CompletedNCT00180479Updated Nov 23, 2011Results posted

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

A Phase 3 interventional study of XIENCE V® Everolimus Eluting Coronary Stent and TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent in Stents, Coronary Artery Disease and Total Coronary Occlusion, sponsored by Abbott Medical Devices. Completed at 65 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-23.

Sponsored by Abbott Medical Devices · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,002
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study is divided into 5 arms:

Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan

The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.

Read the detailed description

The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will be compared to an active control group represented by the FDA approved commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).

The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS® EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and \<= 3.75 mm.

The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25 mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese non-randomized arm as follows:

105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 2.25 mm and \< 2.5 mm and lesion length \<= 22 mm will be enrolled concurrently in the US 2.25 mm non-randomized treatment arm
80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.75 mm and >= 4.25 mm and lesion length \<= 28 mm will be enrolled concurrently in the US 4.0 mm non-randomized treatment arm
105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.0 mm and \< 4.25 mm and lesion length > 24 mm and \< 32 mm will be enrolled concurrently in the US 38 mm non-randomized treatment arm.
88 Japanese subjects with a maximum of two de novo native coronary artery lesions within vessel sizes >= 2.5 mm and \<= 4.25 mm and lesion length \<= 28 mm will be enrolled concurrently in the non-randomized Japanese arm.

All subjects in the RCT and the four non-randomized arms will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the TAXUS® arm of US RCT.

Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:

Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)

All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected through 270 days will be submitted as the primary data set for US and Japanese market approval), and 1, 2, 3, 4, and 5 years (for annual reports).

All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0 mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects enrolled in these arms.

All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.

All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup (angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their primary assignment at randomization. At sites without IVUS capability, subjects receiving bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240 days after the index procedure). Angiographic follow-up is required for all bailout subjects at 240 days.

Data from the US RCT will be submitted to the FDA as the primary data set for product approval for RVD >= 2.5 mm and \<= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Japanese approval for RVD>=2.5 mm and \<= 4.25 mm (2.5 mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be submitted to the FDA as additional safety data. Data from the US non-randomized arms of the trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD > 2.25 mm and \< 2.5 mm), 4.0 mm diameter stent (RVD > 3.75 mm and \<= 4.25 mm) and 38 mm length stent (RVD > 3.0 mm and \<= 4.25 mm and lesion length > 24 mm and \<= 32 mm), respectively in the US.

A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects (minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK measurements performed. These subsets will include subjects receiving overlapping stents.

Conditions studied

Stents
Coronary Artery Disease
Total Coronary Occlusion
Coronary Artery Restenosis
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis

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Keywords

Everolimus

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 1,002 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and \<= 4.25 mm and a lesion length \<= 32 mm
The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and \< 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1
Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)

Exclusion criteria

Exclusion Criteria:

Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
Located in a major epicardial vessel that has been previously treated with brachytherapy
Located in a major epicardial vessel that has been previously treated with percutaneous intervention \< 9 months prior to index procedure
Total occlusion (TIMI flow 0), prior to wire passing
The target vessel contains thrombus
Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 1,002 participants (actual)

Study arms

Experimental
1
XIENCE V® Everolimus Eluting Coronary Stent System
Device: XIENCE V® Everolimus Eluting Coronary Stent
Active comparator
2
TAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System
Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent

Interventions

DeviceXIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Also known as: XIENCE V® Everolimus Eluting Coronary Stent System
DeviceTAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Also known as: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System

What researchers measure

Primary outcomes

Primary Endpoint: In-segment Late Loss (LL)
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

