SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) - Study Results

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Conditions:	Stents Coronary Artery Disease Total Coronary Occlusion Coronary Artery Restenosis Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis
Interventions:	Device: XIENCE V® Everolimus Eluting Coronary Stent Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1002 subjects were recruited at 65 sites. Eligible subjects invited to participate either in-hospital or in-clinic prior to first procedure and required to provide signed informed consent prior to enrollment. Final eligibility based on angiogram before the intended procedure. Dates of recruitment: 6/22/05 through 3/15/06.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized via telephone randomization and stratified by single and dual lesion/vessel treatment, diabetes mellitus status, and study sites. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
STARTED	669	333^[1]
COMPLETED	653	320
NOT COMPLETED	16	13
Death	4	2
Lost to Follow-up	9	7
Withdrawal by Subject	3	3
Informed consent not signed	0	1

[1]	1 patient randomized never signed consent, therefore no data collected. Analysis group = 332.

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS	Total
Number of Participants [units: participants]	669	333	1002
Age^[1] [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	376	191	567
>=65 years	293	141	434
Age^[2] [units: years] Mean ± Standard Deviation	63.23 ± 10.53	62.80 ± 10.24	63.08 ± 10.43
Gender^[3] [units: participants]
Female	200	114	314
Male	469	218	687
Region of Enrollment^[4] [units: participants]
United States	669	333	1002

[1]	1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[2]	1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[3]	1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[4]	1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measure Type	Primary
Measure Title	Primary Endpoint: In-segment Late Loss (LL)
Measure Description	In-segment minimal lumen diameter (MLD) post-procedure minus (–) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
Time Frame	240 days
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	301	134
Primary Endpoint: In-segment Late Loss (LL) [units: millimeters] Mean ± Standard Deviation	0.14 ± 0.41	0.28 ± 0.48

Statistical Analysis 1 for Primary Endpoint: In-segment Late Loss (LL)

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	t-test, 1 sided
P Value ^[4]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Primary endpoint analyzed for intent-to-treat & per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
Measure Description	The composite endpoint comprised of: Cardiac death (death in which a cardiac cause cannot be excluded) Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Time Frame	270 days
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	657	321
Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) [units: percentage of participants]	7.2	9.0

Statistical Analysis 1 for Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	t-test, 1 sided
P Value ^[4]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis was evaluated using a non-inferiority Z statistic. Non-inferiority was defined as a one-sided alpha of 0.05 and a difference in TVF rate of no more than 5.5%.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Study had 89% statistical power based on major secondary endpoint to prove non-inferiority of XIENCE® V to TAXUS®, non-inferiority delta=5.5%, true TVF rate 9.4% in both arms with overall 5% alpha (one-sided), assuming 1% subject dropout rate.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Target Vessel Failure (TVF)
Measure Description	The composite endpoint comprised of: Cardiac death (death in which a cardiac cause cannot be excluded) Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Time Frame	30 days
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	667	330
Target Vessel Failure (TVF) [units: percentage of participants]
30 days	1.6	3.3

No statistical analysis provided for Target Vessel Failure (TVF)

Measure Type	Secondary
Measure Title	Target Vessel Failure (TVF)
Measure Description	The composite endpoint comprised of: Cardiac death (death in which a cardiac cause cannot be excluded) Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Time Frame	180 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	664	326
Target Vessel Failure (TVF) [units: percentage of participants]	4.1	5.5

No statistical analysis provided for Target Vessel Failure (TVF)

Measure Type	Secondary
Measure Title	Target Vessel Failure (TVF)
Measure Description	The composite endpoint comprised of: Cardiac death (death in which a cardiac cause cannot be excluded) Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Time Frame	1 year
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	654	319
Target Vessel Failure (TVF) [units: percentage of participants]	8.6	11.6

No statistical analysis provided for Target Vessel Failure (TVF)

Measure Type	Secondary
Measure Title	Target Vessel Failure (TVF)
Measure Description	The composite endpoint comprised of: Cardiac death (death in which a cardiac cause cannot be excluded) Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Time Frame	2 year
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	637	305
Target Vessel Failure (TVF) [units: percentage of participants]	11.3	16.4

No statistical analysis provided for Target Vessel Failure (TVF)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Measure Description	Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Time Frame	30 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	667	330
Ischemia Driven Target Lesion Revascularization (ID-TLR) [units: percentage of participants]	0.4	0.3

