Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting

NCT ID: NCT00960648

Last Updated: 2010-06-29

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

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Brief Summary

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The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (EES) and to determine clinical device and procedural success during commercial use of EES in the real world.

The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Xience/Promus

Active prospective registration of patients receiving everolimus eluting stent

Xience/Promus

Intervention Type DEVICE

Active prospective registration of patients receiving everolimus-eluting stent

Cypher

Retrospective historical controls that received sirolimus-eluting stent

Cypher

Intervention Type DEVICE

Retrospective historical controls that received sirolimus-eluting stent

Interventions

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Xience/Promus

Active prospective registration of patients receiving everolimus-eluting stent

Intervention Type DEVICE

Cypher

Retrospective historical controls that received sirolimus-eluting stent

Intervention Type DEVICE

Other Intervention Names

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EES SES

Eligibility Criteria

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Inclusion Criteria

* The patient agrees to participate in this study by signing the informed consent form.
* Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Hyo-Soo Kim, MD,PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Dankook University Hospital

Cheonan, , South Korea

Site Status

Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Site Status

Kwangju Veterans Hospital

Gwangju, , South Korea

Site Status

Chonbuk National University Hospital

Iksan, , South Korea

Site Status

Wonkwang University Hospital

Iksan, , South Korea

Site Status

Inje University Ilsan Paik Hospital

Ilsan, , South Korea

Site Status

Gachon Kil Medical Center

Inchon, , South Korea

Site Status

Chungbuk National University Hospital

Jeonju, , South Korea

Site Status

Presbyterian Medical Center

Jeonju, , South Korea

Site Status

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status

Inje University Pusan Paik Hospital

Pusan, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Kyung Hee University Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Yonsei University Medical Center

Seoul, , South Korea

Site Status

St. Carollo Hospital

Suncheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EXCELLENT-REGISTRY

Identifier Type: -

Identifier Source: org_study_id

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