Evaluate the Continued Safety and Effectiveness of the XIENCE PRIME EECSS in a Cohort of Real-world Patients Receiving the XIENCE PRIME EECSS During Commercial Use.
Conditions: Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease, Coronary Restenosis, Myocardial Infarction, Stent Thrombosis, Vascular Disease
Sponsor: Abbott Medical Devices

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PROTOCOL 12-396 
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) 
China Single-Arm Study 
 
  
Version Number 
Version 3.0 
 
Date 
20 September, 2017 
 
Primary Investigator 
Junbo Ge, MB, MSc, MD, FACC, FESC, FSCAI 
Professor of Medicine/Cardiology 
Director, Department of Cardiology 
Zhongshan Hospital Fudan University 
No. 180 Fenglin Road, Xuhui District 
Shanghai  200032,  P.R. China 
 
Co-Primary Investigators  
Xuejun Ren, MD  
Professor of Medicine/Cardiology  
Vice Director, Department of Cardiology  
Anzhen Hospital  
No. 2 Anzhen Road, Chaoyang District  
Beijing 100029 P.R. China 
Abbott Vascular Medical 
Expert 
Peter Staehr, MD  
Senior Director of Clinical Science  
Abbott Cardiovascular Systems, Inc., 
A Subsidiary of Abbott Vascular  
3200 Lakeside Drive  
Santa Clara, CA 95054, USA 
 
Planned Number of Sites and 
Region(s) 
Approximately 45 sites in China 
 
Study Type 
Prospective, observational, open-label, multi-center, single-
arm, post-approval study 
 
Sponsor  
 
 
 
Abbott Cardiovascular Systems, Inc., 
A Subsidiary of Abbott Vascular  
3200 Lakeside Drive  
Santa Clara, CA 95054, USA 
Authorized Representative in 
China 
Abbott Medical Devices Trading (Shanghai) Co., Ltd.  
12F, Phase II IFC, No.8 Century Avenue, Pudong District 

 
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Shanghai  200120,  P. R. China 
 
Data Monitoring 
INC Research, LLC 
3201 Beechleaf Court, Suite 600 
Raleigh, NC 27604, USA 
 
Enrollment Service 
Bracket Global LLC 
303 Second Street, Suite 700 
7th Floor, South Tower 
San Francisco, CA 94107, USA 
 
Electronic Data Capture 
Software 
Medidata RAVE® 
79 Fifth Avenue, 8th Floor 
New York, New York, USA 
 
Protocol Author 
Lijuan (Jenny) Wang, PhD 
Principle Clinical Scientist, Abbott Vascular  
 

 
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TABLE OF CONTENTS 
Compliance Statement: ............................................................................................................................... 5 
1. 
INTRODUCTION................................................................................................................ 8 
2. 
BACKGROUND INFORMATION ................................................................................... 8 
2.1 
Background and Rationale .......................................................................................................... 8 
2.1.1 
Background ................................................................................................................................. 8 
2.1.2 
Rationale to Conduct this Clinical Study ...................................................................................10 
2.2 
Summary of Study Device..........................................................................................................10 
2.2.1 
Name of the Study Device .........................................................................................................10 
3. 
Study Objective .................................................................................................................. 11 
4. 
Clinical Study Flow and Follow-up Schedule .................................................................. 11 
4.1 
Number of Patients to Be Registered .........................................................................................11 
4.2 
Early Termination of the Clinical Study .....................................................................................11 
4.3 
Termination of Study Site Participation .....................................................................................11 
5. 
KEY ENDPOINTS............................................................................................................. 12 
6. 
PATIENT SELECTION AND WITHDRAWAL ........................................................... 12 
6.1 
Patient Screening and Informed Consent ...................................................................................12 
6.1.1 
Patient Screening .......................................................................................................................13 
6.1.2 
Informed Consent ......................................................................................................................13 
6.2 
Eligibility Criteria.......................................................................................................................14 
6.2.1 
Inclusion Criteria .......................................................................................................................14 
6.2.2 
Exclusion Criteria ......................................................................................................................14 
6.3 
Point of Registration ...................................................................................................................14 
6.4 
Patient Deregistration .................................................................................................................14 
6.5 
Patient Discontinuation ..............................................................................................................15 
6.6 
Study Completion .......................................................................................................................15 
7. 
TREATMENT AND EVALUATION OF SAFETY AND EFFICACY ....................... 16 
7.1 
Baseline ......................................................................................................................................16 
7.1.1 
Baseline Laboratory Assessments .............................................................................................16 
7.1.2 
Patient History ...........................................................................................................................17 
7.2 
Pre-procedure .............................................................................................................................17 
7.2.1 
Pre-procedure Laboratory Assessment ......................................................................................17 
7.3 
Index Procedure ..........................................................................................................................17 
7.3.1 
Procedural Information to be Recorded .....................................................................................17 
7.3.2 
Bailout Stenting or Alternative Procedures ...........................................................................18 
7.4 
Post-procedure ...........................................................................................................................18 
7.4.1 
Post-procedure Information to be Recorded ..............................................................................18 
7.4.2 
Post-procedure Laboratory Assessment .....................................................................................18 
7.5 
Clinical Follow-up for All Patients (Hospital/Office Visit or Telephone Contact) ....................18 
7.6 
Additional Follow-up Visits for All Patients ..............................................................................19 
8. 
ADVERSE EVENTS ......................................................................................................... 19 
8.1 
Definitions ..................................................................................................................................19 
8.1.1 
Adverse Event ............................................................................................................................19 
8.1.2 
Serious Adverse Event ...............................................................................................................20 
8.1.3 
Device Deficiency .....................................................................................................................20 

 
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8.2 
Device Relationship ...................................................................................................................21 
8.3 
Adverse Event Reporting ...........................................................................................................21 
8.3.1 
Adverse Event Monitoring.........................................................................................................21 
8.3.2 
Serious Adverse Event and device deficiency/product experience reporting to Sponsor and 
IRB/EC 
21 
8.4  
Safety Monitoring .......................................................................................................................22 
9. 
STATISTICAL ANALYSIS ............................................................................................. 22 
9.1 
Statistical Overview ...................................................................................................................22 
9.2 
Analysis Populations ..................................................................................................................22 
9.3 
Sample Size Calculations and Assumptions ...............................................................................23 
9.4 
Statistical Analyses .....................................................................................................................23 
9.4.1 
Key Endpoint Analysis ..............................................................................................................23 
9.4.2 
Additional Analyses...................................................................................................................23 
9.4.3 
Subgroup Analysis .....................................................................................................................24 
9.4.4 
Procedures for Accounting for Missing, Unused or Spurious Data ...........................................24 
10. DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ............................................. 24 
11. QUALITY CONTROL AND QUALITY ASSURANCE ............................................... 24 
11.1 
Selection of Clinical Sites and Investigators ..............................................................................25 
11.2 
Protocol and Informed Consent Approval ..................................................................................25 
11.3 
Protocol Amendments ................................................................................................................25 
11.4 
Training ......................................................................................................................................25 
11.5 
Monitoring ..................................................................................................................................25 
11.6 
Deviations from Protocol ...........................................................................................................26 
11.7 
Compliance Assessments ...........................................................................................................26 
11.8 
Publications Committee..............................................................................................................27 
12. DATA HANDLING AND RECORD KEEPING ............................................................ 27 
12.1 
Source Documentation ...............................................................................................................27 
12.2 
Electronic Case Report Form Completion ..................................................................................28 
12.3 
Record Retention ........................................................................................................................28 
13. ETHICAL CONSIDERATION ........................................................................................ 28 
13.1 
Ethics Committee Review ..........................................................................................................28 
13.2 
Confidentiality ............................................................................................................................29 
13.3 
Submitting Reports to Competent Authority ..............................................................................29 
14. PUBLICATION POLICY ................................................................................................. 29 
APPENDIX I: 
ABBREVIATIONS AND ACRONYMS ................................................... 30 
APPENDIX II:  
DEFINITIONS ............................................................................................ 32 
APPENDIX III:  STUDY FLOW ........................................................................................... 40 
APPENDIX IV:  SCHEDULE OF EVENTS ......................................................................... 41 
APPENDIX V: 
REFERENCES ............................................................................................ 42 
 
 
 

 
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Compliance Statement:  
 
This study will be conducted in accordance with this Protocol, the Declaration of 
Helsinki and the Good Clinical Practice (GCP) guidelines of the China State Food and 
Drug Administration (CFDA).  The most stringent requirements, guidelines or 
regulations must always be followed.  The conduct of the study will be approved by the 
appropriate Ethics Committee (EC) of the respective investigational site and as specified 
by local regulations. 
 
Sponsor Signatory Representative: 
Approval for this protocol and any subsequent amendments shall be obtained per Abbott 
Vascular Standard / Detailed Operating Procedure(s). 
 
