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

Completed

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

Interventions: Device: XIENCE PRIME SV Everolimus Eluting Coronary Stent

Registration Number: NCT02513719

Lead Sponsor: Abbott Medical Devices

Brief Summary: The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV 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 PRIME SV Everolimus Eluting 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 312

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XIENCE PRIME SV Everolimus Eluting Coronary Stent	XIENCE PRIME SV Everolimus Eluting Coronary Stent	Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent

Primary Outcome Measures

Name	Time	Method
Number of Participants With Stent Thrombosis: Subacute	>24 hours to 30 days post stent implantation	Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual 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: Subacute stent thrombosis : \>24 hours to 30 days after stent implantation
Number of Participants With Stent Thrombosis: Acute	0-24 hours post stent implantation	Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timing: Acute stent thrombosis: 0 to 24 hours after stent implantation
Number of Participants With Stent Thrombosis: Late	30 days to 1 year post stent implantation	Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual 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: Late stent thrombosis : \>30 days to 1 year after stent implantation

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Stent Thrombosis: Very Late	>1 year post stent implantation	Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual 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: Very late stent thrombosis : \>1 year after stent implantation.
Number of Participants With Target Lesion Revascularization	0-5 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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)	0-5 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, non-TLR)
Number of Participants With Target Vessel Failure	0 to 5 years	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).
Number of Participants With Cardiac Death or Target Vessel-MI	0 to 1 year	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).
Percent Diameter Stenosis (%DS)	8 months	The value calculated as 100 \* (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Success Rate: Percentage of Devices With Implant Success	< or = 1 day	The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25mm. Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).
Number of Participants With All Revascularization	0 to 5 years	Revascularization: * Target Lesion Revascularization (TLR) 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. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) 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. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Success Rate: Percentage of Lesions With Procedural Success	< or = 1 day	Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).
Success Rate: XIENCE PRIME Implant Success by Patient	< or = 1 day	The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25 mm. Implant success is assessed as per physicians decision, but means that the stent could be implanted at the intended location.
Number of Death	0-５ 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 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 clinically indicated target lesion revascularization (CI-TLR).
Number of Participants With Cardiac Death or Target-Vessel MI	0 to 8 months	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 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).
Number of Participants With Myocardial Infarction	0-5 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.
Acute Gain: In-stent,In-segment	Pre procedure to post procedure (on day 0)	The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD).
Net Gain: In-stent, In-segment	Post-Procedure (on day 0)	Difference between acute gain and late loss.
Number of Participants With Non-target Vessel Revascularization (Non-TVR)	0 to 5 years	Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.
Number of Participants With Hemorrhage	0 to 5 years	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding.
Number of Participants With Target Lesion Failure	0 to 5 years	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Late Loss(LL): In-stent,In-segment,Proximal, and Distal	8 months	Proximal and distal late loss was calculated by \[post-procedure minimum lumen diameter (MLD)\] - \[MLD at 8 months\].
Number of Participants With All Death/All MI/All Revascularization	0 to 5 years
Number of Participants With Death or 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 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 Cardiac Death or 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.) 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.

Trial Locations

Locations (33): Kimitsu Chuo Hospital
🇯🇵
Chiba, Japan
Nagoya Daini Red Cross Hospital
🇯🇵
Nagoya, Japan
Sakurabashi Watanabe Hospital
🇯🇵
Osaka, Japan
Osaka University Hospital
🇯🇵
Osaka, Japan
Tokyo Women's Medical University Hospital
🇯🇵
Tokyo, Japan
Saiseikai Yokohama City Tobu Hospital
🇯🇵
Yokohama, Japan
Hoshi general hospital
🇯🇵
Fukushima, Japan
Hyogo Prefectural Amagasaki Hospital
🇯🇵
Hyogo, Japan
Fukuoka Wajiro Hospital
🇯🇵
Fukuoka, Japan
Mitsui Memorial Hospital
🇯🇵
Tokyo, Japan
Tsukuba Medical Center Hospital
🇯🇵
Ibaraki, Japan
Tsuchiya General Hospital
🇯🇵
Hiroshima, Japan
Shonan Kamakura General Hospital
🇯🇵
Kanagawa, Japan
Kumamoto Chuo Hospital
🇯🇵
Kumamoto, Japan
Tokeidai memorial hospital
🇯🇵
Sapporo, Japan
Tokushima Red Cross Hospital
🇯🇵
Tokushima, Japan
Okamura memorial hospital
🇯🇵
Shizuoka, Japan
Kokura Memorial Hospital
🇯🇵
Fukuoka, Japan
Miyazaki City-Gun Ishikai Hospital
🇯🇵
Miyazaki, Japan
Osaka police hospital
🇯🇵
Osaka, Japan
Hokkaido Ohno hospital
🇯🇵
Sapporo, Japan
Ishikawa Prefectual Central Hospital
🇯🇵
Ishikawa, Japan
Tokai University Hospital
🇯🇵
Kanagawa, Japan
Kyoto University Hospital
🇯🇵
Kyoto, Japan
Kansai Rosai Hospital
🇯🇵
Nagoya, Japan
Heart disease center Sakakibara hospital
🇯🇵
Okayama, Japan
Kurashiki Central Hospital
🇯🇵
Okayama, Japan
Tokorozawa Heart Center
🇯🇵
Saitama, Japan
JCHO Hokkaido Hospital
🇯🇵
Sapporo, Japan
Sendai Kousei Hospital
🇯🇵
Sendai, Japan
Teikyo University Hospoital
🇯🇵
Tokyo, Japan
Toranomon hospital
🇯🇵
Tokyo, Japan
Showa University Fujigaoka hospital
🇯🇵
Yokohama, Japan