• Primary Endpoint: In-segment Late Loss (LL) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
  

• Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
  
• Target Vessel Failure (TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  
• Target Vessel Failure (TVF) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  
• Target Vessel Failure (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  
• Target Vessel Failure (TVF) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  
• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  
• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 270 days ] [ Designated as safety issue: No ]
  
• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 1 years ] [ Designated as safety issue: No ]
  
• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  
• Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  
• Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
  
• Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  
• Ischemia Drive Target Vessel Revascularization (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  
• Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  
• Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  
• Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
  
• Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  
• Ischemia Driven Major Adverse Cardiac Event(MACE) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  
• In-stent % Angiographic Binary Restenosis (% ABR) Rate [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
  
• In-segment % Angiographic Binary Restenosis (% ABR) Rate [ Time Frame: 240 days ] [ Designated as safety issue: No ]
  
• Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
  
• Acute Success: Clinical Device [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  
• Acute Success: Clinical Procedure [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
  
• Proximal Late Loss [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
  
• Distal Late Loss [ Time Frame: 240 days ] [ Designated as safety issue: No ]
  
• In-stent Late Loss [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
  
• % Volume Obstruction (% VO) [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
  
• In-stent % Diameter Stenosis (% DS) [ Time Frame: at 240 days ] [ Designated as safety issue: No ]
  
• In-segment % Diameter Stenosis (% DS) [ Time Frame: 240 days ] [ Designated as safety issue: No ]
  

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.