continue for at least 12 
months following the index procedure. 
Key Inclusion Criteria 
Clinical Inclusion Criteria: 
CI1. Subject must be ≥ 18 but < 80 years of age 
CI2. Subject (or legal guardian) understands the trial requirements 
and the treatment procedures and provides written informed 
consent before any trial-specific tests or procedures are 
performed 
CI3. Subject is eligible for percutaneous coronary intervention (PCI) 
CI4. Subject has symptomatic coronary artery disease or myocardial 
infraction (MI) with objective evidence of ischemia or silent 

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ischemia 
CI5. Subject is an acceptable candidate for coronary artery bypass 
grafting (CABG) 
CI6. Subject is willing to comply with all protocol-required follow-
up evaluation 
CI7. Subject has a left ventricular ejection fraction (LVEF) ≥45% as 
measured within 60 days prior to enrollment 
 
Angiographic Inclusion Criteria: 
AI1. A maximum of one de novo CTO lesion in a native coronary 
arterywith thrombolysis in Myocardial Infarction (TIMI) flow grade 
0 
AI2. Non-acute CTO lesion with an estimated duration of at least 3 
months by clincial history and/or comparison with previous 
angiogram or electrocardiogram(ECG) 
AI3. The CTO lesion must have an angiographic landing zone≥ 10 
mm proximal to any major bifurcation without severe calcification. 
AI4. Lesion length < 40mm without excessive tortuosity and 
angulation(>45°) 
Key Exclusion Criteria 
Clinical Exclusion Criteria: 
CE1. Subject has clinical symptoms and/or ECG changes consistent 
with Acute MI(include STEMI and Non- STEMI) within 1 week 
CE2. Subject has cardiogenic shock, hemodynamic instability 
requiring inotropic or mechanical circulatory support, intractable 
ventricular arrhythmias, or ongoing intractable angina. 
CE3. Subject has received an organ transplant or is on a waiting list 
for an organ transplant 
CE4. Subject is receiving or scheduled to receive chemotherapy 
within 30 days before or after the index procedure 
CE5. Planned PCI (including staged procedures) or CABG after the 
index procedure 
CE6. Subject has a known allergy to contrast (that cannot be 
adequately pre-medicated)and/or protocol-required concomitant 
medications (e.g.,  aspirin or all thienopyridines) 
CE7. Subject has one of the following (as assessed prior to the index 
procedure): 
• 
Other serious medical illness (e.g.,  cancer,  congestive heart 
failure) with estimated life expectancy of less than 12 months 
• 
Current problems with substance abuse (e.g.,  alcohol,  cocaine,  
heroin,  etc.)  
• 
Planned procedure that may cause non-compliance with the 
protocol or confound data interpretation 
CE8. Subject is receiving chronic (≥72 hours) anticoagulation 
therapy (i.e.,  heparin,  coumadin) 
CE9. Subject with out of range complete blood count (CBC) values 
that are determined by the study physician to be clinically significant. 

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CE10. Subject has documented or suspected liver disease,  including 
laboratory evidence of hepatitis 
CE11. Subject is on dialysis or has baseline serum creatinine level 
>2.0 mg/dL (177µmol/L) 
CE12. Subject has a history of bleeding diathesis or coagulopathy or 
will refuse blood transfusions 
CE13. Subject has had a history of cerebrovascular accident (CVA) 
or transient ischemic attack (TIA) within the past 6 months 
CE14. Subject has an active peptic ulcer or active gastrointestinal 
(GI) bleeding 
CE15. Subject has signs or symptoms of active heart failure (i.e.,  
NYHA class IV) or LVEF < 45%at the time of the index procedure 
CE16. Subject is participating in another investigational drug or 
device clinical trial that has not reached its primary endpoint or 
intends to participate in another investigational drug or device 
clinical trial within 12 months after the index procedure 
CE17. Subject had PCI within the previous 2 weeks 
CE18. Subject with known intention to procreate within 12 months 
after the index procedure (women of child-bearing potential who are 
sexually active must agree to use a reliable method of contraception 
from the time of screening through 12 months after the index 
procedure) 
CE19. Subject is a woman who is pregnant or nursing (a pregnancy 
test must be performed within 7 days prior to the index procedure in 
women of child-bearing potential) 
 
Angiographic Exclusion Criteria: 
AE1. Target lesion is an aorto-ostial lesion or located in left main 
coronary artery,  previous venous or arterial bypass grafts 
AE2. Target lesion involving a segment of previous stent 
AE3. Target vessel has excessive tortuosity and/or angulation 
proximal to the target lesion(>45°) 
AE4. Target lesion and/or the target vessel proximal to the target 
lesion is moderately to severely calcified by visual estimate 
AE5. Target lesion is located within 5 mm of the origin of the left 
anterior descending (LAD) coronary artery or left circumflex (LCx) 
coronary artery by visual estimate 
AE6. Target lesion will be accessed via a saphenous vein graft or 
arterial graft 
AE7. Subject has unprotected left main coronary artery disease 
(>50% diameter stenosis) 
AE8. Thrombus,  or possible thrombus,  present in the target vessel 
(by visual estimate) 
AE9. Target vessel has a dissection greater than National Heart,  
Lung,  Blood Institute (NHLBI) type C 
Statistical Methods 
Primary 
Statistical There is no formal statistical hypothesis for this observational,  

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Hypothesis 
single-arm study. In order to support the stated objectives,  the 
sample size for this trial will be approximately 100 subjects. 
Descriptive statistics will be performed for key variables collected in 
the study. The detail will be documented in the statistical analysis 
plan. 
Safety Parameters 
All serious adverse events (SAE),  adverse device effects (ADE),  
major adverse cardiac events (MACE) and stent thrombosis will be 
collected up to 12months follow-up intervals. A clinical events 
committee (CEC) will adjudicate for MACE and stent thrombosis 
through the 12-month follow- up. 
 

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3. Table of Contents 
1. 
TITLE PAGE………………………………………………………………………………. 1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................... 5 
3. 
TABLE OF CONTENTS ........................................................................................................ 10 
Table of Figures ............................................................................................................... 13 
Table of Tables ................................................................................................................. 13 
 
4.    BACKGROUND…………………………………………………………………………14 
4.1 
First-in-man (FIM) Clinical Trial ......................................................................... 14 
4.1.1 
Characteristics of the Subjects ............................................................... 15 
4.1.2 
Lesion Characteristic ............................................................................... 15 
4.1.3 
Technical and Procedure Success ........................................................... 15 
4.1.4 
Safety ......................................................................................................... 15 
4.1.5 
Conclusion ................................................................................................ 15 
4.2 
European Union (EU) Clinical Trials ................................................................... 15 
4.2.1 
Clinical Trial Design ................................................................................ 16 
4.2.2 
Primary Efficacy Endpoint ..................................................................... 16 
4.2.3 
Secondary Efficacy Endpoint ................................................................. 16 
4.2.4 
Safety Results ........................................................................................... 16 
4.2.5 
Results ....................................................................................................... 16 
4.2.6 
Conclusion ................................................................................................ 18 
4.3 
FAST-CTO Clinical Trial ...................................................................................... 18 
4.3.1 
Study Objective ........................................................................................ 18 
4.3.2  
Study Design ............................................................................................. 18 
4.3.3      Result ......................................................................................................... 18 
4.3.4  
Conclusion ................................................................................................ 22 
5. 
DEVICE DESCRIPTION ....................................................................................................... 22 
5.1 
CrossBoss Catheter ................................................................................................ 22 
5.2 
Stingray LP Catheter ............................................................................................. 22 
5.3 
Stingray Guidewire and Extension Wire ............................................................. 23 
5.4 
Installation Instructions and the Use of Device ................................................... 23 
5.5 
Necessary Training and Experience Required for Using Investigation Devices23 
6. 
STUDY OBJECTIVES ........................................................................................................... 23 
7. 
STUDY ENDPOINTS ............................................................................................................ 23 
7.1 
Primary Study Endpoint ....................................................................................... 23 
7.2 
Secondary Study Endpoint .................................................................................... 23 

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8. 
STUDY DESIGN ................................................................................................................... 24 
9. 
SUBJECT ENROLLMENT .................................................................................................... 25 
9.1. Inclusion Criteria ................................................................................................... 25 
9.2. Exclusion Criteria .................................................................................................. 26 
10. SUBJECT ACCOUNTABILITY .............................................................................................. 27 
10.1 Point of Enrollment ................................................................................................ 27 
10.2 Withdrawal ............................................................................................................. 27 
10.3 Enrollment Controls .............................................................................................. 28 
11. STUDY METHODS .............................................................................................................. 28 
11.1 Data Collection ....................................................................................................... 28 
11.2 Screening of Study Subjects .................................................................................. 32 
11.3 Informed Consent ................................................................................................... 32 
11.4 Up to 14 Days Prior to the Procedure .................................................................. 32 
11.5 Concomitant Medication Required in This Study .............................................. 32 
11.6 Up to 3 Days Prior to the Index Procedure .......................................................... 33 
11.7 Enrollment and Index Procedure ......................................................................... 33 
11.8 End of Procedure / Prior to Hospital Discharge ................................................. 34 
11.9 Follow-up ................................................................................................................ 34 
11.9.1 
Loss to Follow-up ...................................................................................... 35 
11.10 Study End ................................................................................................................ 35 
11.11 Source Documents .................................................................................................. 35 
12. STATISTICAL CONSIDERATIONS ....................................................................................... 35 
Study Endpoint ................................................................................................................ 35 
11.3 General Statistical Methods .................................................................................. 36 
11.3.1 
Analysis Set ............................................................................................... 36 
11.3.2 
Data Analysis ............................................................................................. 36 
12 DATA MANAGEMENT ........................................................................................................ 36 
12.1 Data Collection, Processing, and Review ............................................................. 36 
12.2 Data Retention ........................................................................................................ 37 
12.3 Core Laboratory ..................................................................................................... 37 
13. AMENDMENTS ................................................................................................................... 37 
14. DEVIATIONS ....................................................................................................................... 37 
15. DEVICE / EQUIPMENT INVENTORY ................................................................................... 38 

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16. COMPLIANCE ..................................................................................................................... 38 
17. INVESTIGATOR RESPONSIBILITIES ................................................................................... 38 
Delegation of Responsibility .................................................................................... 40 
18. INSTITUTIONAL REVIEW BOARD/ ETHICS COMMITTEE .................................................. 40 
19. SPONSOR RESPONSIBILITIES ............................................................................................. 40 
20. ROLE OF BOSTON SCIENTIFIC REPRESENTATIVES .......................................................... 40 
21. INSURANCE ........................................................................................................................ 41 
22. MONITORING ...................................................................................................................... 41 
23. POTENTIAL RISKS AND BENEFITS ..................................................................................... 42 
23.1 Risks Related to PCI / Stent Implantation ........................................................... 42 
23.2 Risks Related to Study Device ............................................................................... 42 
23.3 Risks Related to Participating in Clinical Study ................................................. 43 
23.4 Risk Minimization Actions .................................................................................... 43 
23.5 Anticipated Benefits ............................................................................................... 43 
23.6 Risk Benefit Ratio .................................................................................................. 43 
24. SAFETY REPORT ................................................................................................................ 43 
24.1 Definitions and Classifications .............................................................................. 43 
24.2 Relationship to Study Device(s) ............................................................................ 45 
25 BOSTON SCIENTIFIC DEVICE DEFICIENCIES .................................................................... 48 
26 INFORMED CONSENT ......................................................................................................... 48 
27 COMMITTEES .................................................................................................................... 50 
27.1 Safety Monitoring Process ..................................................................................... 50 
27.2 Ethics Committee ................................................................................................... 50 
27.3 Clinical Events Committee .................................................................................... 50 
27.4 Executive Committee ............................................................................................. 50 
28 SUSPENSION OR TERMINATION ......................................................................................... 50 
28.1 Premature Termination of the Study ................................................................... 50 
28.1.1 
Criteria for Premature Termination of the Study ....................................... 50 
28.2 Investigator Terminates the Study or Ethical Approval Withdrawal .............. 51 
28.3 Requirements for Documentation and Subject Follow-up ................................. 51 
28.4 Criteria for Suspending/ Termination of a Study Site ........................................ 51 
29 PUBLICATION POLICY ....................................................................................................... 51 

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30 BIBLIOGRAPHY .................................................................................................................. 52 
31. ABBREVIATIONS AND DEFINITIONS .................................................................................. 54 
31.1 Abbreviations .......................................................................................................... 54 
31.2 Definitions ............................................................................................................... 55 
 
Table of Figures 
 Figure 8-1 Study Design Flow Chart ..................................................................................... 24 
 
Table of Tables 
Table 4-1: Methods of Technical Success ......................................................................................... 15 
Table 4-2: Statistics of Subject .......................................................................................................... 16 
Table 4-3: Characteristics of Lesion .................................................................................................. 17 
Table 4-4: Demographic Characteristics of Subjects Classified According to Refractoriness .......... 19 
Table 4-5: Target Vessels And Devices Used ................................................................................... 19 
Table 4-6: 30-Day MACE .................................................................................................................. 20 
Table 4-7: Technical Success Classified by Used Devices ................................................................ 20 
Table 4-8: Procedure and X-ray Time in Successful and Failed Procedure ...................................... 21 
Table 4-9: Perforation Rate in Contemporary CTO Clinical Trials ................................................... 21 
Table 24-1: Safety Reporting Definitions .......................................................................................... 43 
Table 24-2: Criteria for Assessing Relationship of Study Device or Procedure to AE ..................... 45 
Table 24-3: Criteria for Assessing Relationship of Antiplatelet Medication to AE .......................... 46 
Table 24-1: Investigator Reporting Requirements……………………………………….…………45 
 

