Trial Outcomes & Findings for XIENCE PRIME Japan Post-Marketing Surveillance (PMS) (NCT NCT01721096)

Last Updated: 2019-12-20

Results Overview

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Recruitment status

COMPLETED

Target enrollment

536 participants

Primary outcome timeframe

Time Frame: Acute (0-24 hours)

Results posted on

2019-12-20

Participant Flow

A total of 536 patients (213 in the Core Size (CS) arm and 323 in the Long Length (LL) arm) were recruited from the 25 sites between October 11, 2013 and June 30, 2013. All the patients except those terminated the surveillance have completed their follow-up at the end of the study.

To date, out of 536 patients, 524 (320 in LL arm and 204 in CS arm) have terminated the surveillance before completing their follow-ups

Participant milestones

Participant milestones
Measure	XIENCE PRIME - Long Length (LL) Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Overall Study STARTED	323	213
Overall Study COMPLETED	3	9
Overall Study NOT COMPLETED	320	204

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Total n=536 Participants Total of all reporting groups
Age, Continuous	68.6 years STANDARD_DEVIATION 10.7 • n=5 Participants	69.1 years STANDARD_DEVIATION 10.4 • n=7 Participants	68.8 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	46 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	264 Participants n=5 Participants	167 Participants n=7 Participants	431 Participants n=5 Participants
Region of Enrollment Japan	323 Participants n=5 Participants	213 Participants n=7 Participants	536 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time Frame: Acute (0-24 hours)

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Acute Stent Thrombosis (ST) Definite	0 Participants	0 Participants
Number of Participants With Acute Stent Thrombosis (ST) Probable	0 Participants	0 Participants
Number of Participants With Acute Stent Thrombosis (ST) Definite/Probable	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Subacute (>24 hours to 30 days)

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=212 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Subacute Stent Thrombosis (ST) Probable	0 Participants	0 Participants
Number of Participants With Subacute Stent Thrombosis (ST) Definite	3 Participants	0 Participants
Number of Participants With Subacute Stent Thrombosis (ST) Definite/Probable	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Late (>30 days to 1 year)

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=212 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Late Stent Thrombosis (ST) Definite/Probable	0 Participants	0 Participants
Number of Participants With Late Stent Thrombosis (ST) Definite	0 Participants	0 Participants
Number of Participants With Late Stent Thrombosis (ST) Probable	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=212 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Total Number of Participants With Overall Stent Thrombosis	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an average of 5 days

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up. Implant Success rate is calculated per stent base.

Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=522 Device used Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=259 Device used Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Success Rate: Percentage of Participants With Implant Success Rate by Device	99.8 percentage of devices Interval 98.9 to 100.0	99.6 percentage of devices Interval 97.9 to 100.0

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an average of 5 days

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up. Procedural Success rate is calculated per lesion base.

Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=402 Lesions Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=241 Lesions Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Success Rate: Percentage of Participants With Procedural Success by Lesion	100 Percentage of Lesions Interval 99.3 to 100.0	100 Percentage of Lesions Interval 98.8 to 100.0

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an average of 5 days

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=212 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)	100 percentage of participants Interval 99.1 to 100.0	99.5 percentage of participants Interval 97.4 to 100.0

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Failure (TLF)	8 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Failure (TLF)	17 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Failure (TLF)	20 Participants	7 Participants

