Scripps Evaluation of Antiplatelet Therapies for Intermediate Duration With the Endeavor Stent (Seaside) (SEASIDE)

Inclusion Criteria:

1. The patient is > 18 years of age.
2. The patient must be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up
3. The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
4. The patient has at least one lesion ≥50% diameter stenosis (de novo and/or restenotic, including in-stent bare metal stent restenosis) within a native coronary artery or bypass graft requiring percutaneous revascularization with stenting. (Note: Measurements may be made by careful visual estimate, on-line quantitative coronary angiography or intravascular ultrasound [IVUS].)
5. The target lesion(s) reference vessel diameter is 2.5 to 4.0 mm
6. The patient is an acceptable candidate for PTCA, stenting, and emergent coronary artery bypass grafting (CABG) surgery.
7. Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
8. The patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the enrolling clinical site.

Exclusion Criteria:

1. Planned treatment for any of the following patient and/or lesion characteristics:

   • Unprotected left main disease
   • Stage 4 chronic kidney disease, defined as creatinine clearance <30 mL/min and/or hemodialysis
   • Planned 2-stent treatment of a bifurcation lesion
   • Lesion length >30 mm
   • Lesion containing angiographic evidence of thrombus
   • Treatment of 3 vessel coronary disease
   • Severe left ventricular dysfunction (<25%)
   • In-stent restenosis of previously placed DES
2. A known hypersensitivity or contraindication to cobalt, nickel, chromium, molybdenum, polymer coatings (e.g., phosphorylcholine), or a sensitivity to contrast media, which cannot be adequately pre-medicated.
3. History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative.
4. A known hypersensitivity to clopidogrel, ticlopidine, aspirin, heparin or bivalirudin. Note: allergy to one thienopyridine type, but not another, does not constitute an exclusion.
5. A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³.
6. Evidence of recent/acute MI/acute coronary syndrome within preceding 6 months of the intended index procedure (defined as: dynamic ST-segment/T wave electrocardiographic changes and/or Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes > 2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution's upper limit of normal, or troponin level elevated above the Institution's upper limit of normal).
7. Treatment within the target vessel with any stent type within the previous 9 months
8. Prior to procedure, intended use of DES other than Endeavor stent
9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
10. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusions.
11. Concurrent medical condition with a life expectancy of less than 12 months.
12. Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
13. Currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints
14. Inability to comply with protocol required medication regimen (eg, [minimum] 6 month protocol-specified dual antiplatelet duration).