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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180479
• Other study ID #: 03-360
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 16, 2011
• Start date: June 2005
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: November 2011
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
• TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.

Locations

Country	Name	City	State
United States	Presbyterian Hospital	Albuquerque	New Mexico
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Heart Hospital of Austin	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Baptist Health System - Montclair	Birmingham	Alabama
United States	Baptist Medical Center Princeton	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	St John Hospital & Medical Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Elmhurst Memorial Hospital	Elmhurst	Illinois
United States	EMH Regional Medical Center	Elyria	Ohio
United States	Sacred Heart Medical Center	Eugene	Oregon
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Holy Cross Medical Center (prev. North Ridge MC)	Fort Lauderdale	Florida
United States	Spectrum Health Hospital	Grand Rapids	Michigan
United States	Hackensack Medical Center	Hackensack	New Jersey
United States	Pinnacle Health @ Harrisburg Hospital	Harrisburg	Pennsylvania
United States	Methodist Hospital	Houston	Texas
United States	The Heart Center of IN, LLC	Indianapolis	Indiana
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Scripps Memorial Hospital	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Nebraska Heart Hospital	Lincoln	Nebraska
United States	Good Samaritan Hospital	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	Baptist Hospital of Miami	Miami	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	St. Patrick Hospital	Missoula	Montana
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Alta Bates Summit Medical Center	Oakland	California
United States	Integris Baptist Medical, Inc.	Oklahoma City	Oklahoma
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Arizona Heart Hospital	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	Wake Medical Center	Raleigh	North Carolina
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Mercy General Hospital	Sacramento	California
United States	TexSan Heart Hospital	San Antonio	Texas
United States	Swedish Medical Center	Seattle	Washington
United States	St. John's Hospital	Springfield	Illinois
United States	Barnes Jewish Hospital	St. Louis	Missouri
United States	St. Joseph's Hospital Health Center	Syracuse	New York
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	St. Joseph Medical Center	Towson	Maryland
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View Citation

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-elutin — View Citation

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 co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	240 days	Yes
Secondary	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	270 days	Yes
Secondary	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	30 days	Yes
Secondary	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	180 days	No
Secondary	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	1 year	No
Secondary	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	2 year	No
Secondary	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	3 year	Yes
Secondary	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	4 year	Yes
Secondary	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	30 days	No
Secondary	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	180 days	No
Secondary	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	270 days	No
Secondary	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	1 years	No
Secondary	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	2 years	No
Secondary	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	3 year	No
Secondary	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	4 year	No
Secondary	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	30 days	No
Secondary	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	180 days	No
Secondary	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	270 days	Yes
Secondary	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	1 year	No
Secondary	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	2 years	No
Secondary	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	3 years	No
Secondary	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	4 years	No
Secondary	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	30 days	Yes
Secondary	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	180 days	Yes
Secondary	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	270 days	Yes
Secondary	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	1 year	Yes
Secondary	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	2 years	Yes
Secondary	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	3 year	Yes
Secondary	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	4 year	Yes
Secondary	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)	at 240 days	No
Secondary	In-segment % Angiographic Binary Restenosis (% ABR) Rate	Percent of subjects with a follow-up in-segment percent diameter stenosis of = 50% per QCA	240 days	No
Secondary	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.	at 240 days	No
Secondary	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%.	In-hospital	Yes
Secondary	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%.	In-hospital	No
Secondary	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)	at 240 days	No
Secondary	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)	240 days	No
Secondary	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)	at 240 days	No
Secondary	% Volume Obstruction (% VO)	Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.	at 240 days	No
Secondary	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.	at 240 days	No
Secondary	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.	240 days	No
Secondary	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	5 years	Yes
Secondary	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	5 years	No
Secondary	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	5 years	No
Secondary	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	5 years	Yes