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

 
XIENCE Xpedition 2.25mm stent JAPAN 
PMS 
Execution Overview 
14-306 
Version 1.0 
Page 1 of 11 
 
Confidential and Proprietary 
Do not distribute or reproduce without the prior written permission of Abbott Vascular Inc. 
 
 
 
 
 
 
 
 
XIENCE Xpediton 
Everolimus-Eluting Coronary Stent 
Post Marketing Surveillance 
 
Protocol number: 14-306 
 
Execution Overview 
 
【2.25 mm diameter stent】 
 
 
 
 
 
 
 
 
 
Abbott Vascular Japan Co., Ltd. 
 
 
 
 
The Ministry of Health, Welfare and Labor requires this post-marketing surveillance as a 
condition of XIENCE Xpedition Everolimus-Eluting Coronary Stent System approval for 
2.25mm stent. Your kind cooperation in this surveillance will be highly appreciated. 
 
＜This is a translation of the Japanese Version Created on: 5/29/2014 Ver. 1.0＞ 
 
 

 
XIENCE Xpedition 2.25mm stent JAPAN 
PMS 
Execution Overview 
14-306 
Version 1.0 
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Approval Number 
 
22500BZX00309000 
 
Approval Date 
 
May 20, 2014 
 
Generic Name of the Device 
 
Coronary Stent 
 
Brand Name of the Device 
 
XIENCE Xpedition Everolimus-Eluting Coronary 
Stent  
2.25mm stent 
Surveillance Period 
 
 
July 01, 2014 – March 31, 2021 
 
Sponsor 
 
Abbott Vascular Japan Co., Ltd. 
3-5-27 Mita, Minato-ku, Tokyo 108-6304 
Responsible 
Manager 
for 
Post-
marketing Surveillance 
 
Noriyuki Niki 
Post-marketing surveillance group,  
Clinical Research 
Abbott Vascular Japan Co., Ltd. 
 
 
 
 
 
 
 

 
XIENCE Xpedition 2.25mm stent JAPAN 
PMS 
Execution Overview 
14-306 
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 Xpedition Everolimus-Eluting 2.25mm Stent (Approval 
Number: 22500BZX00309000; Approval Date: May 20, 2014), 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 
 
• 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 attending or will attend other PMS with invasive medical procedure will not 
be registered. 
• Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered. 
• The observations will be compiled on a per-patient basis even if multiple XIENCE 
Xpedition 2.25mm stents are implanted during the index procedure. 

 
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PMS 
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• A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be 
registered. In such a case, main vessel should be treated by XIENCE Xpedition.  
• The observations will not be compiled on a per-patient basis if a patient is treated by 
XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose. 
• 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 Xpedition 2.25mm stent 
and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are 
implanted) must also be registered. In such a case, only the stent information, device 
deficiency information and reportable adverse events related to the Xpedition stent, if any, 
are required to be captured. Follow-up of the patient who does not receive any XIENCE 
Xpedition 2.25mm stent is not required. 
• A patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) 
stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by 
other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion. 
 
 
2.3 
Number of Patients to be Registered 
 
The goal is to register about 100 patients from approximately 10 sites. 
 
The XIENCE Xpedition 2.25 mm stent is identical to the stent of the XIENCE PRIME SV 
Everolimus-Eluting Coronary Stent System (Approval No. 22500BZX00070000) which is 
currently under use result surveillance. The sample size is calculated based on the following 
statistical hypothesis and assumptions: The in-stent late loss = 0.2 mm (SD = 0.5 mm) for both 
the XIENCE PRIME SV stent and the XIENCE Xpedition 2.25 mm stent; the QCA follow-up 
rate of the XIENCE PRIME SV PMS (300 patients) = 75% (225 lesions); one-tailed test with 
alpha = 0.05; power = 90%; non-inferiority delta = 0.195 mm. Given the above assumptions, 75 
patients are needed to demonstrate the non-inferiority to the XIENCE PRIME SV stent. 
Assuming drop-outs, approximately 100 patients are considered a target sample size which 
ensures the effectiveness of the XIENCE Xpedition 2.25 mm stent. 
 
 
3.  
PMS DURATION 
 
Patients will be followed by 5 years. After signing the contract with each sites and the enrollment 
can be started, the target duration of patient registration for the PMS will be by September 5th, 
2015. 
 
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  
 

 
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PMS 
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• Baseline (before procedure) 
• Procedure 
• Post-Procedure through discharge 
• 8 months follow-up (follow-up angiogram) 
• 1 year post-procedure (site visit is recommended) 
• 2 year post-procedure (site visit/telephone contact) 
• 3 year post-procedure (site visit/telephone contact) 
• 4 years post-procedure (site visit/telephone contact) 
• 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 latest 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 Xpedition 2.25mm stent (Only basic information, non-implant stent 
form and device deficiency form must be completed in the case all XIENCE Xpedition 
2.25mm stents are failed to implant) 
• Gender 
• Height 
• Weight 
• Admission and Discharge dates 
 

 
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PMS 
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2) 
Cardiac Status at the Index Procedure and Cardiac History 
 
• Cardiac Status (Symptom of ischemia) at the Registration 
• History of Myocardial Infarction 
• Previous CABG 
• Previous PCI 
 
 
3) 
Risk Factors 
 
• Family History of Premature Coronary Artery Disease 
• 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 
• Cilostazol 
 
 

 
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PMS 
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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) 
• 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 
• Post-procedure within stent after Post-dilatation 
• Other concomitantly-used medical device 
 
3) 
Bifurcated Lesion (If applicable) 
 
• Side Branch AHA Segment 
• Bifurcation Lesion Type 
• Technique Used 
• Kissing Balloon 
 
 

 
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PMS 
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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 
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  
 
 
 
 
 
 

 
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PMS 
Execution Overview 
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5.5 
8 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 
• ％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.) 
 

 
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PMS 
Execution Overview 
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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 XIENCE Xpedition 2.25mm stent cannot be ruled out 
• All other adverse events related to taking antiplatelet medication(s) 
 
   * 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 
reason for considering the event as an SAE. 
 
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 
3) 
Longitudinal stent deformation 
 
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 quantitative coronary angiography (QCA) analysis. 
 
Core-lab:  KIC Co., Ltd Core-lab Department 
34-15 Yanagi-cho Kanazawa-ku Yokohama city 
 

 
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PMS 
Execution Overview 
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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. 
 
The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the 
XIENCE PRIME SV Stent approved on March 7, 2013. Therefore, the data collected from the 
PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.