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

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Stents, Immunosuppressive Agents, Coronary restenosis, Safety Read More

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.