Evaluating short-term dual antiplatelet therapy after a specific heart stent implantation
Official title: 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
Run by Genoss Co., Ltd. · NCT06075420 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Genoss Co., Ltd. Industry-sponsored |
| Locations | 1 site (Wŏnju, Gangwon State) |
| Status | Recruiting |
| Started | August 18, 2021 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | February 21, 2025 |
| Trial ID | NCT06075420 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 19 and over with coronary artery disease who have received a GENOSS® drug-eluting stent.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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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.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.