 

 
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PROTOCOL SUMMARY 
 
Study Name and 
Number 
XIENCE PRIME China Single-Arm Study (XP China SAS): 12-
396 
Title 
XIENCE PRIME Everolimus Eluting Coronary Stent System 
(EECSS) China Single-Arm Study 
Objectives 
Evaluate the continued safety and effectiveness of the XIENCE 
PRIME EECSS in a cohort of real-world patients receiving the 
XIENCE PRIME EECSS during commercial use. 
Study Device 
Clinical Study Device: XIENCE PRIME EECSS 
Product Name and Sizes 
Product Name 
Stent Diameter (mm) 
Stent Length (mm) 
XIENCE PRIME 
2.5, 2.75, 3.0, 3.5, 4.0 
8, 12, 15, 18, 23, 28 
XIENCE PRIME SV 
(Small Vessel)  
 
2.25 
 
8, 12, 15, 18, 23, 28 
XIENCE PRIME LL 
(Long Lesion) 
 
2.5, 2.75, 3.0, 3.5, 4.0 
 
33, 38 
Targeted number of 
patients to receive 
study device 
Approximately 2000 patients will be consecutively registered 
from the general Chinese interventional cardiology population at 
approximately 45 sites in China. 
Study Design 
Prospective, observational, open-label, multi-center, single-arm, 
post-approval study 
Key Endpoints 
The following site reported endpoints will be assessed at 1, 2, 3, 4, 
and 5 years: 
 
Composite rate of cardiac death and all myocardial infarction 
(MI) (Q-wave and non–Q-wave)  
 
Composite rate of all death and all myocardial infarction (MI) 
(Q-wave and non–Q-wave)  
 
Target lesion failure (TLF): the composite rate of cardiac 
death, target vessel MI, and ischemia-driven TLR (ID-TLR)  
 
Target vessel failure (TVF): the composite rate of cardiac 
death,  all MI, and ischemia-driven TVR (ID-TVR) 
 
Stent thrombosis (definite and probable, per Academic 
Research Consortium [ARC] definition)  
 
Death (cardiac, vascular, and non-cardiovascular) 
 
All MI (Q-wave and non–Q-wave) 
 
Revascularization (target lesion, target vessel, and non-target 
vessel) (PCI and CABG) 

 
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Patient Follow-up 
Clinical follow-up will occur at 1, 2, 3, 4, and 5 years.  
The investigator/designee may conduct clinical follow-up(s) as 
hospital/office visits or telephone contacts. 
Treatment Strategy 
The investigator will determine the treatment strategy.  
Each enrolling investigator should review the most current 
XIENCE PRIME Everolimus Eluting Coronary Stent System 
Instructions for Use (IFU). 
Inclusion Criteria 
 
The patient must be at least 18 years of age at the time of 
signing the informed consent 
 
The patient or his/her legally-authorized representative agrees 
to participate in this study by signing the Ethics Committee 
(EC) approved informed consent form (ICF) 
 
Only XIENCE PRIME stent(s) is (are) implanted during the 
index procedure 
Exclusion Criteria 
No other exclusion criteria are specified for this study.  
Analytical 
Population 
The analytical population is defined as patients who received only 
XIENCE PRIME EECSS during the index procedure. 
Descriptive analyses will be provided on the analytical population 
and subgroups of interest. No pre-specified hypothesis tests are 
planned for this study. 

 
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1. 
INTRODUCTION 
 
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus 
Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food 
and Drug Administration (CFDA) on August 10th, 2011.  
 
This prospective, observational, open-label, multi-center, single-arm, post-approval study 
is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME 
EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during 
commercial use in real-world settings in China. 
 
2. 
BACKGROUND INFORMATION 
2.1 
Background and Rationale 
2.1.1 
Background 
 
Coronary Heart Disease in China 
Coronary heart disease (CHD) is the second leading cause of cardiovascular death in 
Chinese population. CHD mortality in Chinese population is relatively low compared 
with that in western countries; however the burden of CHD has been increasing in recent 
years. About 400,000 patients died from CHD in 2004.1 The CHD mortality rate is higher 
in north China compared to that in southeast China and other economically 
underdeveloped areas.2,3,4  
 
Coronary Heart Disease Risk Factors in the Chinese Population 
China’s emergence as a developing country has been a key contributing factor to its 
increase in CHD risk. By 2002 China had an estimated 540 million people with 
conditions such as hypertension, dyslipidemia, diabetes, and being overweight.5 Large 
studies report that these listed risk factors significantly contribute to China’s increase in 
CHD-related death. 6,7,8,9,10  
 
Drug-Eluting Stent Use in China 
China experienced a rapid growth of percutaneous coronary intervention (PCI) between 
2002 and 2012 (Figure 1).11 An article in BMC Public Health12 projects that absolute 
numbers of CHD events and deaths will increase dramatically in China over 2010–2029, 
due to a growing and aging population alone. The authors went on to predict 7.8 million 
excess CHD events (a 69% increase) and 3.4 million excess CHD deaths (a 64% 
increase) in the decade 2020–2029 compared with 2000–2009.  Additionally, a recent 
economic analysis13 reported that the Chinese market for coronary stent devices reached 
$323.1 million in 2011. By 2016, it is expected to reach $678.4 million, a projected 
compound annual growth rate (CAGR) of 16.0% between 2011 and 2016. The majority 
of these early PCI procedures used balloon angioplasty.14 Coronary stenting was not 

 
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introduced in China until 1992, and subsequently Drug Eluting Stents (DES) followed in 
2002.15  
 
China’s increased DES utilization has precipitated the need for the collection of CFDA 
mandated long-term, real-world safety and efficacy data. To address these surveillance 
needs, several studies are being conducted in China using the XIENCE V, ENDEAVOR, 
CYPHER, FIREBIRD, and TAXUS DES. The EXCEL sirolimus-eluting biodegradable 
stent is also being studied.16,17,18  
 
Figure 1:   Number of PCI procedures and coronary stents from 2002 to 2012 in 
China 11  (* estimates) 
25
40
60
82
110
143
186
242
310
384
468
40
64
96
144
176
229
298
387
496
615
750
0
100
200
300
400
500
600
700
800
2002
2003
2004
2005
2006
2007
2008
2009
2010*
2011*
2012*
Year
Amount / Thousand 
PCI
Stent
 
 
Clinical Studies of the XIENCE V and XIENCE Prime EECSS 
XIENCE V EECSS has demonstrated outstanding clinical outcomes in both pre-
marketing and post-marketing studies.19 It is important to note that the XIENCE V 
EECSS has also been previously evaluated in native Chinese populations, including 63 
patients from mainland China in the SPIRIT V single-arm study and 50 patients from the 
SPIRIT Women single-arm study.20 Additionally, Abbott Vascular completed enrollment 
for two clinical studies (XIENCE V China Randomized, Controlled Trial [RCT] and 
XIENCE V single-arm study [SAS]) in China, 2011. These two studies are designed to 
evaluate the long-term safety and effectiveness of XIENCE V in real-world clinical 
settings in China, with approximately 500 patients enrolled in XIENCE V China RCT 
and 2500 patients enrolled in the XIENCE V SAS.  In the SPIRIT V single-arm study, 
the primary endpoint (the adjudicated composite rate of all death, myocardial infarction 
[MI], and target vessel revascularization [TVR] at 30 days) was a composite of safety and 
effectiveness. The study’s primary endpoint rate in overall patient population (2663 

 
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patients) was 2.6% compared to 0.0% in the China sites. Additionally, for these 63 
patients no stent thrombosis (ST) was reported and clinical device and procedural 
successes were 100%.21 The positive results from these Chinese patients thus suggest the 
safety and effectiveness of the XIENCE V EECSS in the Chinese population.  
 
The XIENCE PRIME EECSS, the next generation DES from the XIENCE V EECSS, has 
showed similar and consistent safety and effectiveness profile. The safety and 
effectiveness of the XIENCE PRIME was demonstrated in the SPIRIT PRIME study by 
meeting its primary endpoint of target lesion failure at 1 year when compared to pre-
specified performance goal derived from trials with XIENCE V. 22 
 
2.1.2 
Rationale to Conduct this Clinical Study 
 
This is a CFDA-mandated study aiming to assess the continued safety and effectiveness 
of XIENCE PRIME EECSS in real-world settings in China. Furthermore, this study will 
add to the group of DES studies currently being conducted in China and provide 
additional region-specific information. 
 
2.2 
Summary of Study Device 
2.2.1 
Name of the Study Device 
 
The Clinical Study Device to be used is the XIENCE PRIME Everolimus Eluting 
Coronary Stent System, manufactured by Abbott Vascular, Santa Clara, USA.  
 
The XIENCE PRIME EECSS is composed of 2 regulated components: the base device 
(MULTI-LINK VISION Coronary Stent System (CSS) or MULTI-LINK MINI VISION 
CSS) and the drug (everolimus, [contained in a polymer coating]). The MULTI-LINK 
VISION® stents are manufactured from medical grade L-605 cobalt chromium (CoCr) 
alloy. Refer to the most recent Instructions for Use (IFU) for descriptions, indications for 
use, contraindications, system preparation, precautions, and warnings.  
 
