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

Inclusion criteria

• Patient is ≥18 years old;
• 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;
• Single de novo lesion with ≥50% and <90% stenosis in 1 coronary artery;

Exclusion criteria

• Documented left ventricular ejection fraction (LVEF) ≤30%;
• Unstable angina pectoris(Braunwald Class A I-III)
• Three-vessel coronary artery disease
• Evidence of myocardial infarction within 72 hours prior to the index procedure;
• 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)
• A platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/mm3;
• Acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or >150µmol/L);
• Total occlusion (TIMI 0 or 1);
• Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment;
• Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
• Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
• Target lesion is located in or supplied by an arterial or venous bypass graft;
• Ostial target lesion (within 5.0mm of vessel origin);
• Target lesion involves a side branch >2.0mm in diameter;
• Unprotected Left main coronary artery disease (stenosis >50%);