Status:
ENROLLING_BY_INVITATION
Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES)
Lead Sponsor:
Genoss Co., Ltd.
Conditions:
Coronary Artery Disease
Percutaneous Coronary Intervention
Eligibility:
All Genders
19+ years
Brief 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)...
Detailed Description
This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSS® DES drug-eluting stent. As it is a prospective, multice...
Eligibility Criteria
Inclusion
- \<Inclusion Criteria\>
- Adults over 19 years of age
- Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
- Severe coronary artery stenosis suitable for GENOSS® DES insertion
- 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\>
- 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)
- Patients who also received other drug-eluting stents
- If you have a disease with a remaining life expectancy of less than 1 year
- Pregnant or lactating women or women who may be pregnant
- 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.
- Patients judged by researchers to be unsuitable for research
Exclusion
Key Trial Info
Start Date :
July 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06086496
Start Date
July 15 2022
End Date
December 31 2027
Last Update
October 6 2025
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, Seoul, South Korea