A Study of the Presillion Stent in de Novo Coronary Lesions

• The patient must be >= 18 years of age.
• Patient is eligible for percutaneous coronary intervention (PCI).
• Acceptable candidate for coronary artery bypass surgery (CABG).
• Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for trial duration.
• 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.
• Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries.
• Target reference vessel diameter of both lesions must be >= 2.5mm and \<= 4.0mm in diameter (visual estimate).
• Target lesion length must be \<= 30mm and be covered by one study stent.
• Target lesion stenosis for both lesions is > 50% and \< 100% (visual estimate).
• At least TIMI I coronary flow.
• Patient is willing to comply with the specified follow-up evaluation.
• Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee.

Exclusion Criteria:

• Recent myocardial infarction (either STEMI or non STEMI \< 48 hours prior to planned index procedure).
• The patient has unstable angina classified as Braunwald A I-II-III.
• The patient has unprotected left main coronary artery disease (stenosis >50%).
• A significant (> 50%) stenosis proximal or distal to the target lesion.
• Angiographic evidence of thrombus within the target lesion.
• Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated and/or an excessively tortuous vessel which makes it unsuitable for stent delivery and deployment.
• Left ventricular ejection fraction \<= 25%.
• Totally occluded lesion (TIMI 0 level).
• The patient has impaired renal function (creatinine 3.0mg/dL) at the time of treatment.
• The patient had a Cerebrovascular Accident (CVA) within the past 6 months.
• Prior stent within 10mm of target lesion.
• The target lesion is ostial in location (within 3.0mm of vessel origin).
• The target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >= 2.0mm in diameter (or side branch requiring intervention of protection).
• The target lesion is located in a bypass graft. Note: stenting of lesions in bypassed native coronary arteries is allowed.
• Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix ®) and ticlopidine (Ticlid ®), heparin, cobalt chromium, contrast agent (that cannot be managed medically).
• The patient has any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
• The patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
• Intervention of another lesion within 30 days prior to, or is planned or highly probably to be performed 30 days after the index procedure.