• SPIRIT V Diabetic Study: in-stent Late Loss(LL) [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
• SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]

• In-stent Late Loss (LL) at 270 days.
• Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 30 days.
• SPIRIT V Diabetic Study(randomized, single blind, active control, parallel two arm efficacy trial:
• SPIRIT V Registry:

• SPIRIT V Diabetic Study: Acute Success (Clinical Device Success and Clinical Procedure Success) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
• SPIRIT V Diabetic Study: adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
• SPIRIT V Diabetic Study: In-segment, proximal and distal Late Loss [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
• SPIRIT V Diabetic Study: In-stent and in-segment Angiographic Binary Restenosis rates [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
• SPIRIT V Diabetic Study: In-stent and in-segment percent Diameter Stenosis [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
• SPIRIT V Diabetic Study: Adjudicated Revascularizations (TLR/TVR/any Revascularization) both clinical-indicated and not clinical-indicated. [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
• SPIRIT V Diabetic Study: Adjudicated Composite rate of Cardiac Death, Myocardial Infarction (MI) attributed to the target vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
• SPIRIT V Diabetic Study: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
• SPIRIT V Registry: Acute Success (Clinical Device Success and Clinical Procedure Success) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
• SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
• SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
• SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
• SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
• SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]

• SPIRIT V Diabetic Study:
• Acute Success (Clinical Device Success and Clinical Procedure Success)
• Adjudicated Stent Thrombosis at 30 days, 240 days, 1, 2, 3, 4 and 5 years (Confirmed/definite, Probable, Possible)
• In-segment, proximal and distal Late Loss at 270 days
• In-stent and in-segment Angiographic Binary Restenosis rates at 270 days
• In-stent and in-segment percent Diameter Stenosis at 270 days
• Adjudicated Target Lesion Revascularization (TLR) rate at 30 days, 240 days, 1, 2, 3, 4 and 5 years (both Clinical-indicated and not clinical-indicated)
• Adjudicated Composite rate of Cardiac Death, Myocardial Infarction (MI) and Clinical-indicated Target Lesion Revascularization (CI-TLR) at 30 days, 240 days, 1, 2, 3, 4 and 5 years
• Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 30 days, 240 days, 1, 2, 3, 4 and 5 years
• SPIRIT V Registry:
• Adjudicated Stent Thrombosis at 30 days, and at 1 and 2 years (Confirmed/definite, Probable, Possible)
• Adjudicated TLR at 30 days, 1 and 2 years
• Adjudicated Composite rate of Cardiac Death, MI and CI-TLR at 30 days, 1 and 2 years*
• Adjudicated Composite rate of All Death, MI and TVR at 1 and 2 years
• * All TLR in Registry will be Clinical Ischemia-driven

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Study and the Registry. The study will be conducted in up to 150 study centers outside the United States. Approximately 3,000 patients will be enrolled in the study.

The SPIRIT V Diabetic Study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.

The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.

• Coronary Disease
• Coronary Artery Disease
• Coronary Restenosis

• Device: XIENCE V® Everolimus Eluting Coronary Stent
• Device: TAXUS™ LIBERTÉ™ Paclitaxel Eluting Coronary Stent

• Experimental: XIENCE V® Everolimus Eluting Coronary Stent System
• Active Comparator: TAXUS™ Liberté™ Paclitaxel Eluting Coronary Stent System

Inclusion Criteria:

SPIRIT V Diabetic Study:

• at least 18 years
• able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
• diagnosed with diabetes, as documented by medical history.
• evidence of myocardial ischemia
• acceptable candidate for CABG surgery
• agree to undergo all CIP-required follow-up examinations
• artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
• maximum of one, de novo, target lesion per native major epicardial vessel or side branch
• target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
• target lesion ≤ 28 mm in length by visual estimate
• target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1

SPIRIT V Registry:

• at least 18 years
• able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
• evidence of myocardial ischemia
• acceptable candidate for coronary artery bypass graft (CABG) surgery
• undergo all CIP-required follow-up examinations
• artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
• target lesions must be de novo lesions
• target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
• target lesion ≤ 28 mm in length by visual estimate

Exclusion Criteria:

SPIRIT V Diabetic Study:

• known diagnosis of AMI within 72 hours preceding the index procedure
• current unstable arrhythmias
• LVEF < 30%
• received a heart or any other organ transplant or is on a waiting list for any organ transplant
• receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
• receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
• known hypersensitivity or contraindication to specific agents
• elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
• platelet count limits, WBC limits or documented or suspected liver disease
• renal insufficiency
• history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• CVA or TIA within the past 6 months
• significant GI or urinary bleed within the past 6 months
• other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
• already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.

Angiographic Exclusion Criteria of the Diabetic Study

• target lesion meets specific criteria
• target vessel contains visible thrombus
• patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)
• patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

SPIRIT V Registry:

Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.