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4. Background 
At present, chronic total occlusion (CTO) is still the greatest challenge of percutaneous coronary 
revascularization to treat coronary atherosclerotic heart disease (CAD), and in fact, it is also the 
most common cause for a transfer treatment to the surgery of coronary artery bypass grafting 
(CABG) [1]. Treating CTO lesion through conventional percutaneous transluminal coronary 
angioplasty (PTCA) and/or stent implantation has been a widely accepted treatment method with 
good effects [2-5]. However, the success of PTCA or stent implantation depends on whether the 
conventional guidewire can cross CTO lesion or not. The conventional guidewire technology often 
fails to cross CTO lesion, so that the percutaneous method cannot be taken for treatment. The 
causes of failure to cross CTO lesion usually are: (a) insufficient force to cross the plaque that 
causes the occlusion; (b) mechanical guidewire trends to enter the subintimal pathway [6]; or (c) 
unable to operate the guidewire effectively towards the true vessel lumen to reenter the distal vessel 
of the CTO lesion. In the interventional procedure to treat CTO lesion, there are usually two ways 
to move the guidewire to cross CTO lesion: 1) in the true vessel lumen; or 2) along the vessel 
subintimal pathway. In fact, in CTO cases that lesion hinders the guidewire from crossing the true 
lumen, high-skilled interventional doctors develop a time consuming non-standard technology, 
attempting to use the special guidewire to cross the occlusion segment by subintimal pathway [7]. 
In almost 50% successful CTO lesion recanalization procedures carried out by these high-skilled 
interventional doctors, subintimal pathway and reentry into the true lumen are used [8]. 
BridgePoint Medical Inc acquired by Boston Scientific developed a new technology, intended to 
facilitate a safe and reliable crossing of CTO lesions, enabling the conventional guidewire to cross 
stenosed target lesion through true vessel lumen or subintimal pathway. BridgePoint Medical CTO 
System includes CrossBoss™ Catheter and Stingray™ system. CrossBoss Catheter is intended to 
help the guidewire cross stenosis lesion by getting through an intraluminal pathway crossing CTO 
lesion or building a subintimal pathway beyond CTO lesions. CrossBoss Cathetercombines the 
function of new recanalization guidewire and the supporting of probe catheter or recanalization 
catheter (please refer to section 2.1-2.3 for details). 
In addition, BridgePoint Medical also developed a patent system to facilitate the reentry into the 
true lumen, which is applicable to the case that when CrossBoss Catheter has crossed CTO lesion 
but entered the vessel subintimal. This Stingray  system includes Stingray Catheterand Stingray 
Guidewire and Extension Wire. Stingray catheter uses special technologies to facilitate the 
replacement of a guidewire in the true vessel lumen through the vessel subintimal pathway (please 
refer to section 5 for details). Stingray Guidewire and Extension Wire are used in conjunction with 
Stingray catheter,  facilitating cardiologists to reenter a guidewire in the true vessel lumen through 
the vessel subintimal pathway ( please refer to section 5 for details). These two products have been 
approved by CFDA and launch in China in 2014 and 2017. 
BridgePoint Medical (BSCI) has conducted three clinical trials in the European Union and the 
United States, to assess the BridgePoint Medical CTO System. 
4.1 First-in-man (FIM) Clinical Trial 
Three sites in Santiago, Vina del Mar and Chile have made the first assessment for device 
feasibility and use of BridgePoint Medical CTO System in human subjects. For each subject, the 
objective is to use BridgePoint Medical device to cross CTO lesions, but the device selection is 
decided by physician preferences and/or lesion characteristics. 44 subjects have received the 
treatment, where 43 used CrossBoss catheter for treatment, 20 used Stingray catheter for treatment 
and 20 used Stingray guidewire for treatment. The procedural and 30 day post-procedural clinical 
follow-up results were evaluated. The following results include the clinical outcomes of all subjects 
that used BridgePoint Medical CTO System devices in treating refractory coronary artery CTO 
lesions. 

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4.1.1 
Characteristics of the Subjects 
The subjects that used BridgePoint Medical devices for treatment had an average age of 61.0 ± 
10.4, where most subjects were male (77%). Most subjects suffered from mild or moderate 
hypertension (83%) and high cholesterol (63%). 46% subjects suffered from diabetes type I or type 
II and 32% subjects had a smoking history. 16% subjects had previous CABG procedure history 
and 15% subjects had family history of coronary heart disease. 
4.1.2 
Lesion Characteristic  
CTO lesion is located in three main coronary arteries, where 42% in right coronary artery (RCA), 
35% in left anterior descending (LAD) and 23% in left circumflex (LCX). 
4.1.3 
Technical and Procedure Success 
Technical success is defined as the placement of a guidewire in the true vessel lumen outside the 
CTO distal end. Procedure success is defined as a successful recanalization of vessel (TIMI 3 flow). 
Technical success is realized in all subjects except for seven subjects, and then, revascularization is 
obtained successfully by drug eluting and/or placement of bare metal stent (37/44, 84%). Various 
methods are used in the procedure to achieve the success of the procedure. Table 4-1 summarizes 
the method to achieve technical success. 
Table 4-2: Methods of Technical Success 
Result 
Number of subjects 
Percentage of total 
subjects (%) 
Use CrossBoss CTO catheter to enter the true lumen 
24 
55% 
Use CrossBoss CTO Reentry System to reenter the true lumen 
12 
27% 
Use a standard guidewire to cross and reenter 
1 
2% 
Failed case 
7 
16% 
Total 
44 
100% 
Average procedure time is 99.5 ± 61.5 minutes. Average Fluoroscopy time is 32.1 ± 28.1 minutes, 
and average amount of radiation is 3.6 ± 2.3 Gray. 
4.1.4 
Safety 
During the study, there was no acute adverse event. Retrospective follow-up was performed on 31 
subjects 30 days after the procedure. In these 31 subjects, 3 (9.7%) experienced the adverse event 
within 30 days post procedure. Two subjects with an unsuccessful procedure had the angina again 
with slight myocardial enzymes elevation, and they received the CABG procedure subsequently. 
One subject had the angina again with slight (2x) troponin elevation after the procedure, but he did 
not receive a further treatment. 
4.1.5 
Conclusion 
For BridgePoint Medical CTO devices, during the initial general clinical use, the devices 
represented a high success rate in entering CTO distal true lumen with acceptable short-term 
complication rates. Although subjects had no inclusion/exclusion criteria and surgeon lacked 
technical experiences of the system, the overall results still numerically showed a very low 
complication rates. Its clinical results showed a high learning curve and good performance in 
technically challenging cases. 
4.2 European Union (EU) Clinical Trials 
From July, 2008 to June, 2009, the second clinical trial was conducted in Germany. The trial 
originally planned to enroll 100 subjects, but it was terminated prematurely due to the incoming CE 
mark approval. Forty-two subjects were enrolled at four sites with CTO-PCI experience. 

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The primary objective of this trial is to test the efficacy and safety of CrossBoss, Stingray catheter 
and Stingray guidewire in facilitating the placement of a guidewire beyond a coronary artery CTO 
lesion distal end, while not increasing the incidence of major acute complications when compared 
to traditional guidewire / supporting catheter technologies. The secondary objective is to assess 
ergonomic and engineering performances of CrossBoss and Stingray devices from physician’s 
preferences. 
4.2.1 
Clinical Trial Design 
It is a prospective, non-randomized, and multi-center study on subjects with coronary artery CTO 
lesions, and the subjects 1) planned to receive interventional procedures by using standard 
guidewire and catheter facilities, or 2) planned to conduct a procedure to open or bypass CTO. 
Study results will be compared with safety and efficacy of traditional guidewire technology 
reported by literatures, and data will be collected in the process of using traditional guidewire to 
determine refractory CTO for comparison.  
4.2.2 
Primary Efficacy Endpoint 
The primary efficacy endpoint of this study is the technical success. Technical success is defined as 
successful placement of a guidewire in the CTO distal true vessel lumen by using BridgePoint 
Medical System to cross the CTO lesion in those cases that were otherwise refractory to treatment 
with a currently marketed guidewire. 
The published success rate that using a variety of mechanical guidewires, guiding and supporting 
catheters and/or CTO-special device combination to cross the CTO is between 39% to 100% [3-6,9-
19]. If the data shows that in patients with CTO lesion that are uncrossable by using traditional 
guidewires, and the success rate is greater than 30% under 95% confidence level, the study is 
considered to be successful. 
4.2.3 
Secondary Efficacy Endpoint 
Total procedure time and total Fluoroscopy time are the secondary efficacy endpoints of the study. 
One month (30 days) result will also be summarized in a table. 
4.2.4 
Safety Results 
This study assessed relevant complications within 30 days after the procedure for BridgePoint 
Medical CTO System. Acute complications related to devices include: 
• 
Perforation with hemopericardium or pericardial tamponade. AMI caused by CrossBoss and 
Stingray devices. AMI is defined as remarkable CPK elevation (> 3 times of the upper limit 
with positive MB results) and troponin level between 0.02 to 0.10 microg/L. 
• 
MACE(including cardiogenic death, AMI related to lesions and emergent bypass procedure 
related to treatment segment) events. 
4.2.5 
Results 
In all enrolled 42 subjects, the average age was 66 ± 9 years old, 85.7% were male, 31.0% suffered 
from diabetes. 16.7% subjects had CABG history and 45.2% suffered from MI previously. Table 4-
2 below shows the overall statistics of enrolled subjects in the study. 
Table 4-3: Statistics of Subject 
Statistics 
results 
average age 
66 ± 9 years  (ranging from 48-83 years) 
Gender (male) 
36/42 (85.7%) 
CABG history 
7/42 (16.7%) 

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Statistics 
results 
MI history 
19/42 (45.2%) 
Hypertension (moderate and severe) 
25/42 (59.9%) 
Diabetes (all were type II) 
13/42 (31.0%) 
Hyperlipemia (moderate and severe) 
12/40 (30.0%) 
CAD family history 
8/34 (23.5%) 
Smoking history  
11/41 (26.8%) 
Angina 
36/42 (85.7%) 
CCS Angina classification (Class II or III) 
34/36 (94.4%) 
LVEF 
56 ± 15% 
4.2.5.1 
Characteristics of vessel and lesion 
The most commonly treated vessel was RCA (57.1%, 24/42), followed by LAD (21.4%, 9/42) and 
LCX (21.4%, 9/42). Nine subjects (21.4%) suffered from two vascular diseases and seven (16.7%) 
suffered from three vascular disease. The incidence of collateral branch bypass (circulation) is 
41.5%. Additional characteristics of vessel and lesion can be found in Table 4-3 below.  
Table 4-4: Characteristics of Lesion 
Characteristics of lesion 
Result 
Average vessel diameter 
2.9±0.4 (ranging from 2.0-3.5) 
Average lesion length 
36.0±30.1 (ranging from 3-150) 
Tortuosity (moderate) 
9/42 (21.4%) 
Angulation (≥90˚) 
10/42 (23.8%) 
Calcification (moderate and severe) 
9/42 (21.4%) 
Collateral branch involvement (moderate and severe) 
19/42 (45.2%) 
Ipsilateral collateral branch 
Contralateral collateral branch 
18/42 (42.9%) 
24/42 (57.1%) 
collateral branch bypass (circulation) 
17/41 (41.5%) 
Ostial lesion 
2/42 (4.8%) 
Proximal lesion 
27/42 (64.3%) 
Distal lesion 
10/42 (23.8%) 
Proximal to distal end 
2/42 (4.8%) 
Ostial to distal end 
1/42 (2.4%) 
4.2.5.2 
Primary efficacy endpoint 
In total 44 operations on 42 subjects, 28 subjects achieved the placement of the guidewire in CTO 
distal true lumen. Among them, one subject obtained the success after two procedures. The total 
success rate was 67% (28/42), slightly lower than the prespecified rate. Although the study only 
enrolled 42 subjects of the originally planned 100, the success rate was much higher than the 
historical benchmark result. Therefore, the study met the primary efficacy endpoint. 
The study did not prespecify the rate of secondary procedure endpoint, however, its result was very 
prospective. Total procedure time and total fluoroscopy time incorporated in the literature were 146 
minutes and 53 minutes respectively in average [19-23]. Total procedure time is defined as the time 
from inserting the first guiding catheter to withdrawing the last guiding catheter. The average 
procedure time of using BridgePoint Medical CTO System devices was 111±62 minutes 
(comparing to the literature average value, p < 0.001). The total X-ray radiation time of is defined 

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as the total time of exposure to the X-ray throughout the whole procedure. The Fluoroscopy time 
during the whole procedure was 41±22 minutes (compared with the average literature value, p = 
0.008). The 30-day revascularization result matches its primary efficacy endpoint result of 
28/42(67%). 
4.2.5.3 
Primary safety endpoint 
This study had two complication events in total, both of which were non-Q-wave myocardial 
infarction (NQMI) related to collateral branch loss. The two complication events were both MACE, 
therefore, the rate of MACE is 4.8% (2/42). Although it is not statistically significant, this result is 
better than prespecified endpoint of 5/100 (p=ns); and it is lower than prespecified upper limit of 
MACE 12/100 (p=0.23). Therefore, the study met its primary safety endpoint. There was no 
perforation in this study (0.0%, 0/42), and its result is also better than prespecified endpoint of 
6/100 (p=ns). 
4.2.6  Conclusion 
Although it only included 42 of planned 100 subjects, the study has overall beneficial results and 
achieves its safety and efficacy endpoint. Its primary efficacy endpoint (placing a guidewire in CTO 
distal true lumen) is significantly superior to the prespecified study endpoint (p<0.005). The 
primary safety endpoints, periprocedural AMI or perforation rate, are also within the prespecified 
ranges. The additional endpoints, total procedure time and total X-ray time, are also better than data 
in the existing literatures. High success rate and low complication rate observed in the study support 
to expand it to larger IDE trials.  
4.3 FAST-CTO Clinical Trial 
BridgePoint Medical CTO System was further assessed in FAST-CTO IDE clinical trial. On 
January 21st, 2009, FDA conditionally approved FAST-CTO IDE clinical trial (IDE #G080144). 
First subject was enrolled into the study on March 6th, 2009 and the last subject was enrolled on 
July 13th, 2010. A total of 147 subjects were enrolled at 16 sites. All subjects used one or more 
components of BridgePoint Medical System to treat at least one coronary artery chronic total 
occlusion (CTO) lesion. A summary of its clinical trial protocol and results are as following. 
4.3.1  Study Objective 
The primary objective of this trial is to test the efficacy and safety of CrossBoss, Stingray LP 
catheter and Stingray guidewire in facilitating the placement of a guidewire beyond a coronary 
artery CTO lesion distal end, while not increasing the incidence of major acute complications when 
compared to traditional techniques.  
4.3.2  Study Design 
The subjects enrolled in the FAST-CTO study had at least one refractory coronary artery CTO 
lesion. Data and Safety Monitoring Committee (DSMC) is responsible for auditing and adjudicating 
data during the whole study process. Similar to European Union study, primary safety endpoint is 
the incidence of MACE 30 days after the procedure. Primary efficacy endpoint is the technical 
success, and secondary efficacy endpoint includes total procedure time and total X-ray time. 
4.3.3   Result 
4.3.3.1  Demographic Characteristics of Subjects 
Subject’s demographic characteristics of FAST-CTO study are similar to those of subjects receiving 
CTO PCI in literatures,  but its lesion length is longer than CTO lesion length reported in the 
existing literatures. The average CTO length of subjects is 32.3±20.8 mm. Demographic 
characteristics of subjects are shown in the table below. Most subjects were male (86%) and 
suffering from one or more accompanying diseases, such as diabetes, hyperlipaemia, hypertension, 

