SPIRIT Small Vessel Registry

Spirit Small Vessel Registry (SPIRIT SV)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00783796

Acronym

SPIRIT SV

Enrollment

150

Registered

2008-11-03

Start date

2008-10-31

Completion date

2013-12-31

Last updated

2019-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Coronary Artery Disease, Myocardial Ischemia

Keywords

Coronary artery disease, Atherosclerosis, Myocardial ischemia

Brief summary

To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.

Interventions

DEVICE2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System

Treatment of a maximum of two de novo native coronary artery lesions in small vessels.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

General Inclusion Criteria 1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure. 3. 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). 4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. 5. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria 1. One target or two (two target or one target and one non-target) de novo lesion(s), each in a different epicardial vessel. 2. If there are two target lesions or one target and one non-target lesion, both lesions must satisfy the angiographic eligibility criteria. 3. The target lesion(s) or non-target lesion must be located in a major artery or branch with a visually estimated diameter stenosis of ≥50% and \< 100% with a TIMI flow of ≥1. 4. The target lesion(s) or non-target lesion must be located in a native coronary artery with a reference vessel diameter by visual estimation of: Target Lesion: ≥ 2.25 mm to \< 2.5 mm for treatment by the 2.25 mm XIENCE V® EECS. Non-target Lesion: ≥2.5 mm to ≤4.25 mm for treatment by the commercial XIENCE V® EECS. 5. The target lesion(s) or non-target lesion must be located in a native coronary artery with a lesion length by visual estimation of ≤28 mm. General

Exclusion criteria

1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB (creatine kinase myocardial-band isoenzyme) ≥2 times the upper limit of normal) and CK and CK-MB levels have not returned to within normal limits at the time of procedure. 2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes. 3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability. 4. Subject has a known left ventricular ejection fraction (LVEF) \< 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary). 5. Subject has received coronary brachytherapy in any epicardial vessel. 6. Subject has received any organ transplant or is on a waiting list for any organ transplant. 7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure. 8. Subject is receiving or scheduled to receive planned radiation therapy to the chest or mediastinum. 9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.). 10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin). 11. Subjects who will require Low Molecular Weight Heparin (LMWH) post-procedure. 12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated. 13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel. 14. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC (white blood cell) of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis). 15. Subject has known renal insufficiency (eg, serum creatinine level ≥ 2.5 mg/dL, or on dialysis). 16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. 17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months. 18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months. 19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. 20. 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 limited life expectancy (i.e., less than one year). 21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint. 22. 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 per site standard test. Angiographic

Design outcomes

Primary

Measure	Time frame	Description
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).	1 year	This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

Secondary

Measure	Time frame	Description
Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)	From start of index procedure to end of index procedure	Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of \<50%.
Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)	From the start of index procedure to end of index procedure	Achievement of a final in-stent diameter stenosis of \<50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.
In-Stent Late Loss	240 days	In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.
In-segment Late Loss (LL)	240 Days	In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.
Proximal Late Loss	240 days	Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).
Distal Late Loss	240 days	Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).
In-stent % Diameter Stenosis	240 days	Value calculated as 100\*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.
In-segment % Diameter Stenosis	240 days	Value calculated as 100\*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.
Proximal % Diameter Stenosis	240 days	Value calculated as 100\*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.
Distal % Diameter Stenosis	240 days	Value calculated as 100\*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.
In-stent Angiographic Binary Restenosis (ABR) Rate	240 days	Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.
In-segment Angiographic Binary Restenosis (ABR) Rate	240 days	Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.
Distal Angiographic Binary Restenosis (ABR) Rate	240 days	Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.
All Death (Cardiac, Vascular, Non-cardiovascular)	30 days	All death, including death from cardiac, vascular, and non-cardiovascular causes.
Proximal Angiographic Binary Restenosis (ABR) Rate	240 days	Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.
Stent Thrombosis (ARC Defined)	0 to 1 day (Acute)	ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Stent Thrombosis (Protocol Defined)	0 to 1 day (Acute)	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (\>1 day and ≤30 days), and late (\>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction\* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (\*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
All Death/ All MI/All Coronary Revascularization	30 days	This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Cardiac Death/ All MI /CI-TLR	30 days	This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Cardiac Death/MI	30 days	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
All Coronary Revascularization (TVR and Non-TVR)	30 days	Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
All TVR (CI and Non-CI)	30 days	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
All TLR (CI and Non-CI)	30 days	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Clinically Indicated Target Vessel Revascularization (TVR)	30 days	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Clinically Indicated Target Vessel Revascularization	240 days	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Clinically Indicated Target Lesion Revascularization (CI-TLR)	30 days	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	30 days	Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)	30 days	ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	30 days	ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)	30 days	Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Countries

