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

Launched by CHEOL WHAN LEE, MD, PHD. · Jan 23, 2012

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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)