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Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus

NCT ID: NCT00997763

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- 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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Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)

Conditions

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Coronary Artery Disease

Keywords

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stenting, XIENCE V, CYPHER

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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XIENCE V

everolimus-eluting stent

Group Type ACTIVE_COMPARATOR

XIENCE V

Intervention Type DEVICE

everolimus-eluting stent

CYPHER

Using Cypher stent

Group Type ACTIVE_COMPARATOR

CYPHER

Intervention Type DEVICE

sirolimus-eluting stent

Interventions

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XIENCE V

everolimus-eluting stent

Intervention Type DEVICE

CYPHER

sirolimus-eluting stent

Intervention Type DEVICE

Other Intervention Names

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Xience V stent Cypher elect stent

Eligibility Criteria

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Inclusion Criteria

* Diabetic patients with angina and documented ischemia or patients with documented silent ischemia
* Patients who are eligible for intracoronary stenting
* Age \>18 years, \<75 ages
* 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

1. Left main disease
2. In-stent restenosis
3. 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Site Status

Busan Saint Mary's Hospital

Busan, , South Korea

Site Status

Soonchunhyang University Cheonan Hospital

Cheonan, , South Korea

Site Status

Cheongju Saint Mary's Hospital

Cheongju-si, , South Korea

Site Status

Kangwon University Hospital

Chuncheon, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Daejeon St Mary's Hospital Catholic University

Daejeon, , South Korea

Site Status

Asan Medical Center

Gangneung, , South Korea

Site Status

Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Kyungsang University Hospital

Jinju, , South Korea

Site Status

Inje University Pusan Paik Hospital

Pusan, , South Korea

Site Status

Pusan Natioanal University Hospital

Pusan, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Pyeongchon, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Seoul, , South Korea

Site Status

Korea Veterans Hospital

Seoul, , South Korea

Site Status

Soonchunhyang University Seoul Hospital

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2008-0220

Identifier Type: -

Identifier Source: org_study_id