Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft

Inclusion Criteria: * Anticipated patient life expectancy of at least 1 year from enrollment. * Patient (or their legal guardian) has provided a signed informed consent. * Patient is willing to comply with the protocol requirements. * Candidate for PCI, stenting and CABG. * Total CK verified to be within hospital normal limits at the time of enrollment. * Myocardial ischemia as evidenced by one or more of the following: * Diagnosis at time of enrollment of stable or unstable angina pectoris * Reversible 12 lead ECG changes consisted with ischemia * Positive function study (e.g. stress test) * Recent myocardial infarction (\>24 hours prior to enrollment with total CK verified to be within hospital normal limits at the time of enrollment). * Lesions amendable to PCI. * Lesion(s) is located within SVG and has ≥50% and \<100% stenosis (angiographic visual assessment). * Only single SVG graft to be treated. * Vessel has thrombolysis in myocardial infarction (TIMI) grade 1 or higher flow before the passage of a guidewire. * Reference vessel diameter where the GARDEX™ system is to be placed is ≥ 3.5mm and ≤6.0mm in diameter by angiographic visual estimation. Exclusion Criteria: * A hypersensitivity or contraindication to heparin and bivalirum (Angiomax), aspirin, ticlopidine, clopidogrel, murine products, procedure equipment material, and a sensitivity to contrast dye which cannot be adequately pre-treated with diphenhydramine and/or steroids. * Myocardial infarction with documented total CK\> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction. * A stroke or transient ischemic attach (TIA) within the past 2 months. * A history of bleeding diathesis or coagulopathy. * Major gastrointestinal (GI) bleeding within 3 months of index procedure. * Baseline creatinine ≥ 2.5 mg/dl. * A planned invasive surgical procedure within 30 days. * Undergone cardiac surgery within the past 60 days. * The lesion is in a SVG that is less than 2 months post implant. * Left ventricular ejection fraction \< 20% * The lesion is an arterial conduit. * Anatomical exclusions that preclude placement of the GARDEX™ system per the Instruction for Use. * More than one SVG graft that need to be treated at the index procedure. * Chronic occlusion of the target lesion/severe calcification.