Secondary outcomes

Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
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
Target Vessel Failure (TVF)
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
Target Vessel Failure (TVF)
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
Target Vessel Failure (TVF)
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
Target Vessel Failure (TVF)
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
Target Vessel Failure (TVF)
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: 3 year
Target Vessel Failure (TVF)
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: 4 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
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
Ischemia Driven Target Lesion Revascularization (ID-TLR)
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
Ischemia Driven Target Lesion Revascularization (ID-TLR)
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
Ischemia Driven Target Lesion Revascularization (ID-TLR)
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
Ischemia Driven Target Lesion Revascularization (ID-TLR)
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
Ischemia Driven Target Lesion Revascularization (ID-TLR)
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: 3 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
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: 4 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
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 Derived from Non-Hierarchical Subject Counts of Adverse Events
Time frame: 30 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
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 Derived from Non-Hierarchical Subject Counts of Adverse Events
Time frame: 180 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
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 Derived from Non-Hierarchical Subject Counts of Adverse Events
Time frame: 270 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
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 Derived from Non-Hierarchical Subject Counts of Adverse Events
Time frame: 1 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
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 Derived from Non-Hierarchical Subject Counts of Adverse Events
Time frame: 2 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
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 Derived from Non-Hierarchical Subject Counts of Adverse Events
Time frame: 3 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
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 Derived from Non-Hierarchical Subject Counts of Adverse Events
Time frame: 4 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
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
Ischemia Driven Major Adverse Cardiac Event (MACE)
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
Ischemia Driven Major Adverse Cardiac Event (MACE)
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
Ischemia Driven Major Adverse Cardiac Event (MACE)
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
Ischemia Driven Major Adverse Cardiac Event(MACE)
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
Ischemia Driven Major Adverse Cardiac Event (MACE)
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: 3 year
Ischemia Driven Major Adverse Cardiac Event (MACE)
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: 4 year
In-stent % Angiographic Binary Restenosis (% ABR) Rate
Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
Time frame: at 240 days
In-segment % Angiographic Binary Restenosis (% ABR) Rate
Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA
Time frame: 240 days
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection
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
Acute Success: Clinical Device
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
Acute Success: Clinical Procedure
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
Proximal Late Loss
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
Distal Late Loss
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
In-stent Late Loss
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
% Volume Obstruction (% VO)
Defined as stent intimal hyperplasia and calculated as 100\*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.
Time frame: at 240 days
In-stent % Diameter Stenosis (% DS)
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
In-segment % Diameter Stenosis (% DS)
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
Target Vessel Failure (TVF)
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: 5 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
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: 5 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
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 Derived from Non-Hierarchical Subject Counts of Adverse Events
Time frame: 5 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
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: 5 years

Results

Posted Dec 15, 2008

Participant flow

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.

Participant flow — Overall Study
Milestone	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Started	669	333
Completed	653	320
Not completed	16	13
Withdrew: Death	4	2
Withdrew: Lost to follow-up	9	7
Withdrew: Withdrawal by subject	3	3
Withdrew: Informed consent not signed	0	1

Outcome measures

PrimaryPrimary Endpoint: In-segment Late Loss (LL)

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
Reported as:: Mean · millimeters

Primary Endpoint: In-segment Late Loss (LL)
millimeters	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Primary Endpoint: In-segment Late Loss (LL)	0.14 ± 0.41	0.28 ± 0.48

Statistical analysis

XIENCE V® EECSS vs TAXUS® EXPRESS2™ ECSS · t-test, 1 sided · p = <0.0001

SecondaryMajor Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)

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
Reported as:: Number · percentage of participants

Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)	7.2	9.0

Statistical analysis

XIENCE V® EECSS vs TAXUS® EXPRESS2™ ECSS · t-test, 1 sided · p = <0.0001

SecondaryTarget Vessel Failure (TVF)

Time frame:: 30 days
Reported as:: Number · percentage of participants

Target Vessel Failure (TVF)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Target Vessel Failure (TVF)	1.6	3.3

SecondaryTarget Vessel Failure (TVF)

Time frame:: 180 days
Reported as:: Number · percentage of participants

Target Vessel Failure (TVF)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Target Vessel Failure (TVF)	4.1	5.5

SecondaryTarget Vessel Failure (TVF)

Time frame:: 1 year
Reported as:: Number · percentage of participants

Target Vessel Failure (TVF)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Target Vessel Failure (TVF)	8.6	11.6

SecondaryTarget Vessel Failure (TVF)

Time frame:: 2 year
Reported as:: Number · percentage of participants

Target Vessel Failure (TVF)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Target Vessel Failure (TVF)	11.3	16.4

SecondaryTarget Vessel Failure (TVF)

Time frame:: 3 year
Reported as:: Number · percentage of participants

Target Vessel Failure (TVF)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Target Vessel Failure (TVF)	14.3	20.0