The stent diameters and stent lengths are as follows: 
 
Clinical Study Device: XIENCE PRIME EECSS 
Product Name 
Stent Diameter (mm) 
Stent Length (mm) 
XIENCE PRIME 
2.5, 2.75, 3.0, 3.5, 4.0 
8, 12, 15, 18, 23, 28 
XIENCE PRIME SV (Small Vessel) 
2.25 
8, 12, 15, 18, 23, 28 
XIENCE PRIME LL (Long Lesion) 
2.5, 2.75, 3.0, 3.5, 4.0 
33, 38 

 
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3. 
STUDY OBJECTIVE 
 
The study is to evaluate the continued safety and effectiveness of the XIENCE PRIME 
EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during 
commercial use in China. 
 
4. 
CLINICAL STUDY FLOW AND FOLLOW-UP SCHEDULE 
 
Clinical follow-ups will occur at 1, 2, 3, 4, and 5 years. See APPENDIX III:  
 for 
detailed flow chart. The Investigator/designee may conduct follow-ups as hospital/office 
visits (preferable) or telephone contacts. If follow-ups have to be conducted by telephone, 
the Investigator/designee should contact the study patient.  If efforts to reach the patient 
by telephone are unsuccessful or the patient wishes to continue his/her participation but is 
not immediately available by telephone, a relative may be contacted.   
 
If the patient or his/her relative cannot be reached after 3 telephone attempts on different 
days at different times, it is then recommended to send a registered letter requesting the 
patient to follow up.  
 
4.1 
Number of Patients to Be Registered  
 
Approximately 2000 patients at approximately 45 sites across China will be 
consecutively registered in this study. Only patients who agree to participate by signing 
the informed consent form (ICF) and who will have or have received only XIENCE 
PRIME stents during the index procedure are eligible to be registered.  
 
4.2 
Early Termination of the Clinical Study 
 
No statistical rule for early study termination is defined. However, Abbott Vascular may 
discontinue the study in part or in total at any time with written notice to the Investigators.  
 
If a study is terminated early, AV will provide a written statement describing why this 
will occur and notify the CFDA if applicable. In the case of early study termination, the 
Investigators are responsible for notifying the Ethics Committee (EC) and their patients. 
All applicable clinical study documents will be maintained under the same retention 
policy as detailed in section 12.3 Record Retention.  
 
4.3 
Termination of Study Site Participation  
 

 
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AV reserves the right to terminate study site participation and remove appropriate study 
materials at any time. Specific instances that may lead to such termination include, but 
are not limited to: 
 
 Unsatisfactory patient enrollment  
 Failure to comply with protocol 
 Failure to comply with applicable CFDA guidelines 
 Inaccurate and/or incomplete data recording on a recurrent basis 
 
The Investigator may also discontinue study participation with suitable written notice to 
AV. 
 
5. 
KEY ENDPOINTS 
 
The following key site reported endpoints will be assessed at 1, 2, 3, 4, and 5 years: 
 
 Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non–Q-
wave)  
 Composite rate of all death and all myocardial infarction (MI) (Q-wave and non–Q-wave)  
 Target lesion failure (TLF): the composite rate of cardiac death, target vessel  MI (TV-
MI), and ischemia-driven target lesion revascularization (ID-TLR)   
 Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia-
driven target vessel revascularization (ID-TVR)   
 Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] 
definition)  
 Death (cardiac, vascular, and non-cardiovascular) 
 All MI (including Q-wave and non–Q-wave) 
 Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary 
Artery Bypass Graft [CABG]) 
 
The clinical endpoints described above are direct measurement of safety and 
effectiveness of coronary stent implantation. These endpoints are widely used in stenting 
randomized control studies and registries and accepted by cardiac intervention medical 
communities.  
 
 
6. 
PATIENT SELECTION AND WITHDRAWAL  
 
6.1 
Patient Screening and Informed Consent 
 

 
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6.1.1 
Patient Screening 
 
Patients admitted for PCI, and who will have or have had only XIENCE PRIME EECSS 
implanted, should be invited to participate in the study. Once informed consent is 
obtained, patient’s data is to be entered into the electronic Case Report Form (eCRF) 
screening log. 
 
6.1.2 
Informed Consent 
The Investigator or designee, who has been trained on the protocol, will explain the 
nature and scope of the study and answer questions for the patients. A patient who is 
considered as part of a vulnerable population may not be registered in the study, except 
for members of the armed forces. However, special protection must be given to these 
patients. When obtaining Informed Consent from these patients, the physician should be 
particularly cautious if the subject is in a dependent relationship with the physician or 
may consent under duress.  When obtaining the consent, provision of a copy to the 
patient, along with the date and time must be documented in the patient’s medical records. 
All patients or their legally-authorized representatives and the investigator/designee must 
personally sign and date the EC-approved ICF. 
 
It is strongly recommended that patients (or legally authorized patients’ representatives if 
applicable) sign, date and time the Ethics Committee (EC) approved ICF prior to the 
index procedures. In the event that the signed ICF cannot be obtained prior to the 
procedure, it must be obtained no later than the time of hospital discharge and no later 
than 7 days post index procedure if hospital stay is prolonged due to any reasons. Sites 
must also abide by their respective EC ICF requirements, including signature timelines, if 
site requirements are more stringent.  
 
For patients signing the ICF post procedure, data for the study is to be collected 
retrospectively and can only be entered into eCRF after the ICF is obtained. Finally, at 
the time of signing the ICF, patients must be assessed and deemed capable of signing. 
 
Failure to obtain a signed ICF will render the patient ineligible for the study. The signed 
and dated ICF is to be maintained in the patient’s medical records and a copy given to the 
patient or his/her legally-authorized representative. The ICF will include language that 
satisfies the CFDA requirements and accounts for any applicable regulations. 
 
For any live cases at congresses the patient needs to sign a specific Live Case ICF 
approved by the IRB/EC. The investigator must notify AV prior to performing a live case. 
 
 

 
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6.2 
Eligibility Criteria 
 
Assessment for general eligibility criteria is based on medical records of the site and 
interview with a candidate patient. If some of the clinical and laboratory tests are not 
included in site standard tests, they must be done but after written informed consent 
obtained. Patients must meet ALL of the inclusion criteria to be considered for the 
clinical evaluation. If ANY of the exclusion criteria are met, the patient is excluded from 
the clinical evaluation and cannot be registered.   
 
6.2.1 
Inclusion Criteria 
 
 The patient must be at least 18 years of age at the time of signing the informed consent. 
 
The patient or his/her legally-authorized representative signs the EC-approved 
ICF.  
 
Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.  
 
6.2.2 
Exclusion Criteria 
 
No other exclusion criteria are specified for this study. 
 
6.3 
Point of Registration 
 
The enrollment service must be called after both of the following conditions have been 
met:   
 
1. A patient or patient’s legally-authorized representative has provided an EC approved, 
signed and dated ICF. 
2. Only XIENCE PRIME stent(s) is/are implanted in the coronary vasculature during the 
index procedure.   
 
6.4 
Patient Deregistration 
 
This study will consecutively register all consenting patients who have met these 
eligibility criteria. If a registered patient didn’t receive a XIENCE PRIME stent (s) during 
the index procedure, this patient is to be de-registered.  
A de-registered patient will not undergo the protocol follow-up regimen or follow-up by 
the study team. De-registered patients may be replaced until the total number of required 

 
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patients for the study is reached (refer to section 4.1 Number of Patients to Be 
Registered ). 
 
6.5 
Patient Discontinuation 
 
Each registered patient should remain in the clinical study until the required follow-up 
periods are complete. The patient has the right to withdraw from the study at any time 
without penalty or loss of benefit. Possible reasons for patient discontinuation may 
include, but are not limited to: 
 
 Patient death 
 Patient voluntary withdrawal  
 Patient withdrawn by Investigator 
 Patient lost to follow-up 
 Study is terminated (refer to section 4.2 Early Termination of the Clinical Study) 
 
The Investigator may terminate the patient’s participation without regard to the patient’s 
consent if the Investigator believes the termination is medically necessary. Patient 
participation in a clinical study is voluntary and the patient may discontinue participation 
(refuse all subsequent testing/follow-up) at any time without loss of benefits or receiving 
any penalty. 
 
However, if a patient withdraws from the study due to problems related to the study 
device safety or performance, the investigator shall ask for the patient's permission to 
follow his/her status/condition outside of the clinical investigation 
 
Lost to-follow-up:   
If the patient misses two consecutive scheduled follow-up time points, and the attempts to 
contact the patient or patient’s healthcare provider or relative detailed below are 
unsuccessful, then the patient is considered lost to-follow-up.  
 
 A minimum of three telephone calls to contact the patient should be recorded in the 
source documentation, including date, time, and initials of site personnel trying to make 
contact; 
 If these attempts are unsuccessful, a certified letter should be sent to the patient. 
 
6.6 
Study Completion 
 
A Study Completion form must be completed when: 

 
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 the patient is considered lost to follow-up (refer to section 6.5 Patient Discontinuation) or  
  the patient withdraws from the Clinical Study or 
  the investigator withdraws the patient from the Clinical Study or  
  the patient has died or 
  upon Clinical Study completion (5 year follow-up time point has been reached) 
 
AV must be notified of the reason for patient discontinuation. The site will provide this 
information on the eCRF. Investigators must also report this to their EC as defined by 
their institution’s procedure. Discontinued patients will not be replaced.  
 
