Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients

Study Overview
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Brief Summary
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The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

Detailed Description
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Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 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) Endeavor Resolute stent vs. b) Cypher select. 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 Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

Conditions
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Coronary Artery Disease, Diabetes

Intervention / Treatment
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* Device: Endeavor Resolute stent
* Device: Cypher stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients with angina and documented ischemia Patients who are eligible for intracoronary stenting 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) Acute ST elevation myocardial infarction on admission 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 ≥ 3 times normal Renal dysfunction, creatinine ≥ 2.0mg/dL Contraindication to aspirin, clopidogrel or cilostazol 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).

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endeavor Resolute stent<br>zotarolimus-eluting stent | Device: Endeavor Resolute stent<br>* zotarolimus-eluting stent<br>|
| Active Comparator: Cypher stent<br>sirolimus-eluting stent | Device: Cypher stent<br>* sirolimus-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic in-segment late loss |  | 9-month angiographic follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death (all-cause and cardiac) |  | at 12 months | 
| myocardial infarction |  | at 12 months | 
| stent thrombosis |  | at 12 months | 
| target-lesion revascularization |  | at 12 months | 
| target-vessel revascularization |  | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary disease, stent