Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease

Inclusion Criteria: 1. Age ≥18 and ≤85 years; 2. Stable/unstable angina pectoris (Class I-IV), documented ischemia/silent ischemia; 3. Planned single, de novo, types A, B1 or B2 coronary lesions; 4. Target lesion located in a native coronary artery; 5. Target lesion in vessel ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a 30 mm long stent; 6. Target lesion with \>50% diameter stenosis; 7. Recent Q-wave (\>72 hours) or non-Q-wave myocardial infarction; 8. Patients eligible for PCI; 9. Candidate for CABG ; 10. A patient may have one additional critical non-target lesion. 11. Patient capable of providing informed consent and is willing to comply with all study requirements. Exclusion Criteria: 1. Female patients of childbearing potential who do not have a confirmed negative pregnancy test at baseline and are not on some form of birth control; 2. Recent Q-wave MI \< 72 hours prior to the index procedure. 3. Recent Q- or non-Q-wave MI with still elevated levels of cardiac markers (e.g. CK; and CK-MB if the CK is elevated); 4. LVEF \<30% (within the previous 6-months); 5. Patients in cardiogenic shock; 6. CVA or TIA within the past 6 months; 7. Active GI bleeding within past 3 months; 8. Any prior anaphylactic reaction to contrast agents; 9. Chemotherapy within 30-days before or after the index procedure; 10. Receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease; 11. Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L); 12. Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; 13. White blood cell count \<3,000 cells/mm3; 14. Hepatic disease; 15. Heart transplant recipient; 16. Known contraindication to DAPT; 17. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin and Angiomax (bivalirudin), and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient); 18. Life expectancy less than 12 months; 19. Any major medical condition that may interfere with participation in this study; 20. Patient is currently participating in an investigational drug or another device study and has not completed the follow-up to the primary endpoint, or the patient is planning on participating prior to completing 12-months follow-up; 21. Target vessel has been treated within 10 mm proximal or distal to target lesion with any type of PCI or within a year prior to index procedure; 22. Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter prior to stent placement; 23. Patient previously treated at any time with brachytherapy; 24. Planned coronary angioplasty or CABG in the first 9 months after the index procedure or any other planned intervention within 30-days post index procedure; 25. Prior PCI of a non-target vessel must be at least 14 days prior to study enrollment; 26. The intent to direct stent the target lesion; 27. Angiographic Exclusion Criteria: * In-stent restenotic target lesion; * In-stent restenotic target lesion; * More than one lesion requiring treatment in the target vessel); * Target vessel diameter \<2.5 mm or \>3.5 mm; * Long target lesion not amenable to treatment with up to a 30 mm long stent; * Left main critical disease (≥50% DS); * Target lesion is located in a surgical bypass graft; * Total target vessel occlusion (TIMI flow grade 0-1); * Target lesion ostial location; * Target lesion at bifurcation involving side branch \>2.5 mm or lateral branch that also requires stenting; * Calcified target lesion that anticipates unsuccessful/impracticable predilation; * Target vessel with excessive tortuosity or proximal angulation; * Thrombus present in target vessel; * More than one non-target critical lesion; * Non-target lesion to be treated during the index procedure meets any of the following criteria: 1. Located within the target vessel; 2. Located within a bypass graft ; 3. Left main location; 4. Chronic total occlusion 5. Involves a complex bifurcation.