SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System

Inclusion Criteria

1. Patient must be at least 18 years of age.

2. Patient is able to verbally acknowledge an understanding of the associated risks,benefits and treatment alternatives of receiving the XIENCE™ V Everolimus ElutingCoronary Stent System and his or her legally authorized representative provideswritten informed consent prior to the stent procedure, as approved by the appropriateEthics Committee.

3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,silent ischemia, positive functional study).

4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG)surgery.

5. Patient must agree to undergo all protocol-required follow-up examinations includingangiographic and IVUS follow-up at two time points (180 days and 1 year ).

6. Female patients of childbearing potential must have had a negative pregnancy testwithin 7 days before treatment, and must not be nursing at the time of treatment.

7. Female patients of childbearing potential must also agree at time of consent to usebirth control up to and including the second angiographic follow-up at 1 year. Inclusion Criteria: Angiographic

8. Planned single, de novo, type A - B1, native coronary artery lesion treatment.

9. Target lesion must be located in a native vessel with a diameter of 3.0 mm assessed byQCA on-line.

10. Target lesion length ≤ 12 mm, assessed by QCA on-line.

11. The target lesion must be in a major artery or branch with a stenosis of ≥ 50% and < 100% assessed by QCA on-line and with a TIMI flow of ≥ 1. Exclusion Criteria

12. Patient has had a known acute myocardial infarction (greater than two times the upperlimit of normal CK with presence of CK-MB) within 3 days preceding the index procedureand CK has not returned to normal limits at the time of the procedure.

13. Patient has current or a history of unstable arrhythmias, regardless of whethercardiac rhythm management devices are used (e.g., pacemaker, Automatic ImplantableCardioverter Defibrillator).

14. Patient has a known left ventricular ejection fraction ≥ 30%.

15. Patient has received a heart transplant or any other organ transplant or is on awaiting list for any organ transplant.

16. Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.

17. Patient is receiving immunosuppression therapy or has known immunosuppressive disease.

18. Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).

19. Patient has a known hypersensitivity or contraindication to aspirin, heparin,clopidogrel, cobalt, chromium, nickel, tungsten, everolimus, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated.

20. Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000cells/mm3, or documented or suspected liver disease (including laboratory evidence ofhepatitis).

21. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5mg/dL, patient on dialysis).

22. Patient has a history of bleeding diathesis or coagulopathy or will refuse bloodtransfusions.

23. Patient has had a cerebrovascular accident (CVA) or stroke or transient ischemicneurological attack (TIA) within the past six months.

24. Patient has had a significant GI or urinary bleed within the past six months.

25. Patient has extensive peripheral vascular disease that precludes safe 6 French sheathinsertion or extreme anticoagulation.

26. Patient has other medical illness (e.g., cancer or congestive heart failure) or recenthistory of substance abuse that may cause non-compliance with the protocol, confoundthe data interpretation or is associated with a limited life expectancy (i.e., lessthan one year).

27. Patient is already participating in another investigational use device or drug studyor has completed the follow-up phase of another trial within the last 30 days.

28. Patient has received a drug eluting stent within the last 1 year.

Exclusion Criteria: Angiographic

1. The target lesion meets any of the following criteria:

2. Aorto-ostial location

3. Unprotected left main location

4. Located within 2 mm of the origin of the LAD or LCX

5. Located within or distal to an arterial or saphenous vein graft

6. Located within 2 mm of a bifurcation

7. Located distal to a previously implanted stent (same major epicardial vessel)

8. Located in a major epicardial vessel that has been previously treated withbrachytherapy

9. Located in a major epicardial vessel that has been previously treated with anytype of PCI (e.g., POBA, stent, cutting balloon, atherectomy), except if previoustreatment occurred in a side branch distal to target lesion at least 180 dayspreceding the index procedure

10. Involves jailing of side branches > 2.0 mm in diameter

11. Total occlusion (TIMI flow 0)

12. Excessive tortuosity proximal to or within the lesion

13. Extreme angulation (≥ 90%) proximal to or within the lesion

14. Moderate to heavy calcification

15. Restenotic from previous intervention

16. The target vessel contains thrombus.

17. Another significant lesion (≥ 40 %DS) is located in the same major epicardial vesselas the target lesion.

18. Patient has a high probability that a procedure other than pre-dilatation and stentingwill be required for treatment of the target vessel (e.g. atherectomy, cuttingballoon).

19. Patient has additional lesion(s) for which an intervention within 180 days (prior toor after) of the index procedure would be required or has been performed.