This study is divided into 5 arms: 1. 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 2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS 3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS 4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS 5. 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.
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: 1. 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 2. 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 3. 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. 4. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,002
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Baptist Medical Center Princeton
Birmingham, Alabama, United States
Baptist Health System - Montclair
Birmingham, Alabama, United States
Arizona Heart Hospital
Phoenix, Arizona, United States
Scripps Memorial Hospital
La Jolla, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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