7. 
TREATMENT AND EVALUATION OF SAFETY AND EFFICACY 
 
Patients should be prepared according to the healthcare facility’s standard of care for 
interventional cardiology patients. The schedule of events for this study is located in 
section APPENDIX IV:  
SCHEDULE OF EVENTS. The Investigator will determine 
the treatment strategy. 
 
Each enrolling investigator should review the most current XIENCE PRIME EECSS IFU, 
appropriate Chinese PCI guidelines23, and/or the American College of Cardiology 
(ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and 
Interventions (SCAI) 2005/2007 guidelines for PCI.24   
 
7.1 
Baseline  
7.1.1 
Baseline Laboratory Assessments   
 
Baseline laboratory data may be collected up to 4 weeks prior to the index procedure as 
appropriate. If multiple assessments are performed within 4 weeks prior to the index 
procedure, the most recent assessment value, or clinical significant findings should be 
included with the baseline laboratory information. In the event that the laboratory data 
(excluding cardiac biomarkers and electrocardiogram) is not available within the baseline 
window, it is strongly suggested that it be collected after the index procedure or before 
hospital discharge, but no later than 7 days post index procedure. Refer to Appendix IV:  
SCHEDULE OF EVENTS for specific collection time frames. 
If available, the following baseline laboratory assessments should be collected:  
 Lipid profile (low-density lipoprotein, high-density lipoprotein, triglycerides, and total 
cholesterol) 
 Serum insulin, serum creatinine, serum fasting glucose, and glycated hemoglobin 
(HbA1c) 

 
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 For female subjects of childbearing potential, a urine pregnancy test should be performed 
according to hospital standard of care. 
 
7.1.2 
Patient History 
If available, the following medical history data should be collected at baseline (including, 
but not limited to): 
 Demographics, including age and gender 
 Cardiac history including Canadian Cardiovascular Society and Braunwald classifications 
of angina25 Acute Coronary Syndrome, prior MI, and previous CABG and PCI  
 Physical measurements, including weight, height, and current left ventricular ejection 
fraction 
 Other risk factors, including stroke, diabetes mellitus, hypertension, dyslipidemia, renal 
insufficiency, anemia, tobacco use, and family history of premature coronary artery 
disease (CAD) 
 
Any baseline medical history data that is not collected within 4 weeks prior to the index 
procedure may be obtained up to 7 days post procedure and will still be considered 
baseline data (refer to APPENDIX IV:  
SCHEDULE OF EVENTS for specific data 
collection time periods).  
 
7.2 
Pre-procedure 
 Patients should be prepared according to the healthcare facility’s standard of care for 
cardiology patients undergoing PCI. The XIENCE PRIME stent(s) to be placed should be 
inspected, prepared, and implanted according to the most current IFU. 
 
7.2.1 
Pre-procedure Laboratory Assessment 
If available, the following pre-procedural assessments should be collected within 72 
hours prior to the procedure:  
 
 Creatine kinase (CK), creatine kinase myocardial-band isoenzyme (CK-MB), and/or 
troponin I/T (the most recent assessment) 
 Electrocardiogram (ECG) 
 
7.3 
Index Procedure 
7.3.1 
Procedural Information to be Recorded 
If available, the following data should be collected (including, but not limited to):  

 
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 Stent use attributes (eg, size, diameter, overlapping, and number of stents)  
 Lesion characteristics (ACC/AHA Classification Scheme of Coronary Lesions) 
 All reportable adverse events (AEs) (refer to section 8.3 Adverse Event Reporting) 
 
7.3.2 
Bailout Stenting or Alternative Procedures 
 
If bailout stenting is needed during the index procedure and the patient wants to continue 
to be registered in the study, the bail-out stent(s) must be XIENCE PRIME stents.  
 
For patients who will have planned staged procedures scheduled at the index procedure, it 
is recommended that the physician treat these patients with only the XIENCE PRIME 
EECSS.  If these planned staged procedure patients receive stents other than XIENCE 
PRIME stents during their follow-up procedure(s), they will still remain in the study. 
 
7.4 
Post-procedure 
7.4.1 
Post-procedure Information to be Recorded 
If available, the following data should be collected post procedure/on discharge: 
 All reportable AEs (refer to list in section 8.3 Adverse Event Reporting): 
7.4.2 
Post-procedure Laboratory Assessment 
If available, the following post-procedure cardiac biomarkers and ECG should be 
collected between 12 hours post procedure and the time of hospital discharge. For those 
patients with prolonged hospital stays, it is recommended that the assessment be 
conducted no later than 72 hours post procedure.  
 CK, CK-MB, and/or troponin I/T 
 Electrocardiogram (ECG) 
 
7.5 
Clinical Follow-up for All Patients (Hospital/Office Visit or Telephone 
Contact) 
Clinical follow-up will occur as either hospital/office visits (preferable) or telephone 
contacts at the following time points: 
 
Follow-up time point 
Time window (± days) 
Type of Visit 
1 year 
60 
Hospital/office visit or telephone contact 

 
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2 years 
60 
Hospital/office visit or telephone contact 
3 years 
60 
Hospital/office visit or telephone contact 
4 years 
60 
Hospital/office visit or telephone contact 
5 years 
60 
Hospital/office visit or telephone contact 
 
When possible, all contacts should be directly with the patient. If the patient cannot be 
reached, follow-up visit information may be collected from the patient’s relative. Data 
involving the following events should be collected at the specified time points: 
 
 All reportable AEs (refer to list in section 8.3 Adverse Event Reporting) 
 Dual antiplatelet therapy (aspirin, thienopyridine) 
 
7.6 
Additional Follow-up Visits for All Patients  
 
If a patient completes a hospital/office visit independent of this protocol and outside of 
the protocol-recommended follow-up time points for an AE-driven visit, all efforts must 
be made to obtain follow-up information on patients who have undergone procedures or 
have been treated for reportable AEs in a non–study-related health care facility. 
The following data should be collected at any additional follow up visits: 
 
 All reportable AEs (refer to list in section 8.3 Adverse Event Reporting) 
 Dual antiplatelet therapy (aspirin, thienopyridine) 
 
8. 
ADVERSE EVENTS 
 
8.1 
Definitions  
 
To comply with worldwide standards and guidelines on clinical trial adverse event 
reporting (ISO14155, MEDDEV2.7/3, US 21 CFR 812), AV has developed the below 
definitions to be used and adhered to by the investigators. The exact definitions as 
referenced in these standards and guidelines are included in APPENDIX II:       
DEFINITIONS. 
  
8.1.1 Adverse Event 
 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device. 
 

 
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NOTE 1: This definition includes events related to the investigational medical device or 
the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
 
An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product. 
 
8.1.2 Serious Adverse Event 
 
If the AE meets any of the criteria below, it is regarded as serious adverse event (SAE).  
 
a) Led to a death 
b) Led to a serious deterioration in health that either: 
1) Resulted in a life-threatening illness or injury, or 
2) Resulted in a permanent impairment of a body structure or a body function, or 
3) Required in-patient hospitalization or prolongation of existing hospitalization, or 
4) Resulted in medical or surgical intervention to prevent life threatening illness or injury 
or permanent impairment to a body structure or a body function. 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect 
d) An important medical event that may not result in death, be life-threatening, or require 
hospitalization but may be considered serious when based upon appropriate medical 
judgment, may jeopardize the subject and/or may require intervention to prevent one of 
the outcomes listed in this definition 
 
NOTE 1: This includes device deficiencies that might have led to a SAE if a) suitable 
action had not been taken or b) intervention had not been made or c) if circumstances had 
been less fortunate. These are handled under the SAE reporting system. 
 
NOTE 2: A planned hospitalization for pre-existing condition, or a procedure required by 
the Clinical Investigation Plan, without a serious deterioration in health, is not considered 
to be a serious adverse event. 
 
8.1.3 Device Deficiency 
All device deficiencies should be reported to Abbott Vascular customer service at (800) 
227-9902 in the USA or (951) 914-4669 outside the USA. Device deficiencies should be 
reported to the IRB/EC per the investigative site’s local requirements. 
 

 
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8.2 
Device Relationship 
 
Determination of whether there is a reasonable possibility that an investigational product 
or device caused or contributed to an AE is to be determined by the Investigator and 
recorded on the appropriate CRF form. Determination should be based on assessment of 
temporal relationships, biologic plausibility, association (or lack of association) with 
underlying disease and presence (or absence) of a more-likely cause. 
 
