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Enrolling by invitation Observational

Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES)

NCT06086496 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2022-07-15
Last updated
2025-10-06

Condition(s) studied

Coronary Artery DiseasePercutaneous Coronary Intervention

Investigational drug(s) / intervention(s)

GENOSS® DES Sirolimus Eluting Coronary Stent System

GENOSS® DES Sirolimus Eluting Coronary Stent System: The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Study summary

In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
\<Inclusion Criteria\> 1. Adults over 19 years of age 2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty. 3. Severe coronary artery stenosis suitable for GENOSS® DES insertion 4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution. \<Exclusion Criteria\> 1. Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded) 2. Patients who also received other drug-eluting stents 3. If you have a disease with a remaining life expectancy of less than 1 year 4. Pregnant or lactating women or women who may be pregnant 5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low. 6. Patients judged by researchers to be unsuitable for research

Primary outcome measure(s)

  • Target Lesion Failure (TLF) — at 12 months after the procedure
    The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)

Trial sites (1)

FacilityCityRegionStatus
Korea University Anam Hospital Seoul Seoul
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 NCT06086496 on ClinicalTrials.gov ↗ ← All trials in South Korea