XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)

Completed

Conditions: Coronary Artery Disease
Myocardial Ischemia
Angina Pectoris
Ischemic Heart Disease

Interventions: Device: XIENCE Xpedition 2.25 mm stent

Registration Number: NCT02513732

Lead Sponsor: Abbott Medical Devices

Brief Summary: The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.

Detailed Description: Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent 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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XIENCE Xpedition 2.25 mm stent arm	XIENCE Xpedition 2.25 mm stent	Patients receiving XIENCE Xpedition 2.25 mm stent

Primary Outcome Measures

Name	Time	Method
Number of Participants With Stent Thrombosis: Late	30 days to 1 year post stent implantation-Day 212	Scaffold/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 subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cardiac Death/All MI	0 to 5 years	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. 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. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants With Cardiac Death or Target-Vessel MI	0 to 5 years	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Mean Net Gain: In-stent, In-segment	At 8 months, post index procedure	Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).
Mean Reference Vessel Diameter (RVD)	During follow-up, at 8 months post procedure	Reference vessel diameter measured by QCA
Number of Participants With All Revascularization	0 to 5 years	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Number of Participants With Death	0 to 5 years	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * 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.
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	0 to 5 years	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.
Number of Participants With Cardiac Death	0 to 5 years	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Number of Participants With MI Related to Target Vessel	0 to 5 years	Myocardial Infarction (MI) - 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
Number of Participants With Target Vessel Failure (TVF)	0 to 5 years	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants With Target Vessel Revascularization (Non-TLR)	0 to 5 years	Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.
Percent Diameter Stenosis (%DS)	During follow-up, at 8 months post procedure	In-segment, In-stent, Proximal and Distal. The value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Number of Participants Using Antiplatelet Therapy	5 years observation day from the procedure day	Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Number of Participants With Myocardial Infarction	0 to 5 years	Myocardial Infarction (MI) - 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
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	0 to 5 years	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	0 to 5 years	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	0 to 5 years	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants With Target Lesion Failure (TLF)	0 to 5 years	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Mean Lesion Length	Pre-procedure	The lesion length will be measured by QCA.
Mean Acute Gain: In-stent, In-segment	At 8 months, post index procedure	The difference between post- and pre-procedural MLD.
Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal	At 8 months, post index procedure	Late loss is calculated as MLD post procedure - MLD at follow-up.
Minimum Blood Vessel Diameter	During follow-up, at 8 months post procedure	Minimum blood vessel diameter measured by QCA
Number of Participants With Death/All MI	0 to 5 years	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. 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. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

Trial Locations

Locations (11): Hyogo Prefectural Amagasaki Hospital
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Hyogo, Japan
Osaka Police Hospital
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Osaka, Japan
Hanaoka Seishu Memorial Cardiovascular Clinic
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Sapporo, Japan
JCHO Hokkaido Hospital
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Sapporo, Japan
Mitsui Memorial Hospital
🇯🇵
Tokyo, Japan
Tokushima Red Cross Hospital
🇯🇵
Tokushima, Japan
Teikyo University Hospital
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Tokyo, Japan
Ishikawa Prefectural Central Hospital
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Ishikawa, Japan
Miyazaki Medical Association Hospital
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Miyazaki, Japan
Toranomon Hospital
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Tokyo, Japan
Showa University Fujigaoka Hospital
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Yokohama, Japan