8.3 
Adverse Event Reporting 
8.3.1 Adverse Event Monitoring 
 
During each clinical follow-up, the Investigator/designee will determine and report all of 
the following AEs to AV: 
 
 All events resulting in death  
 Stent Thrombosis (ST)  
 Myocardial Infarction (MI) 
 All coronary revascularizations 
 Major bleeding complications (to be reported per the Global Use of Strategies to Open 
Occluded Coronary Arteries [GUSTO] classification, severe and moderate bleeding 
combined) 
 All device-related AEs, including events in which device relationship is unknown 
 All cardiac AEs which meet one or more of the criteria of a serious AE (SAE) (Refer to 
section 8.1.2 Serious Adverse Event) 
 
The Investigator will monitor the occurrence of AEs for each subject during the course of 
the clinical trial/investigation and report as required by this protocol.  AEs need to be 
collected at the time point of on the appropriate AE eCRF form. A fax form will be made 
available to allow the investigator to report SAEs in the event the eCRF is not available. 
This does not replace the EDC reporting system.  All information must still be entered in 
the EDC system once the system is back to normal function. 
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should 
not be recorded on the AE eCRF page.  
 
8.3.2 Serious Adverse Event and device deficiency/product experience 
reporting to Sponsor and IRB/EC 
 

 
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The investigator should report all SAEs to the Sponsor and IRB/MEC as soon as possible 
but no later than outlined below.  
 
 
Study sites 
Reporting timelines 
 
SAEs must be reported no later than 3 calendar days from the site 
becoming aware of the event or as per the investigative site’s local 
requirements if the requirement is more stringent than those outlined. 
 
The date the site staff became aware that the event met the criteria of a serious adverse 
event must be recorded in the source document.  
 
Serious adverse events that do not occur in the study subject but occur in the user or other 
persons should not be entered in the EDC system, however need to be reported on the fax 
notification form titled SAE Notification Form.   
 
The Investigator will further report the event to the local IRB/EC according to the 
institution’s IRB/EC reporting requirements.    
 
8.4  
Safety Monitoring 
 
Every effort will be made to conduct an unbiased review of patient safety information 
and ensure patient safety. Qualified safety personnel designated by AV will review the 
safety data throughout enrollment and follow-up periods. 
 
  
9. 
STATISTICAL ANALYSIS 
 
9.1 
Statistical Overview  
 
This prospective, open-label, multi-center, observational, single-arm post-approval study 
is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME 
EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during 
commercial use. Approximately 2000 patients will be consecutively registered at up to 45 
sites in China. No pre-specified hypothesis tests are planned for this study. Only 
descriptive analyses will be performed. 
 
9.2 
Analysis Populations  
 
The analytical population is defined as patients who received only XIENCE PRIME 
EECSS during the index procedure. 

 
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9.3 
Sample Size Calculations and Assumptions  
 
Approximately 2000 patients will be consecutively registered into the study from the 
general Chinese interventional cardiology population. The sample size of 2000 is based 
on CFDA’s requirements for post approval studies, but not based on statistical hypothesis 
testing.   
 
9.4 
Statistical Analyses  
 
For binary variables such as ST, Death and MI, results will be summarized with patient 
counts, percentages, and exact 95% Clopper-Pearson confidence intervals. 26  For 
continuous variables such as age, results will be summarized with the numbers of 
observations, means, standard deviations, and 95% confidence intervals for the means. 
These calculations will be done under the assumption that the data are approximately 
normal in distribution. For time-to-event variables, such as time to TLF, survival curves 
may be constructed using Kaplan-Meier estimates, and log rank test results for subgroup 
analysis will be displayed for descriptive purposes only. 
 
9.4.1 
Key Endpoint Analysis  
 
Rates and confidence intervals will be summarized descriptively for the following key 
site reported endpoints at 1, 2, 3, 4, and 5 years: 
 
 Composite rate of cardiac death and all myocardial infarction (MI) (Q-wave and non–Q-
wave)  
 Composite rate of all death and all myocardial infarction (MI) (Q-wave and non–Q-wave)  
 Target lesion failure (TLF): the composite rate of cardiac death, target vessel  MI (TV-
MI), and ischemia-driven target lesion revascularization (ID-TLR)   
 Target vessel failure (TVF): the composite rate of cardiac death, all MI, and ischemia-
driven target vessel revascularization (ID-TVR)   
 Stent thrombosis (definite and probable, per Academic Research Consortium[ARC] 
definition)  
 Death (cardiac, vascular, and non-cardiovascular) 
 All MI (including Q-wave and non–Q-wave) 
 Revascularization (target lesion, target vessel, and non-target vessel) (PCI and Coronary 
Artery Bypass Graft [CABG]) 
 
9.4.2 
Additional Analyses  
 
Descriptive analyses will be provided for patient demographics, medical histories, and 
co-morbidities. 

 
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Logistic regression analyses may be used to screen a wide range of parameters for their 
association with some endpoints. Each patient will serve as their own control. Correlation 
analyses will be conducted for several parameters including, but not limited to, late stent 
thrombosis incidence.  
 
9.4.3 
Subgroup Analysis 
 
Subgroup analyses for diabetic, non-diabetic, single-vessel and dual-vessel patients, etc. 
will be performed descriptively. Results that will be presented are baseline demographics, 
lesion characteristics as well as clinical outcomes. In addition, for future regulatory 
submissions, data may be evaluated to allow data pooling etc. 
 
9.4.4 
Procedures for Accounting for Missing, Unused or Spurious Data 
 
All analyses will be based on available data with missing data excluded.  Any unused or 
spurious data will be noted as appropriate in report. 
10. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
 
The Investigator/designee or institution will permit direct access to source data and 
documents for clinical study-related monitoring, audits, EC review, and regulatory 
inspections. 
 
Patients providing informed consent agree to allow AV/designee access and copying 
rights to pertinent medical record information. As part of informed consent, the 
Investigator/designee will obtain permission for AV representatives or regulatory 
authorities to review, in confidence, any records identifying patients in this clinical study. 
AV will not otherwise release any personal information (refer to section 13.2 
Confidentiality). 
 
11. 
QUALITY CONTROL AND QUALITY ASSURANCE 
 

 
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11.1 
Selection of Clinical Sites and Investigators 
 
AV will select investigators who are qualified physicians with experience in 
interventional cardiovascular procedures and are qualified to perform clinical research. 
Sites will be selected using a combination of Investigator qualifications and site 
assessment criteria. 
 
11.2 
Protocol and Informed Consent Approval  
 The Principal investigator must agree with the content of the protocol prior to taking part 
in the study. 
 Approval of the protocol, informed consent forms, and other documents associated with 
the study must be obtained from the IRB/EC. 
 The investigators are required to keep the IRB/EC informed of the study progress on a 
regular basis until termination of the study. 
 
11.3 
Protocol Amendments  
AV/designee will provide AV-approved protocol amendments to Investigators when the 
protocol is amended. The Principal Investigator will be responsible for notifying the EC 
and/or obtaining documented EC approval of any protocol amendments prior to 
amendment implementation. Documentation of necessary EC approvals must be provided 
to AV. 
 
11.4 
Training 
 
AV/designee will be responsible for providing training to the Investigator and appropriate 
clinical site personnel. All Investigators/study personnel that are trained must sign a 
training log upon completion of the training. Investigators are responsible for assuring 
that their designated study staff is fully trained to this protocol, its procedures and any 
subsequent amendments to the protocol. 
 
AV’s monitors/designees will be appropriately trained to the protocol, eCRFs, and other 
relevant study procedures and process. Training will be conducted and recorded in 
accordance with relevant standard procedures. 
 
11.5 
Monitoring 
 
AV/designee will monitor the study over its duration according to the pre-specified 
monitoring plan which will include the planned extent of source data verification.  

 
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11.6 
Deviations from Protocol 
It is the Investigator's responsibility to ensure that there are no deviations from the 
protocol without prior notification and approval of AV and that all actions are in full 
compliance with all established procedures of the EC or equivalent committee. The 
Investigator will not deviate from the protocol for any reason without prior written 
approval from AV except in cases of medical emergencies, when the deviation is 
necessary to protect the life or physical well-being of the subject or eliminate an apparent 
immediate hazard to the subject. In that event, the Investigator will notify AV 
immediately by phone or in writing. All deviations must be reported to AV. In subject-
specific deviations from the protocol, a Protocol Deviation Case Report Form will be 
completed. The occurrence of protocol deviations will be monitored by AV for 
evaluation of Investigator compliance to the protocol and regulatory requirements, and 
dealt with according to written procedures. Investigators will inform their EC or 
equivalent committee of all Protocol Deviations in accordance with their specific EC or 
equivalent committee reporting policies and procedures.  
 
In the event that an Investigator does not comply with the Clinical Trial Agreement or 
protocol, the Investigator will be notified of the site’s non-compliance.  
 
In the event of repeated non-compliance, as determined by AV, an AV’s monitor or 
company representative will attempt to secure compliance by one or more of the 
following (and not limited to):  
 
 Visiting the Investigator  
 Telephoning the Investigator  
 Corresponding with the Investigator  
 
Repeated non-compliance with the signed agreement, the protocol or any other conditions 
of the study may result in further escalation in accordance with AV’s written procedures 
including securing compliance or, at the sole discretion of AV, terminating the 
Investigator's participation in the study.  
 
