IRIS- DESyne X2 in the IRIS-DES Registry

Coronary Disease Clinical Trial

— IRIS DESyne X2  

Official title:

Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588481
• Other study ID #: AMCCV2018-09
• Status: Recruiting
• Start date: November 28, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Jung-hee Ham, RN
• Phone: 82230104728
• Email: cvcrc5[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2028
• 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

• Intervention with DeSyne X2 drug-eluting coronary stent

• Agreed with written informed consent form

Exclusion Criteria:

• Intervention with DeSyne X2 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

• Coronary Disease
• Coronary Occlusion
• Coronary Stenosis

Intervention

Device:
• DESyne X2
Novolimus-eluting stent

Locations

Country	Name	City	State
Korea, Republic of	Hallym Hospital	Incheon
Korea, Republic of	Asan Medical Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul
Korea, Republic of	St.carollo Hospital	Suncheon

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	Death, non-fatal myocardial infarction, Target Vessel Revascularization	1year
Secondary	All death		5years
Secondary	Cardiac death		5years
Secondary	Myocardial infarction		5years
Secondary	Composite event of death or myocardial infarction		5years
Secondary	Composite event of cardiac death or myocardial infarction		5years
Secondary	Target Vessel revascularization		5years
Secondary	Target Lesion revascularization		5years
Secondary	Stent thrombosis	stent thrombosis as classified by an Academic Research Consortium	5years
Secondary	Stroke		5years
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.	3days