Study Stopped
Funding issue
IRIS-BioFreedom Cohort in the IRIS-DES Registry
IRISBioFreedom
Evaluation of Effectiveness and Safety of BIOFREEDOM™ FAMILY Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
1 other identifier
observational
218
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedStudy Start
First participant enrolled
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2025
CompletedSeptember 30, 2025
September 1, 2025
6.4 years
June 13, 2017
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
1 year
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (1)
Consecutive percutaneous coronary intervention
Interventions
Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent
Eligibility Criteria
Patient with BIOFREEDOM™ FAMILY stent
You may qualify if:
- Age 19 and more
- Patient with BIOFREEDOM™ FAMILY stent
- Written consent
You may not qualify if:
- Intervention with BIOFREEDOM™ FAMILY stent and other drug eluting stent at the same time
- Life-expectancy less than 1 year
- Cardiac shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 16, 2017
Study Start
May 20, 2019
Primary Completion
September 29, 2025
Study Completion
September 29, 2025
Last Updated
September 30, 2025
Record last verified: 2025-09