SECONDARY outcome

Timeframe: 3 years post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Failure (TLF)	23 Participants	7 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Failure (TLF)	26 Participants	7 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Death/All MI/All Revascularization (DMR)	32 Participants	14 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Death/All MI/All Revascularization (DMR)	63 Participants	29 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Death/All MI/All Revascularization (DMR)	85 Participants	41 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Death/All MI/All Revascularization (DMR)	94 Participants	46 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Death/All MI/All Revascularization (DMR)	106 Participants	55 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Failure (TVF)	11 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Failure (TVF)	25 Participants	8 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Failure (TVF)	31 Participants	14 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Failure (TVF)	37 Participants	15 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Failure(TVF)	43 Participants	17 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	8 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	17 Participants	6 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	21 Participants	9 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	26 Participants	9 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)	30 Participants	9 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All deaths includes cardiac death, vascular death and non-cardiovascular death. 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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Death or Myocardial Infarction (MI)	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Death or Myocardial Infarction (MI)	7 Participants	9 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Death or Myocardial Infarction (MI)	16 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Death or Myocardial Infarction (MI)	23 Participants	13 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Death or Myocardial Infarction (MI)	29 Participants	15 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Myocardial Infarction (MI)	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Myocardial Infarction (MI)	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Myocardial Infarction (MI)	7 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Myocardial Infarction (MI)	10 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Myocardial Infarction (MI)	11 Participants	3 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	6 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	6 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)	16 Participants	11 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)	19 Participants	13 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Myocardial Infarction (MI)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Myocardial Infarction (MI)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Myocardial Infarction (MI)	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Myocardial Infarction (MI)	5 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Myocardial Infarction (MI)	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Revascularization (TLR)	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Revascularization (TLR)	16 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Revascularization (TLR)	23 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Revascularization (TLR)	26 Participants	8 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Lesion Revascularization(TLR)	29 Participants	9 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	12 Participants	8 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	16 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	17 Participants	15 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Lesion Revascularization (Non-TLR)	20 Participants	17 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	12 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR))	28 Participants	13 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	37 Participants	19 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	41 Participants	23 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))	46 Participants	25 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	18 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	34 Participants	9 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	43 Participants	15 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	50 Participants	19 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	57 Participants	25 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Revascularization	28 Participants	9 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Revascularization	57 Participants	22 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Revascularization	72 Participants	33 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Revascularization	77 Participants	37 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

All revascularization includes ischemia driven and non-ischemia driven revascularization.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants With All Revascularization	87 Participants	45 Participants

SECONDARY outcome

Timeframe: 8 months post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Bleeding	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Bleeding	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Bleeding	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Bleeding	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 4 year post index procedure

Population: The number of participants analyzed excludes subjects who were lost-to-follow-up.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=323 Participants Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=213 Participants Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Number of Participants Experienced Bleeding	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=377 Number of lesion analyzed Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=245 Number of lesion analyzed Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Percent Diameter Stenosis (%DS)	73.96 percentage of DS Standard Deviation 17.73	70.27 percentage of DS Standard Deviation 15.13

SECONDARY outcome

Timeframe: Post procedure

The value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=375 Number of lesion analyzed Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=245 Number of lesion analyzed Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Percent Diameter Stenosis (%DS)	25.94 percentage of DS Standard Deviation 11.76	23.58 percentage of DS Standard Deviation 10.79

SECONDARY outcome

Timeframe: 8 months post index procedure

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

The value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=275 Number of lesion analyzed Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=175 Number of lesion analyzed Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Percent Diameter Stenosis (%DS)	29.17 percentage of DS Standard Deviation 15.50	25.12 percentage of DS Standard Deviation 12.88

SECONDARY outcome

Timeframe: 8 months post index procedure

The difference between post- and pre-procedural MLD.

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=375 Lesions Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=244 Lesions Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Acute Gain: In-stent, In-segment Stent	1.81 mm Standard Deviation 0.56	1.81 mm Standard Deviation 0.53
Acute Gain: In-stent, In-segment Segment	1.42 mm Standard Deviation 0.62	1.40 mm Standard Deviation 0.61

SECONDARY outcome

Timeframe: 8 months post index procedure

Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=273 Lesions Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=174 Lesions Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Net Gain: In-stent, In-segment Stent	1.53 mm Standard Deviation 0.66	1.68 mm Standard Deviation 0.58
Net Gain: In-stent, In-segment Segment	1.31 mm Standard Deviation 0.67	1.34 mm Standard Deviation 0.64

SECONDARY outcome

Timeframe: 8 months post index procedure

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

Outcome measures

Outcome measures
Measure	XIENCE PRIME - Long Length (LL) n=273 Lesions Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	XIENCE PRIME - Core Size n=175 Lesions Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Late Loss(LL): In-stent, In-segment, Proximal, and Distal Stent	0.27 mm Standard Deviation 0.41	0.15 mm Standard Deviation 0.29
Late Loss(LL): In-stent, In-segment, Proximal, and Distal Proximal	0.13 mm Standard Deviation 0.44	0.08 mm Standard Deviation 0.40
Late Loss(LL): In-stent, In-segment, Proximal, and Distal Distal	-0.04 mm Standard Deviation 0.36	0.03 mm Standard Deviation 0.35
Late Loss(LL): In-stent, In-segment, Proximal, and Distal Segment	0.12 mm Standard Deviation 0.50	0.06 mm Standard Deviation 0.45

Adverse Events

XIENCE PRIME - Long Length (LL) and Core Size (CS)

