Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System

Inclusion Criteria: General Inclusion Criteria

1. Patient is ≥18 years old;
2. Patient is eligible for percutaneous coronary intervention (PCI);
3. Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG)surgery;
4. Patient has clinical evidence of ischemic heart disease, stable or unstable angina,silent ischemia, or a positive functional study;
5. Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure;
6. Patient or subject's legal representative has been informed of the nature of the trialand agrees to its provisions and has provided written informed consent as approved bythe Hospital Research Ethics Committee (HREC) of the respective investigational site;and
7. Patient agrees to comply with specified follow-up evaluations and to return to thesame investigational site where the procedure was performed. Angiographic Inclusion Criteria
8. Patient has either a single target lesion, or two lesions (target and non-target)located in separate coronary arteries;
9. If a non-target lesion is treated, it must be treated first and only with commerciallyavailable PTCA balloons and/or stents. Post PCI of the non-target vessel, all of thefollowing conditions must be met:
10. Residual diameter stenosis < 30%;
11. Absence of any angiographic complications;
12. Absence of ischemic symptoms; and
13. Absence of significant new arrhythmia or ECG monitoring changes suggestive ofischemia.
14. Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;
15. Target lesion < 20 mm in length by visual estimate (the intention is to cover theentire lesion with one stent of adequate length); and
16. Target lesion stenosis ≥ 50% and < 100% by visual estimate.

Exclusion Criteria: General Exclusion Criteria

1. Patient is currently enrolled in another investigational device or drug trial that hasnot completed the primary endpoint or that clinically interferes with the currentstudy endpoints Note: Trials requiring extended follow-up for products that wereinvestigational, but have since become commercially available, are not consideredinvestigational trials;
2. The patient requires a staged procedure of the target vessel within 6-months or astaged procedure of a non-target vessel within 30-days post-procedure;
3. The target lesion requires treatment with a device other than PTCA prior to stentplacement (such as, but not limited to, directional coronary atherectomy, excimerlaser, rotational atherectomy, etc.);
4. Any DES deployment anywhere in the target vessel within the past 9-months;
5. Any BMS deployment anywhere in the target vessel within the past 6-months;
6. Any previous stent placement within 10 mm (proximal or distal) of the target lesion;
7. Myocardial infarction within 72-hours of the index procedure, with the exception of:
8. Patients who have had a STEMI and PCI to the culprit lesion may be included ifthey have a suitable lesion in another vessel, and have been clinically andhemodynamically stable for 72-hours;
9. Patients who have had a non-STEMI may be included if their troponin levels arewithin the laboratory normal range within 24-hours pre-procedure.
10. Co-morbid condition(s) that could limit the patient's ability to participate in thetrial or to comply with follow-up requirements, or impact the scientific integrity ofthe trial;
11. Concurrent medical condition with a life expectancy of less than 12-months;
12. Documented left ventricular ejection fraction (LVEF) ≤ 30%;
13. Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
14. Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate,Ticlopidine, Prasugrel, Rapamycin, Zotarolimus, PEAIII AcBz, Heparin/ Bivalirudin, orcontrast agent (that cannot be adequately premedicated);
15. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3.000 cells/mm3or hemoglobin < 100g/l;
16. Acute or chronic renal dysfunction (serum creatinine > 170μmol/L);
17. History of a stroke or transient ischemic attack (TIA) within the prior 6-months;
18. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months;
19. History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and
20. Patients requiring ongoing anticoagulation with warfarin or dabigatran. Angiographic Exclusion Criteria
21. Total occlusion (TIMI 0 or 1);
22. Target vessel has angiographic evidence of thrombus
23. Target vessel is excessively tortuous or has heavy calcification;
24. Significant (> 50%) stenosis proximal or distal to the target lesion that mightrequire revascularization or impede run off;
25. Target lesion is located in or supplied by an arterial or venous bypass graft;
26. Ostial target lesion (within 5.0 mm of vessel origin) or any location within the leftmain coronary artery;
27. Target lesion involves a side branch > 2.0 mm in diameter; and
28. Unprotected Left Main coronary disease (stenosis > 50%).