Trial Outcomes & Findings for XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS) (NCT NCT02513732)

NCT ID: NCT02513732

Last Updated: 2021-05-13

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 100 participants
• Primary outcome timeframe: 30 days to 1 year post stent implantation-Day 212
• Results posted on: 2021-05-13

Participant Flow

A total of 100 subjects were enrolled from multiple sites.

Participant milestones

Measure	XIENCE Xpedition 2.25 mm Stent Arm Patients receiving XIENCE Xpedition 2.25 mm stent
Overall Study STARTED	100
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	XIENCE Xpedition 2.25 mm Stent Arm Patients receiving XIENCE Xpedition 2.25 mm stent
Overall Study Lost to Follow-up	11
Overall Study Death	9
Overall Study Changing hospital	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Age, Continuous	68.2 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	100 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	100 Participants n=5 Participants
Region of Enrollment Japan	100 participants n=5 Participants
Height	162.58 cm STANDARD_DEVIATION 8.31 • n=5 Participants
Weight	64.22 kg STANDARD_DEVIATION 10.05 • n=5 Participants
BMI	24.23 kg/m^2 STANDARD_DEVIATION 2.82 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days to 1 year post stent implantation-Day 212

Population: Intend To Treat population(ITT population)

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Stent Thrombosis: Late	1 Participants

SECONDARY outcome

Timeframe: Pre-procedure

Population: ITT population

In-segment, In-stent, Proximal and Distal. 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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions Patients receiving XIENCE Xpedition 2.25 mm stent
Percent Diameter Stenosis (%DS)	72.02 Percent Diameter stenosis Standard Deviation 16.97

SECONDARY outcome

Timeframe: Immediately after the procedure

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions Patients receiving XIENCE Xpedition 2.25 mm stent
Percent Diameter Stenosis (%DS)	23.15 Percent Diameter stenosis Standard Deviation 12.01

SECONDARY outcome

Timeframe: During follow-up, at 8 months post procedure

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=79 Number of lesions Patients receiving XIENCE Xpedition 2.25 mm stent
Percent Diameter Stenosis (%DS)	32.14 Percent Diameter Stenosis Standard Deviation 20.43

SECONDARY outcome

Timeframe: At baseline before procedure

Population: ITT population

Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants Using Antiplatelet Therapy Cilostazol	3 Participants
Number of Participants Using Antiplatelet Therapy Prasugrel	25 Participants
Number of Participants Using Antiplatelet Therapy Compounding agent	6 Participants
Number of Participants Using Antiplatelet Therapy Other	2 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + clopidogrel	68 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + ticlopidine	2 Participants
Number of Participants Using Antiplatelet Therapy Aspirin	92 Participants
Number of Participants Using Antiplatelet Therapy Clopidogrel	67 Participants
Number of Participants Using Antiplatelet Therapy Ticlodipine	2 Participants

SECONDARY outcome

Timeframe: Date of discharge from procedure day

Population: ITT population

Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants Using Antiplatelet Therapy Aspirin + clopidogrel	62 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + ticlopidine	2 Participants
Number of Participants Using Antiplatelet Therapy Aspirin	79 Participants
Number of Participants Using Antiplatelet Therapy Clopidogrel	61 Participants
Number of Participants Using Antiplatelet Therapy Ticlodipine	2 Participants
Number of Participants Using Antiplatelet Therapy Cilostazol	2 Participants
Number of Participants Using Antiplatelet Therapy Prasugrel	17 Participants
Number of Participants Using Antiplatelet Therapy Compounding agent	6 Participants
Number of Participants Using Antiplatelet Therapy Other	2 Participants

SECONDARY outcome

Timeframe: 8 months observation day from the procedure day

Population: ITT population

Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants Using Antiplatelet Therapy Aspirin + clopidogrel	54 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + ticlopidine	2 Participants
Number of Participants Using Antiplatelet Therapy Aspirin	70 Participants
Number of Participants Using Antiplatelet Therapy Clopidogrel	52 Participants
Number of Participants Using Antiplatelet Therapy Ticlodipine	2 Participants
Number of Participants Using Antiplatelet Therapy Cilostazol	2 Participants
Number of Participants Using Antiplatelet Therapy Prasugrel	7 Participants
Number of Participants Using Antiplatelet Therapy Compounding agent	5 Participants
Number of Participants Using Antiplatelet Therapy Other	1 Participants

