Actively Recruiting
Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Led by Seung-Jung Park · Updated on 2026-01-02
1000
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Seung-Jung Park
Lead Sponsor
C
CardioVascular Research Foundation, Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of the DESyne X2, a Novolimus-eluting coronary stent, in routine clinical practice. This observational study focuses on patients with coronary stenosis, occlusion, or coronary disease who receive this device. The study is led by Seung-Jung Park and aims to observe real-world outcomes for patients treated with this stent. Participants receive the DESyne X2 stent as part of their usual care. The study observes patients who have undergone intervention with this drug-eluting stent, without additional treatments being assigned or altered by the study. The study collects information over a period extending up to five years to monitor various clinical events. During the study, participants will be followed to assess outcomes such as composite event rates at one year, and several important heart-related events including death, myocardial infarction, stent thrombosis, and stroke over five years. Procedural success is also evaluated shortly after intervention. The study lasts for several years, allowing researchers to gather long-term safety and effectiveness data in a real-world setting.
CONDITIONS
Brief Title
IRIS- DESyne X2 in the IRIS-DES Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 and more
- Intervention with DeSyne X2 drug-eluting coronary stent
- Agreed with written informed consent form
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants receive the DESyne X2 drug-eluting coronary stent as part of routine clinical practice.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored for safety and effectiveness outcomes over several years following stent implementation.
Follow-up visits over 5 years
Trial Site Locations
Total: 6 locations
1
Hallym Hospital
Incheon, South Korea
Actively Recruiting
2
Asan Medical Hospital
Seoul, South Korea
Actively Recruiting
3
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
4
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Withdrawn
5
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea
Terminated
6
St.carollo Hospital
Suncheon, South Korea
Terminated
Research Team
J
Jung-hee Ham, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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