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family history of coronary artery disease and/or smoking history. Table 4-4 below summaries the 
demographic characteristics of subjects, which are classified according to total difficulty in crossing 
the lesion: 
Table 4-5: Demographic Characteristics of Subjects Classified According to Refractoriness 
Subject parameter 
Total 
(n=147) 
Failure history 
of previous 
operation 
(n=59) 
Still difficult to 
cross for 10-15 
minutes under 
perspective (n=50) 
Guidewire 
enters the 
subintimal 
(n=38) 
p-value 
Age 
63.3± 9.1 
61.5± 9.3 
64.7± 8.6 
64.6± 9.1 
0.02 a 
Gender (male %) 
86% 
(127/147) 
85% 
(50/59) 
86% 
(43/50) 
89% 
(34/38) 
0.83 b 
Diabetes (type I or type II) 
36% 
(53/147) 
37% 
(22/59) 
34% 
(17/50) 
37% 
(14/38) 
0.93 b 
Hyperlipemia (moderate and 
severe) 
62% 
(88/143) 
58% 
(33/57) 
80% 
(39/49) 
43% 
(16/37) 
0.002 c 
Hypertension (moderate and 
severe) 
52% 
(75/144) 
43% 
(25/58) 
61% 
(30/49) 
54% 
(20/38) 
0.18 c 
CAD family history 
37% 
(52/142) 
49% 
(28/57) 
31% 
(15/49) 
25% 
(9/36) 
0.04 b 
Smoking history 
19% 
(28/147) 
22% 
(13/59) 
10% 
(5/50) 
26% 
(10/38) 
0.10 b 
Myocardial 
infarction 
history 
39% 
(58/147) 
34% 
(20/59) 
44% 
(22/50) 
42% 
(16/38) 
0.55 b 
Angina 
86% 
(126/147) 
83% 
(49/59) 
90% 
(45/50) 
84% 
(32/38) 
0.57 b 
CABG procedure history 
22% 
(33/147) 
17% 
(10/59) 
28% 
(14/50) 
24% 
(9/38) 
0.39 b 
History of previous attempts 
to cross  CTO lesion 
46% 
(67/147) 
100% 
(59/59) 
12% 
(6/50) 
5% 
(2/38) 
0.46 d 
a Using Kruskal-Wallis test 
b Using Freeman-Halton Exact test 
c Using Freeman-Halton Exact test and comparing moderate / severe to none / slight 
d Using Freeman-Halton Exact test and comparing the group with lesions that uncrossable after 10-
15 minutes’ attempt to the group that guidewire enters the subintimal 
4.3.3.2 
Characteristics of Target Vessel and CTO Lesion 
Target vessels receiving treatments in this study included all three primary coronary arteries, where 
right coronary artery (RCA) accounted for the vast majority. Table 4-5 summaries target vessel and 
devices used in its treatment. 
Table 4-6: Target Vessels And Devices Used 
CTO vessel 
Total (n=150) 
Only CrossBoss cases 
(n=73) 
True lumen reentry 
casesa(n=77) 
p-valueb 
Right coronary artery 
71% 
(106/150) 
75% 
(55/73) 
66% 
(51/77) 
0.24 

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Left anterior 
descending artery 
19% 
(29/150) 
14% 
(10/73) 
25% 
(19/77) 
Left circumflex artery 
10% 
(15/150) 
11% 
(8/73) 
9% 
(7/77) 
a Only including cases that used Stingray only and used all systems.  
b Using Freeman-Halton Exact test 
4.3.3.3  Primary Safety Endpoint 
It was adjudicated by the Data and Safety Monitoring Committee (DSMC) that eight adverse events 
occurred on seven subjects met the definition of major adverse cardiac events (MACE), the primary 
safety endpoint. The incidence of 30-day MACE 4.8%, which is lower than the acceptable rate of 
8.5% as described in clinical investigation plan (CIP),  so that it can refuse a null hypothesis of 30-
day MACE rate of 14% (p value is 0.0003). Therefore, FAST-CTO study met its primary safety 
endpoint. Table 4-6 summaries 30-day MACE and components of 30 days MACE. 
Table 4-7: 30-Day MACE 
Subject Events 
Total (n=147) 
MACE 
4.8% (7/147) 
Cardiac death 
1.4% (2/147) 
Q-wave MI 
0.0% (0/147) 
Non-Q-wave MI 
4.1% (6/147) 
Non-Q-wave MI a 
4.2% (6/143) 
Target lesion revascularization 
0.0% (0/147) 
Emergency CABG 
0.0% (0/147) 
a Excluding subjects that had no blood drawing or only one blood drawing in 6-8 hours. 
4.3.3.4  Primary Efficacy Endpoint 
Primary efficacy endpoint of FAST-CTO study is the technical success. Technical success is 
defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a 
guidewire in the CTO distal true lumen. The total success rate is 76.7% (115/150) according to 
lesions and 76.9% (113/147) according to subjects. This result is better than 54%, the lower limit of 
success rate set in this study, and higher than 61%, the acceptable upper limit. If the true potential 
success rate is 54%, it is observed that among 150 CTO lesions, 115 or more lesions were 
successful and p value <0.0001 (provided that these CTO lesions were independent lesions). 
Similarly, if the true potential success rate is 54%, it is observed that among 147 subjects, 113 or 
more subjects were successful and p value <0.0001 (provided that the success rate is a constant). 
Table 4-7 summaries the technical success rate according to used devices. Although there was no 
independent classification to support it, the results in all used modes exceeded the primary efficacy 
endpoint threshold. 
Table 4-8: Technical Success Classified by Used Devices  
CTO endpoint 
Total (n=150) 
Only CrossBoss 
(n=73) 
Reentry casesa 
(n=77) 
p-valueb 
Technical success 
77% 
(115/150) 
77% 
(56/73) 
77% 
(59/77) 
1.00 
a Only includes cases that used Stingray only and used all systems.  
b Using Fisher’s Exact test 

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4.3.3.5 
Secondary Efficacy Endpoint 
Total procedure time and total Fluoroscopy time are the secondary efficacy endpoints in FAST-
CTO study. Total procedure time is calculated from starting to place the guiding catheter in the 
target vessel to withdrawing the last guiding catheter from the target vessel. If it is needed to 
determine the refractoriness of a lesion in the procedure, total time of procedure shall minus the 
procedure time that used to determine the refractoriness of a lesion. X-ray time is total time of X-
ray during the procedure minus X-ray time needed for determination of the refractoriness of a 
lesion. The average total time of procedure is 105±54 minutes. The procedure time is remarkably 
less than historical data of 146 minutes (p value < 0.0001). The average total time of X-ray is 44±25 
minutes, which is also remarkebly less than historical data of 53 minutes (p value < 0.0001). 
As expected, failed procedures often needed a longer operation and X-ray time (Table 4-8) with a 
statistical significance. 
Table 4-9: Procedure and X-ray Time in Successful and Failed Procedure 
Measured 
values 
classified 
by 
procedure 
Total (n=145) 
Technical success 
(n=112) 
Technical failure 
(n=33) 
p-
valuea 
Procedure time 
-Average 
value 
± 
standard 
deviation 
- median (range) 
 
104.5±54.4 
96 (17-332) 
 
98.7±50.9 
90 (17-296) 
 
124.5±61.9 
105 (46-332) 
 
 
0.02 
X-ray time 
-Average 
value 
± 
standard 
deviation 
- median (range) 
 
44.2±25.4 
41 (5-163) 
 
41.4±24.2 
38.5 (5-138) 
 
53.4±27.7 
47 (10-163) 
 
 
0.01 
a Using Wilcoxon test 
4.3.3.6 
Safety Data Summary Related to Perforation 
Perforation rate in FAST-CTO study is similar to those observed in other CTO devices study (Table 
4-9) [9-12, 24]. The total perforation rate in FAST-CTO study is 6.8% (10/147), where 5 (3.4%) 
cases are attributed to BridgePoint Medical devices by the surgeon. Compared to perforation rate 
(12.4%) summarized in the literature,  in fact,  the total perforation rate in FAST-CTO study is 
remarkbly lower than the summarized perforation rate in the literature (p value =0.02). 
Table 4-10: Perforation Rate in Contemporary CTO Clinical Trials 
Surgeon 
Year 
Device 
Number of 
subjects (N) 
Perforation (count) 
Perforation (%) 
Tiroch23 
2008 
Crosser 
125 
14* 
11.2% 
Baim14 
2004 
SafeCross 
116 
3 
2.6% 
Cannon3 
2005 
Crosser 
45 
0 
0.0% 
Hamburger11 
1997 
Prima 
345 
73 
21.2% 
Melzi13 
2006 
Crosser 
28 
1 
3.6% 
Oesterle4 
1998 
Prima 
179 
24 
13.4% 
Orlic15 
2005 
Frontrunner 
50 
9 
18.0% 
Corcos10 
1998 
CrossWire 
56 
2 
3.6% 
Morino24 
2010 
Guidewire 
498 
53** 
10.6% 
Summarized literature data 
1442 
179 
12.4% 
FAST-CTO 
147 
10 
6.8% 

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*Including the following classifications defined in the paper: angiography result of guidewire 
exiting the true lumen (2.4%), myocardial blush of occluded location (2.4%), myocardial stain 
(4.8%) and adventitia spillage (angiography perforation, 1.6%). 
** including perforation at CTO lesion location (36) and perforation in retrograde channel (17) 
4.3.4  
Conclusion 
FAST-CTO clinical trial has successfully met its primary safety and efficacy endpoints, 30-day 
MACE and technical success. The study has also obtained positive results in procedure time, X-ray 
time and other secondary endpoints.  
Summary of clinical trial 
BridgePoint Medical CTO System has been assessed in many clinical trialsat different regions. The 
results of the above three trials showed its safety and performance, as well as consistently achieved 
safety and efficacy endpoints of the study. Using BridgePoint Medical CTO System can also reduce 
procedure and X-ray time. 
5. Device Description 
BridgePoint Medical CTO System (including CrossBoss Catheter,  Stingray LP catheter and 
Stingray Guidewire and Extension Wire) is intended to facilitate the placement of a currently 
marketed guidewire in the lumen across coronary artery stenosis lesion (including chronic total 
occlusion) before PTCA or stent implantation.  
Test Device : 
CrossBoss  Catheter  
Stingray LP Catheter 
Stingray Guidewire and Extension Wire 
5.1 CrossBoss Catheter: 
CrossBoss Catheter is a percutaneous catheter which is sterile and single-use with a diameter of 
2.3F, designed to facilitate the cross of occlusion in coronary vessel. It is achieved by pushinhing 
the 1mm diameter distal tip of the device to the occluded location in the autologous vessel lumen 
and then rotating and pushing the catheter when necessary to facilitate the cross of stenosis lesion. 
This device is designed to deliver the guidewire across the diseased segment. After the placement of 
a conventional guidewire, PTCA catheter and/or stent can be used to provide treatment benefits. In 
addition to facilitating the cross of guidewire simply, no treatment effect or benefit is provided by 
BridgePoint Medical CrossBoss Catheter or itself. 
The distal axle tube of CrossBoss Catheter provides a transition area between distal elasticity and 
turning expanded circular distal tips. The distal portion of CrossBoss Catheter has a hydrophilic 
coating, to enhance the lubricity. The torque meter is coaxially located above the proximal portion 
of CrossBoss Catheterr, to provide a comfortable user interface for device operations and provide a 
system based on ratchets at the same time, to prevent an excessive torque. 
5.2 Stingray LP Catheter: 
Stingray LP catheter is a 1.9F catheter which is sterile,  single-use and overall exchange type,  
designed to further facilitate the placement of the guidewire across CTO lesion by achieving to 
reenter the true vessel lumen on the condition that conventional guidewire or CrossBoss Catheter 
has been pushed into the subintimal plane. It is achieved by using a distal expandable element, and 
when using a radiopaque contrast medium for expansion, it provides visibility and intra-arterial 
stability. The distal expandable element includes two small-caliber expandable balloons adjacent 
the guidewire cavity. When expanding, these small-caliber balloons and lumens are usually defined 

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as plane geometry, where the structural width is about 2.5 times of its height (2.5mm and 1mm 
respectively). In the expandable element, the distal portion of catheter includes two face-to-face 
side ports, connecting with the center guidewire cavity. These ports allow the operator to guide the 
guidewire to the catheter axis tube in the guidewire cavity at a certain angle. Expandable element 
and side port can achieve to locate the distal tip of guidewire properly and accurately, to allow the 
reentry of subintimal interior tissue without any injury to adventitia and outer vessel wall. The 
device provides a passageway for re-pushing the guidewire into CTO distal true vessel lumen in this 
way. 
5.3 Stingray Guidewire and Extension Wire: 
Stingray Guidewire and Extension Wire is a guidewire series which is sterile and single-use with a 
diameter of 0.014 inch,  designed to facilitate the reentry of the guidewire into true vessel lumen 
during the use of the special reentry true lumen balloon dilatation catheter. In this device series, the 
distal portion of guidewire is designed to provide a variety of different distal elasticity. In addition, 
the distal portion also includes a platinum coil, to achieve the visibility. The distal tip of guidewire 
includes an angular geometric structure with transition to the circular tip. The short projecting 
portion (<0.014 inch) is protruded from the tip, helpful for the reentry into subintimal interior tissue 
smoothly without any injury to adventitia and outer vessel wall.  
Similarly, like CrossBoss Catheter, PTCA, atherectomy and/or stent technology can be used to 
achieve treatment requirements once a guidewire is placed. Like CrossBoss Catheter, in addition to 
facilitating the cross of guidewire simply, no treatment effect or benefit is provided by Stingray LP 
catheter and Stingray Guidewire and Extension Wire.  
5.4 Installation Instructions and the Use of Device 
Installation instructions will be provided with each device, including information on device 
preparation and use. In addition, for cases using investigative devices, the sponsor personnel will 
also be present. 
5.5 Necessary Training and Experience Required for Using Investigation Devices 
BridgePoint Medical study personnel will give investigative device use, clinical investigation plan 
(CIP) and case report form (CRF) trainings to all sites. The device training will include device 
demonstration which is consistent with the direction for use (DFU), including device preparation 
and product operation. All site trainings will be recorded in the training form stored at the sites.  
6. Study Objectives 
To assess the safety and efficacy of the BridgePoint CTO system in recanalization of  CTO lesions 
in a multicenter study in Chinese population.  
7. Study Endpoints 
All primary and secondary study endpoints will be assessed on the basis of intention to treat,  i.e.,  
analyzing all subjects who received BridgePoint CTO Medical System devices. 
7.1 Primary Study Endpoint 
• 
Technical Success: the ability of the BridgePoint Medical System to successfully facilitate 
placement of a guidewire beyond a CTO lesion in the true vessel lumen/within the collaterals  
• 
30-day MACE rate for CTO cases in which the BridgePoint Medical System was used   
MACE is defined as the composite of cardiac death, Q-wave and non-Q-wave myocardial 
infarction, and any ischemia-driven target lesion revascularization. (for MI definition please 
refer to section 31.2) 
7.2 Secondary Study Endpoint 

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• 
Procedural success: is a mean lesion diameter stenosis <50% in 2 near-orthogonal projections 
with TIMI 2-3 flow, as visually assessed by the physician, without the occurrence of in-
hospital Q wave MI, TLR, or cardiac death. 
• 
Total procedure time, defined as the time from inserting the first guiding catheter to 
withdrawing the last guiding catheter. If it is needed to determine the refractoriness of a 
lesion in the procedure, total procedure time shall minus the time used to determine the 
refractoriness of a lesion. 
• 
Total fluoroscopy time (i.e., total fluoroscopy time recorded in the procedure minus  
fluoroscopy time needed in determining refractoriness of a lesion in the procedure) and 
total radiation dose (mSv) of X-ray 
• 
Total contrast dose  
• 
Rate of MACE at 30 days, 6 months and 12 months 
• 
Rate of stent thrombosis (ST) at 30 days, 6 months and 12 months 
• 
Rate of cardiac tamponade at hospital discharge after the index procedure 
• 
Rate of kidney failure caused by contrast at hospital discharge after the index procedure 
8. Study Design 
FAST-CTO China clinical trial is a prospective,  non-randomized,  single-arm and multi-center 
post-marketing observational study,  intended to collect intraoperative and postoperative clinical 
data of BridgePoint CTO Medical System in the revascularization of CTO lesions in China’s real 
world settings. 
This trial planned to enroll 100 subjects at up to 10 sites in China. All subjects will be screened 
according to inclusion and exclusion criteria of the study protocol (see section 9). 
100 subjects are expected to be enrolled within 12 months. The study requires follow-up via 
telephone or clinical visit at the following time points: 30 days,  6 months and 12 months after the 
index procedure. The study design flow is shown in Figure 8-1. 
 