No statistical analysis provided for Ischemia Driven Target Lesion Revascularization (ID-TLR)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Measure Description	Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Time Frame	180 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	664	326
Ischemia Driven Target Lesion Revascularization (ID-TLR) [units: percentage of participants]	1.5	2.1

No statistical analysis provided for Ischemia Driven Target Lesion Revascularization (ID-TLR)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Measure Description	Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Time Frame	270 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	659	320
Ischemia Driven Target Lesion Revascularization (ID-TLR) [units: percentage of participants]	2.7	5.0

No statistical analysis provided for Ischemia Driven Target Lesion Revascularization (ID-TLR)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Measure Description	Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Time Frame	1 years
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	654	319
Ischemia Driven Target Lesion Revascularization (ID-TLR) [units: percentage of participants]	3.4	5.6

No statistical analysis provided for Ischemia Driven Target Lesion Revascularization (ID-TLR)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Measure Description	Revascularization @ target lesion associated w/ any of following: (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Time Frame	2 years
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	637	305
Ischemia Driven Target Lesion Revascularization (ID-TLR) [units: percentage of participants]	4.6	7.5

No statistical analysis provided for Ischemia Driven Target Lesion Revascularization (ID-TLR)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Measure Description	Revascularization at the target vessel associated with any of the following Positive functional ischemia study Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Time Frame	30 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	667	330
Ischemia Driven Target Vessel Revascularization (ID-TVR) [units: percentage of participants]	0.3	0.9

No statistical analysis provided for Ischemia Driven Target Vessel Revascularization (ID-TVR)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Measure Description	Revascularization at the target vessel associated with any of the following Positive functional ischemia study Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Time Frame	180 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	664	326
Ischemia Driven Target Vessel Revascularization (ID-TVR) [units: percentage of participants]	1.2	1.8

No statistical analysis provided for Ischemia Driven Target Vessel Revascularization (ID-TVR)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Measure Description	Revascularization at the target vessel associated with any of the following Positive functional ischemia study Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Time Frame	270 days
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	659	320
Ischemia Driven Target Vessel Revascularization (ID-TVR) [units: percentage of participants]	2.9	4.1

No statistical analysis provided for Ischemia Driven Target Vessel Revascularization (ID-TVR)

Measure Type	Secondary
Measure Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Measure Description	Revascularization at the target vessel associated with any of the following Positive functional ischemia study Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Time Frame	1 year
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	654	319
Ischemia Driven Target Vessel Revascularization (ID-TVR) [units: percentage of participants]	3.1	4.7

No statistical analysis provided for Ischemia Driven Target Vessel Revascularization (ID-TVR)

Measure Type	Secondary
Measure Title	Ischemia Drive Target Vessel Revascularization (ID-TVR)
Measure Description	Revascularization at the target vessel associated with any of the following Positive functional ischemia study Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Time Frame	2 years
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	637	305
Ischemia Drive Target Vessel Revascularization (ID-TVR) [units: percentage of participants]	4.9	6.6

No statistical analysis provided for Ischemia Drive Target Vessel Revascularization (ID-TVR)

Measure Type	Secondary
Measure Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Measure Description	The composite endpoint comprised of: Cardiac death Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Time Frame	30 days
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	667	330
Ischemia Driven Major Adverse Cardiac Event (MACE) [units: percentage of participants]	1.3	3.0

No statistical analysis provided for Ischemia Driven Major Adverse Cardiac Event (MACE)

Measure Type	Secondary
Measure Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Measure Description	The composite endpoint comprised of: Cardiac death Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Time Frame	180 days
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	664	326
Ischemia Driven Major Adverse Cardiac Event (MACE) [units: percentage of participants]	2.9	5.2

No statistical analysis provided for Ischemia Driven Major Adverse Cardiac Event (MACE)

Measure Type	Secondary
Measure Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Measure Description	The composite endpoint comprised of: Cardiac death Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Time Frame	270 days
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	659	320
Ischemia Driven Major Adverse Cardiac Event (MACE) [units: percentage of participants]	5.0	8.8

No statistical analysis provided for Ischemia Driven Major Adverse Cardiac Event (MACE)

Measure Type	Secondary
Measure Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Measure Description	The composite endpoint comprised of: Cardiac death Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Time Frame	1 year
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	654	319
Ischemia Driven Major Adverse Cardiac Event (MACE) [units: percentage of participants]	6.0	10.3

No statistical analysis provided for Ischemia Driven Major Adverse Cardiac Event (MACE)

