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

Exclusion Criteria

• •Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
• •The subject is currently experiencing clinical symptoms consistent with AMI
• •Subject has current unstable arrhythmias
• •Subject has a known left ventricular ejection fraction (LVEF) \< 30%
• •Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
• •Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
• •Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)
• •Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
• •Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
• •Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure
• •Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• •Subject has known renal insufficiency (e.g., serum creatinine level 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)
• •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 requiring PCI during the index procedure
• •Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure