XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance
Conditions: Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Myocardial Ischemia
Sponsor: Abbott Medical Devices

 
XIENCE PRIME SV JAPAN PMS 
Execution Overview 
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Confidential and Proprietary 
Do not distribute or reproduce without the prior written permission of Abbott Vascular Inc. 
 
 
 
 
 
 
 
 
XIENCE PRIME SV 
Everolimus Eluting Coronary Stent 
Post Marketing Surveillance 
 
Protocol number: 12-303 
 
Execution Overview 
 
【2.25 mm diameter】 
 
 
 
 
 
 
 
 
 
Abbott Vascular Japan 
 
 
 
The Ministry of Health, Welfare and Labor requires this post-marketing surveillance as a 
condition of XIENCE PRIME Everolimus Eluting Coronary Stent System approval. Your kind 
cooperation in this surveillance will be highly appreciated. 
 
＜This is a translation of the Japanese Version Created on: 3/15/2013 Ver. 1.0＞ 
 
 

 
XIENCE PRIME SV JAPAN PMS 
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Approval Number 
 
22500BZX00070000 
 
Approval Date 
 
March 7, 2013 
 
Generic Name of the Device 
 
Coronary Stent 
 
Brand Name of the Device 
 
XIENCE PRIME SV Everolimus Eluting 
Coronary Stent 
 
Surveillance Period 
 
 
March 07, 2013 – December 31, 2019 
 
Sponsor  
 
Abbott Vascular Japan Co., Ltd. 
3-5-27 Mita, Minato-ku, Tokyo 108-6304 
Authorized Representative in Japan 
 
Noriyuki Niki 
Post-marketing surveillance,  
Clinical Research Department 
Abbott Vascular Japan Co., Ltd. 
 
 
 
 
 
 
 

 
XIENCE PRIME SV JAPAN PMS 
Execution Overview 
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Version 1.0 
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1.  
PURPOSE OF THIS SURVEILLANCE 
 
This post-marketing surveillance (hereinafter referred to as “the PMS”) is to be conducted for a 
medical device prescribed in Paragraph 1 in Article 14 of the Pharmaceutical Affairs Law (Law 
No. 145, August 10, 1960, hereinafter referred to as “PAL”) by a marketing approval holder or 
restrictive foreign approval holder of medical device prescribed in the standard for post-
marketing surveillance and post-marketing study (excluding those set forth in Ministerial 
Ordinance Concerning the Standards for Executing Clinical Tests on Medical Devices, 
Ministerial Ordinance No. 36, March 23, 2005), which is part of the standard established by the 
Minister of Health, Welfare and Labor set forth in Paragraph 4 in Article 14-4 and Paragraph 4 in 
Article 14-6 (including when applied mutatis mutandis to Paragraph 4 in Article 19 of PAL). The 
objectives of the PMS are to observe the frequency, type, and degree of device deficiency to 
assure the safety of the new medical device as well as to collect information on evaluation of the 
efficacy and safety for reevaluation.  
 
The PMS is to be conducted in accordance with Ministerial Ordinance Concerning the Standards 
for Post-marketing Surveillance and Tests of Medical Devices (Ministerial Ordinance No. 36, 
March 23, 2005, hereinafter referred to as “Good Post-marketing Study Practice: GPSP”). 
 
2.  
ELIGIBILITY AND PLANNED REGISTRATION 
 
2.1 
Target Patient Population 
 
Based on GPSP regulation, general patient population with ischemic heart disease who are 
eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent (Approval Number: 
22500BZX00070000; Approval Date: March 7, 2013) , will be registered, with no particular 
inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and 
clinical follow-up at one year.  
 
2.2 
Enrollment Method 
 
• Patient informed consent is required for registration of this PMS In cases where patient 
informed consent (or providing some type of information) is required for PMS per the 
participating site policy, the Sponsor will cooperate as needed. 
• If it is known at the time of index procedure that the patient is not able to return for the 8-
month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient 
should not be registered in the PMS. 
• Patients who are treated (stent delivery system inserted into the body) by XIENCE PRIME 
SV will be registered (including provisional stenting for side branch treatment but excluding 
bail-out only use) 
• The observations will be compiled on a per-patient basis even if multiple stents are 
implanted during the index procedure. 

 
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• A patient whose side-branch is treated by XIENCE PRIME SV can be registered. In such 
a case, main vessel should be treated by XIENCE PRIME.  
• A patient who are treated by other DES for planned stent and XIENCE PRIME SV for 
bail-out purpose cannot be registered. 
• Additional revascularization procedures as a part of AE treatment and planned staged 
procedures will not be considered as another registration, or adverse events. 
• A patient who is treated, but failed to be implanted by XIENCE PRIME SV and finally 
treated by other devices only (No XIENCE PRIME SV are implanted) must also be 
registered. In such a case, only the stent information, device deficiency information and 
reportable adverse events related to the PRIME stent, if any, are required to be captured. 
Follow-up of the patient who does not receive any XIENCE PRIME SV stent is not 
required. 
• A patient may have another lesion(s) that may be treated by larger diameter stent(s). In such 
a case, treatment by XIENCE PRIME is preferable. Lesion(s) treated by other than XIENCE 
PRIME is not considered as the target lesion. 
 