SecondaryTarget Vessel Failure (TVF)

Time frame:: 4 year
Reported as:: Number · percentage of participants

Target Vessel Failure (TVF)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Target Vessel Failure (TVF)	18.5	22.5

SecondaryIschemia Driven Target Lesion Revascularization (ID-TLR)

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
Reported as:: Number · percentage of participants

Ischemia Driven Target Lesion Revascularization (ID-TLR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Lesion Revascularization (ID-TLR)	0.4	0.3

SecondaryIschemia Driven Target Lesion Revascularization (ID-TLR)

Time frame:: 180 days
Reported as:: Number · percentage of participants

Ischemia Driven Target Lesion Revascularization (ID-TLR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Lesion Revascularization (ID-TLR)	1.5	2.1

SecondaryIschemia Driven Target Lesion Revascularization (ID-TLR)

Time frame:: 270 days
Reported as:: Number · percentage of participants

Ischemia Driven Target Lesion Revascularization (ID-TLR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Lesion Revascularization (ID-TLR)	2.7	5.0

SecondaryIschemia Driven Target Lesion Revascularization (ID-TLR)

Time frame:: 1 years
Reported as:: Number · percentage of participants

Ischemia Driven Target Lesion Revascularization (ID-TLR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Lesion Revascularization (ID-TLR)	3.4	5.6

SecondaryIschemia Driven Target Lesion Revascularization (ID-TLR)

Time frame:: 2 years
Reported as:: Number · percentage of participants

Ischemia Driven Target Lesion Revascularization (ID-TLR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Lesion Revascularization (ID-TLR)	5.7	9.2

SecondaryIschemia Driven Target Lesion Revascularization (ID-TLR)

Time frame:: 3 year
Reported as:: Number · percentage of participants

Ischemia Driven Target Lesion Revascularization (ID-TLR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Lesion Revascularization (ID-TLR)	5.7	9.2

SecondaryIschemia Driven Target Lesion Revascularization (ID-TLR)

Time frame:: 4 year
Reported as:: Number · percentage of participants

Ischemia Driven Target Lesion Revascularization (ID-TLR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Lesion Revascularization (ID-TLR)	8.0	10.6

SecondaryIschemia Driven Target Vessel Revascularization (ID-TVR)

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 Derived from Non-Hierarchical Subject Counts of Adverse Events

Time frame:: 30 days
Reported as:: Number · percentage of participants

Ischemia Driven Target Vessel Revascularization (ID-TVR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Vessel Revascularization (ID-TVR)	0.3	0.9

SecondaryIschemia Driven Target Vessel Revascularization (ID-TVR)

Time frame:: 180 days
Reported as:: Number · percentage of participants

Ischemia Driven Target Vessel Revascularization (ID-TVR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Vessel Revascularization (ID-TVR)	1.2	1.8

SecondaryIschemia Driven Target Vessel Revascularization (ID-TVR)

Time frame:: 270 days
Reported as:: Number · percentage of participants

Ischemia Driven Target Vessel Revascularization (ID-TVR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Vessel Revascularization (ID-TVR)	2.9	4.1

SecondaryIschemia Driven Target Vessel Revascularization (ID-TVR)

Time frame:: 1 year
Reported as:: Number · percentage of participants

Ischemia Driven Target Vessel Revascularization (ID-TVR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Vessel Revascularization (ID-TVR)	3.1	4.7

SecondaryIschemia Driven Target Vessel Revascularization (ID-TVR)

Time frame:: 2 years
Reported as:: Number · percentage of participants

Ischemia Driven Target Vessel Revascularization (ID-TVR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Vessel Revascularization (ID-TVR)	4.9	6.6

SecondaryIschemia Driven Target Vessel Revascularization (ID-TVR)

Time frame:: 3 years
Reported as:: Number · percentage of participants

Ischemia Driven Target Vessel Revascularization (ID-TVR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Vessel Revascularization (ID-TVR)	6.7	8.9

SecondaryIschemia Driven Target Vessel Revascularization (ID-TVR)

Time frame:: 4 years
Reported as:: Number · percentage of participants

Ischemia Driven Target Vessel Revascularization (ID-TVR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Vessel Revascularization (ID-TVR)	7.8	9.6

