Evaluating short-term dual antiplatelet therapy after a specific heart stent implantation
A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease
This study is testing whether a short period of dual antiplatelet therapy after getting a specific heart stent can keep patients with coronary artery disease safe and healthy over a year.
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 | NCT06075420 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of a short duration of dual antiplatelet therapy (DAPT) following the implantation of the GENOSS® drug-eluting stent in patients with coronary artery disease. The study will collect real-world clinical outcomes data from six sites in South Korea, focusing on a device-oriented composite endpoint and a patient-oriented composite endpoint over a 12-month period. Participants will be monitored for cardiac events and revascularization needs to determine the optimal duration of DAPT after stent placement.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and over with coronary artery disease who have received a GENOSS® drug-eluting stent.
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 lead to safer and more effective management of patients undergoing coronary interventions, potentially reducing the duration of antiplatelet therapy.
How similar studies have performed: While the efficacy and safety of the GENOSS® stent have been previously investigated, this specific approach to short-duration DAPT is novel and lacks extensive prior data.
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.