Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation

Inclusion Criteria:

1. Males or females, aged >18 years.
2. Patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary artery.
3. Target lesion must be in a native coronary vessel of 2.25 – 4.0 mm size.
4. Target lesion has to be of less than or equal to 25 mm length.

5. Tandem lesion may be included as long as:

   • overall length is less than or equal to 25 mm
   • tandem lesion will be treated with one stent and counted as one lesion.

Exclusion Criteria:

The following exclusion criteria must not be present at Baseline visit 1 (BL1, Screening visit prior to coronary intervention). If an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study.

1. Target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter.
2. Target lesion is a total occlusion or located at a bifurcation.
3. Treatment affords implantation of more than one stent per treated lesion.
4. Target lesion was already treated by brachytherapy.

5. Target lesion has one or more of the following criteria:

   • Left main lesion
   • Ostial lesion of the RCA
   • Located at less than 2 mm after the origin of the LAD or RCX.

Other protocol defined inclusion/exclusion criteria may apply.