IRIS-BioFreedom Cohort in the IRIS-DES Registry

Coronary Stenosis Clinical Trial

— IRISBioFreedom  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03190057
• Other study ID #: AMCCV2017-04
• Status: Recruiting
• Start date: May 20, 2019
• Est. completion date: December 31, 2029

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Duk-woo Park, MD
• Phone: +82230104728
• Email: dwpark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• BIOFREEDOM™ FAMILY stent
Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Soonchunhyang University Hospital, Cheonan	Cheonan
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Eulji General Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)		1 year
Secondary	All cause death		5 year
Secondary	Cardiac death		5 year
Secondary	Myocardial Infarction		5 year
Secondary	Composite event rate of death or myocardial infarction (MI)		5 year
Secondary	Composite event rate of cardiac death or myocardial infarction (MI)		5 year
Secondary	Target- Vessel Revascularization		5 year
Secondary	Target- Lesion Revascularization		5 year
Secondary	Stent thrombosis		5 year
Secondary	Stroke		5 year
Secondary	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