First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease

Inclusion Criteria: 1. Male/female patients 18-85 years; 2. Stable or unstable angina pectoris, ischemia, or silent ischemia; 3. Planned single, de novo, types A, B1 and B2 coronary lesions; 4. Target lesion located in a native coronary artery; 5. Target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm long stent; 6. Target lesion \>50% diameter stenosis; 7. Patients eligible for percutaneous coronary intervention (PCI); 8. Acceptable candidate for myocardial revascularization surgery; 9. A patient may have one additional critical non-target lesion. 10. The patient will provide written informed consent. Exclusion Criteria: 1. Female of childbearing potential not on some form of birth control with a confirmed negative pregnancy test at baseline; 2. Recent Q-wave myocardial infarction occurred \<72 hours prior to the index procedure. Recent myocardial infarction with elevated levels of cardiac markers; 3. Left ventricular ejection fraction \<30%; 4. Patients in cardiogenic shock; 5. Cerebrovascular accident or transient ischemic attack within 6 months; 6. Active GI bleed within three months; 7. Any prior true anaphylactic reaction to contrast agents; 8. Patient receiving/scheduled to receive chemotherapy within 30-days before or after the index procedure; 9. Patient is receiving immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease; 10. Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L); 11. Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; 12. White blood cell count \<3,000 cells/mm3; 13. Hepatic disease; 14. Heart transplant recipient; 15. Known contraindication to dual antiplatelet therapy; 16. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin, and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient); 17. Life expectancy \<12 months; 18. Any major medical condition that may interfere with the optimal participation of the patient in this study; 19. Patient is currently participating/planning to participate in an investigational drug or another device study prior to completing 12-months follow-up; 20. Target vessel(s) has been treated within 10 mm proximal or distal to target lesion with any type of PCI within a year prior to index procedure; 21. 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; 22. Previous coronary intravascular brachytherapy; 23. Planned coronary angioplasty or coronary artery bypass grafting (CABG)in the first 9 months after the index procedure; 24. Prior PCI of a non-target vessel must be at least 30 days prior to study enrollment; 25. The intent to direct stent the target lesion; 26. Angiographic Exclusion Criteria: Assessed prior to stent placement; * 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; * Target lesion not amenable to treatment with a 23 mm long stent; * Unprotected coronary artery branch lesion (≥50% DS); * Target lesion located in a surgical bypass graft; * Total vessel occlusion; * Target lesion with ostial location; * Target lesion located in a lateral branch bifurcation \>2.5mm or requiring lateral branch stenting; * Calcified target lesion that anticipates unsuccessful/impracticable predilation; * Target vessel excessive tortuosity or proximal angulation (\>90 degrees); * 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: * Within the target vessel; * Within a bypass graft; * Left main location; * Chronic total occlusion; * Involves a complex bifurcation.