A Study of the Presillion Stent in de Novo Coronary Lesions

Inclusion Criteria:

• 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 7days prior to enrolment and utilize reliable birth control for trial duration.

• Diagnosis of angina pectoris as defined by Canadian Cardiovascular SocietyClassification (CCS I, II, III, IV) or unstable angina pectoris (BraunwaldClassification 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 twomajor coronary arteries.

• Target reference vessel diameter of both lesions must be >= 2.5mm and <= 4.0mm indiameter (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 thatis approved by the local Ethics Committee.

Exclusion Criteria:

• Recent myocardial infarction (either STEMI or non STEMI < 48 hours prior to plannedindex 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 successfullypredilated and/or an excessively tortuous vessel which makes it unsuitable for stentdelivery 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 oftreatment.

• 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 bypassednative coronary arteries is allowed.

• Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix ®) andticlopidine (Ticlid ®), heparin, cobalt chromium, contrast agent (that cannot bemanaged medically).

• The patient has any significant medical condition which in the investigator's opinionmay interfere with the patient's optimal participation in the study.

• The patient is currently participating in an investigational drug or device study thathas not completed the primary endpoint or that clinically interferes with the studyendpoints.

• Intervention of another lesion within 30 days prior to, or is planned or highlyprobably to be performed 30 days after the index procedure.