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

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

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-07-31

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.

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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.

Conditions

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Coronary Artery Disease Diabetes

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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Endeavor Resolute stent

zotarolimus-eluting stent

Group Type EXPERIMENTAL

Endeavor Resolute stent

Intervention Type DEVICE

zotarolimus-eluting stent

Cypher stent

sirolimus-eluting stent

Group Type ACTIVE_COMPARATOR

Cypher stent

Intervention Type DEVICE

sirolimus-eluting stent

Interventions

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Endeavor Resolute stent

zotarolimus-eluting stent

Intervention Type DEVICE

Cypher stent

sirolimus-eluting stent

Intervention Type DEVICE

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No