United States

Participant flow

Recruitment details

150 subjects were recruited at 33 sites from the general interventional cardiology population. Dates of recruitment: 12/08/08 through 11/04/09.

Pre-assignment details

Subjects were screened for study eligibility by a member of the study team. Subjects meeting eligibility criteria were asked to sign an informed consent form. Pre-procedure angiography was used for final assessment of eligibility.

Participants by arm

Arm	Count
2.25mm XIENCE V® Patients receiving the 2.25 mm XIENCE V® stent	150
Total	150

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Did not receive any stent	4
Overall Study	Received commercial XIENCE V stent	1
Overall Study	Received non-XIENCE V stent	1

Baseline characteristics

Characteristic	2.25mm XIENCE V®
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	65 Participants
Age, Categorical Between 18 and 65 years	85 Participants
Age, Continuous	62.97 years STANDARD_DEVIATION 10.59
Region of Enrollment United States	150 participants
Sex/Gender, Customized Female	57 participants
Sex/Gender, Customized Male	92 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	83 / 139
serious Total, serious adverse events	79 / 139

Outcome results

Primary

Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).

This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

Time frame: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).	12.1 Percentage of Participants

Primary

Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).

This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).	8.3 Percentage of Participants

Primary

Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).

This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).	8.1 Percentage of Participants

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Coronary Revascularization (TVR and Non-TVR)	23.5 percentage of participants

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Coronary Revascularization (TVR and Non-TVR)	2.1 Percentage of Participants

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Coronary Revascularization (TVR and Non-TVR)	12.9 Percentage of Participants

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Coronary Revascularization (TVR and Non-TVR)	14.7 Percentage of Participants

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Coronary Revascularization (TVR and Non-TVR)	20.3 percentage of participants

Secondary

All Death/ All MI/All Coronary Revascularization

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death/ All MI/All Coronary Revascularization	26.5 percentage of participants

Secondary

All Death/ All MI/All Coronary Revascularization

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death/ All MI/All Coronary Revascularization	22.6 percentage of participants

Secondary

All Death/ All MI/All Coronary Revascularization

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death/ All MI/All Coronary Revascularization	16.9 Percentage of Participants

Secondary

All Death/ All MI/All Coronary Revascularization

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death/ All MI/All Coronary Revascularization	15.1 Percentage of Participants

Secondary

All Death/ All MI/All Coronary Revascularization

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death/ All MI/All Coronary Revascularization	3.5 Percentage of Participants

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

All death, including death from cardiac, vascular, and non-cardiovascular causes.

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death (Cardiac, Vascular, Non-cardiovascular)	0.7 Percentage of Participants

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

All death, including death from cardiac, vascular, and non-cardiovascular causes.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death (Cardiac, Vascular, Non-cardiovascular)	1.5 Percentage of Participants

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

All death, including death from cardiac, vascular, and non-cardiovascular causes.

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death (Cardiac, Vascular, Non-cardiovascular)	1.5 percentage of participants

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death (Cardiac, Vascular, Non-cardiovascular)	3.8 percentage of participants

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

All death, including death from cardiac, vascular, and non-cardiovascular causes.