SECONDARY outcome

Timeframe: 1 year observation day from the procedure day

Population: ITT population

Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=98 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants Using Antiplatelet Therapy Ticlodipine	1 Participants
Number of Participants Using Antiplatelet Therapy Cilostazol	2 Participants
Number of Participants Using Antiplatelet Therapy Prasugrel	6 Participants
Number of Participants Using Antiplatelet Therapy Compounding agent	4 Participants
Number of Participants Using Antiplatelet Therapy Other	1 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + clopidogrel	43 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + ticlopidine	1 Participants
Number of Participants Using Antiplatelet Therapy Aspirin	67 Participants
Number of Participants Using Antiplatelet Therapy Clopidogrel	44 Participants

SECONDARY outcome

Timeframe: 2 years observation day from the procedure day

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=96 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants Using Antiplatelet Therapy Aspirin + clopidogrel	31 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + ticlopidine	1 Participants
Number of Participants Using Antiplatelet Therapy Aspirin	64 Participants
Number of Participants Using Antiplatelet Therapy Clopidogrel	33 Participants
Number of Participants Using Antiplatelet Therapy Ticlodipine	1 Participants
Number of Participants Using Antiplatelet Therapy Cilostazol	2 Participants
Number of Participants Using Antiplatelet Therapy Prasugrel	4 Participants
Number of Participants Using Antiplatelet Therapy Compounding agent	4 Participants
Number of Participants Using Antiplatelet Therapy Other	1 Participants

SECONDARY outcome

Timeframe: 3 years observation day from the procedure day

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=95 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants Using Antiplatelet Therapy Aspirin + clopidogrel	29 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + ticlopidine	1 Participants
Number of Participants Using Antiplatelet Therapy Aspirin	60 Participants
Number of Participants Using Antiplatelet Therapy Clopidogrel	31 Participants
Number of Participants Using Antiplatelet Therapy Ticlodipine	1 Participants
Number of Participants Using Antiplatelet Therapy Cilostazol	2 Participants
Number of Participants Using Antiplatelet Therapy Prasugrel	4 Participants
Number of Participants Using Antiplatelet Therapy Compounding agent	4 Participants
Number of Participants Using Antiplatelet Therapy Other	1 Participants

SECONDARY outcome

Timeframe: 4 years observation day from the procedure day

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=94 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants Using Antiplatelet Therapy Aspirin + clopidogrel	26 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + ticlopidine	1 Participants
Number of Participants Using Antiplatelet Therapy Aspirin	59 Participants
Number of Participants Using Antiplatelet Therapy Clopidogrel	27 Participants
Number of Participants Using Antiplatelet Therapy Prasugrel	3 Participants
Number of Participants Using Antiplatelet Therapy Ticlodipine	1 Participants
Number of Participants Using Antiplatelet Therapy Cilostazol	2 Participants
Number of Participants Using Antiplatelet Therapy Compounding agent	4 Participants
Number of Participants Using Antiplatelet Therapy Other	1 Participants

SECONDARY outcome

Timeframe: 5 years observation day from the procedure day

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=91 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants Using Antiplatelet Therapy Aspirin + clopidogrel	23 Participants
Number of Participants Using Antiplatelet Therapy Aspirin + ticlopidine	1 Participants
Number of Participants Using Antiplatelet Therapy Aspirin	52 Participants
Number of Participants Using Antiplatelet Therapy Clopidogrel	23 Participants
Number of Participants Using Antiplatelet Therapy Prasugrel	4 Participants
Number of Participants Using Antiplatelet Therapy Ticlodipine	1 Participants
Number of Participants Using Antiplatelet Therapy Cilostazol	2 Participants
Number of Participants Using Antiplatelet Therapy Compounding agent	3 Participants
Number of Participants Using Antiplatelet Therapy Other	1 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death	1 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death	4 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death	7 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death	8 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death	9 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	1 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	3 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	4 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	6 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	6 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings	6 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Myocardial Infarction	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Myocardial Infarction	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Myocardial Infarction	1 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Myocardial Infarction	1 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Myocardial Infarction	1 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Myocardial Infarction	1 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Myocardial Infarction	1 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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.)

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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.)

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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.)

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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.)

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death	0 Participants

SECONDARY outcome

Timeframe: 0 to 3 Years

Population: ITT population

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.)

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death	0 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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.)

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death	0 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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.)