11.7 
Compliance Assessments 
 
AV/designee may conduct periodic compliance assessments at various study sites.  
AV/designee may request access to all study records including source documentation for 
inspection and duplication during a compliance assessment. The Investigator and 
Research Coordinator must be available to respond to reasonable requests and queries 
made during the compliance assessment process.  
 

 
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11.8 
Publications Committee 
The Publication Committee is composed of Principle Investigators, KOLs (as needed) 
and representatives from AV Clinical Research. This team will oversee and determine 
presentation and/or publication aspects of the study. The committee will also review and 
approve all external study-related data and publication requests. This committee will 
follow AV’s applicable policies and standard operating procedures. 
 
12. 
DATA HANDLING AND RECORD KEEPING  
AV/designee will perform all data management activities including documentation of the 
systems and procedures to be used. All eCRF data collection will be performed through a 
secure web portal and all authorized personnel with access to the electronic data capture 
(EDC) system must use an electronic signature access method to enter, review or correct 
data.  Passwords and electronic signatures will be strictly confidential.   
 
All eCRF data will be downloaded from the EDC system and reformatted into a data 
structure acceptable to AV. The data will be subject to consistency and validation checks 
within the EDC system and will be subject to supplemental validation following 
download.  At the conclusion of the study, completed eCRF images with the date-and-
time stamped electronic audit trail indicating the user, the data entered, and any reason 
for change (if applicable) will be archived at the Investigator’s site and a backup copy 
archived with AV. 
 
The Investigator will maintain complete and accurate documentation including but not 
limited to medical records, clinical trial progress records, laboratory reports, eCRF, 
signed ICF, device accountability records, correspondence with the EC and clinical trial 
monitor/AV, AE reports, and information regarding subject discontinuation or 
completion of the clinical trial.  
 
12.1 
Source Documentation 
 
 
Regulations and Good Clinical Practice (GCP) require that the Investigator maintain 
information in the subject’s medical records that corroborate data collected on the Case 
Report Forms. In order to comply with these regulatory requirements/GCP, the following 
information should be included in the subject’s record, at a minimum, and if applicable to 
the study: 
 Medical history/physical condition of the subject before involvement in the study 
sufficient to verify protocol entry criteria 
 Dated and signed notes on the day of entry into the study referencing AV, protocol 
number, subject ID number and treatment assigned, and a statement that Informed 
Consent was obtained 

 
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 Dated and signed notes from each subject visit (for specific results of procedures and 
exams) 
 Adverse Events reported and their resolution including supporting documents such as 
discharge summaries, catheterization laboratory reports, ECGs, and lab results including 
documentation of site awareness of SAEs and of Investigator’s device relationship 
assessment of SAEs. 
 Study-required laboratory reports and 12-lead ECGs, signed and dated for review and 
annotated for clinical significance of out of range results. 
 Notes regarding protocol-required and prescription medications taken during the study 
(including start and stop dates) 
 Subject’s condition upon completion of or withdrawal from the study 
 Any other data required to substantiate data entered into the eCRF 
 
12.2 
Electronic Case Report Form Completion  
 
Primary data collection based on source-documented hospital and/or clinic chart reviews 
will be performed clearly and accurately by site personnel trained on the protocol and 
eCRF completion. eCRF data will be collected for all patients that are registered into the 
study. AV or designee will provide clinical monitoring as specified in Section 11.5 
Monitoring. 
 
12.3 
Record Retention 
 
The Investigator must maintain all study records for a minimum of 10 years following 
study completion or as otherwise instructed by AV.  AV will maintain copies of 
correspondence, data, adverse device effects, and other relevant clinical study records. 
The Investigator must obtain permission from AV in writing before destroying or 
transferring control of any clinical study records. 
 
13. 
ETHICAL CONSIDERATION 
 
13.1 
Ethics Committee Review  
EC approval for study required documents will be obtained by the Investigator prior to 
study participation. No changes may be made to study required documents without 
appropriate approval from the EC, AV, and/or the regulatory agencies. Any protocol 
amendments and/or associated informed consent changes will be submitted to the EC as 
needed, with written approval required prior to implementation. 
 

 
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13.2 
Confidentiality 
To ensure compliance with the CFDA and any applicable private information protection 
laws, confidentiality of protected health information shall be maintained by all parties 
throughout the study. All data should be secured against unauthorized access. Study 
patients will be assigned a unique coded identifier on his/her eCRF and other study 
records sent to AV. 
 
13.3 
Submitting Reports to Competent Authority 
 
AV will prepare and submit interim reports to the CFDA according to the CFDA’s 
appropriate guidelines. Annual clinical updates will be distributed to Investigators. 
Reports may also be distributed to other regulatory bodies. 
 
14. 
PUBLICATION POLICY  
Study-derived data are the sole property of AV. Investigators will not use study-related 
data without written consent from AV for any purpose other than study completion, as 
stated in the study site agreement. 
 
The presentation and/or publication of individual site results must not precede those from 
multiple centers.  In order to publish multicenter results, investigators are required to 
obtain the approval of AV’s Publication Committee.   
 
Presentation and/or publication materials must be received at least 60 days prior to any 
deadlines. AV will review all materials for compliance and alignment with AV’s 
scientific publication policy and presentation and publication strategy. Any exceptions 
must be approved by the Publication Committee.  
 
AV will control and maintain responsibility for international study registration and results 
posting, as appropriate. 

 
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APPENDIX I: 
ABBREVIATIONS AND ACRONYMS 
 
Acronym/ 
Abbreviation 
Term 
ACC 
American College of Cardiology 
AE 
Adverse Event 
AHA 
American Heart Association 
ARC 
Academic Research Consortium 
AV 
Abbott Vascular 
CABG 
Coronary Artery Bypass Graft 
CAD 
Coronary Artery Disease 
CAGR 
Compound Annual Growth Rate 
CFDA 
China Food and Drug Administration 
CHD 
Coronary Heart Disease 
CK 
Creatine Kinase 
CK-MB 
Creatine Kinase Myocardial-Band Isoenzyme 
CoCr 
Cobalt Chromium  
CSS 
Coronary Stent System 
CVD 
Cardiovascular Disease 
DES 
Drug-eluting Stent 
DD 
Device Deficiency 
DS 
Diameter Stenosis 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EECSS 
Everolimus Eluting Coronary Stent System 
FFR 
Function Flow Reserve 
GCP 
Good Clinical Practice 
GUSTO 
Global Use of Strategies to Open Occluded Coronary Arteries 
HbA1c 
Hemoglobin A1c (glycated hemoglobin) 
ICF 
Informed Consent Form 
ID 
Ischemia-Driven  
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
KOL 
Key Opinion Leader 
LAD 
Left Anterior Descending Artery 
LBBB 
Left Bundle Branch Block 
LCX 
Left Circumflex Artery 
MI 
Myocardial Infarction 
PAS 
Post-Approval Study 
PCI 
Percutaneous Coronary Intervention 
RCA 
Right Coronary Artery 
SAE 
Serious Adverse Event 
SAS 
Single-arm Study 
SC 
Study Completion 
SCAI 
Society for Cardiovascular Angiography and Interventions 
ST 
Stent Thrombosis 

 
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Acronym/ 
Abbreviation 
Term 
TIMI 
Thrombosis in Myocardial Infarction flow 
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 
USFDA 
United States Food and Drug Administration 
WHO 
World Health Organization 
 
 

 
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APPENDIX II:  
DEFINITIONS 
ACC/AHA Classification Scheme of Coronary Lesions: Lesion-Specific 
Characteristics 
Type A Lesions (High Success, >85%; Low Risk) 
 
Discrete (< 10 mm length) 
 
Little or no calcification 
 
Concentric 
 
Less than totally occlusive 
 
Readily accessible 
 
Not ostial in location 
 
Nonangulated segment, < 45 
 
No major branch involvement 
 
Smooth contour 
 
Absence of thrombus 
Type B Lesions* (Moderate Success, 60-85%; Moderate risk) 
 
Tubular (10-20 mm length) 
 
Moderate-to-heavy calcification 
 
Eccentric 
 
Total occlusions < 3 mo old 
 
Moderate tortuosity of proximal segment 
 
Ostial in location 
 
Moderately angulated segment, > 45, < 90 
 
Bifurcation lesions requiring double guide wires 
 
Irregular contour 
 
Some thrombus present 
* Type B1 lesions: One adverse characteristic 
* Type B2 lesions:  two adverse characteristics 
Type C Lesions (Low Success, <60%; High Risk) 
 
Diffuse (> 2 cm length) 
 
Total occlusions > 3 mo old 
 
Excessive tortuosity of proximal segment 
 
Inability to protect major side branches 
 
Extremely angulated segments > 90 
 
Degenerated vein grafts with friable lesions 
 
Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device. 

