Evaluation of Effectiveness and Safety of the GENOUS STENT (IRIS-GENOUS STEMI)

NCT ID: NCT01348373

Last Updated: 2015-11-11

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

Total Enrollment

464 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-06-30

Brief Summary

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The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).

Detailed Description

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This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GENOUS EPC-coated stent

Patients treated with GENOUS EPC-coated stent

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* STEMI Patients requiring primary PCI.
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria

* Patients with a mixture of other DESs
* Terminal illness with life expectancy \<1 year
* Patients with cardiogenic shock
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

OrbusNeich Medical Korea Co., Ltd.

UNKNOWN

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

Asan Medical Center

Ki Bae Seung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital, Catholic University of Korea

Locations

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Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , 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 Medical Center

Daegu, , 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

National Health Insurance Corporation Ilsan Hospital

Ilsan, , South Korea

Site Status

Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Pusan National University Yangsan Hospital

Pusan, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Kangbuk Samsung Medical Center

Seoul, , South Korea

Site Status

SMA-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Wonju Christian Hospital

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CVRF2010-05

Identifier Type: -

Identifier Source: org_study_id

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