SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

Coronary Artery Disease Clinical Trial

Official title:

SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307047
• Other study ID #: 05-368
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2006
• Last updated: October 8, 2012
• Start date: August 2006
• Est. completion date: May 2012

Study information

• Verified date: October 2012
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific.

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

Description:

The completion of the SPIRIT IV clinical trial at three years is justified by the consistent long-term clinical evidence supporting the safety and efficacy of the XIENCE V EECSS in complex, real-world patients across multiple geographies. As SPIRIT IV was designed as a continued access trial, completing the clinical follow-up at the three-year visit does not conflict with any FDA requirements. Abbott Vascular is committed to providing clinical outcomes through three years. The clinical evidence provided from across multiple geographies, in complex populations thus supports Abbott Vascular's proposal to complete the SPIRIT IV RCT at the three-year clinical follow-up.

The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE V®: TAXUS®). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) ≥ 2.5 mm to ≤ 4.25 mm and lesion lengths ≤ 28 mm. (NOTE: RVD ≥ 2.5 mm to ≤ 3.75 mm until 4.0 mm TAXUS® is commercially available). All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, and 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3687
• Est. completion date: May 2012
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

General Inclusion Criteria:

• Subject must be at least 18 years of age

• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

• Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)

• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery

• Subject must agree to undergo all protocol-required follow-up procedures

• Subject must agree not to participate in any other clinical study for a period of one year following the index procedure

Angiographic Inclusion Criteria:

• Target lesion(s) must be located in a native coronary artery with visually estimated diameter of =2.5 mm to =4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD =2.5 mm to =3.75 mm until 4.0 mm TAXUS® is commercially available)

• Target lesion(s) must measure =28 mm in length by visual estimation(=3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent)

• If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria

• If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria

• The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of = 50% and < 100% with a TIMI flow of = 1

• Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done = 9 months prior to the index procedure

• Non-study percutaneous intervention for lesions in a non-target vessel involving:

• Successful and uncomplicated (visually estimated diameter stenosis < 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done = 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be < 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted

• Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done = 30 days prior to the index procedure

• Drug-eluting stent treatment is allowed if done = 90 days prior to the index procedure

• Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done = 9 months after the index procedure

General Exclusion Criteria:

• Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB = 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure

• The subject is currently experiencing clinical symptoms consistent with AMI

• Subject has current unstable arrhythmias

• Subject has a known left ventricular ejection fraction (LVEF) < 30%

• Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant

• Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure

• Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)

• Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)

• Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated

• Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure

• Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)

• Subject has known renal insufficiency (e.g., serum creatinine level of > 2.5 mg/dL or subject on dialysis)

• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

• Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months

• Subject has had a significant GI or urinary bleed within the past six months

• Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion

• Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year

• Subject is already participating in another clinical study that has not yet reached its primary endpoint

• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used up to 1 year following the index procedure)

• Angiographic Exclusion Criteria

• The target lesion(s) meets any of the following criteria:

• Left main coronary artery location including left main ostial location (NOTE:

RCA-aorto-ostial lesions are not excluded)

• Located within 2 mm of the origin of the LAD or LCX

• Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis > 20%) arterial or saphenous vein graft

• Involves a bifurcation in which the side branch is = 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation

• Involves a side branch requiring pre-dilatation

• Total occlusion (TIMI flow 0) prior to wire crossing

• Excessive tortuosity proximal to or within the lesion

• Extreme angulation (= 90º) proximal to or within the lesion

• Heavy calcification

• Restenotic from previous intervention

• Subject has received brachytherapy in any epicardial vessel (including side branches)

• The target vessel contains thrombus

• Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure

• Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure

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 Disease
• Myocardial Ischemia