SecondaryIschemia Driven Major Adverse Cardiac Event (MACE)

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
Reported as:: Number · percentage of participants

Ischemia Driven Major Adverse Cardiac Event (MACE)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Major Adverse Cardiac Event (MACE)	1.3	3.0

SecondaryIschemia Driven Major Adverse Cardiac Event (MACE)

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
Reported as:: Number · percentage of participants

Ischemia Driven Major Adverse Cardiac Event (MACE)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Major Adverse Cardiac Event (MACE)	2.9	5.2

SecondaryIschemia Driven Major Adverse Cardiac Event (MACE)

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
Reported as:: Number · percentage of participants

Ischemia Driven Major Adverse Cardiac Event (MACE)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Major Adverse Cardiac Event (MACE)	5.0	8.8

SecondaryIschemia Driven Major Adverse Cardiac Event (MACE)

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
Reported as:: Number · percentage of participants

Ischemia Driven Major Adverse Cardiac Event (MACE)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Major Adverse Cardiac Event (MACE)	6.0	10.3

SecondaryIschemia Driven Major Adverse Cardiac Event(MACE)

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
Reported as:: Number · percentage of participants

Ischemia Driven Major Adverse Cardiac Event(MACE)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Major Adverse Cardiac Event(MACE)	7.7	13.8

SecondaryIschemia Driven Major Adverse Cardiac Event (MACE)

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:: 3 year
Reported as:: Number · percentage of participants

Ischemia Driven Major Adverse Cardiac Event (MACE)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Major Adverse Cardiac Event (MACE)	9.7	16.4

SecondaryIschemia Driven Major Adverse Cardiac Event (MACE)

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:: 4 year
Reported as:: Number · percentage of participants

Ischemia Driven Major Adverse Cardiac Event (MACE)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Major Adverse Cardiac Event (MACE)	12.8	18.5

SecondaryIn-stent % Angiographic Binary Restenosis (% ABR) Rate

Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)

Time frame:: at 240 days
Reported as:: Number · percentage of participants

In-stent % Angiographic Binary Restenosis (% ABR) Rate
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
In-stent % Angiographic Binary Restenosis (% ABR) Rate	2.3	5.7

SecondaryIn-segment % Angiographic Binary Restenosis (% ABR) Rate

Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA

Time frame:: 240 days
Reported as:: Number · percentage of participants

In-segment % Angiographic Binary Restenosis (% ABR) Rate
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
In-segment % Angiographic Binary Restenosis (% ABR) Rate	4.7	8.9

SecondaryPersisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection

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
Reported as:: Number · percentage of participants

Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection	24.4	14.0

SecondaryAcute Success: Clinical Device

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
Reported as:: Number · percentage of participants

Acute Success: Clinical Device
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Acute Success: Clinical Device	98.3	98.7

SecondaryAcute Success: Clinical Procedure

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
Reported as:: Number · percentage of participants

Acute Success: Clinical Procedure
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Acute Success: Clinical Procedure	98.5	97.3

SecondaryProximal Late Loss

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
Reported as:: Mean · millimeters

Proximal Late Loss
millimeters	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Proximal Late Loss	0.12 ± 0.40	0.20 ± 0.41

SecondaryDistal Late Loss

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
Reported as:: Mean · millimeters

Distal Late Loss
millimeters	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Distal Late Loss	0.09 ± 0.36	0.10 ± 0.37

SecondaryIn-stent Late Loss

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
Reported as:: Mean · millimeters

In-stent Late Loss
millimeters	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
In-stent Late Loss	0.16 ± 0.41	0.30 ± 0.53

Secondary% Volume Obstruction (% VO)

Defined as stent intimal hyperplasia and calculated as 100\*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.