Figure 8-1: Study Design Flow Chart 

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9. Subject Enrollment 
If a subject meets all clinical and angiography inclusion criteria (see section 9.2) and fails to meet 
any clinical and angiography exclusion criteria (see section 9.3), he/she can be enrolled into FAST-
CTO China clinical trial. 
9.1. Inclusion Criteria 
Clinical Inclusion Criteria: 
CI1. Subject must be ≥ 18 but < 80 years of age 
CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and 
provides written informed consent before any trial-specific tests or procedures are performed 
CI3. Subject is eligible for percutaneous coronary intervention (PCI) 
CI4. Subject has symptomatic coronary artery disease or myocardial infraction (MI) with objective 
evidence of ischemia or silent ischemia 
CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG) 
Clinical screening (clinical inclusion 
criteria and signing ICF) 
Coronary angiography 
Screening and enrolling according to angiography 
inclusion criteria 
BridgePoint CTO System application 
Index PCI treatment 
Follow-up at 30th days 
Follow-up at 6th months 
Follow-up at 12th months 

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CI6. Subject is willing to comply with allprotocol-required follow-up evaluation 
CI7. Subject has a left ventricular ejection fraction (LVEF) ≥45% as measured within 60 days prior 
to enrollment 
Angiographic Inclusion Criteria: 
AI1. A maximum of one de novo CTO lesion in a native coronary arterywith thrombolysis in 
Myocardial Infarction (TIMI) flow grade 0 
AI2. Non-acute CTO lesion with an estimated duration of at least 3 months by clincial history 
and/or comparison with previous angiogram or electrocardiogram(ECG) 
AI3. The CTO lesion must have an angiographic landing zone≥ 10 mm proximal to any major 
bifurcation without severe calcification. 
AI4. Lesion length < 40mm without excessive tortuosity and angulation(>45°) 
9.2. Exclusion Criteria 
Clinical Exclusion Criteria: 
CE1. Subject has clinical symptoms and/or ECG changes consistent with Acute MI(include STEMI 
and Non- STEMI) within 1 week 
CE2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical 
circulatory support, intractable ventricular arrhythmias,  or ongoing intractable angina. 
CE3. Subject has received an organ transplant or is on a waiting list for an organ transplant 
CE4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the 
index procedure 
CE5. Planned PCI (including staged procedures) or CABG after the index procedure 
CE6. Subject has a known allergy to contrast (that cannot be adequately pre-medicated)and/or 
protocol-required concomitant medications (e.g.,  aspirin or all thienopyridines) 
CE7. Subject has one of the following (as assessed prior to the index procedure): 
• 
Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life 
expectancy of less than 12 months 
• 
Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)  
• 
Planned procedure that may cause non-compliance with the protocol or confound data 
interpretation 
CE8. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) 
CE9. Subject with out of range complete blood count (CBC) values that are determined by the study 
physician to be clinically significant. 
CE10. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis 
CE11. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L) 
CE12. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions 
CE13. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack 
(TIA) within the past 6 months 
CE14. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding 
CE15. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) or LVEF < 

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45%at the time of the index procedure 
CE16. Subject is participating in another investigational drug or device clinical trial that has not 
reached its primary endpoint or intends to participate in another investigational drug or device 
clinical trial within 12 months after the index procedure 
CE17. Subject had PCI within the previous 2 weeks 
CE18. Subject with known intention to procreate within 12 months after the index procedure 
(women of child-bearing potential who are sexually active must agree to use a reliable method of 
contraception from the time of screening through 12 months after the index procedure) 
CE19. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 
7 days prior to the index procedure in women of child-bearing potential) 
Angiographic Exclusion Criteria: 
AE1. Target lesion is an aorto-ostial lesion or located in left main coronary artery,  previous venous 
or arterial bypass grafts 
AE2. Target lesion involving a segment of previous stent 
AE3. Target vessel has excessive tortuosity and/or angulation proximal to the target lesion(>45°) 
AE4. Target lesion and/or the target vessel proximal tothe target lesionis moderately to severely 
calcified by visual estimate 
AE5. Target lesion is located within 5 mm of the origin of the left anterior descending (LAD) 
coronary artery or left circumflex (LCx) coronary artery by visual estimate 
AE6. Target lesionwill be accessed via a saphenous veingraft or arterial graft 
AE7. Subject has unprotected left main coronary artery disease (>50% diameter stenosis) 
AE8. Thrombus,  or possible thrombus,  present in the target vessel (by visual estimate) 
AE9. Target vessel has a dissection greater than National Heart,  Lung,  Blood Institute (NHLBI) 
type C 
10. Subject Accountability 
10.1 Point of Enrollment 
IF a subject signs an IRB/IEC approved informed consent form (ICF) and meets all inclusion 
criteria and fails to meet any exclusion criterion, it is considered that this subject is eligible to be 
enrolled into this study. The point of inserting any BridgePoint CTO device(s) into the body of the 
subject is the formal enrollment time point of this subject.  
10.2 Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study or lost 
to follow-up) shall be accounted for and documented. Subjects may choose to withdraw from the 
study at any time, with or without reason and without prejudice to further treatment, although 
withdrawal is not encouraged. Withdrawn subjects will not undergo any additional follow-up, nor 
will they be replaced. If a subject withdraws from the clinical investigation,  the reason(s) shall be 
reported. 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 
follow-up 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. 

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10.3 Enrollment Controls 
At least 100 subjects shall be enrolled at 5-10 China sites for this study and each site is allowed to 
enroll up to 25 subjects. 
11. Study Methods 
11.1 Data Collection 
Data collection schedule of FAST-CTO China study is summarized in Table 11.1-1. 
 

 
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Table 11.1-1: Data Collection Schedule 
 
Pre-procedure 
≤14 days 
Pre- 
procedure 
≤3days 
Procedure 
Post- 
procedure 
/prior to 
discharge 
follow-up and visit 
Telephone or 
hospital visit at 30 
days (±7 days) a 
Telephone or 
hospital visit at 6 
months (±30 days) a 
Telephone or 
hospital visit at 12 
months (±30 days) a 
Informed Consent Formb,  including 
date of signature 
 
X 
 
 
 
 
 
Demographic data,  including age and 
gender 
X 
 
 
 
 
 
 
Physical assessment,  including weight 
and height 
X 
 
 
 
 
 
 
Medical history,  including diabetes 
situation 
X 
 
 
 
 
 
 
Angina assessment 
X 
 
 
X 
X 
X 
X 
LVEFc 
X 
 
 
 
 
 
 
12 lead ECG 
 
X 
 
X 
 
 
 
Laboratory detection 
 
 
 
 
 
 
 
Serum creatinine and urea 
nitrogen 
X 
 
 
 
 
 
 
complete blood countd 
X 
 
 
 
 
 
 
Pregnancy teste 
X 
 
 
 
 
 
 
Total CK/CK-MB 
 
Xf 
 
Xg 
 
 
 
Troponinh 
 
X 
 
X 
 
 
 
Cardiac medication 
X 
Xi 
Xi 
Xi 
Xi 
Xi 
Xi 
Anticoagulant 
 
 
X 
 
 
 
 
Antiplatelet drug 
 
X 
X 
X 
X 
X 
X 
Recent previous PCI procedure 
information 
 
X 
 
 
 
 
 

 
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Table 11.1-1: Data Collection Schedule 
 
Pre-procedure 
≤14 days 
Pre- 
procedure 
≤3days 
Procedure 
Post- 
procedure 
/prior to 
discharge 
follow-up and visit 
Telephone or 
hospital visit at 30 
days (±7 days) a 
Telephone or 
hospital visit at 6 
months (±30 days) a 
Telephone or 
hospital visit at 12 
months (±30 days) a 
Procedure,  target lesion,  pre-dilation,  
post-dilation (if applicable) and study 
stent information 
 
 
X 
 
 
 
 
Angiography 
 
 
X 
 
 
 
 
AE assessment j 
 
 
X 
X 
X 
X 
X 
ADE、SAE、SADE、UADE、
USADE and device deficiency 
assessment k 
 
 
X 
X 
X 
X 
X 
a: All follow-up dates shall be calculated according to the index procedure. However, other protocol required follow-ups may be performed via 
telephone interview or an office visit within the applicable follow-up window. 
b: If the study Informed Consent Form is modified during the course of the trial, study subjects will be re-consented, if necessary. 
c: LVEF may be evaluated by angiography, echocardiogram, or radionuclide ventriculography within 60 days prior to enrollment. 
d: Differential is only required for subjects who have abnormal leukocyte values. 
e: A pregnancy test must be performed within7days prior to the index procedure in females of childbearing potential. 
f: Preprocedure cardiac enzymes can be drawn from the sheath at the time of sheath insertion. 
g: A minimum of 1 CK Total or CK-MB draw must be obtained within 1 day after the index procedure. If CK Total values are abnormal (>1× ULN), 
CK MB or troponin must be run. 
h: If neither CK Total nor CK-MB is drawn, troponin must be drawn. 
i: Collection is only required for subjects with any changes of cardiac medications. 
j: All AEs will be monitored and reported to BSC from the time of enrollment through the 12-month follow-up for all subjects enrolled  
k: ADEs, SAEs, SADEs, UADEs, USADEs, and device deficiencies will be monitored and reported to BSC from the time of enrollment through the 
12-month follow-up for all subjects enrolled. 

 
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Abbreviations: AE= Adverse event; ADE= Adverse device effect; CBC= Complete blood count; CK= Creatine Kinase; CKMB= Creatine kinase 
isoenzyme; ECG= Electrocardiogram; PCI= Percutaneous coronary intervention; SADE= Severe adverse device effect; SAE= Severe adverse event; 
UADE=Unanticipated adverse device effect; USADE= Unanticipated severe adverse device effect 

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11.2 Screening of Study Subjects 
This study will store a patient screening log,  to record the information of subjects failing to meet 
eligibility criteria (including screening failure reasons) of FAST-CTO China study. 
11.3 Informed Consent 
Before any study specific tests or procedures are performed, subjects who meet the clinical 
eligibility criteria will be asked to sign the IRB/IEC-approved study ICF. Subjects must be given 
ample time to review the ICF and have questions answered before signing.  
Study personnel should explain to the subject that even if the subject agrees to participate in the trial 
and signs the ICF,  catheterization may demonstrate that the subject is not a suitable candidate for 
the trial.  
Refer to section 10.1 for definition of point of enrollment. 
11.4 Up to 14 Days Prior to the Procedure 
The following preprocedural data shall be collected within 14 days prior to the index procedure 
(unless otherwise stated): 
• 
Confirmed to meet clinical eligibility criteria 
• 
Demographic data, including age and gender 
• 
Physical assessment, including weight and height 
• 
Medical history (general condition, heart, nerve, kidney and peripheral medical history), 
including but not limited to the following: 
o 
Diabetes condition 
o 
Current angina condition 
o 
LVEF measured within 60 days prior to enrollment 
• 
Laboratory detection 
o 
Serum creatinine and urea nitrogen 
o 
Complete blood count (CBC) and blood platelet 
o 
Women of child-bearing period are required to conduct the pregnancy test within 7 days 
prior to the procedure (according to local clinical routine practice,  serum and/or urine) 
• 
Current usage of cardiac medications 
11.5 Concomitant Medication Required in This Study 
For all subjects, a dual anti-platelet therapy (DAPT,  i.e.,  aspirin and clopidogrel) is recommended 
according to current ACC/AHA/SCAI/ESC guide. Recommended DAPT dose regimen and 
treatment length are as follows:  
Aspirin: 
• 
For subjects who have been taking aspirin ≥ 72 hours at the time of the index procedure, a 
loading dose is not required but recommended. The loading dose shall be described at the 
investigator’s decision . 
• 
For subjects who have not been taking aspirin ≥ 72 hours at the time of the index procedure, a 
loading dose is recommended prior to the procedure (the loading dose is recommended 24 

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hours prior to the procedure but no later than 2 hours after the index procedure). The loading 
dose shall be described at the investigator’s decision. 
• 
All subjects shall take aspirin indefinitely after the index procedure.  
P2Y12  inhibitors 
• 
For subjects who have been taking clopidogrel for ≥ 72 hours at the time of the index 
procedure,  a loading dose is not required. 
• 
For subjects who have not been taking clopidogrel for ≥ 72 hours at the time of the index 
procedure,  a loading dose is required prior to the procedure (the loading dose is recommended 
to be prior to the procedure but no later than 2 hours after the index procedure). The loading 
dose of clopidogrel is recommended as 600mg. 
• 
Subjects must be treated with clopidogrel for at least 6 months following the procedure. For 
subjects not at high risk of bleeding, clopidogrel treatment shall continue for at least 12 months 
following the procedure. 
Index procedure / cath lab medication: a proper anticoagulant therapy shall be given in the 
procedure according to local standard treatment practice. If heparin is used,  an activated clotting 
time (ACT) ＞ 250 seconds is recommended in the whole procedure. 
11.6 Up to 3 Days Prior to the Index Procedure 
The following preprocedural data of all subjects shall be collected within up to 3 days prior to the 
index procedure: 
• 
Current antiplatelet medication 
• 
Current cardiac medications; colletion is only required for subjects with any changes of cardiac 
medications 
• 
12 lead  Electrocardiogram (ECG)  
• 
Collection of the latest PCI procedure information,  including treated vessel,  location and 
procedure type 
• 
Laboratory detection 
o 
Total CK or CK-MB (if the total CK is >1×ULN,  CK-MB or troponin must be run) 
o 
Troponin (if CK / CK-MB cannot be run) 
It is recommended that the same type of cardiac enzyme shall be collected prior to and after the 
procedure during the hospitalization (i.e.,  not converting from CK-MB to troponin,  or vice versa). 
Note: preprocedural cardiac enzymes can be drawn from the sheath at the time of sheath insertion. 
11.7 Enrollment and Index Procedure 
Use the standard catheter puncture technique to perform the procedure. The time of inserting the 
first guiding catheter is the start time of the procedure. 
During the procedure, the following operation and assessment shall be completed: 
• 
coronary artery angiography: all patients shall receive angiography assessment in the procedure 
according to standard clinical routine practice. Angiography data and  films of enrolled subjects 
, as well as working records of technical personnel shall be submitted to Angiographic Core 
Laboratory for qualitative and quantitative analysis,  including the confirmation of the 
guidewire’s entery into the vessel subintimal. Angiography data and films of intervention on 

