Safety and Efficacy Study of Kaname Coronary Stent System for the Treatment of Patients With Coronary Artery Disease

Exclusion Criteria

• •Most recent LVEF of the patient is \< 25%.
• •Known allergies to the following: aspirin, Clopidogrel bisulfate, Prasugrel or Ticlopidine, heparin, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated).
• •A platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
• •WBC count \< 3500 cells/mm3.
• •Evidence of MI with positive Troponin within 72 hours of the intended treatment.
• •Previous PCI (\<30 days) anywhere within the target vessel.
• •Planned interventional treatment of any non-target vessel \<30 days post-procedure will be required. Planned intervention on the target vessel or on a significant lesion of \> 50% stenosis anywhere within the target vessel after the index procedure will be required.
• •The target lesion requires treatment with a device other than PTCA balloon prior to stent placement. (e.g. but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
• •Previous stenting anywhere within the target vessel.
• •Target vessel has evidence of thrombus.
• •Excessive tortuousity (\> 60°) of the target vessel proximal to the target lesion (visual estimate).
• •Either of the following characteristics in the target lesion (visual estimate): a)Ostial target lesion or bifurcation lesion b)Target lesion involves a side branch \> 2mm in diameter c) Target lesion has excessive tortuousity (\> 45°)d)Moderate to severely calcified lesion which can not be successfully predilated e)Target lesion is located in or supplied by an arterial or venous bypass graft f)Significant (\> 40%) stenosis proximal or distal to the target lesion. g) A complete occlusion (TIMI flow 0 or 1).
• •Target lesion located in left main trunk.
• •Stroke or transient ischemic attack \< prior 180 days.
• •Active peptic ulcer or upper GI bleeding \< prior 180 days.
• •The patient has bleeding hemorrhagic diathesis or coagulopathy. The patient will refuse a blood transfusion.
• •The patient has a widespread peripheral vascular disease.
• •Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl).
• •The patient requires multiple stent implantations for a tandem lesion.
• •Life expectancy \< 1 year.
• •Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials.
• •In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
• •Patient is in cardiogenic shock.
• •Female of child-bearing potential.