IRISBioFreedom: IRIS-BioFreedom Cohort in the IRIS-DES Registry

Sponsor

Seung-Jung Park (Other)

Overall Status

Recruiting

CT.gov ID

NCT03190057

Collaborator

CardioVascular Research Foundation, Korea (Other)

1,000

Enrollment

Locations

127.4

Anticipated Duration (Months)

76.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Stenosis	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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 20, 2019

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

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

Arm

Intervention/Treatment

Consecutive percutaneous coronary intervention

Device: BIOFREEDOM™ FAMILY stent

Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
Procedural success rate is defined as ≤ 50% final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Soonchunhyang University Hospital, Cheonan	Cheonan	Korea, Republic of
2	Gangwon National Univ. Hospital	Chuncheon	Korea, Republic of
3	Daegu Catholic University Medical Center	Daegu	Korea, Republic of
4	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of
5	Chungnam National University Hospital	Daejeon	Korea, Republic of
6	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon	Korea, Republic of
7	Chonnam National University Hospital	Gwangju	Korea, Republic of
8	Inje University Pusan Paik Hospital	Pusan	Korea, Republic of
9	Bundang CHA Hospital	Seongnam	Korea, Republic of
10	Asan Medical Center	Seoul	Korea, Republic of
11	Korea University Guro Hospital	Seoul	Korea, Republic of
12	The Catholic Univ. of Korea Seoul St. Mary's hospital	Seoul	Korea, Republic of
13	Pusan National University Yangsan Hospital	Yangsan	Korea, Republic of

Sponsors and Collaborators

Seung-Jung Park
CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seung-Jung Park, Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT03190057

Other Study ID Numbers:

AMCCV2017-04

First Posted:

Jun 16, 2017

Last Update Posted:

Sep 13, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Seung-Jung Park, Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center

BioFreedom

Drug Eluting Stent

Coronary Artery Disease

Additional relevant MeSH terms:

Coronary Stenosis

Study Results

No Results Posted as of Sep 13, 2021