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	The Medical Center of Aurora	Aurora	Colorado
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Bay Regional Medical Center	Bay City	Michigan
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Millard Fillmore Hospital	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Presbyterian Hospital - Charlotte	Charlotte	North Carolina
United States	The Christ Hospital	Cincinnati	Ohio
United States	Sisters of Charity Providence Hospitals	Columbia	South Carolina
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Iowa Heart Center P.C.	Des Moines	Iowa
United States	EMH Regional Medical Center	Elyria	Ohio
United States	Inova Fairfax Hospital	Fairfax	California
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Plaza Medical Center of Fort Worth	Fort Worth	Texas
United States	Spectrum Health Hospital	Grand Rapids	Michigan
United States	Pitt County Memorial Hospital	Greenville	North Carolina
United States	St. Francis Health System	Greenville	South Carolina
United States	St. Francis Hospital and Health Centers	Indianapolis	Indiana
United States	The Heart Center of Indiana	Indianapolis	Indiana
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Research Medical Center	Kansas City	Missouri
United States	St. Luke's Hospital	Kansas City	Missouri
United States	University of Kansas Hospital	Kansas City	Kansas
United States	San Diego Cardiovascular Associates	La Jolla	California
United States	Scripps Memorial Hospital	La Jolla	California
United States	Ingham Regional Medical Center	Lansing	Michigan
United States	Dartmouth Hitchock Medical Center	Lebanon	New Hampshire
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Nebraska Heart Hospital	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Good Samaritan Hospital - LA	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	St. Luke's Medical Center - Milwaukee	Milwaukee	Wisconsin
United States	St. Patrick Hospital	Missoula	Montana
United States	Vanderbilt Vniversity Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	New York Presbyterian Hospital-Cornell	New York City	New York
United States	Sentara Norfolk General	Norfolk	Virginia
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	The Valley Hospital	Pomona	New York
United States	Maine Medical Center	Portland	Maine
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	Mercy General Hospital	Sacramento	California
United States	Sutter Medical Center of Santa Rosa	Santa Rosa	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Stony Brook Hospital and Medical Center	Stony Brook	New York
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	Washington Hospital Center	Washington	District of Columbia
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	Saint Vincent Hospital	Worcester	Massachusetts
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia Driven Target Lesion Failure (TLF)	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).	1 year	Yes
Secondary	Ischemia Driven Target Vessel Failure (TVF)	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR	30 days	Yes
Secondary	Ischemia Driven Target Vessel Failure (TVF)	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR	180 days	Yes
Secondary	Ischemia Driven Target Vessel Failure (TVF)	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR	270 days	Yes
Secondary	Ischemia Driven Target Vessel Failure (TVF)	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR	1 year	Yes
Secondary	Ischemia Driven Target Vessel Failure (TVF)	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR	2 years	Yes
Secondary	Ischemia Driven Target Vessel Failure (TVF)	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR	3 years	Yes
Secondary	Ischemia Driven Target Lesion Revascularization (TLR)	Revascularization of a target lesion associated with any of the following: positive functional ischemia study; ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	30 days	No
Secondary	Ischemia Driven Target Lesion Revascularization (TLR)	Revascularization of a target lesion associated with any of the following: positive functional ischemia study; ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	180 days	No
Secondary	Ischemia Driven Target Lesion Revascularization (TLR)	Revascularization of a target lesion associated with any of the following: positive functional ischemia study; ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	270 days	No
Secondary	Ischemia Driven Target Lesion Revascularization (TLR)	Revascularization of a target lesion associated with any of the following: positive functional ischemia study; ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	1 year	No
Secondary	Ischemia Driven Target Lesion Revascularization (TLR)	Revascularization of a target lesion associated with any of the following: positive functional ischemia study; ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	2 years	No
Secondary	Ischemia Driven Target Lesion Revascularization (TLR)	Revascularization of a target lesion associated with any of the following: positive functional ischemia study; ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	3 years	No
Secondary	Ischemia Driven Target Vessel Revascularization (TVR)	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study; ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	30 days	No
Secondary	Ischemia Driven Target Vessel Revascularization (TVR)	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study; ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	180 days	No
Secondary	Ischemia Driven Target Vessel Revascularization (TVR)	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study; ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	270 days	No