Serious events: 221 serious events

Other events: 254 other events

Deaths: 47 deaths

Serious adverse events

Serious adverse events
Measure	XIENCE PRIME - Long Length (LL) and Core Size (CS) n=536 participants at risk The study has 2 arms depending upon the size of stent used for the treatment: Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length), whereas Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Blood and lymphatic system disorders Anemia	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Acute heart failure	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Acute myocardial infarction	0.93% 5/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Angina pectoris	9.0% 48/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Angina unstable	1.9% 10/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Angiopathy	2.2% 12/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Aortic aneurysm	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Aortic dissection	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Aortic valve stenosis	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Atrial fibrillation	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Atrial tachycardia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Cardio respiration	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Cardiogenic shock	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Chronic heart failure	1.3% 7/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Complete atrioventricular block	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Congestive heart failure	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Contractile pericarditis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Coronary artery disease	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Coronary artery stenosis	8.8% 47/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Heart failure	4.3% 23/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Intermittent claudication	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Myocardial infarction	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Myocardial ischemia	1.1% 6/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Peripheral arterial obstructive disease	2.1% 11/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Peripheral ischemia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Prinzmetal angina	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Second degree atrioventricular block	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Sick sinus syndrome	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Supraventricular arrhythmia	0.93% 5/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Ventricular arrhythmia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Ventricular extrasystole	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Ventricular fibrillation	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Ventricular tachycardia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Ear and labyrinth disorders Dizziness, vertigo	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Eye disorders Diabetic retinopathy	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Eye disorders Macular hole	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Ascites	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Atrophic gastritis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Colon Bleeding	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Colonic polyp	0.93% 5/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Colorectal polyp	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Gastrointestinal Bleeding	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Ileus	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Intestinal polyp	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Ischemic colitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
General disorders Asthenia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
General disorders Death	8.8% 47/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
General disorders Thrombosis in device	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Acute cholangitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Acute cholecystitis	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Bile duct stones	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Cholangitis	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Liver cirrhosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Abdominal wall abscess	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Acute pyelonephritis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Appendicitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Cellulitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Diabetic gangrene	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Discitis	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Diverticulitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Herpes zoster	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Infection	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Influenza	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Liver abscess	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Lymph node tuberculosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Lymphangitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Muscle abscess	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Pneumonia	1.7% 9/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Pyelonephritis	0.75% 4/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Pyoderma	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Sepsis	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Sepsis shock	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Urinary tract Infection	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Cerebral contusion	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Compression fracture	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Coronary artery restenosis	5.8% 31/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Femoral fracture	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Graft vascular occlusion	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Ligament injury	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Ligament tear	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Shunt obstruction	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Subdural hematoma	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Investigations Exercise test abnormal	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Investigations Motor test abnormality	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Dehydration	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Hyperkalemia	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Hypoglycaemia	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Malnutrition	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Marasmus	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Crystalline joint disorder	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Intervertebral stenosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Intramuscular Bleeding	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal cancer	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of the liver	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of the tongue, stage unknown	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pancreatic cancer	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal sigmoid carcinoma	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Recurrent liver malignant neoplasm	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Stomach cancer	1.3% 7/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Altered state of consciousness	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Amyotrophic lateral sclerosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Carotid artery stenosis	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Cerebellar infarction	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Cerebral infarction	0.93% 5/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Dementia with Lewy bodies	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Diabetic neuropathy	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Embolic stroke	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Floating dizziness	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Hepatic encephalopathy	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Hypoglycaemic coma	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Lacunar infarct	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Subarachnoid hemorrhage	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Transient ischemic attack	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Acute renal failure	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Chronic renal failure	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Kidney failure	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Renal dysfunction	0.75% 4/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Reproductive system and breast disorders Prostatitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Aspiration Pneumonia	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Asthma	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Sleep apnea syndrome	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Surgical and medical procedures Medical device related thrombosis	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Surgical and medical procedures Medical equipment blockage	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Vascular disorders Aortic aneurysm	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Vascular disorders Peripheral arterial occlusive disease	0.75% 4/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Vascular disorders Peripheral ischemia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.

