Status:
COMPLETED
Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
Lead Sponsor:
CHEOL WHAN LEE, MD, PhD.
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21-74 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 estimatio...
Eligibility Criteria
Inclusion
- 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
- History of bleeding diathesis or coagulopathy
- Pregnant state
- Known hypersensitivity or contra-indication to contrast agent and heparin
- Limited life-expectancy (less than 1 year)
- ST-elevation acute myocardial infraction requiring primary stenting
- Characteristics of lesion: left main disease, in-stent restenosis, graft vessels
- Hematological disease (Neutropenia \< 3000/mm3), Thrombocytopenia \< 100,000/mm3)
- Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3times normal
- Renal dysfunction, creatinine ≥ 2.0mg/dL
- Contraindication to aspirin, clopidogrel or cilostazol
- Contraindication to Paclitaxel or everolimus
- Left ventricular ejection fraction \< 30%
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT01515228
Start Date
January 1 2012
End Date
January 1 2015
Last Update
January 9 2015
Active Locations (9)
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1
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
2
Daegu Catholic University Medical Center
Daegu, South Korea
3
Keimyung University Dongsan Medical Center
Daegu, South Korea
4
Chungnam National University Hospital
Daejeon, South Korea