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

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

To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.

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