Time frame:: at 240 days
Reported as:: Mean · percent of volume obstruction

% Volume Obstruction (% VO)
percent of volume obstruction	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
% Volume Obstruction (% VO)	6.91 ± 6.35	11.21 ± 9.86

SecondaryIn-stent % Diameter Stenosis (% DS)

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
Reported as:: Mean · percent diameter stenosis

In-stent % Diameter Stenosis (% DS)
percent diameter stenosis	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
In-stent % Diameter Stenosis (% DS)	5.92 ± 16.40	10.30 ± 21.43

SecondaryIn-segment % Diameter Stenosis (% DS)

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
Reported as:: Mean · percent of in-segment diameter stenosis

In-segment % Diameter Stenosis (% DS)
percent of in-segment diameter stenosis	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
In-segment % Diameter Stenosis (% DS)	18.77 ± 14.43	22.82 ± 16.35

SecondaryTarget Vessel Failure (TVF)

Time frame:: 5 years
Reported as:: Number · percentage of participants

Target Vessel Failure (TVF)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Target Vessel Failure (TVF)	20.3	26.6

SecondaryIschemia Driven Target Lesion Revascularization (ID-TLR)

Time frame:: 5 years
Reported as:: Number · percentage of participants

Ischemia Driven Target Lesion Revascularization (ID-TLR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Lesion Revascularization (ID-TLR)	8.9	12.9

SecondaryIschemia Driven Target Vessel Revascularization (ID-TVR)

Time frame:: 5 years
Reported as:: Number · percentage of participants

Ischemia Driven Target Vessel Revascularization (ID-TVR)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Target Vessel Revascularization (ID-TVR)	8.8	11.9

SecondaryIschemia Driven Major Adverse Cardiac Event (MACE)

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:: 5 years
Reported as:: Number · percentage of participants

Ischemia Driven Major Adverse Cardiac Event (MACE)
percentage of participants	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Ischemia Driven Major Adverse Cardiac Event (MACE)	14.4	22.0

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
XIENCE V® EECSS	—	—	—
TAXUS® EXPRESS2™ ECSS	—	—	—

Most frequent serious events

Showing 10 of 182

Most frequent serious events
Event	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Coronary revascularisationSurgical and medical procedures	60/438	43/211
Angina pectorisCardiac disorders	42/438	37/211
Myocardial ischaemiaCardiac disorders	25/438	12/211
Noncardiac chest painGeneral disorders	16/438	11/211
Myocardial infarctionCardiac disorders	11/438	10/211
Coronary angioplastySurgical and medical procedures	9/438	9/211
Cardiac failure congestiveCardiac disorders	6/438	6/211
AnaemiaBlood and lymphatic system disorders	1/438	5/211
Coronary artery bypass graftSurgical and medical procedures	10/438	3/211
Gastrointestinal haemorrhageVascular disorders	6/438	4/211

Most frequent other events

Most frequent other events
Event	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Angina pectorisCardiac disorders	71/438	35/211
Catheter site haematomaGeneral disorders	12/438	11/211
Myocardial infarctionCardiac disorders	7/438	11/211

Baseline characteristics

Age Categorical
Age Categorical(participants)	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS	Total
<=18 years	0	0	0
Between 18 and 65 years	376	191	567
>=65 years	293	141	434

Age Continuous
Age Continuous(years)	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS	Total
Mean	63.23 ± 10.53	62.80 ± 10.24	63.08 ± 10.43

Gender
Gender(participants)	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS	Total
Female	200	114	314
Male	469	218	687

Region of Enrollment
Region of Enrollment(participants)	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS	Total
United States	669	333	1002