 
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Angina 
Braunwald Classification of Unstable Angina25 
I. New onset of severe or accelerated angina: Patients with new onset (< 2 months in 
duration) exertional angina pectoris that is severe or frequent (> 3 episodes/day) or patients 
with chronic stable angina who develop accelerated angina (that is, angina distinctly more 
frequent, severe, longer in duration, or precipitated by distinctly less exertion than previously) 
but who have not experienced pain at rest during the preceding 2 months. 
II. Angina at rest, subacute: Patients with 1 or more episodes of angina at rest during the 
preceding month but not within the preceding 48 hours. 
III. Angina at rest, acute: Patients with 1 or more episodes of angina at rest within the 
preceding 48 hours. 
Canadian Cardiovascular Society Classification of Stable Angina 
I.  Ordinary physical activity does not cause angina, such as walking or climbing stairs.  
Angina occurs with strenuous, rapid or prolonged exertion at work or recreation. 
II. Slight limitation of ordinary activity. Angina occurs on walking or climbing stairs rapidly, 
walking uphill, walking or stair climbing after meals, or in cold, in wind, under emotional 
stress or only during the few hours after awakening. Angina occurs on walking more than 
two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace 
and in normal condition. 
III. Marked limitation of ordinary physical activity. Angina occurs on walking one to two 
blocks on the level and climbing one flight of stairs in normal conditions and at a normal 
pace. 
IV. Inability to carry on any physical activity without discomfort – angina symptoms may be 
present at rest. 
 
Bail-out stent 
Bailout stenting may be performed in cases of one of the following during the index 
procedure: 
 Dissection  
 Occlusive complication as evidenced by a decrease in target vessel flow 
 Chest pain or ischemic ECG changes that do not respond to treatment 
 Unplanned additional stent required to fully cover the target lesion (caused by geographic 
miss or under estimation of lesion length) 
 

 
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Bifurcation Lesion 
A lesion located at both the main vessel and a side branch of that main vessel. 
 
Coronary Artery Bypass Graft (CABG) Surgery 
Acute CABG surgery is defined as immediate transfer from the catheterization laboratory to 
the operative room for emergent bypass surgery during the initial treatment phase.  Coronary 
artery bypass graft surgery during follow-up is only considered as a target vessel 
revascularization and major adverse coronary event if coronary angiography indicates a 
diameter of stenosis >50% of the stented coronary segment associated with one of the 
following conditions: 
 A positive history of recurrent angina pectoris presumably related to the target vessel 
 Objective signs of ischemia (exercise test or equivalent) presumably related to the target 
vessel 
 Abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity 
reserve, fractional flow reserve) 
 
Death  
Death is defined by the Academic Research Consortium27 as follows:                             
All deaths are considered cardiac unless an unequivocal noncardiac cause can be established. 
Specifically, any unexpected death even in patients with coexisting potentially fatal 
noncardiac disease (eg, cancer, infection) should be classified as cardiac.  
 Cardiac death 
Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal 
arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related 
deaths, including those related to concomitant treatment, will be classified as cardiac death. 
 
Vascular death 
Death caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary 
embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. 
 Non-cardiovascular death 
Any death not covered by the above definitions, such as death caused by infection, 
malignancy, sepsis, pulmonary causes, accident, suicide, or trauma. 
 

 
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Deregistration 
Refers to patients who, after having previously been registered are removed from the study 
population. De-registered patients are no longer associated with the study.  They do not 
receive the study device, do not take part in study-required follow-up and are not part of the 
Intent-to-Treat population. 
 
Device deficiency 
 
A device deficiency (DD) is an inadequacy of a medical device related to its identity, 
quality, durability, reliability, safety or performance, such as malfunction, misuse or use 
error and inadequate labeling. 
 
Epicardial Vessels 
 Left anterior descending artery (LAD) with septal and diagonal branches 
 Left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches 
 Right coronary artery (RCA) and any of its branches 
 
Legally-Authorized Representative 
An individual or judicial or other body authorized under applicable law to consent on behalf 
of a prospective patient to the patient’s participation in the procedure(s) involved in the 
research.  
 
Myocardial Infarction (MI)  by World Health Organization (WHO)    
 
 Q wave MI 
Development of new, pathological Q wave on the ECG 
 
Non-Q wave MI 
Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated 
CK-MB in the absence of new pathological Q waves 
 
Percutaneous Coronary Intervention (PCI) 
Refers to all interventional cardiology procedures used to treat coronary artery disease. 
 
Primary Investigator 

 
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A physician-specialist who is responsible for overseeing study conduct at all sites, protocol 
compliance, and relevant regulations 
 
Principal Investigator 
A physician responsible for conducting the study at each investigational site 
 
Restenosis 
Re-narrowing of the artery following the removal or reduction of a previous narrowing 
 
Revascularization  
Revascularization is defined as follows: 
 Target Lesion Revascularization  (TLR) 
Target lesion revascularization is defined as any repeat percutaneous intervention of the 
target lesion or bypass surgery of the target vessel performed for restenosis or other 
complication of the target lesion. All TLR should be classified prospectively as ischemia-
driven (ID) or not ischemia-driven by the investigator prior to repeat angiography. An 
independent angiographic core laboratory should verify that the severity of percent diameter 
stenosis meets requirements for ischemia-driven and will overrule in cases where investigator 
reports are not in agreement if applicable. The target lesion is defined as the treated segment 
from 5 mm proximal to the scaffold/stent and to 5 mm distal to the scaffold/stent. 
 Target Vessel Revascularization (TVR) 
Target vessel revascularization is defined as any repeat percutaneous intervention or surgical 
bypass of any segment of the target vessel. The target vessel is defined as the entire major 
coronary vessel proximal and distal to the target lesion, which includes upstream and 
downstream branches and the target lesion itself.   
 Non Target Lesion Revascularization (non-TLR) 
Any revascularization in the target vessel for a lesion other than the target lesion is 
considered a non-TLR.   
 Non Target Vessel Revascularization (non-TVR) 
Revascularization of the vessel identified and treated as the non-target vessel at the time of 
the index procedure.   
 Ischemic-Driven (ID) Revascularization (TLR/TVR) 
A revascularization is considered ischemic driven if associated with any of the following: 
a) Positive functional ischemia study including positive functional flow reserve (FFR) 

 
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b) Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA 
c) Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or 
positive functional study 
 
Serious Adverse Event (SAE) 
If the AE meets any of the criteria below, it is regarded as serious adverse event (SAE).  
 
a) Led to a death, 
b) Led to a serious deterioration in health that either: 
1) Resulted in a life-threatening illness or injury, or 
2) Resulted in a permanent impairment of a body structure or a body function, or 
3) Required in-patient hospitalization or prolongation of existing hospitalization, or 
4) Resulted in medical or surgical intervention to prevent life threatening illness or 
injury or permanent impairment to a body structure or a body function. 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
d) An important medical event that may not result in death, be life-threatening, or require 
hospitalization but may be considered serious when, based upon appropriate medical 
judgment, may jeopardize the subject and/or may require intervention to prevent one of 
the outcomes listed in this definition. 
 
Stent Thrombosis                                                                                                              
Stent thrombosis is defined by the Academic Research Consortium27 as follows: 
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 guiding 
catheter has been removed and the patient left the catheterization laboratory.  
       Timing 
Acute stent thrombosis* 
0-24 hours post stent implantation 
Subacute stent thrombosis* 
> 24 hours-30 days post stent implantation 
Late stent thrombosis† 
> 30 days-1 year post stent implantation 
Very late stent thrombosis† 
> 1 year post stent implantation 
* Acute/subacute can also be replaced by early stent thrombosis. Early stent 
thrombosis (0-30 days) – this definition is currently used in the community.  
† Including “primary” as well as “secondary” late stent thrombosis; “secondary” late 
stent thrombosis is a stent thrombosis after a target segment revascularization.  
 
     Stent Thrombosis Categories: a) Definite b) Probable, and c) Possible 
  

 
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a) Definite stent thrombosis 
Definite stent thrombosis is considered to have occurred by either angiographic or 
pathologic confirmation. 
 
 
Angiographic confirmation of stent thrombosis* 
The presence of a thrombus† that originates in the stent or in the segment 5 mm 
proximal or distal to the stent and presence of at least 1 of the following criteria 
within a 48-hour time window:  
 
Acute onset of ischemic symptoms at rest  
 
New ischemic ECG changes that suggest acute ischemia  
 
Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous 
MI)  
 
Nonocclusive thrombus 
-Intracoronary thrombus is defined as a (spheric, ovoid, or irregular) 
noncalcified filling defect or lucency surrounded by contrast material (on 3 
sides or 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  
-TIMI 0 or TIMI 1 intrastent or proximal to a stent up to the most adjacent 
proximal side branch or main branch (if originates from the side branch).  
*The incidental angiographic documentation of stent occlusion in the absence of 
clinical signs or symptoms is not considered a confirmed stent thrombosis (silent 
occlusion). 
 
†Intracoronary thrombus. 
 
