Evaluating the effectiveness of Onyx drug eluting stents in patients with coronary artery disease
Evaluation of Effectiveness and Safety of Resolute Onyx™ and Onyx Frontier™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
This study is testing whether the Onyx drug-eluting stent works better and is safer than other stents for people with coronary artery disease who are having a certain heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 33 sites (Seoul, Republic Of Korea and 32 other locations) |
| Trial ID | NCT02593994 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of the Onyx drug eluting stent compared to other drug eluting stents in patients undergoing percutaneous transluminal angioplasty. Participants aged 19 and older who consent to the intervention will be monitored for outcomes related to coronary artery disease and arterial occlusive diseases. The study will gather data from multiple medical centers in South Korea to provide insights into routine clinical practice. The focus is on real-world effectiveness rather than controlled conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who require intervention with an Onyx drug eluting stent.
Not a fit: Patients with a life expectancy of one year or less, those in cardiac shock, or those receiving multiple stent interventions simultaneously may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the relative effectiveness of Onyx stents, potentially leading to improved treatment options for patients with coronary artery disease.
How similar studies have performed: Other studies evaluating the effectiveness of drug eluting stents have shown promising results, suggesting that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 19 and more * Intervention with Onyx Drug Eluting Stent * Agreed with written informed consent form Exclusion Criteria: * Intervention with Onyx 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
Seoul, Republic Of Korea and 32 other locations
- The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul, Republic Of Korea, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Songpa-gu, Korea, Republic of (Recruiting)
- Hallym University Sacred Heart Hospital — Anyang, Korea, Republic of (Recruiting)
- Soon Chun Hyang University Hospital Bucheon — Bucheon, Korea, Republic of (Recruiting)
- Soon Chun Hyang University Hospital Cheonan — Cheonan, Korea, Republic of (Recruiting)
- Gangwon National Univ. Hospital — Chuncheon, Korea, Republic of (Recruiting)
- Daegu Catholic University Medical Center — Daegu, Korea, Republic of (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, Korea, Republic of (Recruiting)
- Chungnam National University Hospital — Daejeon, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon, Korea, Republic of (Terminated)
- Gangneung Asan Hospital — Gangneung, Korea, Republic of (Recruiting)
- Chonnam National University Hospital — Gwangju, Korea, Republic of (Recruiting)
- Inje University Ilsan Paik Hospital — Ilsan, Korea, Republic of (Recruiting)
- Gachon University Gil Hospital — Incheon, Korea, Republic of (Withdrawn)
- Inha University Hospital — Incheon, Korea, Republic of (Withdrawn)
- Presbyterian Medical Center — Jeonju, Korea, Republic of (Recruiting)
- Kwangju Christian Hospital — Kwangju, Korea, Republic of (Recruiting)
- Dong-A Medical Center — Pusan, Korea, Republic of (Recruiting)
- Inje University Pusan Paik Hospital — Pusan, Korea, Republic of (Recruiting)
- Pusan National University Hospital — Pusan, Korea, Republic of (Recruiting)
- Bundang CHA Hospital — Seongnam, Korea, Republic of (Terminated)
- Gangnam Severance Hospital — Seoul, Korea, Republic of (Recruiting)
- Hallym University Kangnam Sacred Heart Hospital — Seoul, Korea, Republic of (Recruiting)
- Kangbuk Samsung Hospital — Seoul, Korea, Republic of (Recruiting)
- Kangdong Sacred Heart Hospital — Seoul, Korea, Republic of (Recruiting)
- Korea University Anam Hospital — Seoul, Korea, Republic of (Recruiting)
- Korea University Guro Hospital — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of Korea Seoul St. Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of Korea St. Paul's Hospital — Seoul, Korea, Republic of (Terminated)
- St.carollo Hospital — Suncheon, Korea, Republic of (Recruiting)
- Ulsan University Hospital — Ulsan, Korea, Republic of (Recruiting)
- Wonju Severance Christian Hospital — Wonju, Korea, Republic of (Recruiting)
- Pusan National University Yangsan Hospital — Yangsan, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Seung-jung Park, MD, PhD
- Email: sjpark@amc.seoul.kr
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.