Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)

• All Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Target vessel revascularization (ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Target lesion revascularization (ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Stent thrombosis (by ARC definition) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Binary restenosis in both in-stent and in-segment [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Angiographic pattern of restenosis [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Procedural success [ Time Frame: At discharge from the index hospitalization, an expected average of 3 days. ] [ Designated as safety issue: No ]
  achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay
• All Death [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
• All Death [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
• All Death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Cardiac death [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
• Cardiac death [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
• Cardiac death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Myocardial infarction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
• Myocardial infarction [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
• Myocardial infarction [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Target vessel revascularization (ischemia-driven) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
• Target vessel revascularization (ischemia-driven) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
• Target vessel revascularization (ischemia-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Target lesion revascularization (ischemia-driven) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
• Target lesion revascularization (ischemia-driven) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
• Target lesion revascularization (ischemia-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Stent thrombosis (by ARC definition) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
• Stent thrombosis (by ARC definition) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
• Stent thrombosis (by ARC definition) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.

Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

• Device: Xience Prime
  everolimus-eluting stent implantation
  Other Name: everolimus-eluting stent
• Device: Cilotax stent
  paclitaxel with cilostazol dual drug eluting stent implantation
  Other Name: paclitaxel with cilostazol dual drug eluting stent

• Active Comparator: Xience Prime stent
  everolimus eluting stent
  Intervention: Device: Cilotax stent
• Experimental: Cilotax stent
  paclitaxel with cilostazol dual drug eluting stent
  Intervention: Device: Xience Prime

Inclusion Criteria:

Clinical:

• Diabetic patients with active treatment (oral agent or insulin)
• Patients with angina and documented ischemia or patients with documented silent ischemia
• Patients who are eligible for intracoronary stenting
• Age > 20 years, < 75 years

Angiographic:

• De novo lesion
• Percent diameter stenosis ≥ 50%
• Reference vessel size ≥ 2.5 mm by visual estimation

Exclusion Criteria:

1. History of bleeding diathesis or coagulopathy
2. Pregnant state
3. Known hypersensitivity or contra-indication to contrast agent and heparin
4. Limited life-expectancy (less than 1 year)
5. ST-elevation acute myocardial infraction requiring primary stenting
6. Characteristics of lesion: left main disease, in-stent restenosis, graft vessels
7. Hematological disease (Neutropenia < 3000/mm3), Thrombocytopenia < 100,000/mm3)
8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3times normal
9. Renal dysfunction, creatinine ≥ 2.0mg/dL
10. Contraindication to aspirin, clopidogrel or cilostazol
11. Contraindication to Paclitaxel or everolimus
12. Left ventricular ejection fraction < 30%
13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
14. 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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)