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Clinical Trials in South Korea / NCT05444452
Recruiting Not applicable

GENOSS Coronary Stent Clinical Trial

NCT05444452 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Not applicable
Started
2022-04-24
Last updated
2022-07-06

Condition(s) studied

Ischemic Heart Disease

Investigational drug(s) / intervention(s)

Implanatation of Genoss DES sirolimus-eluting coronary systemImplanatation of Xience DES everolimus-eluting coronary system

Implanatation of Genoss DES sirolimus-eluting coronary system: Percutaneous coronary intervention will proceed as per clinical guidelines, under operator's discretion. Genoss stent will be implanted if the lesion is deemed necessary to be revascularized by stenting

Implanatation of Xience DES everolimus-eluting coronary system: Percutaneous coronary intervention will proceed as per clinical guidelines, under operator's discretion. Xience stent will be implanted if the lesion is deemed necessary to be revascularized by stenting

Study summary

This study aims to evaluate the efficacy and safety of abluminal biodegradable polymer ultrathin sirolimus-eluting stent (Genoss stent) as compared with a durable-polymer everolimus-eluting stent (Xience stent) in patients with coronary artery disease.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • TLF at 1 year — 1 year
    A composite of cardiac death, target vessel-MI, or clinically indicated TLR by percutaneous or surgical methods at 1 year

Trial sites (1)

FacilityCityRegionStatus
Cardiac and Vascular Center; Samsung Medical Center Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05444452 on ClinicalTrials.gov ↗ ← All trials in South Korea