DESyne in Routine Clinical Practice

Coronary Artery Disease Clinical Trial

— IRIS DESYNE  

Official title:

Evaluation of Effectiveness and Safety of DESyne in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02039713
• Other study ID #: AMCCV2014-01
• Status: Terminated
• Start date: July 2014
• Est. completion date: March 2018

Study information

• Verified date: September 2021
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate effectiveness and safety of DESyne in Routine Clinical Practice

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 342
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age 20 and more

• Intervention with DeSyne drug eluting coronary stent

• Agreed with written informed consent form

Exclusion Criteria:

• Intervention with DeSyne drug eluting coronary stent and other drug eluting stent at the same time

• Life expectancy of 1year and under

• Cardiac shock

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• DeSyne drug eluting stent group

Locations

Country	Name	City	State
Korea, Republic of	Sam Anyang Hospital	Anyang
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Cheonan
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Hallym University Chuncheon Sacred Heart Hospital	Chuncheon
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Konkuk University Chungju hospital	Chungju
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Kwangju Christian Hospital	Kwangju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	St.carollo Hospital	Suncheon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	Amg Korea Co. Ltd., 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	Death, non fatal myocardial infarction, Target Vessel Revascularization	1year
Secondary	All death		5year
Secondary	Cardiac death		5year
Secondary	Myocardial infarction		5year
Secondary	Composite event of death or myocardial infarction		5year
Secondary	Composite event of cardiac death or myocardial infarction		5year
Secondary	Target Vessel revascularization		5year
Secondary	Target Lesion revascularization		5year
Secondary	Stent thrombosis	stent thrombosis as classified by an Academic Research Consortium	5year
Secondary	Stroke		5year
Secondary	Procedural success	defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization; participants will be followed for the duration of hospital stay, an expected average of 3days.	3day