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death	0 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With MI Related to Target Vessel	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With MI Related to Target Vessel	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With MI Related to Target Vessel	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With MI Related to Target Vessel	0 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With MI Related to Target Vessel	0 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With MI Related to Target Vessel	0 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With MI Related to Target Vessel	0 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	2 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	23 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	29 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	41 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	47 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	48 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)	50 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With All Revascularization	2 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With All Revascularization	23 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With All Revascularization	29 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With All Revascularization	38 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With All Revascularization	41 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With All Revascularization	42 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With All Revascularization	44 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Failure (TVF)	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Failure (TVF)	2 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Failure (TVF)	6 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Failure (TVF)	7 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Failure (TVF)	9 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Failure (TVF)	10 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Failure (TVF)	11 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (Non-TLR)	2 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (Non-TLR)	6 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (Non-TLR)	7 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (Non-TLR)	9 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (Non-TLR)	11 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (Non-TLR)	12 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (Non-TLR)	13 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	2 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	11 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	16 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	19 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	22 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	23 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	24 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	1 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	4 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	5 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	7 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	8 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	8 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death/All MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death/All MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death/All MI	2 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death/All MI	5 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death/All MI	8 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death/All MI	10 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Death/All MI	11 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI	1 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI	1 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI	1 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI	2 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death/All MI	2 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death or Target-Vessel MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death or Target-Vessel MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death or Target-Vessel MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death or Target-Vessel MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death or Target-Vessel MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death or Target-Vessel MI	0 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Cardiac Death or Target-Vessel MI	0 Participants

SECONDARY outcome

Timeframe: During hospitalization

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Failure (TLF)	0 Participants

SECONDARY outcome

Timeframe: 0 to 8 months

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Failure (TLF)	1 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Failure (TLF)	3 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Failure (TLF)	4 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Failure (TLF)	6 Participants

SECONDARY outcome

Timeframe: 0 to 4 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Failure (TLF)	6 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Number of Participants With Target Lesion Failure (TLF)	6 Participants

SECONDARY outcome

Timeframe: At 8 months, post index procedure

Population: ITT population

The difference between post- and pre-procedural MLD.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions QCA Patients receiving XIENCE Xpedition 2.25 mm stent
Mean Acute Gain: In-stent, In-segment Stent	1.51 mm Standard Deviation 0.46
Mean Acute Gain: In-stent, In-segment Segment	1.20 mm Standard Deviation 0.50

SECONDARY outcome

Timeframe: At 8 months, post index procedure

Population: ITT population

Late loss is calculated as MLD post procedure - MLD at follow-up.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions QCA Patients receiving XIENCE Xpedition 2.25 mm stent
Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal Stent	0.28 mm Standard Deviation 0.36
Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal Proximal	0.03 mm Standard Deviation 0.36
Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal Distal	-0.06 mm Standard Deviation 0.28
Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal Segment	0.20 mm Standard Deviation 0.50

SECONDARY outcome

Timeframe: At 8 months, post index procedure

Population: ITT population

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).

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions QCA Patients receiving XIENCE Xpedition 2.25 mm stent
Mean Net Gain: In-stent, In-segment Stent	1.26 mm Standard Deviation 0.52
Mean Net Gain: In-stent, In-segment Segment	1.04 mm Standard Deviation 0.62

SECONDARY outcome

Timeframe: Pre-procedure

Population: ITT population

The lesion length will be measured by QCA.

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions QCA Patients receiving XIENCE Xpedition 2.25 mm stent
Mean Lesion Length	17.38 mm Standard Deviation 10.27

SECONDARY outcome

Timeframe: Pre-procedure

Population: ITT population

Minimum blood vessel diameter measured by QCA

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions QCA Patients receiving XIENCE Xpedition 2.25 mm stent
Minimum Blood Vessel Diameter	0.55 mm Standard Deviation 0.34

SECONDARY outcome

Timeframe: Immediately after the procedure

Population: ITT population

Minimum blood vessel diameter measured by QCA

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions QCA Patients receiving XIENCE Xpedition 2.25 mm stent
Minimum Blood Vessel Diameter	2.03 mm Standard Deviation 0.27

SECONDARY outcome

Timeframe: During follow-up, at 8 months post procedure

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Minimum blood vessel diameter measured by QCA

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=79 Number of lesions QCA Patients receiving XIENCE Xpedition 2.25 mm stent
Minimum Blood Vessel Diameter	1.54 mm Standard Deviation 0.51

SECONDARY outcome

Timeframe: Pre-procedure

Population: ITT population.

Reference vessel diameter measured by QCA

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions Patients receiving XIENCE Xpedition 2.25 mm stent
Mean Reference Vessel Diameter (RVD)	2.04 mm Standard Deviation 0.36

SECONDARY outcome

Timeframe: Immediately after the procedure

Population: ITT population.