2.3 
Number of Patients to be Registered 
 
The goal is to register 300 patients from approximately 30 sites. 
 
MACE (composite of cardiac death, myocardial infarction and ischemia-driven target lesion 
revascularization) rate of this surveillance is expected to be 15%, based on past trials. For 300 
patients, half of 95% confidence interval of MACE rate of 15% is 4.2%. This is 28% of expected 
MACE rate of 15%. This range will be enough to evaluate safety and efficacy of XIENCE 
PRIME SV in real world practice in Japanese hospitals.  
 
3.  
PMS DURATION 
 
Duration of patient registration for the PMS will not be set, however the target is to complete 
registry by June 30th, 2014. 
 
Annual reports will be submitted to PMDA every year. After the re-submission, data will 
continue to be collected until 5 year follow-up is complete for all patients. 
 
Patient data from the following time points will be collected  
 
• Baseline (before procedure) 
• Procedure 
• Post-Procedure through discharge 
• 8 months follow-up (follow-up angiogram) 
• 1 year post-procedure (site visit is recommended but telephone contact is allowed) 
• 2 year post-procedure (site visit/telephone contact) 
• 3 year post-procedure (site visit/telephone contact) 
• 4 years post-procedure (site visit/telephone contact) 

 
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• 5 years post-procedure (site visit/telephone contact) 
 
 
4. 
PATIENT TREATMENT 
 
Patient treatment strategy should be determined by the physicians based on standard PCI 
procedure at each of the sites. Physicians should review the most updated IFU, and carefully 
consider contraindications, warnings, and precautions when considering patient treatment. 
 
Although dual antiplatelet management is ultimately determined by physicians, enrolled patients 
will be encouraged to receive adjunctive antiplatelet therapy consisting of an indefinite duration 
of aspirin in addition to a required minimum of 12 months of thienopyridine (clopidogrel, 
ticlopidine, etc.). It is recommended that physicians review the requirements of the most recent 
thienopyridine IFU before treating patients.  
 
 
5. 
OBSERVATION ITEMS AT EACH TIME POINT 
 
5.1 
Baseline Information 
 
1) 
Patient Basic Information 
 
• Index Procedure Date (Date of Registration) 
• Birth year and month 
• Implant of XIENCE PRIME STENT (Only basic information, non-implant stent form 
and device deficiency form must be completed in the case all PRIME stents are failed to 
implant) 
• Gender 
• Height 
• Weight 
• Admission and Discharge dates 
 
2) 
Cardiac Status at the Index Procedure and Cardiac History 
 
• Cardiac Status (Symptom of ischemia) at the Index Procedure 
• History of Myocardial Infarction 
• Previous CABG 
• Previous PCI 
 
3) 
Risk Factors 
 
• Family History of Premature Coronary Artery Disease 

 
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• Smoking History 
• Hypertension 
• Dyslipidemia 
• Diabetic Mellitus 
• Renal Disease 
• History of Stroke 
• History of Major Bleeding 
• Unstable Arrhythmia 
• Chronic Anticoagulant Therapy 
 
4) 
Pre-Procedure ECG 
 
5) 
Pre-Procedure Cardiac Enzyme and Creatinine 
 
• Cardiac Enzyme 
o CK 
o CK-MB (If MI is suspected then must be measured per site standard practice) 
• Serum Creatinine 
 
6) 
Pre-Procedure Antiplatelet 
 
• Aspirin 
• Clopidogrel 
• Ticlopidine 
• Other anti-platelet medications 
•  
 
5.2 
Procedure Information 
 
1) 
General Information 
 
• Physician Name 
• Procedure Start Time (Insertion of Guide Catheter) 
• Procedure End Time (Removal of Guide Catheter) 
• Access Site 
• Number of Diseased Vessels 
• Number of Treated Lesions 
o Treated only by XIENCE PRIME (Target Lesion) 
o Treated by XIENCE PRIME and Other Stent (Target Lesion) 
o Treated only by other devices (Non-target Lesion) 

 
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• LVEF 
 
2) 
Lesion Information 
 
Angiographic corelab analysis data will be adopted when it is applicable. 
 