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All Death (Cardiac, Vascular, Non-cardiovascular)	1.4 Percentage of Participants

Secondary

All TLR (CI and Non-CI)

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TLR (CI and Non-CI)	6.8 percentage of participants

Secondary

All TLR (CI and Non-CI)

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TLR (CI and Non-CI)	5.8 Percentage of Participants

Secondary

All TLR (CI and Non-CI)

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TLR (CI and Non-CI)	0.7 Percentage of Participants

Secondary

All TLR (CI and Non-CI)

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TLR (CI and Non-CI)	8.3 percentage of participants

Secondary

All TLR (CI and Non-CI)

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TLR (CI and Non-CI)	6.6 Percentage of Participants

Secondary

All TVR (CI and Non-CI)

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TVR (CI and Non-CI)	13.6 percentage of participants

Secondary

All TVR (CI and Non-CI)

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TVR (CI and Non-CI)	1.4 Percentage of Participants

Secondary

All TVR (CI and Non-CI)

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TVR (CI and Non-CI)	8.6 Percentage of Participants

Secondary

All TVR (CI and Non-CI)

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TVR (CI and Non-CI)	10.3 Percentage of Participants

Secondary

All TVR (CI and Non-CI)

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	All TVR (CI and Non-CI)	11.3 percentage of participants

Secondary

Cardiac Death/ All MI /CI-TLR

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/ All MI /CI-TLR	12.1 percentage of participants

Secondary

Cardiac Death/ All MI /CI-TLR

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/ All MI /CI-TLR	2.1 Percentage of Participants

Secondary

Cardiac Death/ All MI /CI-TLR

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/ All MI /CI-TLR	7.2 Percentage of Participants

Secondary

Cardiac Death/ All MI /CI-TLR

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/ All MI /CI-TLR	8.3 percentage of participants

Secondary

Cardiac Death/ All MI /CI-TLR

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/ All MI /CI-TLR	8.1 Percentage of Participants

Secondary

Cardiac Death/MI

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/MI	2.1 Percentage of Participants

Secondary

Cardiac Death/MI

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/MI	5.3 percentage of participants

Secondary

Cardiac Death/MI

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/MI	3.0 percentage of participants

Secondary

Cardiac Death/MI

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/MI	2.9 Percentage of Participants

Secondary

Cardiac Death/MI

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Cardiac Death/MI	2.9 Percentage of Participants

Secondary

Clinically Indicated Target Lesion Revascularization (CI-TLR)

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Lesion Revascularization (CI-TLR)	5.1 Percentage of Participants

Secondary

Clinically Indicated Target Lesion Revascularization (CI-TLR)

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Lesion Revascularization (CI-TLR)	6.8 percentage of participants

Secondary

Clinically Indicated Target Lesion Revascularization (CI-TLR)

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Lesion Revascularization (CI-TLR)	0.0 Percentage of Participants

Secondary

Clinically Indicated Target Lesion Revascularization (CI-TLR)

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Lesion Revascularization (CI-TLR)	4.3 Percentage of Participants

Secondary

Clinically Indicated Target Lesion Revascularization (CI-TLR)

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Lesion Revascularization (CI-TLR)	5.3 percentage of participants

Secondary

Clinically Indicated Target Vessel Revascularization

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Vessel Revascularization	8.8 Percentage of Participants

Secondary

Clinically Indicated Target Vessel Revascularization

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Vessel Revascularization	12.1 percentage of participants

Secondary

Clinically Indicated Target Vessel Revascularization

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Vessel Revascularization	7.2 Percentage of Participants

Secondary

Clinically Indicated Target Vessel Revascularization

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Vessel Revascularization	9.8 percentage of participants

Secondary

Clinically Indicated Target Vessel Revascularization (TVR)

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Clinically Indicated Target Vessel Revascularization (TVR)	1.4 Percentage of Participants

Secondary

Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)

Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of \<50%.

Time frame: From start of index procedure to end of index procedure

Population: Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)	95.21 Percentage of Lesions

Secondary

Distal Angiographic Binary Restenosis (ABR) Rate

Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.