Measure Type	Secondary
Measure Title	Ischemia Driven Major Adverse Cardiac Event(MACE)
Measure Description	The composite endpoint comprised of: Cardiac death Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Time Frame	2 years
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	637	305
Ischemia Driven Major Adverse Cardiac Event(MACE) [units: percentage of participants]	7.7	13.8

No statistical analysis provided for Ischemia Driven Major Adverse Cardiac Event(MACE)

Measure Type	Secondary
Measure Title	In-stent % Angiographic Binary Restenosis (% ABR) Rate
Measure Description	Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
Time Frame	at 240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	343	158
In-stent % Angiographic Binary Restenosis (% ABR) Rate [units: percentage of participants]	2.3	5.7

No statistical analysis provided for In-stent % Angiographic Binary Restenosis (% ABR) Rate

Measure Type	Secondary
Measure Title	In-segment % Angiographic Binary Restenosis (% ABR) Rate
Measure Description	Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA
Time Frame	240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	344	158
In-segment % Angiographic Binary Restenosis (% ABR) Rate [units: percentage of participants]	4.7	8.9

No statistical analysis provided for In-segment % Angiographic Binary Restenosis (% ABR) Rate

Measure Type	Secondary
Measure Title	Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection
Measure Description	Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition. Persisting dissection @ follow-up, present post-procedure.
Time Frame	at 240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	90	43
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection [units: percentage of participants]	24.4	14.0

No statistical analysis provided for Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection

Measure Type	Secondary
Measure Title	Acute Success: Clinical Device
Measure Description	Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.
Time Frame	In-hospital
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	763	379
Acute Success: Clinical Device [units: percentage of participants]	98.3	98.7

No statistical analysis provided for Acute Success: Clinical Device

Measure Type	Secondary
Measure Title	Acute Success: Clinical Procedure
Measure Description	Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.
Time Frame	In-hospital
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	661	331
Acute Success: Clinical Procedure [units: percentage of participants]	98.5	97.3

No statistical analysis provided for Acute Success: Clinical Procedure

Measure Type	Secondary
Measure Title	Proximal Late Loss
Measure Description	Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)
Time Frame	at 240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	293	134
Proximal Late Loss [units: millimeters] Mean ± Standard Deviation	0.12 ± 0.40	0.20 ± 0.41

No statistical analysis provided for Proximal Late Loss

Measure Type	Secondary
Measure Title	Distal Late Loss
Measure Description	Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
Time Frame	240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	327	154
Distal Late Loss [units: millimeters] Mean ± Standard Deviation	0.09 ± 0.36	0.10 ± 0.37

No statistical analysis provided for Distal Late Loss

Measure Type	Secondary
Measure Title	In-stent Late Loss
Measure Description	In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)
Time Frame	at 240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	342	158
In-stent Late Loss [units: millimeters] Mean ± Standard Deviation	0.16 ± 0.41	0.30 ± 0.53

No statistical analysis provided for In-stent Late Loss

Measure Type	Secondary
Measure Title	% Volume Obstruction (% VO)
Measure Description	Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.
Time Frame	at 240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	98	39
% Volume Obstruction (% VO) [units: percent of volume obstruction] Mean ± Standard Deviation	6.91 ± 6.35	11.21 ± 9.86

No statistical analysis provided for % Volume Obstruction (% VO)

Measure Type	Secondary
Measure Title	In-stent % Diameter Stenosis (% DS)
Measure Description	In-stent: Within the margins of the stent, the value calculated as 100 * (1 – in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame	at 240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	343	158
In-stent % Diameter Stenosis (% DS) [units: percent diameter stenosis] Mean ± Standard Deviation	5.92 ± 16.40	10.30 ± 21.43

No statistical analysis provided for In-stent % Diameter Stenosis (% DS)

Measure Type	Secondary
Measure Title	In-segment % Diameter Stenosis (% DS)
Measure Description	Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 – in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame	240 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Reporting Groups

	Description
XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values

	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed [units: participants]	344	158
In-segment % Diameter Stenosis (% DS) [units: percent of in-segment diameter stenosis] Mean ± Standard Deviation	18.77 ± 14.43	22.82 ± 16.35

No statistical analysis provided for In-segment % Diameter Stenosis (% DS)

Responsible Party:	Abbott Vascular ( Abbott Vascular )
Study ID Numbers:	03-360
Study First Received:	September 13, 2005
Results First Received:	October 15, 2008
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00180479 History of Changes
Health Authority:	United States: Food and Drug Administration