IRIS-BioFreedom Cohort in the IRIS-DES Registry (IRISBioFreedom)

September 29, 2025 updated by: Seung-Jung Park

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Anyang, South Korea
        • Hallym University Sacred Heart Hospital
      • Cheonan, South Korea
        • Soonchunhyang University Hospital, Cheonan
      • Daejeon, South Korea
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
      • Gwangju, South Korea
        • Chonnam National University Hospital
      • Incheon, South Korea
        • Gachon University Gil Hospital
      • Pusan, South Korea
        • Inje University Pusan Paik Hospital
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Eulji General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient with BIOFREEDOM™ FAMILY stent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Consecutive percutaneous coronary intervention
Device: BIOFREEDOM™ FAMILY stent
Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 5 year
5 year
All cause death
Time Frame: 5 year
5 year
Myocardial Infarction
Time Frame: 5 year
5 year
Composite event rate of death or myocardial infarction (MI)
Time Frame: 5 year
5 year
Composite event rate of cardiac death or myocardial infarction (MI)
Time Frame: 5 year
5 year
Target- Vessel Revascularization
Time Frame: 5 year
5 year
Target- Lesion Revascularization
Time Frame: 5 year
5 year
Stent thrombosis
Time Frame: 5 year
5 year
Stroke
Time Frame: 5 year
5 year
Procedural Success rate
Time Frame: 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.
5 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

September 29, 2025

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2017-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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