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

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: Recruiting
• Conditions: Coronary Stenosis
• Intervention / Treatment: Device: BIOFREEDOM™ FAMILY stent

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Duk-woo Park, MD; Phone Number: +82230104728; Email: dwpark@amc.seoul.kr
• Study Contact Backup: Name: Jung-hee Ham, Project leader; Phone Number: +82230104728; Email: cvcrc5@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Recruiting
    • Hallym University Sacred Heart Hospital
    • Contact: Kyoung-ha Park, MD
    • Principal Investigator: Kyoung-ha Park, MD
  • Cheonan, Korea, Republic of
    • Terminated
    • Soonchunhyang University Hospital, Cheonan
  • Chuncheon, Korea, Republic of
    • Withdrawn
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Withdrawn
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Withdrawn
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • Terminated
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Daejeon, Korea, Republic of
    • Withdrawn
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Young-keun Ahn, MD
    • Principal Investigator: Young-keun Ahn, MD
  • Ilsan, Korea, Republic of
    • Recruiting
    • Inje University Ilsan Paik Hospital
    • Contact: Joon-hyung Do, MD
    • Principal Investigator: Joon-hyung Do, MD
  • Incheon, Korea, Republic of
    • Recruiting
    • Gachon University Gil Hospital
    • Contact: Kyoung-hoon Lee, MD
    • Principal Investigator: Kyoung-hoon Lee, MD
  • Pusan, Korea, Republic of
    • Recruiting
    • Inje University Pusan Paik Hospital
    • Contact: Jae-sik Jang, MD
    • Principal Investigator: Jae-sik Jang, MD
  • Seongnam, Korea, Republic of
    • Withdrawn
    • Bundang CHA Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Duk-woo Park, MD
    • Principal Investigator: Duk-woo Park, MD
  • Seoul, Korea, Republic of
    • Terminated
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • Withdrawn
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Withdrawn
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Yangsan, Korea, Republic of
    • Withdrawn
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		5 year
All cause 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	Procedural success rate is defined as ≤ 50% final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization.	5 day

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2029

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 (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Drug Eluting Stent; BioFreedom
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• 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