Evaluation of a new biodegradable polymer coronary stent for heart disease

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 clinical trial evaluates the efficacy and safety of the Genoss biodegradable polymer ultrathin sirolimus-eluting stent compared to the durable-polymer everolimus-eluting Xience stent in patients with coronary artery disease. The study aims to address the risks of ischemic events associated with traditional drug-eluting stents by utilizing a newer generation stent designed to reduce inflammation and improve re-endothelialization. Participants will undergo stent implantation and be monitored for outcomes related to device-related failure and target lesion failure. The trial includes patients with stable coronary artery disease or acute coronary syndrome who meet specific eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

① Subject must be at least 19 years of age

② Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

③ Patients with stable coronary artery disease or acute coronary syndrome and at least one lesion with greater than 50% diameter stenosis suitable for stent implantation

Exclusion Criteria:

* Pregnant women ② Patients unable to provide consent, ③ Patients with known intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, heparin or components of drug-eluting stents (sirolimus or everolimus)

  * Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

Where it's running

• Cardiac and Vascular Center; Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Hyeon-Cheol Hyeon-Cheol, MD, PhD — Samsung Medical Center
• Study coordinator: Hyeon-Cheol Gwon, MD, PhD
• Email: hcgwon@naver.com
• Phone: 82-2-3410-3694

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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.