The IRIS-Resolute Integrity (IRIS-Integrity)

NCT ID: NCT01392846

Last Updated: 2021-09-13

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

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2020-03-02

Brief Summary

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This is a prospective, observational, cohort study to evaluate the relative efficacy and safety of Resolute Integrity stent compared to other (drug eluting stents) DES.

Detailed Description

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Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.

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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Resolute Integrity

Patients receiving Resolute-Integrity stent

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with significant coronary artery disease and receiving Resolute Integrity stent.
* 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

Medtronic

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

Locations

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Inje University Ilsan Paik Hospital

Ilsan, Gyeonggi-do, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Site Status

The Catholic University of Korea, Bucheon ST.Mary's Hospital

Bucheon-si, , South Korea

Site Status

Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Yeungnam University Medical Center

Daegu, , South Korea

Site Status

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

Daejeon, , South Korea

Site Status

Gang Neung 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

Presbyterian Medical Center

Jeonju, , South Korea

Site Status

Kwangju Christian Hospital

Kwangju, , South Korea

Site Status

Pusan National University Yangsan Hospital

Pusan, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

St.carollo Hospital

Suncheon, , 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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CVRF2011-07

Identifier Type: -

Identifier Source: org_study_id

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