Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)

NCT ID: NCT01078038

Last Updated: 2012-08-08

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

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-08-31

Brief Summary

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This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus versus everolimus-eluting stent implantation for long coronary lesions.

Detailed Description

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Following angiography, patients with significant diameter stenosis \>50% and lesion length (\> 25mm) requiring single or multiple long-stent placement (total stent length \>28mm) by visual estimation and eligible for LONG-DES III trial inclusion and exclusion criteria will be randomized 1:1 to a) sirolimus-eluting and b) everolimus-eluting stent by the stratified randomization method.

Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Disease Stent

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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Cypher

Sirolimus-eluting stent

Group Type ACTIVE_COMPARATOR

Cypher

Intervention Type DEVICE

Sirolimus-eluting stent implantation

Xience V

Everolimus-eluting stent

Group Type ACTIVE_COMPARATOR

Xience V

Intervention Type DEVICE

Everolimus-eluting Stent implantation

Interventions

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Cypher

Sirolimus-eluting stent implantation

Intervention Type DEVICE

Xience V

Everolimus-eluting Stent implantation

Intervention Type DEVICE

Other Intervention Names

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Sirolimus-eluting stent Everolimus-eluting Stent

Eligibility Criteria

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Inclusion Criteria

* The patient must be at least 18 years of age.
* Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (\>=28mm)
* Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria

* Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
* Acute ST-segment-elevation MI or cardiogenic shock
* Terminal illness with life expectancy \<1 year
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
* In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted)
* Patients with EF\<30%.
* Serum creatinine level \>=3.0mg/dL or dependence on dialysis.
* Patients with left main stem stenosis (\>50% by visual estimate).
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, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Locations

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Sam Anyang Hospital

Anyang, , South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Site Status

Busan Paik Hospital

Busan, , South Korea

Site Status

St.Mary's Catholic Medical Center

Busan, , South Korea

Site Status

Soonchunhyang University Cheonan Hospital

Cheonan, , South Korea

Site Status

St.Mary's Catholic Medical Center

Cheongju-si, , South Korea

Site Status

Gangwon National University Hospital

Chuncheon, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Asan Medical Center

Gangneung, , South Korea

Site Status

Gwangju Christian Hospital

Gwangju, , South Korea

Site Status

Dongguk University Hospital

Gyongju, , South Korea

Site Status

St.Mary's Catholic Medical Center

Inchon, , South Korea

Site Status

Jeju Hanla Hospital

Jeju City, , South Korea

Site Status

Gyeongsang Uniservity Hospital

Jinju, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Hangang Sacred Heart Hospital

Seoul, , South Korea

Site Status

Seoul Veterans Hospital

Seoul, , South Korea

Site Status

St.Mary's Catholic Medical Center

Seoul, , South Korea

Site Status

Ajou University Hospital

Suwon, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

References

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Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Seung KB, Yang TH, Lee SG, Lee JH, Seong IW, Cheong SS, Lee BK, Lee NH, Lee SW, Lee SW, Lee K, Kim HS, Jeon DS, Kim MK, Nah DY, Tahk SJ, Park SJ. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial. JACC Cardiovasc Interv. 2011 Oct;4(10):1096-103. doi: 10.1016/j.jcin.2011.05.024.

Reference Type DERIVED
PMID: 22017935 (View on PubMed)

Other Identifiers

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2008-0250

Identifier Type: -

Identifier Source: org_study_id