Other adverse events

Other adverse events
Measure	XIENCE PRIME - Long Length (LL) and Core Size (CS) n=536 participants at risk The study has 2 arms depending upon the size of stent used for the treatment: Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length), whereas Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Cardiac disorders Angina pectoris	10.8% 58/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Coronary artery stenosis	10.1% 54/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Acute myocardial infarction	0.93% 5/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Unstable angina	2.4% 13/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Aortic valve stenosis	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Supra ventricular arrhythmia	1.3% 7/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Atrial fibrillation	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Atrial tachycardia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Complete atrioventricular block	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Second degree atrioventricular block	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Heart failure	4.3% 23/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Cardio respiration	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Cardiogenic shock	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Coronary artery disease	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Coronary embolism	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Myocardial infarction	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Myocardial ischemia	1.9% 10/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Contractile pericarditis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Prinzmetal angina	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Sick sinus syndrome	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Ventricular arrhythmia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Ventricular extrasystole	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Ventricular fibrillation	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Ventricular tachycardia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Coronary dissection	0.75% 4/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Cardiac puncture	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Coronary artery no re flow phenomenon	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Angiopathy	3.2% 17/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Aortic aneurysm	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Aortic dissection	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Intermittent claudication	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Peripheral ischemia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Peripheral arterial obstructive disease	2.1% 11/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Reperfusion injury	0.93% 5/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Asthma	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Nose bleeding	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Respiratory, thoracic and mediastinal disorders Sleep apnea syndrome	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Ascites	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Ischemic colitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Colonic polyp	0.93% 5/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Atrophic gastritis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Gastrointestinal bleeding	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Ileus	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Intestinal polyp	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Colorectal polyp	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Gastrointestinal disorders Colon bleeding	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Bile duct stone	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Cholangitis	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Acute cholecystitis	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Liver cirrhosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Skin and subcutaneous tissue disorders Drug eruption	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Lumbar spinal canal stenosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Intramuscular hemorrhage	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Crystalline joint disorder	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Musculoskeletal and connective tissue disorders Intervertebral stenosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Hematuria	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Acute renal failure	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Renal dysfunction	0.75% 4/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Reproductive system and breast disorders Prostatitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
General disorders Asthenia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Surgical and medical procedures Medical device related thrombosis	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Surgical and medical procedures Medical device obstruction	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Investigations Increased myocardial enzyme	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Investigations Motor test abnormality	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Compression fracture	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Femoral fracture	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Shunt obstruction	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Subdural hematoma	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Graft vascular occlusion	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Contusion	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Cerebral contusion	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Coronary restenosis	7.1% 38/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Ligament injury	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Ligament tear	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
General disorders Can not pass target lesion	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Injury, poisoning and procedural complications Balloon rupture	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Product Issues Tearing	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Product Issues Stent damaged / deformed after indwelling-others	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Appendicitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Cellulitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Diabetic gangrene	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Diverticulitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Herpes zoster	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Infection	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Influenza	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Liver abscess	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Lymph node tuberculosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Lymphangitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Pneumonia	1.7% 9/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Pyelonephritis	0.75% 4/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Pyoderma	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Sepsis	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Septic shock	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Urinary tract infection	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Muscle abscess	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Abdominal segment abscess	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Disc flame	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Stomach cancer	1.3% 7/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver malignant neoplasm	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal cancer	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pancreatic cancer	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of the tongue, stage unknown	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic lung cancer	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Blood and lymphatic system disorders Anemia	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Immune system disorders Drug hypersensitivity	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Dehydration	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Hyperkalemia	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Hypoglycemia	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Marasmus	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Malnutrition	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Ear and labyrinth disorders Dizziness, vertigo	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Eye disorders Diabetic retinopathy	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Eye disorders Macular hole	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders State of consciousness transformation	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Amyotrophic lateral sclerosis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Carotid stenosis	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Cerebellar infarction	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Cerebral infarction	0.93% 5/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Diabetic neuropathy	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Floating dizziness	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Hepatic encephalopathy	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Metabolism and nutrition disorders Hypoglycemia coma	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Subarachnoid hemorrhage	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Transient ischemic attack	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Lacunar infarct	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Embolic stroke	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Nervous system disorders Lewy body dementia	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Acute heart failure	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Chronic heart failure	1.3% 7/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Cardiac disorders Congestive heart failure	0.56% 3/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Hepatobiliary disorders Acute cholangitis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Infections and infestations Acute pyelonephritis	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal sigmoid carcinoma	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Chronic renal failure	0.19% 1/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Renal and urinary disorders Kidney failure	0.37% 2/536 • 4 years This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency\&status of adverse device effects\&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.

Additional Information

David R Rutledge

Abbott Vascular

Phone: (408) 845-3820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60