An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

The purpose and objective is to assess the safety and efficacy of the Resolute Integrity
Stent for the treatment of de novo lesions in native coronary arteries with a reference
vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients
receiving stents less than or equal to 30mm in length.

General and Angiographic Inclusion Criteria highlights:

- Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and
emergency coronary artery bypass graft surgery

- Clinical evidence of ischemic heart disease, stable or unstable angina, silent
ischemia and/or positive functional study

- Informed consent

- Patient agrees to comply with specified follow-up evaluations

- Single target lesion or two target lesions located in separate coronary arteries

- De novo lesion(s) in native coronary artery(ies)

- Target lesion(s) ≤ 27 mm in length

- Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm

General and Angiographic Exclusion Criteria highlights:

- Within 7 days of index procedure platelet count <100,000 cells/mm³ or >700,000
cells/mm³; White Blood Cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5
mg/dl

- Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of
Creatine Kinase-MB (CK-MB) > lab upper limit of normal)

- Previous PCI of target vessel(s) within 9 months prior to the procedure

- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of
target vessel(s) within 12 months post-index procedure

- History of stroke or Transient Ischemic Attack (TIA) within prior 6 months

- Participating in investigational drug/device study that has not completed primary
endpoint or interferes with study endpoints

- Inability to comply with required trial antiplatelet regimen

- Previous stent in target vessel unless it has been at least 9 months since stent
placed and target lesion(s) is/are at least 15 mm from previous stent

- Target vessel(s) has/have other lesions w/ > 40% diameter stenosis

- Unprotected left main coronary artery disease