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non-target vessel in the index procedure do not need to be submitted to Angiographic Core 
Laboratory. 
• 
Confirm the lesion meets the inclusion criteria of angiography and fails to meet any exclusion 
criterion of angiography. 
• 
 
• 
When BridgePoint CTO device facilitates a guidewire to cross the target lesion and the 
guidewire is confirmed to locate in the true vessel lumen or distal collateral branch vessel 
lumen of target lesion, all subjects shall receive PCI treatment on the target lesion according to 
local clinical practice, such as using balloon catheters to make pre-dilation, stent implantation,  
etc.,  to target lesion. 
In this study, before the failure of BridgePoint CTO System device, other devices against CTO 
(such as Frontrunner,  Crosser or SafeCross, etc.) shall not be used,  but the intravascular 
ultrasound-guided true-lumen seeking and tracking (IVUS-TST) is allowed,  i.e.,  the technique in 
which the guidewire can cross (or re-cross) the true lumen and move forward along the true lumen 
to the distal vessel under the guidance of IVUS and taking the occluded segment as the target.  
11.8 End of Procedure / Prior to Hospital Discharge 
The end time of procedure is defined as the time of removing the guiding catheter (after the final 
angiography). The following steps shall be completed after removing the catheter sheath according 
to local clinical routine practice: 
• 
Record information of target lesion, guidewire and balloon catheter used, and information of 
pre-dilation, post-dilation (if applicable) and stent implantation and other information on 
corresponding eCRFs. 
• 
Record procedure information on corresponding eCRFs,  including start and end time of 
procedure,  total fluoroscopy time of X-ray,  total contrast dose used in the procedure,  etc. 
• 
Collect current cardiac medications: collection is only required for subjects with any changes of 
cardiac medications. 
• 
Record anticoagulation and antiplatelet medications during the procedure. 
• 
As described in section 24, complete recording and  assessment of adverse events in the 
procedure and and collect source documents. 
• 
12 lead ECG within 1 day post procedure 
• 
Laboratory detection  
o 
At least one CK Total or CK-MB draw must be obtained within 1 day after the index 
procedure. If the CK Total value is abnormal,  CK-MB must be run.  
o 
If CK/CK-MB is not used,  the troponin shall be run.  
Note: it is recommended that the same type of cardiac enzymes shall be collected prior to and after 
the procedure during the hospitalization. 
11.9 Follow-up 
All subjects will receive assessments at the following points; 
• 
30-day follow-up (30  7 days) 
• 
6-month follow-up (180  30 days) 

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• 
1-year follow-up (365  30 days) 
Follow-up may be performed via telephone interview or clinical visit. The following data will be 
collected at each follow-up visit: 
• 
Collection and assessment of adverse events during the follow-ups, as well as collection of 
the source documents, as described in section 24 
• 
Current angina condition assessment 
• 
Current antiplatelet medications (aspirin and thiophene pyridines). Information on dose 
change,  medication interruption and discontinuation  must be recorded. 
• 
Current cardiac medications: collection is only required for subjects with any changes of 
cardiac medications. 
11.9.1  Loss to Follow-up 
If a subject cannot return for follow up or cannot be contacted through telephone,  at least 3 
telephone contacts shall be made to obtain necessary information of the subject. All attempts shall 
be recorded in source documents. If a subject does not response to 3 telephone follow-ups,  a letter 
must be sent to the subject in registered post subsequently. If a subject does not response to the 
letter,  this subject shall be considered as a “loss to follow-up” of current study treatment or 
telephone contact. Investigators must attempt to contact the subject at each follow-up point and a 
registered mail shall be sent again if the subject cannot be contacted after 3 telephone contacts. 
Only after the subject cannot be contacted at the last follow-up,  the subject shall be considered as a 
loss to follow-up and a study end form shall be filled. 
11.10  Study End 
A 12 months follow-up will be conducted to all subjects after the procedure. In order to assess the 
study endpoint,  12 months follow-up data of each subject must be collected. 
11.11  Source Documents 
Where copies of the original source document as well as printouts of original electronic source 
documents are retained,  it is required that the copies be signed and dated by a member of the 
investigation center team with a statement that it is a true reproduction of the original source 
document 
12. Statistical Considerations 
Study Endpoint 
Primary Effectiveness Endpoint 
Technical success is defined as the ability of the BridgePoint Medical System to successfully 
facilitate placement of a guidewire beyond a CTO lesion in the true vessel lumen/within the 
collaterals 
Safety Endpoint 
30 days MACE is defined as cardiac death, Q-wave and non-Q-wave myocardial infarction (total 
CK is two times larger than normal upper limit and MB score is positive) and ischemia driven  
target lesion revascularization (TLR) . 
Additional Study Endpoints 
• 
Procedure success: is a mean lesion diameter stenosis <50% in 2 near-orthogonal 
projections with TIMI 2-3 flow, as visually assessed by the physician, without the 

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occurrence of in-hospital Q wave MI, TLR, or cardiac death. 
• 
Total procedure time, and the definition is the time from inserting the first guiding catheter 
to withdrawing the last guiding catheter minus the procedure time for determing the 
refractoriness of a lesion. 
• 
Total time (i.e., total time of X-ray measured by site fluoroscopy system minus X-ray time 
for determining refractoriness of a lesion) and total radiation dose (mSv)  
• 
Total contrast dose 
• 
Rate of MACE at 30 days, 6 months and 12 months 
• 
Rate of stent thrombosis (ST) at 30 days, 6 months and 12 months 
• 
Rate of cardiac tamponade before hospital discharge 
• 
Rate of kidney failure caused by contrast before hospital discharge 
11.2 Hypothesis and Sample Size 
This study is an observational single-arm trial with no formal statistical hypothesis. The study 
planned to enroll 100 patients with CTO lesions,  and will use BridgePoint Medical CTO System 
for treatment. The enrollment be completed at up to 10 sites. 
11.3 General Statistical Methods 
11.3.1  Analysis Set 
Effectiveness: 
Primary effectiveness analysis will include enrolled subjects that meet all inclusion/exclusion 
criteria and use any component of BridgePoint Medical CTO System (CrossBoss catheter, Stingray 
LP catheter or Stingray guidewire). 
Safety: 
Safety analysis will include all enrolled subjects that use any component of BridgePoint Medical 
CTO System. 
11.3.2  Data Analysis  
Continuous variables (mean, standard deviation, observation number, minimum and maximum) and 
discontinuous variables (percentage and number of events / number of samples) of baseline and 
clinical outcome variables will be summarized by descriptive statistics. 
This study will collect patient follow-up information during and post procedure, at hospital 
discharge or at 30 days, 6 months and 12 months post procedure as described in the clinical trial 
schedule,  using descriptive statistics to summarize continuous variables such as procedure time and 
X-ray time (such as mean,  standard deviation,  observed value,  minimum and maximum value) 
and discontinuous variables (frequency table or percentage). 
Clinical event rate will be expressed by percentage, and continuous variables will be expressed by 
number of samples, mean value, standard deviation, minimum and maximum value, where point 
estimation and 95% confidence limit will be provided. 
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 Medidata EDC System. All 

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changes made to the clinical data will be captured in an electronic audit trail and available for 
review by the sponsor 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 Medidata 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 his/her designee or Investigational site will maintain,  at the 
investigative site,  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 study completion/termination,  or follow the individual site guidance if 
the site required retention period is longer. BSC will retain these documents until the product/device 
is no longer in use according to 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. 
12.3 Core Laboratory  
FAST-CTO China study will use Angiographic Core Laboratory to analyze angiographic data. The 
result of Angiographic Core Laboratory will be input and uploaded to EDC system and provided to 
BSC only. For specific operations, refer to core laboratory operation manual.  
Angiographic data of the index procedure and revascularization on target vessel at 1 year follow-up 
shall be submitted to Angiographic Core Laboratory for QCA analysis and assessment. Relevant 
data obtained outside the site shall also be sent to Core Laboratory for assessment. 
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/REB 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 

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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. 
15. Device / Equipment Inventory 
This study is a post-marketing clinical study, and the sponsor will not provide investigational device 
/ equipment.  
16. Compliance 
Statement of Compliance 
This study will be conducted in accordance with ISO 14155:2011 (2nd Edition; 2011-02-01) Clinical 
Investigation of Medical Devices for Human Subjects- GCP,  or the relevant parts of the ICH 
Guidelines for GCP,  ethical principles that have their origins in the Declaration of Helsinki,  and 
pertinent China’s laws and regulations. The study shall not begin until the required 
approval/favorable opinion from the IRB/IEC and/or regulatory authority has been obtained,  if 
appropriate. Any additional requirements imposed by the IRB/IEC or regulatory authority shall be 
followed,  if appropriate 
17. 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.  
• 
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. 

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• 
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 theclinical research monitor or auditorand 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. 
• 
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 

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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. 
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. 
18. 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 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. 
19. 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 protocols 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.  
20. Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health care 
personnel (collectively HCP) as needed during implant,  testing required by the protocol,  and 

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follow-ups. Support may include HCP training,  addressing HCP questions,  or providing 
clarifications to HCPs concerning the operation of BSC equipment/devices 
In addition,  BSC personnel may perform certain activities to ensure study quality. These activities 
may include the following. 
• 
Observing testing or medical procedures to provide information relevant to protocol 
compliance 
• 
Reviewing collected data and study documentation for completeness and accuracy 
• 
Boston Scientific personnel will not do the following.  
• 
Practice medicine 
• 
Provide medical diagnosis or treatment to subjects 
• 
Discuss a subject’s condition or treatment with a subject without the approval and presence of 
the investigator 
• 
Independently collect critical study data (defined as primary or secondary endpoint data) 
• 
Enter data in electronic data capture systems or on paper case report forms 
21. 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. 
22. Monitoring 
According to study monitoring plan, the monitoring shall be conducted during the whole study, to 
assess clinical study and approved protocol/amendment as well as compliance with relevant 
regulations. In addition, the monitor will check informed consent form from all enrolled subjects at 
the site, and preservation of study records, including data timeliness, completeness and accuracy 
and whether site has sufficient investigators and equipments to conduct this study safely and 
effectively. If protocol violations and compliance exceed the prespecified threshold, it will need to 
increase the site monitoring frequency and / or take corresponding corrective actions. Source 
documents shall include but are not limited to: informed consent forms (ICF), patient source 
medical record, angiographic results, laboratory results, SAEs reports and device inventory record 
forms. Data related to device deficiency, relationship between AE and study device, procedure and 
anticipatory assessment of ADE recorded on eCRF can also be considered as source data of this 
study. Source data verification (SDV) shall be performed on data reaching primary endpoints. SDV 
of this study can be reduced as appropriate after reaching primary endpoints. 
Investigator / study site guarantees that Boston Scientific study personnel and its designated 
personnel and relevant regulatory authorities can check source documents directly (electronic 
source documents refer to the scanning documents signed and approved by clinician or hard copy 
source documents refer to hand-written medical records in clinical practice). If an source medical 
record cannot be obtained due to the reason that the subject was admitted to a non-study hospital 
and non-study doctor, copies of source documents shall be verified. As described in section 20, 
copies of source documents related to SAE (from site and non-study hospital, if applicable) need to 
be obtained and submitted to Boston Scientific Safety team. 
This study may also be possible to be audited by Boston Scientific and its designated personnel, or 

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be inspected by supervision organizations. It shall be ensured that duiring the monitoring visit or 
inspection,  investigators and other study personnel shall be present on site with plenty of time. 
23. Potential Risks and Benefits  
23.1 Risks Related to PCI / Stent Implantation 
Potential AEs (in alphabetical order) which may be associated with the implantation of a coronary 
stent in a native coronary artery include those associated with percutaneous transluminal coronary 
angioplasty as well as additional risks related to the use of stents are listed below:  
• Abrupt stent closure 
• Acute MI 
• Allergic reaction to anticoagulant and/or antiplatelet therapy, contrast medium, or stent 
materials  
• Angina 
• Arrhythmias, including ventricular fibrillation and ventricular tachycardia 
• Arteriovenous fistula 
• Bleeding 
• Cardiac tamponade 
• Cardiogenic shock/pulmonary edema 
• Coronary aneurysm 
• Death 
• Dissection 
• Emboli, distal ( air, tissue, or thrombotic material or material from devices(s) used in the 
procedure)  
• Heart failure 
• Hematoma 
• Hemorrhage, which may require transfusion 
• Hypotension/hypertension 
• Infection, local or systemic 
• Myocardial ischemia  
• Pain at access site 
• Perforation or rupture of coronary artery 
• Pericardial effusion 
• Femoral pseudoaneurysm,  
• Renal insufficiency or failure 
• Respiratory failure 
• Restenosis of stented segment 
• Stent deformation 
• Stent embolization or migration 
• Stent fracture 
• Stent thrombosis/occlusion 
• Stroke/cerebrovascular accident/transient ischemic attack 
• Total occlusion of coronary artery 
• Vessel spasm 
• Vessel trauma requiring surgical repair or reintervention 
23.2 Risks Related to Study Device 
Potential adverse events related to the use of BridgetPoint CTO System device include but are not 
limited to the following items;   

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 
Acute myocardial infarction 
 
Vessel trauma requiring surgical repair or reintervention 
 
Massive hemorrhage or hematoma  
 
Arterial spasm 
 
Embolism 
 
Stroke 
 
Neurologic impairment 
 
Drug reactions, allergic reactions to contrast medium 
 
Infection 
 
Cardiac tamponade 
 
Recurrence of angina  
23.3 Risks Related to Participating in Clinical Study 
Except for the above risks of PCI and coronary artery stent implantation,  long time use of dual 
antiplatelet treatment after the procedure may increase the risk of bleeding. 
23.4 Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol,  
performing procedures in the appropriate hospital environment,  adherence to subject selection 
criteria,  close monitoring of the subject's physiologic status during research procedures and/or 
follow-ups and by promptly supplying BSC with all pertinent information required by this protocol. 
23.5 Anticipated Benefits 
Anticipated benefits of this study is the ability to successfully facilitate the antegrade placement of a 
guidewire beyond a chronic complete occlusion lesion (CTO) in a PCI procedure, so that this kind 
of coronary artery lesions may receive interventional treatment and patient’s symptoms may 
improve.  
23.6 Risk Benefit Ratio 
BridgetPoint CTO System device is anticipated to achieve its intended treatment objectives. There 
are no unacceptable residual risks / intolerable risks, and all applicable risks have been stated in the 
product instruction for use. Anticipated risk and benefit assessment for BridgetPoint CTO System 
device states that its benefits exceed its risks under established conditions of use. 
24. Safety Report 
24.1 Definitions and Classifications 
Table24-1: Safety Reporting Definitions 
Term 
Definition 
Adverse Event(AE) 
 
Ref: ISO 14155 
Ref: MEDDEV 2.7/3 12 
 
 
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 

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Table24-1: Safety Reporting Definitions 
Term 
Definition 
to the investigational medical device. 
Adverse Device Effect (ADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3 / 
Adverse event related to the use of an investigational medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies or 
inadequaciesin 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 
 
Ref: MEDDEV 2.7/3  
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 
 
Ref: MEDDEV 2.7/3  
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 
 
Ref: MEDDEV 2.7/3 
 
Note: only for clinical study 
outside of the United States,  
otherwise please delete this item 
Serious adverse device effect which by its nature, incidence, severity, or outcome 
has not been identified in the current version of the risk analysis report. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect which 
by its nature, incidence, severity or outcome has been identified in the risk 
analysis report. 
Device Deficiency 
 
Ref: ISO 14155- 
 
Ref: MEDDEV 2.7/3  
A inadequacy of an investigational 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 

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Table24-1: Safety Reporting Definitions 
Term 
Definition 
regulations, or the protocol. 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 
Unless its severity or frequency increases during the study,  basic diseases shall not be reported as 
AEs. Death shall not be reported as AEs and shall be reflected as a specific SAE outcome (AE 
definition is given in Table 24.1-1). 
All AE of study subjects occurred after the enrollment,  whether occurred during or after the 
procedure,  shall be recorded in eCRF. 
Known risks related to study device are given in section 23. 
Device deficiency and other device problems shall not be reported as a AE. On the contrary,  
according to CRF completion guideline of this study,  they shall be reported on corresponding 
eCRF (device deficiency form). If there are any AEs caused by device deficiency and other device 
problems,  this AE shall be reported on corresponding eCRF (adverse event form). 
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. 
24.2 Relationship to Study Device(s) 
The Investigator must assess the relationship of the AE to the study device or procedure. See 
criteria in Table 24-2. 
Table 24-2: Criteria for Assessing Relationship of Study Device or Procedure to AE 
Classification 
Description 
Not Related 
Ref: MEDDEV 2.7/3 
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. 

