XIENCE 28 USA Study

Inclusion Criteria

• Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:
• ≥ 75 years of age.
• Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy
• History of major bleeding which required medical attention within 12 months of the index procedure.
• History of stroke (ischemic or hemorrhagic).
• Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
• Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count 2 lesions requiring treatment within both the LAD and a diagonal branch in total.
• If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
• Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
• Exclusive use of XIENCE family of stent systems during the index procedure.
• Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion Criteria

• Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
• Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
• Subject has a known left ventricular ejection fraction (LVEF) <30%.
• Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
• Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
• Subject with a current medical condition with a life expectancy of less than 12 months.
• Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure. Transferring to the XIENCE 90 study will not be an exclusion criterion.
• 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.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Angiographic Exclusion Criteria

• Target lesion is in a left main location.
• Target lesion is located within an arterial or saphenous vein graft.
• Target lesion is restenotic from a previous stent implantation.
• Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
• Target lesion is implanted with overlapping stents, whether planned or for bailout.