Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of GENOSS® SES in Patients with Acute Coronary Syndrome (GENOSS ACS)
Lead Sponsor:
Genoss Co., Ltd.
Conditions:
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Eligibility:
All Genders
19+ years
Brief Summary
The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.
Detailed Description
The Genoss SES 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 with acute coronary syndrome treated with GENOSS SES
- 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 study 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 :
March 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
757 Patients enrolled
Trial Details
Trial ID
NCT06075368
Start Date
March 16 2020
End Date
December 31 2027
Last Update
February 19 2025
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620