Time frame: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Distal Angiographic Binary Restenosis (ABR) Rate	0.0 Percentage of Participants

Secondary

Distal % Diameter Stenosis

Value calculated as 100\*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.

Time frame: 240 days

Arm	Measure	Value (MEAN)	Dispersion
2.25mm XIENCE V®	Distal % Diameter Stenosis	10.4 Percentage	Standard Deviation 8.45

Secondary

Distal Late Loss

Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).

Time frame: 240 days

Arm	Measure	Value (MEAN)	Dispersion
2.25mm XIENCE V®	Distal Late Loss	0.00 Millimeter	Standard Deviation 0.28

Secondary

In-segment Angiographic Binary Restenosis (ABR) Rate

Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	In-segment Angiographic Binary Restenosis (ABR) Rate	9.6 Percentage of Participants

Secondary

In-segment % Diameter Stenosis

Value calculated as 100\*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.

Time frame: 240 days

Arm	Measure	Value (MEAN)	Dispersion
2.25mm XIENCE V®	In-segment % Diameter Stenosis	20.85 Percentage	Standard Deviation 22.53

Secondary

In-segment Late Loss (LL)

In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.

Time frame: 240 Days

Arm	Measure	Value (MEAN)	Dispersion
2.25mm XIENCE V®	In-segment Late Loss (LL)	0.16 Millimeters	Standard Deviation 0.41

Secondary

In-stent Angiographic Binary Restenosis (ABR) Rate

Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	In-stent Angiographic Binary Restenosis (ABR) Rate	3.8 Percentage of Participants

Secondary

In-stent % Diameter Stenosis

Value calculated as 100\*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.

Time frame: 240 days

Arm	Measure	Value (MEAN)	Dispersion
2.25mm XIENCE V®	In-stent % Diameter Stenosis	12.86 Percentage	Standard Deviation 19.58

Secondary

In-Stent Late Loss

In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.

Time frame: 240 days

Arm	Measure	Value (MEAN)	Dispersion
2.25mm XIENCE V®	In-Stent Late Loss	0.20 Millimeters	Standard Deviation 0.4

Secondary

Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)

ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	0.0 Percentage of participants

Secondary

Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	1.5 percentage of participants

Secondary

Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	4.5 percentage of participants

Secondary

Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	1.5 Percentage of participants

Secondary

Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	1.4 Percentage of participants

Secondary

Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)

Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Time frame: 1 year

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 Percentage of Participants

Secondary

Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)

Time frame: 30 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 Percentage of Participants

Secondary

Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 Percentage of Participants

Secondary

Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)

Time frame: 2 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 percentage of participants

Secondary

Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)

Time frame: 3 years

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 percentage of participants

Secondary

Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)

Achievement of a final in-stent diameter stenosis of \<50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.

Time frame: From the start of index procedure to end of index procedure

Population: Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects.

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)	97.93 Percentage of Participants

Secondary

Proximal Angiographic Binary Restenosis (ABR) Rate

Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.

Time frame: 240 days

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Proximal Angiographic Binary Restenosis (ABR) Rate	2.7 Percentage of Participants

Secondary

Proximal % Diameter Stenosis

Value calculated as 100\*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.

Time frame: 240 days

Arm	Measure	Value (MEAN)	Dispersion
2.25mm XIENCE V®	Proximal % Diameter Stenosis	14.31 Percentage	Standard Deviation 13.16

Secondary

Proximal Late Loss

Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).

Time frame: 240 days

Arm	Measure	Value (MEAN)	Dispersion
2.25mm XIENCE V®	Proximal Late Loss	0.21 Millimeter	Standard Deviation 0.35

Secondary

Stent Thrombosis (ARC Defined)

ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Time frame: 0 to 1 day (Acute)

Arm	Measure	Value (NUMBER)
2.25mm XIENCE V®	Stent Thrombosis (ARC Defined)	0.0 Percentage of Participants

Secondary