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Classification 
Description 
Unlikely Related 
Ref: MEDDEV 2.7/3 
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 
Ref: MEDDEV 2.7/3 
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 
Ref: MEDDEV 2.7/3 
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. 
Causal Relationship 
Ref: MEDDEV 2.7/3 
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 
-the investigational device or procedures are applied to;-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 as related or 
unrelated.  Criteria are defined in Table 24-3. 
Table 24-3: Criteria for Assessing Relationship of Antiplatelet Medication to AE 
Classification 
Description 
Unrelated 
The adverse event is determined to be due to a concurrent illness or effect of a device/drug and is 
not determined to be potentially related to the antiplatelet medication. 
Related 
The adverse event is determined to be potentially related to the antiplatelet medication,  and an 
alternative etiology is equally or less likely compared to the potential relationship to antiplatelet 
medication. 
24.3 Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 24-4. 
Table 24-4: Investigator Reporting Requirements 
Event 
Classification 
Communication Method  
Communication Timeline (pre-
market studies)* 
Communication 
Timeline 
(post-market studies)** 
Unanticipated 
Adverse 
Device 
Effect 
/ 
Unanticipated 
Serious 
Adverse 
Complete AE eCRF page 
with all available new and 
updated information. 
Special for China;  
Within 24 hours of first becoming 
aware of the event 
Within 24 hours of first 
becoming aware of the event 

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Device Effect  
Serious 
Adverse 
Event 
Complete AE eCRF page 
with all available new and 
updated information. 
Special for China;  
Within 24 hours of first becoming 
aware of the event 
Within 24 hours of first 
becoming aware of the event  
Reporting is required through 
the end of the study 
Provide all relevant source 
documentation 
(unidentified) for reported 
event upon request of the 
sponsor 
When source documents are 
available 
When source documents are 
available 
Serious 
Adverse 
Device Effects 
Complete AE eCRF page 
with all available new and 
updated information. 
Within 24 hours of first becoming 
aware of the event 
Within 24 hours of first 
becoming aware of the 
event Reporting of ADEs 
is required through the end of 
the study 
Provide all relevant source 
documentation 
(unidentified) for reported 
event 
When source documents are 
available 
When source documents are 
available 
Device 
Deficiencies 
(including but not 
limited to failures,  
malfunctions,  and 
product 
nonconformities) 
Note: 
 
Any 
Investigational 
Device Deficiency 
that might have led 
to 
a 
serious 
adverse event if a) 
suitable action had 
not been taken or 
b) intervention had 
not been made or 
c) if circumstances 
had 
been 
less 
fortunate 
is 
considered 
a 
reportable event. 
Complete 
CRF 
Device 
Deficiency page with all 
available new and updated 
information. 
Reporting is required within 24 
hours of first becoming aware of 
the event through the end of the 
study. 
Reporting is required within 
24 hours of first becoming 
aware of the event through 
the end of the study. 
Adverse 
Event 
including Adverse 
Device Effects 
Complete AE eCRF page, 
which 
contains 
such 
information as date of AE,  
treatment of AE resolution,  
assessment of seriousness 
and 
relationship 
to 
the 
device. 
 
Timely report (such as ,  
within 10 working days of 
first becoming aware of the 
event) 
 
Reporting 
is 
required 
through the end of the study 
Special for China 
 
no later than 10 working 
days 
of 
first 
becoming 
aware of the event 
 
Reporting 
of 
AEs 
is 
required until the end of 
XXX follow-up 
 Reporting of ADEs is 
• 
Timely reporting (such 
as ,  within 30 of first 
becoming aware of the 
event) 
• 
Reporting is required 
through the end of the 
study 

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required through the end of 
the study  
Abbreviations; AE=Adverse Event; CRF= Case Report Form; eCRF=Electronic Case Report Form; 
IDE= Investigational Device Exemption; UADE=Unanticipated Adverse Device Effect 
25 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. 
Refer to Table 24-4 when reporting. 
Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
BSC is responsible for reporting adverse event information and device deficienciesinformation to 
all participating Principal Investigators and regulatory authorities,  as applicable.  
The Principal Investigator is responsible for informing the IRB/EC,  and regulatory authorities of 
UADE and SAE as required by local/regional regulations. 
According to China local reporting requirements,  Boston Scientific Corporation will report all 
SAEsand device deficienciesthat could lead to SAEs to the local regulatory authorities within 5 
business days of BSC first becoming aware of the event,  and notify all participating 
investigators/sitesand IRBs/ECs in a timely manner.  
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. 
Boston Scientific Corporation,  Investigator,  or Site must notify the EC of UADEs,  USADEs,  
SADEs,  SAEs,  Device Deficiencies and/or other CEC events as applicable according to local 
reporting requirements. A copy of the Investigator’s reports and other relevant reports (if 
applicable) to the IRB/IEC must be provided to BSC in accordance with local requirements. 
26 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 

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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 accepted by BSC or 
its delegate (e.g. CRO), and approved by 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,  
 
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, catheterization may demonstrate that the subject is not a suitable candidate for 
the trial. A Screening Log will be maintained by the investigational site to document select 
information about candidates who fail to meet the trial eligibility criteria, including, but not limited 

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to, the reason for screen failure. 
27 Committees 
27.1 Safety Monitoring Process 
To promote early detection of safety issues, the BSC Safety team and its delegated CRO Safety 
team will provide review, process, monitor and evaluation of the safety events defined in the study-
specific safety plan. Success of this program requires dynamic collection of unmonitored data as 
soon as the event is reported. During regularly scheduled monitoring activities, clinical research 
monitors will support the dynamic reporting process through their review of source document and 
other data information. The BSC Medical Safety group includes physicians with expertise in 
vascular intervention and with the necessary therapeutic and subject matter expertise to evaluate 
and classify the events into the categories outlined above. 
27.2 Ethics Committee 
Prior to the enrollment of subjects into this study and transportation of the study products, Boston 
Scientific must obtain a copy of the written approval (or allowance of performing this clinical 
study) to this protocol and informed consent form (ICF) that provided by EC and / or Institutional  
Review Board. 
The investigator report and a copy of the EC approval letter shall be provided to the sponsor. 
27.3 Clinical Events Committee 
This study will use the Clinical Events Committee (CEC). CEC is an independent organization with 
relevant experiences,  and CEC consists of cardiologists and cardiovascular interventional experts 
with relevant event adjudication experiences. Its responsibilities,  qualifications,  and CEC 
procedures will be listed in the CEC charter. CEC mainly reviews and adjudicates AE related to 
important clinical endpoints that reported by investigators. CEC committed member will review a 
safety event dossier,  which may include source document copies of all TVR,  MI (Q-wave or non-
Q-wave) and death cases provided by site. 
27.4 Executive Committee 
An executive Committee composed of Boston Scientific clinical management personnel,  study 
principle investigators and other experienced investigators. This committee will be responsible for 
the overall conduct of the study which will include protocol development,  study progress,  subject 
safety,  data quality and integrity, and dissemination of study results through appropriate scientific 
sessions and publications. If applicable,  Executive Committee may request participation of  FAST-
CTO China investigators on the Committee. 
28 Suspension or Termination 
28.1 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. 
28.1.1 
Criteria for Premature Termination of the Study 
Reasons for premature termination of the study may include but are not limited to: 
 
Important new information that affects the continuation of the study (such as safety and product 
performance). 
 
Regulatory authorities does not agree to conduct this clinical study. 

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 
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. 
28.2 Investigator Terminates the Study or Ethical Approval Withdrawal 
Any investigator or EC of FAST-CTO China trial may discontinue participation in the study or 
withdraw approval of the study, respectively, with suitable written notice to BSC. Investigators, 
associated ECs, and regulatory authorities, as applicable, will be notified in writing in the event of 
these occurrences. 
28.3 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 sites 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. 
28.4 Criteria for Suspending/ Termination of a Study Site 
BSC reserves the right to stop the inclusion of subjects at a study center at any time after the study 
initiation visit if no subjects have been enrolled, if enrollment is significantly slower than expected, 
or if the center has multiple or severe protocol violations without justification and/or fails to follow 
remedial actions. 
Adverse event assessment and reporting would continue for all subjects who received a study 
device. The Principal Investigator at the center must provide follow-up visits unless BSC notifies 
the investigational center otherwise. 
29 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 

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at the onset of the project. 
30 Bibliography 
1. Oesterle SN, Bittl JA, Leon MB, Hamburger J, Tcheng JE, Litvack F, Margolis J, Gilmore P, 
Madsen R, Holmes D, Moses J, Cohen H, King S, 3rd, Brinker J, Hale T, Geraci DJ, Kerker 
WJ, Poprna J. Laser wire for crossing chronic total occlusions: "learning phase" results from 
the U. S. TOT AL trial. Total Occlusion Trial With Angioplasty by Using a Laser Wire. Cathet 
Cardiovasc Diagn 1998 ;44 (2):235-43. 
2. Simes PA, Golf S, Myreng Y, Molstad P, Ernanuelsson H, Albertsson P, Brekke M, 
Mangschau A, Endresen K, Kjekshus J. Stenting in Chronic Coronary Occlusion (SICCO): a 
randomized, controlled trial of adding stent implantation after successful angioplasty. J Arn 
Coll Cardiol 1996;28 (6): 1444-51. 
3. Moussa I, Di Mai·io C, Moses J, Reimers B, Di Francesco L, Blengino S, Colombo A. 
Comparison of angiographic and clinical outcomes of coronary stenting of chronic total 
occlusions versus subtotal occlusions. Arn J Cardiol 1998;81 (I): 1-6. 
4. Simes PA, Myreng Y, Molstad P, Bonarjee V, Golf S. Improvement in left ventricular ejection 
fraction and wall motion after successful recanalization of chronic coronary occlusions. Eur 
Heart J 1998; 19 (2):2 73-81. 
5. Simes PA, Golf S, Myreng Y, Molstad P, Albertsson P, Mangschau A, Endresen K, Kjekshus J. 
Sustained benefit of stenting chronic coronary occlusion: long-term clinical follow-up of the 
Stenting in Chronic Coronary Occlusion (SICCO) study. J Arn Coll Cardiol 1998;32 (2) :305-1 
0. 
6. Kasper D, Braunwald E, Hauser S, Longo D, Jameson J, Fauci A. Harrisons Principles of 
Internal Medicine: McGraw-Hill Education, 2004. 
7. Surrnely JF, Tsuchikane E, Katoh 0 , Nishida Y, Nakayama M, Nakamura S, Oida A, Hattori E, 
Suzuki T. New concept for CTO recanalization using controlled antegrade and retrograde 
subintirnal tracking: the CART technique. J Invasive Cardiol 2006;18 (7):334-8. 
8. Lombardi W, Christofferson R, Whitlow P. Guidewire Lumen Course During Coronary CTO 
Procedures. Bellingham, WA: St. Joseph Hospital, 2007. 
9. Werner GS, Fritzenwanger M, Prochnau D, Schwarz G, Krack A, Ferrari M, Figulla HR. 
Improvement of the primary success rate of recanalization of chronic total coronary occlusions 
with the Safe-Cross system after failed conventional wire attempts. Clin Res Cardiol 2007;96 
(7):489-96. 
10. Meier B. Chronic Coronary Occlusion - Treatment Options and Results. J Invasive Cardiol 
1997;9 (1):56-60. 
11. Pande AK, Meier B, Urban P, de la Serna F, Villavicencio R, Dorsaz PA, Favre J. 
Magnum/Magnarail versus conventional systems for recanalization of chronic total coronary 
occlusions: a randomized comparison. Arn Heart J 1992;123 (5): 1182-6. 
12. Hosny AA, Lai OM, Mancherje C, Lee G. Successful Recanalization Using a 
HydrophilicCoated Guide Wire in Total Coronary Occlusions After Unsuccessful PTCA 
Attempts with Standard Steerable Guide Wires. Journal oflnterventional Cardiology 1990;3 
(4) :225-30. 
13. Rees M, Sivananthan M, Verma S. The use of hydrophilic T erurno glidewires in the treatment 
of chronic coronary artery occlusions. Circulation 1991 ;84 (11): 519. 
14. Freed M, Boatman JE, Siegel N, Safi.an RD, Grines CL, O'Neill WW. Glidewire treatment 
ofresistant coronary occlusions. Cathet Cardiovasc Diagn 1993;30 (3):201-4. 
15. Reimers B, Camassa N, Di Mario C, Akiyama T, Di Francesco L, Finci L, Colombo A. 
Mechanical recanaliz.ation of total coronary occlusions with the use of a new guide wire. Arn 
Heart J 1998;135 (4):726-31. 

