Evaluation of Effectiveness and Safety of XIENCE PRIME Stent (IRIS-PRIME)

NCT ID: NCT01348399

Last Updated: 2018-06-20

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

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-09-30

Brief Summary

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The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the "real world" daily practice as compared 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 effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.

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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XIENCE PRIME stents

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients receiving XIENCE PRIME stents.
* 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 presented with cardiogenic shock
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Abbott

INDUSTRY

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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Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Soonchunhyang Univ. Bucheon Hospital

Bucheon-si, , South Korea

Site Status

Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Site Status

Gangwon National Univ. 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

The Catholic University of Korea, Daejeon ST. Mary's 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

Presbyterian Medical Center

Jeonju, , South Korea

Site Status

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status

Kwangju Christian Hospital

Kwangju, , South Korea

Site Status

Inje University Pusan Paik Hospital

Pusan, , South Korea

Site Status

Pusan National University Hospital

Pusan, , South Korea

Site Status

Pusan National University Yangsan Hospital

Pusan, , South Korea

Site Status

Bundang Cha Medical Center

Seongnam, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Kyunghee University Hospital at Gangdong

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, , South Korea

Site Status

St.carollo Hospital

Suncheon, , South Korea

Site Status

The Catholic University of Korea St. Vincent's Hospital

Suwon, , South Korea

Site Status

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CVRF2011-01

Identifier Type: -

Identifier Source: org_study_id

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