Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen (HOST-ASSURE)

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Everolimus, Zotarolimus, Cilostazol, Clopidogrel Read More

General Inclusion Criteria

• Subject must be at least 18 years of age.
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the Promus Element or Endeavor Resolute stents, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
• Subject must have significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts.
• Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia). In subjects with diameter stenosis > 70%, evidence of myocardial ischemia does not have to be documented.

Angiographic Inclusion Criteria

• Target lesion(s) must be located in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.00 mm.
• Target lesion(s) must be amenable for percutaneous coronary intervention.

Exclusion criteria

• The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol, Everolimus, Zotarolimus, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
• Systemic (intravenous) Everolimus or Zotarolimus use within 12 months.
• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
• History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), abnormal hemogram (Hb<10g/dL or PLT count <100,000/μL) or will refuse blood transfusions
• Patients with severe LV systolic dysfunction (LVEF<25%) or cardiogenic shock
• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
• Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
• Symptomatic heart failure