Evaluating Genoss drug-eluting stents in high-risk coronary artery disease patients
Safety and Efficacy of Sirolimus-eluting Biodegradable Abluminal Coating Stents in Patients With a High Risk of Ischemic Events: a Single-center, Prospective, Observational Trial (GENTLE Registry)
This study is testing how well Genoss drug-eluting stents work and how safe they are for people with high-risk coronary artery disease who are having heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Yongin, Gyeonggi-do) |
| Trial ID | NCT05448625 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term effects and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease who are at high risk for ischemic events. It focuses on individuals undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) and includes those with complex medical conditions. The study will gather data on the performance of Genoss stents in this specific patient population, which has not been previously evaluated.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with coronary artery disease and high ischemic features who can provide informed consent.
Not a fit: Patients who are pregnant, have a life expectancy of less than 12 months, or have known intolerances to required medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness and safety of Genoss stents, potentially improving treatment options for high-risk coronary artery disease patients.
How similar studies have performed: While this study focuses on a specific type of stent in a high-risk population, similar studies have shown promise in evaluating drug-eluting stents in coronary artery disease, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is ≥ 19 years * Subject has signed informed consent for data release Exclusion Criteria: * Subject did not sign informed consent for data release * Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media * Pregnancy * Subject with life expectancy less than 12 months * Subject with cardiogenic shock
Where this trial is running
Yongin, Gyeonggi-do
- Yongin Severance Hospital — Yongin, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Deok-Kyu Cho, MD, PhD — Yongin Severance Hopistal
- Study coordinator: Yongcheol Kim, MD, Phd
- Email: yongcheol@yuhs.ac
- Phone: +82-031-5189-8967
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.