IRIS-BioFreedom Cohort in the IRIS-DES Registry

Terminated

• Conditions: Coronary Stenosis

• Registration Number: NCT03190057
• Lead Sponsor: Seung-Jung Park

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-16
• Study Start: 2019-05-20
• Status Verified: 2025-09
• Primary Completion: 2025-09-29
• Study Completion: 2025-09-29
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)	1 year

Secondary Outcome Measures

Name	Time	Method
All cause death	5 year
Cardiac death	5 year
Myocardial Infarction	5 year
Composite event rate of death or myocardial infarction (MI)	5 year
Composite event rate of cardiac death or myocardial infarction (MI)	5 year
Target- Vessel Revascularization	5 year
Target- Lesion Revascularization	5 year
Stent thrombosis	5 year
Stroke	5 year
Procedural Success rate	5 day	defined as achievement of a final diameter stenosis of \<30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.

Trial Locations

Locations (8)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, South Korea

Soonchunhyang University Hospital, Cheonan; 🇰🇷 Cheonan, South Korea

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, South Korea

Chonnam National University Hospital; 🇰🇷 Gwangju, South Korea

Gachon University Gil Hospital; 🇰🇷 Incheon, South Korea

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, South Korea

Asan Medical Center; 🇰🇷 Seoul, South Korea

Eulji General Hospital; 🇰🇷 Seoul, South Korea