OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study

This is a prospective, open, non-randomized, study involving two (2) centers in the United
States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented,
treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus
release from the Svelte DES.

Inclusion Criteria:

- Subject is an eligible candidate for PCI

- Subject has symptomatic coronary artery disease with objective evidence of ischemia or
silent ischemia

- Subject is an acceptable candidate for CABG

- Subject has ≤ 3 de novo target lesions in ≤ 2 native coronary artery vessels, with ≤ 2
lesions in a single vessel, each meeting the angiographic criteria and none of the
exclusion criteria

- Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤
4.00mm

Exclusion Criteria:

- Subject has cardiogenic shock, hemodynamic instability requiring inotropic or
mechanical circulatory support, intractable ventricular arrhythmia, or ongoing
intractable angina

- Subject's target lesion(s) is located in the left main coronary artery

- Subject's target lesion(s) is located within 3mm of the origin of the LAD or LCX
coronary artery

- Subject's target lesion(s) is located within a SVG or an arterial graft

- Subject's target lesion(s) will be accessed via SVG or arterial graft