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IRIS-BioFreedom Cohort in the IRIS-DES Registry

NCT03190057 — Terminated, 218 participants, Seung-Jung Park

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Evaluation of Effectiveness and Safety of BIOFREEDOM™ FAMILY Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

RegistryNCT03190057, acronym IRISBioFreedom
StatusTerminated - Funding issue
Study typeObservational
Enrollment218 (Actual)
SponsorSeung-Jung Park (Other); collaborators: CardioVascular Research Foundation, Korea
ConditionsCoronary Stenosis
InterventionsBIOFREEDOM™ FAMILY stent (Device)
Datesstart 2019-05-20, primary completion 2025-09-29, completion 2025-09-29, first posted 2017-06-16, last updated 2025-09-30
Locations8 sites in South Korea

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-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.

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+Detailed description

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

+Arms and interventions

ArmTypeInterventionsDescription
Consecutive percutaneous coronary interventionDevice: BIOFREEDOM™ FAMILY stent
  • BIOFREEDOM™ FAMILY stent (Device): Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent

+Outcome measures

Primary outcomes

  • Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) [1 year]

Secondary outcomes

  • 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.

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (8)

FacilityCityCountryStatus
Hallym University Sacred Heart HospitalAnyangSouth Korea
Soonchunhyang University Hospital, CheonanCheonanSouth Korea
The Catholic University of Korea, Daejeon ST. Mary's HospitalDaejeonSouth Korea
Chonnam National University HospitalGwangjuSouth Korea
Gachon University Gil HospitalIncheonSouth Korea
Inje University Pusan Paik HospitalPusanSouth Korea
Asan Medical CenterSeoulSouth Korea
Eulji General HospitalSeoulSouth Korea

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