Study locations

65 sites

Baptist Medical Center Princeton
Birmingham, Alabama 35211, United States
Baptist Health System - Montclair
Birmingham, Alabama 35213, United States
Arizona Heart Hospital
Phoenix, Arizona 85016, United States
Scripps Memorial Hospital
La Jolla, California 92037, United States
Good Samaritan Hospital
Los Angeles, California 87106, United States
Alta Bates Summit Medical Center
Oakland, California 94609, United States
Mercy General Hospital
Sacramento, California 95819, United States
Poudre Valley Hospital
Fort Collins, Colorado 80528, United States
Washington Hospital Center
Washington, District of Columbia 20010, United States
Holy Cross Medical Center (prev. North Ridge MC)
Fort Lauderdale, Florida 33308, United States
Baptist Hospital of Miami
Miami, Florida 33176, United States
Emory Crawford Long Hospital
Atlanta, Georgia 30308, United States
Piedmont Hospital
Atlanta, Georgia 30309, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia 30342, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois 60148, United States
St. John's Hospital
Springfield, Illinois 62701, United States
The Heart Center of IN, LLC
Indianapolis, Indiana 46290, United States
Jewish Hospital
Louisville, Kentucky 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121, United States
Johns Hopkins Hospital
Baltimore, Maryland 21287, United States
Washington Adventist Hospital
Takoma Park, Maryland 20912, United States
St. Joseph Medical Center
Towson, Maryland 21204, United States
Brigham & Women's Hospital
Boston, Massachusetts 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States
St John Hospital & Medical Center
Detroit, Michigan 48236, United States
Spectrum Health Hospital
Grand Rapids, Michigan 49503, United States
Borgess Medical Center
Kalamazoo, Michigan 49048, United States
Northern Michigan Hospital
Petoskey, Michigan 49770, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota 55407, United States
North Mississippi Medical Center
Tupelo, Mississippi 38801, United States
St. Luke's Hospital
Kansas City, Missouri 64111, United States
Barnes Jewish Hospital
St. Louis, Missouri 63110, United States
St. Patrick Hospital
Missoula, Montana 59802, United States
Nebraska Heart Hospital
Lincoln, Nebraska 68526, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States
Hackensack Medical Center
Hackensack, New Jersey 07601, United States
The Valley Hospital
Ridgewood, New Jersey 07450, United States
Presbyterian Hospital
Albuquerque, New Mexico 28204, United States
Long Island Jewish Medical Center
New Hyde Park, New York 11040, United States
Columbia University Medical Center
New York, New York 10032, United States
St. Joseph's Hospital Health Center
Syracuse, New York 13203, United States
Presbyterian Hospital
Charlotte, North Carolina 87106, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Wake Medical Center
Raleigh, North Carolina 27610, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157, United States
The Christ Hospital
Cincinnati, Ohio 45219, United States
Riverside Methodist Hospital
Columbus, Ohio 43214, United States
EMH Regional Medical Center
Elyria, Ohio 44035, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104, United States
Integris Baptist Medical, Inc.
Oklahoma City, Oklahoma 73112, United States
Sacred Heart Medical Center
Eugene, Oregon 97401, United States
Providence St. Vincent Medical Center
Portland, Oregon 97225, United States
Pinnacle Health @ Harrisburg Hospital
Harrisburg, Pennsylvania 17043, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212, United States
Rhode Island Hospital
Providence, Rhode Island 02903, United States
The Miriam Hospital
Providence, Rhode Island 02906, United States
Medical University of South Carolina
Charleston, South Carolina 29403, United States
Heart Hospital of Austin
Austin, Texas 78756, United States
Medical City Dallas Hospital
Dallas, Texas 75230, United States
Methodist Hospital
Houston, Texas 77030, United States
TexSan Heart Hospital
San Antonio, Texas 78215, United States
Fletcher Allen Health Care
Burlington, Vermont 05401, United States
Swedish Medical Center
Seattle, Washington 98104, United States
St. Luke's Medical Center
Milwaukee, Wisconsin 53215, United States

References and documents

Publications

Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903. PubMed 18430909 ↗
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation. 2009 Feb 10;119(5):680-6. doi: 10.1161/CIRCULATIONAHA.108.803528. Epub 2009 Jan 26. PubMed 19171853 ↗
Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):719-27. doi: 10.1002/ccd.22067. PubMed 19530147 ↗
Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362. PubMed 25940520 ↗
Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16. PubMed 24746650 ↗
Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011 Nov;4(11):1209-15. doi: 10.1016/j.jcin.2011.07.016. PubMed 22115661 ↗
Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018. PubMed 22017936 ↗
Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1229-39. doi: 10.1016/j.jcin.2010.09.014. PubMed 21232716 ↗
Caixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW; SPIRIT II and III Investigators. Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1220-8. doi: 10.1016/j.jcin.2010.07.017. PubMed 21232715 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00180479
Lead sponsor: Abbott Medical Devices
Responsible party: Sponsor
First posted: Sep 16, 2005
Start date: Jun 2005
Primary completion: Dec 2006
Completion: Nov 2011
Results posted: Dec 15, 2008
Last update: Nov 23, 2011

Study contacts

Gregg W Stone, MD

principal investigator · Columbia University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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

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