First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions

Inclusion Criteria: 1. Patient is ≥18 years old; 2. Clinical evidence of ischemic heart disease and / or a positive functional study. Documented stable angina pectoris (Canadian cardiovascular society classification (CCS) 1, 2, 3 or 4 ), or documented silent ischemia; 3. Single de novo lesion with ≥50% and \<90% stenosis in 1 coronary artery; Exclusion Criteria: 1. Documented left ventricular ejection fraction (LVEF) ≤30%; 2. Unstable angina pectoris(Braunwald Class A I-III) 3. Three-vessel coronary artery disease 4. Evidence of myocardial infarction within 72 hours prior to the index procedure; 5. Known allergies to the following: Acetylsalicylic acid (ASA) (Aspirin®), Clopidogrel bisulfate (Plavix®.) or Ticlopidine (Ticlid®.), Heparin, contrast agent (that cannot be adequately premedicated), cobalt-chromium (CoCr), Poly-L-Lactidic Acid (PLLA), silicon carbide (aSiC:H) 6. A platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC \<3.000 cells/mm3; 7. Acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or \>150µmol/L); 8. Total occlusion (TIMI 0 or 1); 9. Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment; 10. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off; 11. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated; 12. Target lesion is located in or supplied by an arterial or venous bypass graft; 13. Ostial target lesion (within 5.0mm of vessel origin); 14. Target lesion involves a side branch \>2.0mm in diameter; 15. Unprotected Left main coronary artery disease (stenosis \>50%);