• Lesion Number 
• Target or Non-target Lesion 
• AHS Lesion Segment Number 
• Lesion Type (de novo or restenosis) 
• Complex Lesion 
• Thrombectomy 
• Lesion Preparation (pre-dilatation) 
• Post-dilatation 
• Use of Bailout Stent 
• Total Number of Stents Implanted 
• Other concomitant device (including intravascular imaging modalities), if any 
• 
Stent recross by intravascular imaging modalities  
o 
Type of imaging  modalities 
 
 
3) 
Bifurcated Lesion (If applicable) 
 
• Side Branch AHA Segment 
• Bifurcation Lesion Type 
• Technique Used 
• Kissing Balloon 
 
4) 
Lesion Visual Assessment (Pre and Post Procedure) 
 
Angiographic corelab analysis data will be adopted when it is applicable. 
 
• Lesion Length 
• Reference Vessel Diameter  
• ％DS 
• TIMI Flow 
 
5) 
Stent Information 
 
• Stent information must be recorded per lesion 
o Length and Diameter 

 
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o Deployment Pressure 
o Successful Deployment 
o Deployed Vessel (main vessel or side branch) 
 
 
5.3 
Post Procedure Information 
 
1) 
Post-Procedure ECG 
 
2) 
Post-Procedure 
 
• Cardiac Enzyme 
o CK 
o CK-MB (If MI is suspected then must be measured per site standard practice) 
 
5.4 
Post-Procedure (Maintenance) Antiplatelet 
 
• Type 
• Start Date 
• Daily Dose 
• Termination or Continuation  
 
5.5 
Eight Months Follow-up 
 
1) 
General Information 
 
• Contact Method 
• Contact Date 
• Reportable adverse event since the last follow-up 
• Change or termination of antiplatelet therapy 
• Device Deficiency 
• Follow-up Angiogram  
• Ischemic Symptoms 
• Revascularization 
 
2) 
Angiographic Information 
 
Angiographic corelab analysis data will be adopted when it is applicable. 
 
• Lesion Length (if restenosis exist) 
• Reference Vessel Diameter 

 
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• ％DS 
 
5.6 
1~5 Years Follow-up (Every Year) 
 
• Contact Method 
• Contact Date 
• Reportable adverse event since the last follow-up 
• Change or termination of antiplatelet therapy 
• Device Deficiency 
 
 
5.7 
Unscheduled Visit (Reportable AE related) 
 
Complete AE form(s) if a patient visits the hospital with reportable adverse event(s). 
 
5.8 
Device Deficiency 
 
• Date of deficiency 
• Type of deficiency 
• Did the device deficiency result in an adverse event?  
• Description of deficiency/comment 
• Product details (lot, serial numbers, etc.) 
 
5.9 
Adverse Event (Reportable Event) 
 
Record the following adverse events (including procedural complications) and their details.  
 
• All Coronary artery related adverse events* 
o Ischemic symptoms, evidences, including test results 
o Diagnostic angiogram 
o Revascularization 
• All serious adverse events** 
• All events for which relationship to the PMS Device cannot be ruled out, and  
• All other adverse events related to taking antiplatelet medication(s) 
 
* Send images to the corelab if revascularization is done to the target vessel. 
** Serious adverse event: death, life-threatening, hospitalization (initial or prolonged), disability 
or permanent damage, congenital anomaly/birth defect, other serious (investigator’s 
judgment). 
 
Evaluate and record relationship of the above adverse events to the Device, procedure, and 
antiplatelet therapy, as well as the outcome of each event. If the event is an SAE, record the 
criteria for considering the event as an SAE. 
 

 
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6. 
EVALUATION ITEMS 
 
6.1 
Important Evaluation Items 
 
Important evaluation items in this PMS are; 
 
1) 
Stent Thrombosis 
2) 
Adverse events caused by Anti-platelet Medications 
 
6.2 
Other Evaluation Items 
 
Other evaluation items will be per standard drug eluting studies. 
 
7.  
DATA ANALYSIS  
 
7.1 
Angiographic Core-Lab 
 
Angiographic data at the index procedure and 8 months follow-up will be analyzed by Core-lab 
for lesion characteristics and coronary quantitative analysis.   
 
7.2 
Independent Review of Adverse Events 
 
 
Objective review of adverse events (Stent Thrombosis, Cardiac Death, Myocardial Infarction, 
and TLR/TVR) will be conducted by a third party (medical professional) up to 3 years post index 
procedure.  These events will be reviewed based on ARC definition. QCA results from 
angiographic core-lab will be provided to the reviewer as necessary. 
 
7.3 
Analysis of Results 
 
Collected data will be analyzed and Annual Report will be submitted according to "Survey 
Report on new medical device usage" (Japan Pharmaceutical and Food Safety Bureau Notice 
1224, no. 4, dated December 24, 2010). Subgroup analyses will be conducted as necessary to 
evaluate safety and efficacy of the device, and included in the resubmission report.