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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Xience Prime
* Device: Cilotax stent


Participation Criteria
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Eligibility Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xience Prime stent<br>everolimus eluting stent | Device: Cilotax stent<br>* paclitaxel with cilostazol dual drug eluting stent implantation<br>* Other names: paclitaxel with cilostazol dual drug eluting stent;|
| Experimental: Cilotax stent<br>paclitaxel with cilostazol dual drug eluting stent | Device: Xience Prime<br>* everolimus-eluting stent implantation<br>* Other names: everolimus-eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late luminal loss |  | at 9 month angiographic follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Death |  | 12 months | 
| Cardiac death |  | 12 months | 
| Myocardial infarction |  | 12 months | 
| Target vessel revascularization (ischemia-driven) |  | 12 months | 
| Target lesion revascularization (ischemia-driven) |  | 12 months | 
| Stent thrombosis (by ARC definition) |  | 12 months | 
| Binary restenosis in both in-stent and in-segment |  | at 9 month angiographic follow-up | 
| Angiographic pattern of restenosis |  | at 9 month angiographic follow-up | 
| Procedural success | 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 | At discharge from the index hospitalization, an expected average of 3 days. | 
| All Death |  | 1 month | 
| All Death |  | 4 months | 
| All Death |  | 9 months | 
| Cardiac death |  | 1 month | 
| Cardiac death |  | 4 months | 
| Cardiac death |  | 9 months | 
| Myocardial infarction |  | 1 month | 
| Myocardial infarction |  | 4 months | 
| Myocardial infarction |  | 9 months | 
| Target vessel revascularization (ischemia-driven) |  | 1 month | 
| Target vessel revascularization (ischemia-driven) |  | 4 months | 
| Target vessel revascularization (ischemia-driven) |  | 9 months | 
| Target lesion revascularization (ischemia-driven) |  | 1 month | 
| Target lesion revascularization (ischemia-driven) |  | 4 months | 
| Target lesion revascularization (ischemia-driven) |  | 9 months | 
| Stent thrombosis (by ARC definition) |  | 1 month | 
| Stent thrombosis (by ARC definition) |  | 4 months | 
| Stent thrombosis (by ARC definition) |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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requiring drug eluting stents