Evaluation of a new biodegradable polymer coronary stent for heart disease
Comparison Between Abluminal Biodegradable Polymer Ultrathin Sirolimus-eluting Stent and Durable-polymer Everolimus-eluting Stent (GENOSS Randomized Clinical Trial)
This study is testing a new type of heart stent made from biodegradable material to see if it works better and is safer for people with coronary artery disease compared to a traditional stent.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05444452 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of the Genoss biodegradable polymer ultrathin sirolimus-eluting stent compared to the durable-polymer everolimus-eluting Xience stent in patients with coronary artery disease. The study aims to address the risks of ischemic events associated with traditional drug-eluting stents by utilizing a newer generation stent designed to reduce inflammation and improve re-endothelialization. Participants will undergo stent implantation and be monitored for outcomes related to device-related failure and target lesion failure. The trial includes patients with stable coronary artery disease or acute coronary syndrome who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with stable coronary artery disease or acute coronary syndrome and significant stenosis suitable for stent implantation.
Not a fit: Patients with known intolerance to the medications used in the stents or with life expectancy less than one year due to non-cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing stent implantation for coronary artery disease.
How similar studies have performed: Previous studies have shown that second-generation drug-eluting stents, particularly those with biodegradable polymers, can provide better ischemic outcomes compared to first-generation stents.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ① Subject must be at least 19 years of age ② Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. ③ Patients with stable coronary artery disease or acute coronary syndrome and at least one lesion with greater than 50% diameter stenosis suitable for stent implantation Exclusion Criteria: * Pregnant women ② Patients unable to provide consent, ③ Patients with known intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, heparin or components of drug-eluting stents (sirolimus or everolimus) * Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Where this trial is running
Seoul
- Cardiac and Vascular Center; Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Hyeon-Cheol Hyeon-Cheol, MD, PhD — Samsung Medical Center
- Study coordinator: Hyeon-Cheol Gwon, MD, PhD
- Email: hcgwon@naver.com
- Phone: 82-2-3410-3694
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.