IRIS-BioFreedom Cohort in the IRIS-DES Registry

NCT ID: NCT03190057

Last Updated: 2025-09-30

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

TERMINATED

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-20

Study Completion Date

2025-09-29

Brief Summary

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The objective of this study is to evaluate effectiveness and safety of BIOFREEDOM™ FAMILY stent in the "real world" daily practice as compared with other drug-eluting stents.

Detailed Description

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BIOFREEDOM™ FAMILY stent means that Biofreedom stent, Biofreedom Ultra and the other stents with names starting with Biofreedom.

Conditions

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Coronary Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Consecutive percutaneous coronary intervention

BIOFREEDOM™ FAMILY stent

Intervention Type DEVICE

Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent

Interventions

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BIOFREEDOM™ FAMILY stent

Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 19 and more
* Patient with BIOFREEDOM™ FAMILY stent
* Written consent

Exclusion Criteria

* Intervention with BIOFREEDOM™ FAMILY stent and other drug eluting stent at the same time
* Life-expectancy less than 1 year
* Cardiac shock
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Soonchunhyang University Hospital, Cheonan

Cheonan, , South Korea

Site Status

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

Daejeon, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Inje University Pusan Paik Hospital

Pusan, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Eulji General Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMCCV2017-04

Identifier Type: -

Identifier Source: org_study_id

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