A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon

Exclusion Criteria

• •1. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, a clopidogrel non-responder, or sensitivity to contrast media that cannot be adequately pre-medicated or replaced with a clinically suitable alternative.
• •2. Known diagnosis of type I myocardial infarction (resulting from primary reduction of flow from a culprit lesion likely to have a thrombotic component) within 7 days prior to the index procedure.
• •3. Known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days prior to index procedure.
• •4. Planned target lesion treatment with atherectomy (rotational, orbital or laser), cutting balloon, thrombectomy, lithotripsy or an unapproved device during the index procedure.
• •5. Serum creatinine \>2.0 mg/dl within 7 days prior to the index procedure.
• •6. Cerebrovascular accident within 6 months prior to the index procedure.
• •7. Active peptic ulcer or active gastrointestinal bleeding within 6 months prior to the index procedure.
• •8. Left ventricular ejection fraction \<30% based on most recent measurement within a year of the index procedure (if LVEF is not available in the medical records, it may be obtained at the time of the index procedure, prior to enrollment).
• •9. Target lesion located within a bypass graft (venous or arterial) or graft anastomosis.
• •10. Previous percutaneous intervention, within 9 months before the study procedure, on lesions in a target vessel (including side branches) that are located within 10 mm from the current target lesion(s).
• •11. Target lesion(s) with complete total occlusion defined as the complete obstruction of a native coronary artery, exhibiting TIMI 0 or TIMI 1 flow, with an occlusion duration of at least 3 months.
• •12. Unstable hemodynamics or shock.
• •13. Other medical condition which might, in the opinion of the investigator, put the patient at risk or confound the results of the study.
• •14. Target lesion(s) longer than 32 mm by visual estimation.
• •15. Extreme angulation (90º or greater) within 5 mm of the target lesion.
• •16. Target lesion(s) demonstrating flow limiting dissection (NHLBI Grade C or higher) prior to deployment of the Lacrosse NSE ALPHA.
• •17. Unprotected left main coronary artery disease (\>50% diameter stenosis).
• •18. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
• •19. Target lesion(s) with angiographic presence of probable or definite thrombus.
• •20. Target lesion(s) involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch \>2.0 mm in diameter.
• •21. Target lesion(s) located in bifurcation beyond stent struts.
• •22. Target lesion(s) located distal to an implanted stent.
• •23. Target lesion(s) with stent damage.
• •24. Non-target lesion that meets any of the following criteria:
• •* Located within a bypass graft (venous or arterial)
• •* Located in an unprotected left main coronary artery
• •* A CTO
• •* Involves a bifurcation