Reference vessel diameter measured by QCA

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=120 Number of lesions QCA Patients receiving XIENCE Xpedition 2.25 mm stent
Mean Reference Vessel Diameter (RVD)	2.34 mm Standard Deviation 0.37

SECONDARY outcome

Timeframe: During follow-up, at 8 months post procedure

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Reference vessel diameter measured by QCA

Outcome measures

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=77 Participants Patients receiving XIENCE Xpedition 2.25 mm stent
Mean Reference Vessel Diameter (RVD)	2.28 mm Standard Deviation 0.38

Adverse Events

XIENCE Xpedition 2.25 mm Stent Arm

Serious events: 63 serious events

Other events: 67 other events

Deaths: 9 deaths

Serious adverse events

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 participants at risk Patients receiving XIENCE Xpedition 2.25 mm stent
Infections and infestations Bacteraemia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Pneumonia	4.0% 4/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Pyelonephritis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Skin infection	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Urinary tract infection	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Infectious peritonitis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Blood and lymphatic system disorders Anaemia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Immune system disorders Contrast media allergy	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Metabolism and nutrition disorders Diabetes mellitus	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Metabolism and nutrition disorders Hyperkalaemia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Nervous system disorders Cervical myelopathy	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Myocardial infarction	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Angina pectoris	12.0% 12/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Angina unstable	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Cardiac failure	4.0% 4/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Coronary artery stenosis	23.0% 23/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Ventricular tachycardia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Acute coronary syndrome	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Vascular disorders Peripheral artery aneurysm	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Vascular disorders Peripheral arterial occlusive disease	7.0% 7/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	7.0% 7/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Colonic polyp	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Enteritis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Gastric ulcer hemorrhage	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Gastrointestinal hemorrhage	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Hepatobiliary disorders Cholecystitis acute	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Hepatobiliary disorders Hepatic mass	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
General disorders Asthenia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Musculoskeletal and connective tissue disorders Arthralgia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Nervous system disorders Cerebral hemorrhage	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Nervous system disorders Cerebral infarction	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Cardiac failure chronic	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Prinzmetal angina	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Sick sinus syndrome	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Hematochezia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Hepatobiliary disorders Cholelithiasis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Skin and subcutaneous tissue disorders Drug eruption	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Renal and urinary disorders Nephropathy toxic	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Renal and urinary disorders Bladder tamponade	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Reproductive system and breast disorders Prostatitis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
General disorders Death	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
General disorders Pyrexia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
General disorders Device-related thrombosis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Injury, poisoning and procedural complications Coronary artery restenosis	20.0% 20/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Injury, poisoning and procedural complications Heat illness	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Aortic valve stenosis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Acute myocardial infarction	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.

Other adverse events

Measure	XIENCE Xpedition 2.25 mm Stent Arm n=100 participants at risk Patients receiving XIENCE Xpedition 2.25 mm stent
Infections and infestations Bacteraemia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Pneumonia	4.0% 4/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Pyelonephritis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Skin infection	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Urinary tract infection	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Infections and infestations Infectious peritonitis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Blood and lymphatic system disorders Anaemia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Immune system disorders Contrast media allergy	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Metabolism and nutrition disorders Diabetes mellitus	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Metabolism and nutrition disorders Hyperkalaemia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Nervous system disorders Cervical myelopathy	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Myocardial infarction	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Angina pectoris	15.0% 15/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Angina unstable	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Cardiac failure	4.0% 4/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Coronary artery stenosis	27.0% 27/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Ventricular tachycardia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Acute coronary syndrome	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Vascular disorders Peripheral artery aneurysm	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Vascular disorders Peripheral arterial occlusive disease	7.0% 7/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	7.0% 7/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Colonic polyp	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Enteritis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Gastric ulcer hemorrhage	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Gastrointestinal hemorrhage	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Hepatobiliary disorders Cholecystitis acute	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Hepatobiliary disorders Hepatic mass	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
General disorders Asthenia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Musculoskeletal and connective tissue disorders Arthralgia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Nervous system disorders Cerebral hemorrhage	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Nervous system disorders Cerebral infarction	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Cardiac failure chronic	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Prinzmetal angina	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Sick sinus syndrome	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Gastrointestinal disorders Hematochezia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Hepatobiliary disorders Cholelithiasis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Skin and subcutaneous tissue disorders Drug eruption	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Renal and urinary disorders Nephropathy toxic	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Renal and urinary disorders Bladder tamponade	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Reproductive system and breast disorders Prostatitis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
General disorders Death	3.0% 3/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
General disorders Pyrexia	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
General disorders Device-related thrombosis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Injury, poisoning and procedural complications Coronary artery restenosis	23.0% 23/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Injury, poisoning and procedural complications Heat illness	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Aortic valve stenosis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Acute myocardial infarction	2.0% 2/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Eye disorders Retinal hemorrhage	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Coronary artery dissection	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Cardiac disorders Coronary artery no-reflow	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 1/100 • 5 Years In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.

Additional Information

Hajime Kusano, Senior Adviser Clinical

Abbott

Phone: +1 4088451626

Email: hajime.kusano@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60