Secondary	Ischemia Driven Target Vessel Revascularization (TVR)	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study; ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	1 year	No
Secondary	Ischemia Driven Target Vessel Revascularization (TVR)	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study; ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	2 years	No
Secondary	Ischemia Driven Target Vessel Revascularization (TVR)	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study; ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA); angiographic diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study	3 years	No
Secondary	Ischemia Driven Major Adverse Cardiac Events (MACE)	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR	30 days	Yes
Secondary	Ischemia Driven Major Adverse Cardiac Events (MACE)	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR	180 days	Yes
Secondary	Ischemia Driven Major Adverse Cardiac Events (MACE)	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR	270 days	Yes
Secondary	Ischemia Driven Major Adverse Cardiac Events (MACE)	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR	1 years	Yes
Secondary	Ischemia Driven Major Adverse Cardiac Events (MACE)	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR	2 years	Yes
Secondary	Ischemia Driven Major Adverse Cardiac Events (MACE)	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR	3 years	Yes
Secondary	Acute Success (Clinical Device)	Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.	Acute: At time of index procedure	No
Secondary	Acute Success (Clinical Procedure)	Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.	Acute: At time of index procedure	Yes
Secondary	All Myocardial Infarction (MI)		30 days	Yes
Secondary	All MI		180 days	Yes
Secondary	All MI		270 days	Yes
Secondary	All MI		1 year	Yes
Secondary	All MI		2 years	Yes
Secondary	All MI		3 years	Yes
Secondary	All Cause Mortality		30 days	Yes
Secondary	All Cause Mortality		180 days	Yes
Secondary	All Cause Mortality		270 days	Yes
Secondary	All Cause Mortality		1 year	Yes
Secondary	All Cause Mortality		2 years	Yes
Secondary	All Cause Mortality		3 years	Yes
Secondary	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)		30 days	Yes
Secondary	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)		180 days	Yes
Secondary	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)		270 days	Yes
Secondary	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)		1 year	Yes
Secondary	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)		2 years	Yes
Secondary	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)		3 years	Yes
Secondary	Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post; * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.; † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.	0-30 days	Yes
Secondary	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post; * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.; † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.	31-393 days	Yes
Secondary	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post; * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.; † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.	0 -393 days	Yes
Secondary	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post; * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.; † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.	0-758 days	Yes
Secondary	Definite + Probable Stent Thrombosis Rate Based on ARC Definition	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post; * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.; † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.	0-1123 days	Yes
Secondary	Protocol Defined Stent Thrombosis Rate	ST will be categorized as acute (= 1day), subacute (>1 day to = 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST; In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.	0-30 days	Yes
Secondary	Protocol Defined Stent Thrombosis Rate	ST will be categorized as acute (= 1day), subacute (>1 day to = 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST; In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.	31-393 days	Yes
Secondary	Protocol Defined Stent Thrombosis Rate	ST will be categorized as acute (= 1day), subacute (>1 day to = 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST; In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.	0-393 days	Yes
Secondary	Protocol Defined Stent Thrombosis Rate	ST will be categorized as acute (= 1day), subacute (>1 day to = 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST; In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.	0-758 days	Yes
Secondary	Protocol Defined Stent Thrombosis Rate	ST will be categorized as acute (= 1day), subacute (>1 day to = 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST; In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.	0-1123 days	Yes
Secondary	Cardiac Death or Target Vessel MI Rate		30 days	Yes
Secondary	Cardiac Death or Target Vessel MI Rate		180 days	Yes
Secondary	Cardiac Death or Target Vessel MI Rate		270 days	Yes
Secondary	Cardiac Death or Target Vessel MI Rate		1 year	Yes
Secondary	Cardiac Death or Target Vessel MI Rate		2 years	Yes
Secondary	Cardiac Death or Target Vessel MI Rate		3 years	Yes
Secondary	Ischemia Driven Target Lesion Failure (TLF)	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).	30 days	Yes
Secondary	Ischemia Driven Target Lesion Failure (TLF)	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).	180 days	Yes
Secondary	Ischemia Driven Target Lesion Failure (TLF)	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).	270 days	Yes
Secondary	Ischemia Driven Target Lesion Failure (TLF)	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).	2 years	Yes
Secondary	Ischemia Driven Target Lesion Failure (TLF)	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).	3 years	Yes