Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

NCT ID: NCT01268371

Last Updated: 2014-02-12

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-07-31

Brief Summary

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To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)

Detailed Description

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Conditions

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Coronary Artery Disease

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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Promus Element

Everolimus-eluting stent

Group Type ACTIVE_COMPARATOR

Promus Element, Boston Scientific Corporation

Intervention Type DEVICE

Everolimus-eluting stent

Nobori

Biolimus-eluting stent with biodegradable polymer

Group Type ACTIVE_COMPARATOR

Nobori, Terumo Corporation (Japan)

Intervention Type DEVICE

Biolimus-eluting stent with biodegradable polymer

Interventions

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Promus Element, Boston Scientific Corporation

Everolimus-eluting stent

Intervention Type DEVICE

Nobori, Terumo Corporation (Japan)

Biolimus-eluting stent with biodegradable polymer

Intervention Type DEVICE

Other Intervention Names

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Everolimus-eluting stent Biolimus-eluting stent with biodegradable polymer

Eligibility Criteria

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Inclusion Criteria

* Significant coronary artery stenosis (\> 50% by visual estimate)
* Stable angina, unstable angina, Non-ST elevation myocardial infarction (NSTEMI) and documented silent ischemia
* Patients eligible for intracoronary stenting
* age ≥ 20 years old

Exclusion Criteria

* ST segment elevation myocardial infarction (within 24 hours)
* Low ejection fraction (\< 25%)
* Cardiogenic shock
* History of bleeding diathesis or known coagulopathy
* Limited life-expectancy (less than 1 year) due to combined serious disease
* Contraindication to heparin, sirolimus, everolimus and biolimus
* Contraindication to aspirin and clopidogrel
* Pregnancy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jea Tahk

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung-Jea Tahk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Ajou University School of Medicine

Locations

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Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Sejong Hospital

Bucheon-si, , South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Site Status

Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Site Status

Kangwon National University Hospital

Chuncheon, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Konyang University Hospital

Daejeon, , South Korea

Site Status

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Inje University ilsan Paik Hospital

Ilsan, , South Korea

Site Status

Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Cheju Halla General Hospital

Jeju City, , South Korea

Site Status

Pusan National University Hospital

Pusan, , South Korea

Site Status

Hallym University Hankang Sacred Heart Hospital

Seoul, , South Korea

Site Status

Hallym University Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status

Kyunghee University Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul ST. Mary's Hospital

Seoul, , South Korea

Site Status

Yonsei University Gangnam Severance Hospital

Seoul, , South Korea

Site Status

St. Carollo Hospital

Suncheon, , South Korea

Site Status

Ajou University Medical Center

Suwon, , South Korea

Site Status

Catholic University ST. Vincent's Hospital

Suwon, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Yonsei University Wonju College of Medicine Wonju Christion Hospital

Wŏnju, , South Korea

Site Status

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BESS

Identifier Type: -

Identifier Source: org_study_id

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