Evaluating 1-year Dual Antiplatelet Therapy after GENOSS® Stent Implantation in Heart Disease Patients

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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

• 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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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.