Evaluating 1-year Dual Antiplatelet Therapy after GENOSS® Stent Implantation in Heart Disease Patients
A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of 1 Year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-Risk Procedure
This study is testing whether a year of dual antiplatelet therapy after getting a GENOSS® stent helps heart disease patients stay healthy and avoid serious heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Genoss Co., Ltd. Industry-sponsored |
| Locations | 1 site (Wŏnju, Gangwon State) |
| Trial ID | NCT06075433 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of a one-year duration of dual antiplatelet therapy (DAPT) following the implantation of the GENOSS® drug-eluting stent (DES) in patients with coronary artery disease. The study will collect real-world clinical outcomes data from multiple centers in South Korea, focusing on patients undergoing complex higher-risk procedures. The primary endpoint will evaluate a composite of cardiac death, target vessel-related myocardial infarction, and clinically indicated target lesion revascularization at 12 months, while secondary endpoints will include all-cause death and any revascularization. This prospective, single-arm study will provide valuable insights into the long-term outcomes of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates include patients aged 19 and over with coronary artery disease who are treated with the GENOSS SES and provide informed consent.
Not a fit: Patients with cardiogenic shock, those who are pregnant, or individuals with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for patients with coronary artery disease, potentially improving their long-term health outcomes.
How similar studies have performed: While the efficacy and safety of the GENOSS DES have been previously investigated, this study aims to provide novel real-world clinical outcomes data, making it a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients of 19 and over 2. Patients with coronary artery disease treated with GENOSS SES 3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants Exclusion Criteria: 1. Patients with cardiogenic shock at the time of hospitalization 2. Patients who are pregnant or planning to become pregnant 3. Patients with a life expectancy of less than 1 year 4. Patients participating in randomized controlled trials using other medical devices 5. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)
Where this trial is running
Wŏnju, Gangwon State
- Wonju Severance Christian Hospital — Wŏnju, Gangwon State, South Korea (Recruiting)
Study contacts
- Study coordinator: YoungJin Youn
- Email: younyj@yonsei.ac.kr
- Phone: 033-741-0910
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.