The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.
The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.
Study Type
OBSERVATIONAL
Enrollment
2,010
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Site Reference ID/Investigator# 104727
Aichi, Japan
Site Reference ID/Investigator# 113428
Aichi, Japan
Site Reference ID/Investigator# 115745
Aichi, Japan
Site Reference ID/Investigator# 104424
Chiba, Japan
Site Reference ID/Investigator# 113645
Chiba, Japan
Site Reference ID/Investigator# 105015
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within 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 ST\&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time frame: Post Procedure to 1 Year
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within 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 ST\&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time frame: From 1 Year to 2 Years
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within 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 ST\&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time frame: From 2 years to 3 years
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From post-procedure to 1 year
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From 1 year to 2 years
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From 2 years to 3 years
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From 3 years to 4 years
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From 4 years to 5 years
Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: Baseline
Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: On day 0 after procedure
Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: At 8 months
Acute Gain
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ehime, Japan
Site Reference ID/Investigator# 105148
Fukuoka, Japan
Site Reference ID/Investigator# 105177
Fukuoka, Japan
Site Reference ID/Investigator# 104677
Gifu, Japan
Site Reference ID/Investigator# 104365
Gunma, Japan
...and 37 more locations
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Time frame: On day 0 after procedure
Late Loss
Proximal and distal late loss was calculated by \[post-procedure minimum lumen diameter (MLD)\] - \[MLD at 8 months\].
Time frame: On day 0 after procedure
Net Gain
Net Gain = Acute Gain - Late Loss, paired analysis only.
Time frame: On day 0 after procedure
Acute Success
Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met: * Stent was successfully delivered to the intended location * Stent was successfully deployed at the intended location * Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure.
Time frame: On day 0 (Immediately post-index procedure)
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
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.
Time frame: Post Procedure to 1 Year
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
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.
Time frame: From 1 to 2 years
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
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.
Time frame: From 2 years to 3 years
Number of Participants With Myocardial Infarctions (MI)
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.
Time frame: Post Procedure to 1 Year
Number of Participants With Myocardial Infarctions (MI)
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.
Time frame: From 1 year to 2 years
Number of Participants With Myocardial Infarctions (MI)
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.
Time frame: From 2 years to 3 years
Number of Participants With 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 clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: Post Procedure to 1 Year
Number of Participants With 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 clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: From 1 year to 2 years
Number of Participants With 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 clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: From 2 years to 3 years
Number of Participants With 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.
Time frame: Post Procedure to 1 Year
Number of Participants With 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.
Time frame: From 1 Year to 2 Years
Number of Participants With 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.
Time frame: From 2 Years to 3 Years
Number of Participants With Cardiac Death and All MI
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.
Time frame: Post Procedure to 1 Year
Number of Participants With Cardiac Death and All MI
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.
Time frame: From 1 Year to 2 Years
Number of Participants With Cardiac Death and All MI
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.
Time frame: From 2 Years to 3 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time frame: Post Procedure to 1 Year
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time frame: From 1 Year to 2 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time frame: From 2 Years to 3 Years
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time frame: Post Procedure to 1 Year
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time frame: From 1 Year to 2 Years
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time frame: From 2 Years to 3 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time frame: Post Procedure to 1 Year
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time frame: From 1 Year to 2 Years
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time frame: From 2 Years to 3 Years
Number of Participants With All Deaths and All MI
Time frame: Post Procedure to 1 Year
Number of Participants With All Deaths and All MI
Time frame: From 1 Year to 2 Years
Number of Participants With All Deaths and All MI
Time frame: From 2 Years to 3 Years
Number of Participants With All Deaths, All MI and All Revascularization
Time frame: Post Procedure to 1 Year
Number of Participants With All Deaths, All MI and All Revascularization
Time frame: From 1 Year to 2 Years
Number of Participants With All Deaths, All MI and All Revascularization
Time frame: From 2 Years to 3 Years
Number of Participants With All Deaths, TVMI and TLR
Time frame: Post Procedure to 1 Year
Number of Participants With All Deaths, TVMI and TLR
Time frame: From 1 Year to 2 Years
Number of Participants With All Deaths, TVMI and TLR
Time frame: From 2 Years to 3 Years
Number of Participants With All Deaths, TVMI and CI-TLR
Time frame: Post Procedure to 1 Year
Number of Participants With All Deaths, TVMI and CI-TLR
Time frame: From 1 Year to 2 Years
Number of Participants With All Deaths, TVMI and CI-TLR
Time frame: From 2 Years to 3 Years