Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)

Inclusion criteria

• The patient must be minimum 18 years of age;
• Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;

3 Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;

• The target lesion is >/=2.0 mm and </=2.5mm in diameter (visual estimate);

• The target lesion can be covered with a single 18mm stent;

• Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);

Exclusion criteria

• Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
• Target lesion is due to in-stent restenosis;
• Ejection fraction 30%;
• Totally occluded vessel (TIMI 0 level);
• Impaired renal function (creatinine > 3.0 mg/dL);