Pathological confirmation of stent thrombosis  
Evidence of recent thrombus within the stent determined at autopsy or via 
examination of tissue retrieved following thrombectomy.  
 
b) Probable stent thrombosis 
Clinical definition of probable stent thrombosis is considered to have occurred after 
intracoronary stenting in the following cases: 
 
Any unexplained death within the first 30 days‡  
 
Irrespective of the time after the index procedure, any MI that is related to 
documented acute ischemia in the territory of the implanted stent without 
angiographic confirmation of stent thrombosis and in the absence of any other 
obvious cause  
        ‡ For studies with ST-elevation MI population, one may consider the exclusion 
of unexplained death within 30 days as evidence of probable stent thrombosis. 
 
c) Possible stent thrombosis 
 

 
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Clinical definition of possible stent thrombosis is considered to have occurred with 
any unexplained death from 30 days after intracoronary stenting until end of study 
follow-up. 
 
Target Lesion 
A lesion to be treated during the index procedure 
 
Target Vessel 
The entire epicardial vessel containing the treated lesion 
 
Thrombosis in Myocardial Infarction (TIMI) Flow Grades                                                      
Thrombosis in Myocardial Infarction flow grades are defined by the following: 
0. No contrast flow through the stenosis. 
1. A small amount of contrast flows through the stenosis but fails to fully opacify the artery 
beyond. 
2. Contrast material flows through the stenosis to opacify the terminal artery segment. 
However, contrast enters the terminal segment perceptibly more slowly than more proximal 
segments. Alternatively, contrast material clears from a segment distal to a stenosis 
noticeably more slowly than from a comparable segment not preceded by a significant 
stenosis. 
3.  Anterograde flow into the terminal coronary artery segment through a stenosis is as 
prompt as anterograde flow into a comparable segment proximal to the stenosis. Contrast 
material clears as rapidly from the distal segment as from an uninvolved, more proximal 
segment. 
 

 
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APPENDIX III:  
STUDY FLOW 
 
Patient is considered for the study
Was/Were only XIENCE PRIME 
EECSS stent(s) implanted?
Index procedure
Was Informed consent obtained*?
Hospital/office visit or telephone 
contact follow up
1, 2, 3, 4, 5 yrs
+/- 42 days
Patient registered into study, 
entered into eCRF
(casebook)
Was enrollment service called?
Note: It is strongly recommended to obtain a signed ICF prior to the index procedure.  In the event that the signed ICF cannot be obtained prior to the procedure, 
it must be obtained no later than the time of hospital discharge and no later than 7 days post index procedure if hospital stay is prolonged due to any reasons. Sites must 
abide by their respective EC ICF requirements, including signature timelines, if site requirements are more stringent.
Was Informed 
consent obtained 
post procedure?
Document in 
eCRF
Was IC obtained pre-procedure
Patient not 
registered
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
No
No

 
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 APPENDIX IV:  
SCHEDULE OF EVENTS 
 
 
 
 
Baseline 
Index Procedure 
Post Procedure 
1 year  
( 60 days) 
hospital/office visit 
or phone contact  
2 years  
( 60 days) 
hospital/office visit 
or  phone contact 
3 years  
( 60 d) 
hospital/office visit 
or  phone contact 
4 years  
( 60 days) 
hospital/office visit 
or  phone contact 
5 years  
( 60 days) 
hospital/office visit 
or phone contact  
Unscheduled visit  
Patient Medical/Clinical History 
(refer to 7.1 Baseline)  
1 
 
 
 
 
 
 
 
 
Patient ICF  
(Inclusion/Exclusion Criteria) 
2 
 
 
 
 
 
 
 
 
Lipid Profile, Serum Insulin, Serum 
Glucose, Serum Creatinine, HbA1c, 
Urine pregnancy test 
1,3 
 
 
 
 
 
 
 
 
CK, CK-MB, and/or Troponin I/T 
4 
 
5 
 
 
 
 
 
 
ECG 
4 
 
 
 
 
 
 
 
 
Stent Attributes 
 
 
 
 
 
 
 
 
 
Lesion Characteristics 
(ACC/AHA/SCAI Classification 
Scheme of Coronary Lesions) 
 
 
 
 
 
 
 
 
 
Dual Antiplatelet Therapy (loading 
dose) 
 
 
 
 
 
 
 
 
 
Dual Antiplatelet Therapy (post-
procedure maintenance dose) 
 
 
 
 
 
 
 
 
 
Reportable AE(s) 
(refer to 8.3 Adverse Event 
Reporting) 
 
 
 
 
 
 
 
 
 
 
1. 
May be collected up to 4 weeks prior to the index procedure. If multiple assessments are performed within 4 weeks prior to the 
index procedure, it is recommended that the most recent assessment value be included with the baseline information. Data that is 
not collected during the baseline time window may be obtained up to 7 days post procedure and will still be considered baseline 
data.  
2. 
It is strongly recommended to obtain a signed ICF prior to the index procedure.  In the event that the signed ICF cannot be 
obtained prior to the procedure, it must be obtained no later than the time of hospital discharge and no later than 7 days post 
index procedure if hospital stay is prolonged due to any reasons. Sites must abide by their respective EC ICF requirements, 
including signature timelines, if site requirements are more stringent. 
3. 
In the event that this information was not available within the baseline window, it is strongly recommended that it be collected 
immediately after, but no later than 7 days post index procedure. 
4. 
If available, these preprocedural laboratory assessments should be collected within 72 hours prior to the procedure (refer to 7.1 
Baseline). 
5. 
If available, postprocedural cardiac biomarkers and ECG should be collected between 12 hours post procedure and the time of 
hospital discharge. For those patients with a prolonged hospital stay, it is recommended that the assessment be conducted no 
later than 72 hours post procedure. 
 

 
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APPENDIX V: 
REFERENCES 
                                                          
 
1 Zhang X-H, Lu Z L and Liu L. Coronary heart disease in China. Heart 2008 94: 1126-1131 
2 Wu ZS, Yao CH, Zhao D, et al. Sino-MONICA Project: a collaborative study on trends and determinants 
in cardiovascular diseases in China, Part I: morbidity and mortality monitoring. Circulation 
2001;103:462–8. 
3 Gu DF, He J, Wu XG, et al. Main causes and its modifiable risks of death among men and women in 
China. Chinese J Prev Contr Chron Non-commun Dis 2006;14:149–54. 
4 Zhou BF. For the study collaborative group. The comparative study on the level and trends of CVD and 
risk factors between high and low incidence areas in China. Data book. Beijing, 1996. 
5 Liu JM, Ye R, Li S, et al. Prevalence of overweight/obesity in Chinese children. Arch Med Res 
2007;38:882-6. 
6 Liu J, Grundy SM, Wang W, et al. Ten-year risk of cardiovascular incidence related to diabetes, 
prediabetes, and the metabolic syndrome. Am Heart J 2007;153:552-8. 
7 Critchley JA, Unal B. Is smokeless tobacco a risk factor for coronary heart disease? A systematic review 
of epidemiological studies. Eur J Cardiovasc Prev Rehabil 2004;11:101-12. 
8 Gu D, Gupta A, Muntner P, et al. Prevalence of cardiovascular disease risk factor clustering among the 
adult population of China: results from the International Collaborative Study of Cardiovascular 
Disease in Asia (InterAsia). Circulation 2005;112:658-65. 
9 He K, Xu Y, Van Horn L. The puzzle of dietary fat intake and risk of ischemic stroke: a brief review of 
epidemiologic data. J Am Diet Assoc 2007;107:287-95. 
10 Zhao SP, Lu ZL, Du BM, et al. Xuezhikang, an extract of cholestin, reduces cardiovascular events in 
type 2 diabetes patients with coronary heart disease: subgroup analysis of patients with type 2 diabetes 
from China coronary secondary prevention study (CCSPS). J Cardiovasc Pharmacol 2007;49:81-4. 
11 China Interventional Cardiovascular Device Industry Report, 2010. 
12 Moran A,  Zhao D,  Gu D, Coxson P,  Chen CS,  Cheng J,  Liu J,  He J, and Goldman L. The future 
impact of population growth and aging on coronary heart disease in China: projections from the 
Coronary Heart Disease Policy Model-ChinaBMC Public Health 2008, 8:394-408. 
13 Crandell MA. Global Markets for Coronary Stent Devices -- Focus on Asia-BCC Research LLC 
49 Walnut Park, Building 2, Wellesley, MA 02481, USA. 
14 Cheng TO. The current state of cardiology in China. Int J Cardiol 2004;96:425-39. 
15 Gao RL. [Drug-eluting stent: is it safe?]. Zhonghua Xin Xue Guan Bing Za Zhi 2006;34:964-5 
16 Gao Z, Yang YJ, Chen JL, et al. [Outcome of patients implanted with bioabsorbable polymer sirolimus-
eluting stent (Excel) and the durable polymer sirolimus-eluting stent (Cypher)]. Zhonghua Xin Xue 
Guan Bing Za Zhi 2008;36:1074-7. 

 
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17 Gao LJ, Chen JL, Chen J, et al. [Comparison of different drug-eluting stents in the treatment of coronary 
artery disease: a single center four-year clinical follow-up]. Zhonghua Nei Ke Za Zhi 2008;47:541-4. 
18 Gao Z, Yang YJ, Chen JL, Qiao SB, Xu B, Gao RL. [A comparative study of in-stent restenosis after 
drug eluting stents]. Zhonghua Nei Ke Za Zhi 2009;48:122-5. 
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