Evaluating the effectiveness of the DESyne X2 coronary stent in clinical practice
Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study
This study is testing how well the DESyne X2 stent works for people with blocked arteries who are getting a heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 6 sites (Incheon and 5 other locations) |
| Trial ID | NCT03588481 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the effectiveness and safety of the DESyne X2 drug-eluting coronary stent in patients undergoing percutaneous coronary intervention (PCI) for coronary stenosis and occlusion. Participants aged 19 and older who consent to the intervention will be monitored in routine clinical settings. The study aims to gather real-world data on the performance of this stent in treating coronary disease. It will exclude patients with concurrent stent interventions or those with a life expectancy of less than one year.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who require intervention with the DESyne X2 drug-eluting coronary stent.
Not a fit: Patients with a life expectancy of one year or less or those undergoing simultaneous interventions with other drug-eluting stents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of the DESyne X2 stent, potentially improving treatment options for patients with coronary artery disease.
How similar studies have performed: Other studies evaluating drug-eluting stents in real-world settings have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Incheon and 5 other locations
- Hallym Hospital — Incheon, South Korea (Recruiting)
- Asan Medical Hospital — Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
- The Catholic University of Korea Seoul St. Mary's Hospital — Seoul, South Korea (Withdrawn)
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, South Korea (Terminated)
- St.carollo Hospital — Suncheon, South Korea (Terminated)
Study contacts
- Study coordinator: Jung-hee Ham, RN
- Email: cvcrc5@amc.seoul.kr
- Phone: 82230104728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.