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16. Corcos T, Favereau X, Guerin Y, T oussaint M, Ouzan J, Zheng H, Pentousis D. Recanalization 
of chronic coronary occlusions using a new hydrophilic guidewire. Cathet Cardiovasc Diagn 
1998;44 (1):83-90. 
17. Freed M. Chronic Total Occlusion. In: Freed M, Grines CL, Safi.an RD, editors. The New 
Manual of Interventional Cardiology: Physicians Press, 1996. 
18. Puma JA, Sketch MH, Jr., Tcheng JE, Harrington RA, Phillips HR, Stack RS, Califf RM. 
Percutaneous revascularization of chronic coronary occlusions: an overview. J Arn Coll Cardiol 
1995;26(1):1-11. 
19. Lindsay J, Jr., Pinnow EE, Pichard AD. Frequency of major adverse cardiac events within one 
month of coronary angioplasty: a useful measure of operator performance. J Arn Coll Cardiol 
1999;34 (7): 1916-23. 
20. Harrell L, Schunkert H, Palacios IF. Risk predictors in patients scheduled for percutaneous 
coronary revascularization. Catheter Cardiovasc Interv 1999;48 (3):253-60. 
21. Cremonesi A, Benit E, Carli er M, Colombo A, Piva R, Probst P, Wirtzfeld A, PicoBourdonnec 
C, Corcos T. Multi.center registry to evaluate the efficacy of the NIROY AL stent in de novo or 
restenotic coronary stenosis. J Invasive Cardiol 2000;12 (5):225-32. 
22. Schuhlen H, Kastrati A, Dirschinger J, Hausleiter J, Elezi S, Wehinger A, Pache J, Hadarnitzky 
M, Schornig A. Intracoronary stenting and risk for major adverse cardiac events during the first 
month. Circulation 1998;98 (2): 104-11. 
23. Biondi-Zoccai GG, Bollati M, Moretti C, Sciuto F, Omede P, Lombardi P, Previ GP, Sheiban I. 
Retrograde percutaneous recanalization of coronary chronic total occlusions: Outcomes from 
17 p atients. Int J Cardiol 2007. 
24. Hoye A, van Domburg RT, Sonnenschein K, Serruys PW. Percutaneous coronary intervention 
for chronic total occlusions: the Thoraxcenter experience 1992-2002. Eur Heart J 2005;26 
(24):2630-6.  
25. Thygesen K, Alpert JS, Allan S, et al. Third universal definition of myocardial infarction. J Am 
Coll Cardiol 2012;60:1581–98. 
26. Moussa ID,  Klein LW, Shah B, et al.  Consideration of a New Definition of Clinically 
Relevant Myocardial Infarction After Coronary Revascularization: An Expert Consensus 
Document From the Society for Cardiovascular Angiography and Interventions (SCAI). J Am 
Coll Cardiol 2013;62:1563–70. 
 

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31. Abbreviations and Definitions 
31.1 Abbreviations  
The abbreviations are shown in Table 31-1 
Table 31-1: Abbreviations  
Abbreviation/Acronym 
Term 
ACC 
American College of Cardiology 
ACT 
Activated Clotting Time 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AHA 
American Heart Association 
ARC 
Academic Research Consortium 
BSC 
BSC China 
BMS 
Bare Metal Stent 
CABG 
Coronary Artery Bypass Graft 
CBC 
Complete Blood Count 
CEC 
Clinical Events Committee 
CFDA 
China Food and Drug Administration 
CK 
Creatine Kinase 
CK-MB 
Creatine Kinase-myoglobin band,  a fraction of Creatine kinase 
CRO 
Contract Research Organization 
eCRF 
Electronic Case Report Form 
CVA 
Cerebrovascular Accident 
DES 
Drug Eluting Stent 
DFU 
Directions for Use 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
ESC 
European Society of Cardiology 
FHU 
First Human Use 
GCP 
Good Clinical Practice 
GI 
Gastrointestinal 
GUSTO 
Global Use of Strategies for Opening  Occluded Coronary Arteries 
IABP 
Intra Aortic Balloon Pump 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
ISDN 
Isosorbide Dinitrate 
ISO 
International Standards Organization 
ITT 
Intention to Treat 
IVRS 
Interactive Voice Response System 
IWRS 
Interactive Web Response System 
LAD 
Left Anterior Descending Coronary Artery 
LBBB 
Left Bundle Branch Block 

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Table 31-1: Abbreviations  
Abbreviation/Acronym 
Term 
LCX 
Left Circumflex Coronary Artery 
LMCA 
Left Main Coronary Artery 
MACE 
Major Adverse Cardiac Events 
MI 
Myocardial Infarction 
MLD 
Minimal Lumen Diameter 
NHLBI 
National Heart, lung, and Blood Institute 
NTG 
Nitroglycerin 
NYHA 
New York Heart Association 
PCI 
Percutaneous Coronary Intervention 
PLGA 
Poly (DL-Lactide-co-Glycolic Acid) 
POBA 
Plain Old Balloon Angioplasty 
QCA 
Quantitative Coronary Angiography 
RCA 
Right Coronary Artery 
RVD 
Reference Vessel Diameter 
SADE 
Severe Adverse Device Effect 
SAE 
Severe Adverse Event 
SCAI 
Society for Cardiovascular Angiography and Interventions 
STEMI 
ST-segment Elevation Myocardial Infarction 
TIA 
Transient Ischemic Attack 
TIMI 
Thrombolysis in myocardial infarction 
TLF 
Target Lesion Failure 
TLR 
Target Lesion Revascularization 
TVF 
Target Vessel Failure 
TVR 
Target Vessel Revascularization 
ULN 
Upper Limit of Normal 
URL 
Upper Reference Limit 
US 
the United States 
WBC 
White Blood Cell 
WH 
Workhouse 
31.2 Definitions  
Abrupt Closure 
Abrupt closure is the occurrence of new severely reduced flow (TIMI grade 0 or 1) within the target 
vessel (including the side branch with a diameter of more than 1.5mm) that persists and requires 
bailout, including emergency surgery, or results in MI or death. Abrupt closure requires proven 
association with a mechanical dissection of the treatment site or instrumented vessel, coronary 
thrombus, or severe spasm. Abrupt closure does not connote “no reflow” due to microvascular flow 
limitation in which the epicardial artery is patent but has reduced flow. Abrupt closure also does not 
connote transient closure with reduced flow in which the assigned treatment reversed the closure. 
Sub-abrupt closure is an abrupt closure that occurs after the target procedure is completed and the 
subject has left the catheterization laboratory and before hospital discharge. 

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Threatened abrupt closure is a grade B dissection and 50% diameter stenosis or any dissection of 
grade C or higher. 
Adverse Device Effect (Reference: ISO 14155-2011,  MEDDEV 2.7/3 12/2010) 
Adverse event related to the use of an investigational medical device. 
Note: This definition includes AEs resulting from insufficient or inadequate instructions for use, the 
deployment, the implantation, the installation, the operation, or any malfunction of the 
investigational medical device.  
Note: This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. 
Adverse Event (Reference: ISO 14155-2011,  MEDDEV 2.7/3 12/2010) 
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs 
(including abnormal laboratory finding) in subjects, users or other persons, whether or not related to 
the investigational medical device. This includes events related to: 
• 
The investigational medical device or comparator 
• 
The procedures involved (study-required) 
Note: For users/other persons, this definition is restricted to events related to the investigational 
medical device 
Adverse Event Relativity Terms  
• 
Unrelated: The AE is determined to be due to a concurrent illness or effect of another device or 
drug and is not related to the investigational device. 
• 
Related:  
o The AE is determined to be potentially related to the investigational device, and an 
alternative etiology is equally or less likely compared to a potential relationship to the 
investigational device. 
o There is a strong relationship to the investigational device or the event recurs on re-
challenge, and another etiology is unlikely. 
o There is no other reasonable medical explanation for the event. 
Annual Follow-ups 
Annual follow-ups are those that occur annually through 5 years after the index procedure. The 
timing of annual follow-ups is calculated based on one calendar year equaling 365 days. The 
follow-up window is 30 days. Therefore, the 1-year, 2-year, 3-year, 4-year, and 5-year follow-ups 
should occur 36530 days, 73030 days, 1,09530 days, 1,46030 days, and 1,82530 days after 
the index procedure, respectively. 
Arrhythmia 
An arrhythmia is any variation from the normal rhythm of the heart, including sinus arrhythmia, 
premature beats, heart block, atrial or ventricular fibrillation, atrial or ventricular flutter, and atrial 
or ventricular tachycardia. 
Arteriovenous Fistula 
An arteriovenous fistula is an abnormal passage or communication between an artery and a vein. It 
may result from injury or it may occur as a congenital abnormality. 

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Bailout 
• 
Bailout typically refers to a peristent dissection but can also include a vessel complication at the 
ostium or along the course of the major coronary artery used to access the target lesion. 
• 
The decision of whether to treat in a bailout situation is at the discretion of the interventionalist. 
• 
If stenting is required in a bailout situation, the stent should be a study stent of the same type 
used to treat the target lesion. 
Bifurcation Lesion 
A bifurcation lesion is a lesion associated with the area where a branch vessel >2.0 mm in diameter 
by visual estimate originates. 
Binary restenosis 
Binary restenosis is a diameter stenosis >50% at the previously treated lesion site, including the 
original treated area and the adjacent proximal and distal QCA analysis segment.  
Bleeding grading (Reference: GUSTO) 
 
Severe or life-threatening: massive intracranial bleeding or bleeding which will cause a 
hemodynamic functional injury and need an intervention treatment.  
 
Moderate: bleeding that needs a transfusion but will not cause any hemodynamic functional 
injury. 
 
Mild: bleeding that fails to meet the criteria of severe or moderate bleeding.  
Braunwald Classification of Unstable Angina   
Severity 
• 
Class I: New onset, severe or accelerated angina. Subjects with angina of less than 2 months 
duration, severe or occurring 3 or more times per day, or angina that is distinctly more frequent 
and precipitated by distinctly less exertion; no pain at rest in the last 2 months. 
• 
Class II: Angina at rest, subacute.  Subjects with 1 or more episodes of angina at rest during the 
preceding month, but not within the preceding 48 hours. 
• 
Class III: Angina at rest, acute. Subjects with 1 or more episodes of angina at rest within the 
preceding 48 hours. 
Clinical Circumstances 
• 
Class A: Secondary unstable angina. A clearly identified condition extrinsic to the coronary 
vascular bed that has intensified myocardial ischemia (e.g., anemia, fever, infection, 
hypotension, tachyarrhythmia, thyrotoxicosis, and hypoxemia secondary to respiratory failure). 
• 
Class B: Primary unstable angina. 
• 
Class C: Postinfarction unstable angina (within 2 weeks of documented MI). 
Calcification 
Readily apparent densities seen within the artery wall and site of lesion either as an X-ray absorbing 
mass or as an echogenic and shadow generating mass in IVUS imaging; these can be classified as 
little/none, moderate, or severe. 
Canadian Cardiovascular Society Classification 
• 
Class 1: Ordinary physical activity does not cause angina, such as walking and climbing stairs. 
Angina with strenuous or rapid or prolonged exertion at work or recreation. 
• 
Class 2: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, 
walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or any 

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only during the first hours after awakening. Walking more than 2 blocks on the level and 
climbing more than 1 flight of ordinary stairs at a normal pace and in normal conditions. 
• 
Class 3: Marked limitations of ordinary physical activity. Walking 1 to 2 blocks on the level and 
climbing 1 flight of stairs in normal conditions and at a normal pace. 
• 
Class 4: Inability to carry on any physical activity without discomfort; angina syndrome 
Pericardial Tamponade 
Cardiac tamponade is an acute compression of the heart due to effusion of the fluid into the 
pericardium, or the collection of blood in the pericardium, from rupture of the heart or penetrating 
trauma. 
Cardiogenic Shock 
Cardiogenic shock is a clinical state with insufficient perfusion,  represented as the systolic pressure 
<80 mmHg and/or the central filling pressure > 20 mmHg or the cardiac index <1.8 L/min/m2,  with 
evidences showing the insufficient perfusion of end-organ. If it needs to maintain the systolic 
pressure > 80 mmHg and the cardiac index > 1.8 L/min/m2 by an intravenous injection of cardiac 
drugs and/or the use of intra aortic balloon pump (IABP),  it is also considered as a shock. .  
Cerebrovascular Accident 
A CVA is a new focal neurological deficit of presumed vascular origin persisting more than 
24 hours and with a neuro-imaging study that does not indicate a different etiology. The 24-hour 
criterion is excluded if the subject undergoes cerebrovascular surgery or dies during the first 
24 hours. It includes subjects presenting with clinical signs and symptoms suggestive of 
subarachnoid hemorrhage, intracerebral hemorrhage, or cerebral infarction. It does not include CVA 
events in cases of blood disorders such as leukemia, and it excludes subjects with a history of CVA 
secondary to trauma. 
Creatine Kinase Myoglobin Band 
Creatine kinase-myoglobin band (CK-MB) is an isoenzyme of creatine kinase (CK) with a distinct 
molecular structure specific as an indicator of myocardial cell injury. It is used to evaluate possible 
causes of chest pain, to detect and diagnose acute MI and re-infarction, and to monitor the severity 
of myocardial ischemia. 
Clinical Events Committee 
A CEC is an independent group of individuals with pertinent expertise that review and adjudicate 
important endpoints and relevant AEs reported by study investigators. 
Clinical Events Committee Event 
The CEC will adjudicate all reported cases of TVR, MI (Q-wave and non–Q-wave), and death (to 
ensure appropriate classification of death as cardiac or non-cardiac). A case adjudicated by the CEC 
is considered to be a CEC event. 
Clinical Procedural Success (visual estimate)  
Clinical procedural success is a mean lesion diameter stenosis <50% in 2 near-orthogonal 
projections with TIMI 2-3 flow, as visually assessed by the physician, without the occurrence of in-
hospital Q wave MI, TLR, or cardiac death. 
Complication (angiographic or clinical) 
A complication (angiographic or clinical) is 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, non-fatal MI, elevated CK Total, 

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prolonged angina, hypotension, hematoma, arrhythmias, etc. Complications may or may not be 
related to the investigational device. 
Congestive Heart Failure 
Congestive heart failure is an inadequacy of the heart such that it fails to maintain adequate 
circulation of blood, so that congestion and edema develop in the tissues. Clinical syndrome is 
characterized by shortness of breath, non-pitting edema, enlargement of the liver, engorged neck 
veins, and pulmonary rales. 
Coronary Aneurysm 
A coronary aneurysm is a pathologic dilatation of a segment of a blood vessel involving all three 
layers of the vessel wall 1.5× the RVD. 
Coronary Artery Spasm 
Coronary artery spasm, or coronary vasospasm, is a spasm of a coronary artery, resulting in a 
decrease in lumen diameter. It may occur distal to the treatment site and is generally reversed with 
intracoronary administration of NTG or with adjunct balloon dilatation. 
Death 
Death is categorized as cardiac or non-cardiac. 
Cardiac death is defined as death due to any of the following. 
• Acute MI 
• Cardiac perforation/pericardial tamponade 
• Arrhythmia or conduction abnormality 
• CVA through hospital discharge or CVA suspected of being related to the procedure 
• Death due to complication of the procedure, including bleeding, vascular repair, transfusion 
reaction, or bypass surgery 
• Any death in which a cardiac cause cannot be excluded 
Non-cardiac death is defined as a death not due to cardiac causes as defined above. 
De Novo Lesion 
A coronary lesion not previously treated. 
Device Deficiency (Reference: ISO 14155-2011,  MEDDEV 2.7/3 12/2010) 
A device deficiency is any inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. 
Note: Device deficiencies include malfunctions, use errors, and inadequate labeling. 
Dissection: NHLBI Classification 
• 
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 

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• 
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 coronary occlusion 
Diabetes  
Subjects will be categorized as having diabetes mellitus if medical treatment (oral or injection) is 
required for control of blood glucose levels. 
Distal Embolization 
Distal embolization is migration of a filling defect or thrombus to distally occlude the target vessel 
or one of its branches. 
Emergency Bypass Surgery 
Emergency bypass surgery is CABG surgery performed on an urgent or emergent basis for severe 
vessel dissection or closure, or treatment failure resulting in new ischemia.  
Epicardial Vessel 
Epicardial vessels include the LAD and its branches, the LCX and its branches, and the RCA and its 
branches. 
Hypertension 
Hypertension is persistently high arterial blood pressure. Various criteria for its threshold have been 
suggested, ranging from 140 mmHg systolic and 90 mmHg diastolic to as high as 220 mmHg 
systolic and 110 mmHg diastolic. Hypertension may have no known cause or be associated with 
other primary diseases. 
Hypotension 
Sustained hypotension is a systolic blood pressure less than 80 mmHg lasting more than 30 minutes 
or requiring intervention (e.g., pacing, IABP, intravenous vasopressors, to sustain systolic blood 
pressure). This excludes transient hypotension or vagal reactions, which are self-limited or readily 
reversible. 
Index Procedure Start Time 
Index procedure start time is defined as the time of guide catheter placement. 
Index Procedure End Time 
Index procedure end time is defined as the time the guide catheter is removed after the final 
angiography. 
Intimal Flap 
An intimal flap is an extension of the vessel wall into the arterial lumen. 
Late Loss 
Late loss is the postprocedure MLD minus the follow-up MLD as determined by QCA. 
Left Main Coronary Artery Disease 
Left main disease is a significant lesion in the left main coronary artery of at least 50% diameter 
stenosis. A protected left main artery means left main with a functioning graft, either venous or 
arterial, placed to any of the branches of the left main. This is usually the LAD or CX, but could 
also include one of the branches of those vessels. Having a stent in the left main coronary artery 
does not in itself constitute a protected left main. 

