Status:
COMPLETED
Efficacy and Safety of GENOSS® DES in Patients with Coronary Artery Disease
Lead Sponsor:
Genoss Co., Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Brief Summary
The objective of this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice.
Detailed Description
The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previou...
Eligibility Criteria
Inclusion
- \<Inclusion Criteria\>
- Patients of 19 and over
- Patients eligible for treatment of coronary artery disease using GENOSSTM DES
- 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 research participants.
- \<Exclusion Criteria\>
- Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents (However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded)
- Patients who are pregnant or planning to become pregnant
- Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration
- Patients with a life expectancy of less than 1 year
- Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment
- Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration
- Patients currently participating in a randomized controlled trial involving medical devices
Exclusion
Key Trial Info
Start Date :
June 24 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
1022 Patients enrolled
Trial Details
Trial ID
NCT06066476
Start Date
June 24 2017
End Date
October 31 2024
Last Update
February 20 2025
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea, 08308