Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.

Exclusion Criteria

• •1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
• •2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• •3. Subject has received an organ transplant or is on a waiting list for an organ transplant
• •4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• •5. Planned PCI (including staged procedures) or CABG after the index procedure
• •6. Subject previously treated at any time with intravascular brachytherapy in the target vessel(s)
• •7. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., Cobalt-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
• •8. Subject has one of the following (as assessed prior to the index procedure):
• •1. Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
• •2. Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
• •3. Planned procedure that may cause non-compliance with the protocol or confound data interpretation
• •9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin, or other anticoagulation therapy) for indications other than acute coronary syndrome
• •10. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
• •11. Subject has a white blood cell (WBC) count \< 3,000 cells/mm3
• •12. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
• •13. Subject is on dialysis or has baseline glomerular filtration rate (GFR) of \<30 ml/min
• •14. Subject has a history of bleeding diathesis, active peptic ulcer or gastrointestinal (GI) bleed, or coagulopathy or will refuse blood transfusions
• •15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
• •16. Subject has severe symptomatic heart failure (i.e., Left Ventricular Ejection Fraction (LVEF) \<30%))
• •17. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• •18. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
• •19. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
• •20. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
• •21. Planned treatment of a single lesion with more than 1 stent
• •22. Planned treatment of more than 3 lesions
• •23. Planned treatment of lesions in more than 2 major epicardial vessels
• •24. Planned treatment of more than 2 lesions in a single major epicardial vessel
• •25. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
• •26. Target lesion(s) is located in the left main or unprotected left
• •27. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
• •28. Target lesion(s) is located within a saphenous vein graft or an arterial graft
• •29. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
• •30. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
• •31. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• •32. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
• •33. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
• •34. Significant thrombus, present in the target vessel (by visual estimate)