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

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 700,000 cells/mm3, a WBC 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 req