IRIS- DESyne X2 in the IRIS-DES Registry

Recruiting

• Conditions: Coronary Stenosis; Coronary Occlusion; Coronary Disease
• Interventions: Device: DESyne X2

• Registration Number: NCT03588481
• Lead Sponsor: Seung-Jung Park

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-17
• Study Start: 2018-11-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary stenosis	DESyne X2	-

Primary Outcome Measures

Name	Time	Method
Composite event rate	1year	Death, non-fatal myocardial infarction, Target Vessel Revascularization

Secondary Outcome Measures

Name	Time	Method
All death	5years
Cardiac death	5years
Myocardial infarction	5years
Composite event of death or myocardial infarction	5years
Composite event of cardiac death or myocardial infarction	5years
Target Vessel revascularization	5years
Target Lesion revascularization	5years
Stent thrombosis	5years	stent thrombosis as classified by an Academic Research Consortium
Stroke	5years
Procedural success	3days	defined as achievement of a final diameter stenosis of \<30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.

Trial Locations

Locations (6)

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, Korea, Republic of