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Subject eligibility clarifications: 
• 
Subjects with unprotected left main coronary artery disease may not be enrolled. 
• 
Subjects with protected left main coronary artery disease are eligible for enrollment. 
Left Ventricular Ejection Fraction 
LVEF is an assessment of the amount of blood emptied from the left ventricle during systolic 
contraction, which is indicative of global ventricular function. 
Lesion Characteristics (ACC/AHA classification) 
• 
Type A lesions: Minimally complex, length <10 mm, concentric, readily accessible, 
non-angulated segment (<45), smooth contour, little or no calcification, less than totally 
occlusive, not ostial in location, no major side branch involvement, and an absence of thrombus. 
• 
Type B lesions: Moderately complex, tubular (length 10 to 20 mm), eccentric, moderate 
tortuosity of proximal segment, moderately angulated segment (>45, <90), irregular contour, 
moderate or heavy calcification, total occlusions <3 months old, ostial in location, bifurcation 
lesions requiring double guidewire, and some thrombus present. 
• 
Type C lesions: Severely complex, diffuse (length 20 mm), excessive tortuosity of proximal 
segment, extremely angulated segments >90, total occlusions >3 months old and/or bridging 
collaterals, inability to protect major side branches, and degenerated vein grafts with friable 
lesions. 
 
Refractory chronic total occlusion (CTO) lesion 
the CTO lesion that cannot be crossed with conventional guidewires, which shall have any of the 
following situations: 
• 
previous failed attempt to cross lesion within the past 12 months 
• 
failed attempt to cross CTO with an antegrade guidewire for 10 - 15 minutes of fluoroscopy 
time 
• 
attempt to cross CTO with an antegrade guidewire resulting in a subintimal wire position 
Lesion Length 
Lesion length is measured as distance from the proximal to the distal shoulder in the view that 
demonstrates the stenosis in its most elongated projection. Lesion length is classified as discrete 
(<10 mm), tubular (10-20 mm), or diffuse (>20 mm). 
Lesion Location 
Lesion location is the location of the lesion according to the specific coronary artery (i.e., left main, 
LAD, LCX, or RCA) or bypass graft, and is specified as proximal, mid, or distal. A standard map 
will be provided to be used for location descriptions. 
Leukopenia 
Leukopenia is a leukocyte count of <3.0 × 109/liter for more than 3 days. 
Malfunction 
A malfunction is a failure of the device to meet performance specifications or otherwise perform as 
intended. 
Myocardial Infarction 
The definition of myocardial infarction in FAST-CTO China clinical trial: 
Spontaneous myocardial infarction25 (> 72 hours post procedure):  

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Detection of rise and/or fall of cardiac biomarkers (CK-MB or troponin) with at least one value 
above the 99th percentile of the upper reference limit (URL) together with evidence of myocardial 
ischemia with at least one of the following: 
• Symptoms of ischemia; 
• ECG changes indicative of new ischemia (new ST-T changes or new left bundle branch block 
[LBBB]); 
• Development of pathological Q waves in the ECG; 
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. 
 Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG) related 
Myocardial infarction 26 ( 72 hours post procedure) 
1. CK-MB in patients with normal baseline concentration reaches any of the following criteria: 
 
An increase in CK-MB peak to ≥10X URL during the first 48 hours following the 
procedure  
 
An increase in CK-MB peak to ≥5X URL during the first 48 hours following the 
procedure, plus new pathological Q-wave in at least 2 contiguous leads, or new persistent 
LBBB 
Or meets any of the following criteria if CK-MB levels are unavailable and baseline troponin 
concentrations are normal: 
 
An increase of troponin (I or T) to ≥70X URL during the first 48 hours following PCI 
 
An increase of troponin (I or T) to ≥35X URL during the first 48 hours following PCI, and 
development of new pathological Q-wave in at least 2 contiguous leads or new persistent 
LBBB 
2. In patient with elevated baseline CK-MB (or troponin) in whom the biomarker levels have 
shown the tendency to be stable or decrease, if the CK-MB (or troponin)  rises by an absolute 
increment equal to those levels recommended above from the most recent pre-procedure level. 
3. In patient with elevated baseline CK-MB (or troponin) in whom the biomarker levels have not 
shown to be stable or decrease, if the CK-MB (or troponin)  rises by an absolute increment 
equal to those levels recommended above from the most recent pre-procedure level, plus new 
ST-segment elevation or depression and clinical symptoms related to myocardial infarction, 
such as new or aggravated heart failure or persistent hypotension. 
New York Heart Association classification  
• Class I: Patients with no limitation of activities; they suffer no symptoms from ordinary 
activities 
• Class II: Patients with slight, mild limitation of activity; they are comfortable with rest or with 
mild exertion 
• Class III: Patients with marked limitation of activity; they are comfortable at rest 
• Class IV: Patients who should be at complete rest, confined to bed or chair; any physical 
activity brings on discomfort and symptoms occur at rest 
Perforation 
Perforations are classified as follows: 
• 
Angiographic perforation: Perforation detected by clinical site or Angiographic Core Laboratory 
at any point during the procedure. 

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• 
Clinical perforation: Perforation requiring additional treatment, including efforts to seal the 
perforation or pericardial drainage, or resulting in significant pericardial effusion, abrupt closure, 
MI, or death. 
• 
Pericardial hemorrhage/tamponade: Perforation causing tamponade. 
Prolonged Angina Pectoris 
Prolonged angina pectoris is angina lasting longer than 1 hour. 
Pseudoaneurysm 
A pseudoaneurysm is an encapsulated hematoma in communication with an artery. It is often 
difficult to distinguish from an expanding hematoma at the site of arterial puncture. It usually 
requires surgical repair. 
Randomization 
Randomization is the procedure by which subjects are assigned to a treatment group based on 
appropriate theories of probability including those involving random chance and conditional 
assignments. 
Reference Diameter of Normal Arterial Segment 
Reference diameter of the normal artery segment is an angiographic measurement of the artery 
proximal and/or distal to the lesion intended for angioplasty. This is also referred to as “reference 
vessel diameter” (RVD). 
Repeated Intervention 
Repeat intervention is a PCI or CABG performed after the end of the index procedure. The repeat 
intervention should be performed to improve blood flow. 
Restenosis Lesion 
A restenosed lesion is a previously treated lesion that again has a stenosis. 
Restenosis 
See Binary Restenosis. 
Severe Adverse Device Effect (Reference: ISO 14155-2011,  MEDDEV 2.7/3 12/2010) 
Adverse device effect that has resulted in any of the consequences characteristic of a SAE. 
Severe Adverse Event (Reference: ISO 14155-2011,  MEDDEV 2.7/3 12/2010) 
An adverse event that causes the following situations: 
Adverse event that: 
• 
Led to death 
• 
Led to a 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 or prolonged hospitalization  of existing hospitalization, or 
o Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to body structure or a body function 
• 
Led to fetal distress fetal death or a congenital abnormality or birth defect 
Stent Thrombosis (Reference: the definition of Academic Research Consortium) (44) 

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Stent thrombosis should be reported as a cumulative value at the different time points and with the 
different separate time points. Time 0 is defined as the time point after the guide catheter has been 
removed and the patient left the catheterization lab. 
Timing: 
• 
Acute stent thrombosis*: 0-24 hours after stent implantation 
• 
Subacute stent thrombosis*: >24 hours to 30 days after stent implantation 
• 
Late stent thrombosis: >30 days to 1 year after stent implantation 
• 
Very late stent thrombosis: >1 year after stent implantation 
* Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0-30 days. 
Stent thrombosis may be defined as: 
• 
Confirmed/definite 
• 
Probable 
• 
Possible 
Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed) 
Angiographic confirmed stent thrombosis is considered to have occurred if: 
• 
TIMI flow is: 
o TIMI flow grade 0 with occlusion originating in the stent or in the segment 5mm proximal 
or distal to the stent region in the presence of thrombus* 
o TIMI flow grade 1, 2 or 3 originating in the stent or in the segment 5mm proximal or distal 
to the stent region in the presence of a thrombus* 
AND at least one of the following criteria, up to 48 hours, has been fulfilled: 
• 
New onset of ischemic symptoms at rest (typical chest pain with duration >20 minutes) 
• 
New ischemic ECG changes suggestive of acute ischemia 
• 
Typical rise and fall in cardiac biomarkers (>2× ULN of CK) 
The incidental angiographic documentation of stent occlusion in the absence of clinical syndromes 
is not considered a confirmed stent thrombosis (silent thrombosis). 
* Intracoronary thrombus 
Non-occlusive thrombus: Spheric, ovoid or irregular non-calcified filling defect or lucency 
surrounded by contrast material (on 3 sides of within a coronary stenosis) seen in multiple 
projections, or persistence of contrast material within the lumen, or a visible embolization of 
intraluminal material downstream. 
Occlusive thrombus: A TIMI 0 or TIMI 1 intra-stent or proximal to a stent up to the most adjacent 
proximal side branch or main branch (if originating from the side branch). 
Probable 
Clinical definition of probable stent thrombosis is considered to have occurred in the following 
cases: 
• 
Any unexplained death within the first 30 days 
• 
Irrespective of the time after the index procedure and MI in the absence of any obvious cause 
which is related to documented acute ischemia in the territory of the implanted stent without 
angiographic confirmation of stent thrombosis 
Possible 
Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained 
death beyond 30 days. 

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Stroke / Cerebrovascular Accident 
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. 
Classification: 
• Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction 
caused by an infarction of central nervous system tissue. 
• Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal 
dysfunction caused by a nontraumatic intraparenchymal, intraventricular, or subarachnoid 
hemorrhage. 
• Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic 
or hemorrhagic. 
An event that lasts < 24 hours may be adjudicated as a stroke if the following treatments were used: 
• Pharmacologic, i. e., thrombolytic drug administration, or 
 
Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty) 
Target Lesion 
The target lesion is the lesion selected by the Investigator for treatment with a study device. The 
target lesion should meet the angiographic enrollment criteria. Only 1 target lesion can be treated 
during the index procedure as described in the enrollment criteria. 
Target Lesion Failure (TLF) 
Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and 
non–Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it 
cannot be determined with certainty whether the MI was related to the target vessel, it will be 
considered a TLF.  
Target Lesion Revascularization (TLR) 
Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve 
blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a 
graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven 
if the target lesion diameter stenosis is 50% by QCA and there is presence of clinical or functional 
ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional 
ischemia is any of the following: 
• 
The subject has a positive functional study corresponding to the area served by the target lesion. 
• 
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel. 
• 
The subject has ischemic symptoms referable to the target lesion. 
A TLR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even 
in the absence of clinical or functional ischemia. 
Target vessel 
The target vessel is any coronary vessel (e.g., left main coronary artery, LAD, LCX, or RCA) 
containing a target lesion. Side branches of a target vessel such as the LAD are also considered part 
of the target vessel. 
Target vessel failure (TVF) 
Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and 
non–Q-wave) related to the target vessel or (cardiac) death related to the target vessel. For the 

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purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the 
target vessel, it will be considered a TVF.  
Target Vessel Revascularization (TVR) 
Target vessel revascularization is defined as a TLR (see definition above) or a TVR remote (see 
definition below). 
Target Vessel  Revascularization Remote 
Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to 
improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis ≥50% by 
QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if 
the target vessel diameter stenosis is 50% by QCA and any of the following are present: 
• 
The subject has a positive functional study corresponding to the area served by the target vessel. 
• 
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel. 
• 
The subject has ischemic symptoms referable to the target vessel. 
A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is 70% even in 
the absence of clinical or functional ischemia. 
Technical Success 
Technical success is the ability of the BridgePoint Medical System to successfully facilitate 
placement of a guidewire beyond a CTO lesion in the true vessel lumen/within the collaterals in 
those cases that were otherwise refractory to treatment with a currently marketed guidewire. 
Thrombus (angiography)  
Thrombus (angiographic) is discrete, mobile intraluminal filling with defined borders with/without 
associated contrast straining, classified as either absent or present. 
Thrombolysis in the Classification of Myocardial Infarction  
• 
TIMI 0: No perfusion. 
• 
TIMI 1: Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the 
stenosis of the duration of the cine run. 
• 
TIMI 2: Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. 
However, the rate of entry and/or clearance is slower in the coronary bed distal to the 
obstruction than in comparable areas not perfused by the dilated vessel. 
• 
TIMI 3: Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed 
distal to stenosis as in other coronary beds. 
Total Occlusion 
A total occlusion is a lesion with no flow (i.e., TIMI flow 0).  
Transient Ischemic Attack 
A TIA is a focal ischemic neurological deficit of abrupt onset and of presumed vascular etiology 
that resolves completely within 24 hours of onset. 
Unanticipated Adverse Device Effect (Reference: 21CFR 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 protocol or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects. 

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Unanticipated Severe Adverse Device Effect (Reference: ISO 14155-2011,  MEDDEV 2.7/3 
12/2110) 
A 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.