Clinical Trials in South Korea / NCT06075368
Active, not recruiting
Observational
Efficacy and Safety of GENOSS® SES in Patients With Acute Coronary Syndrome (GENOSS ACS)
NCT06075368 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Acute Coronary SyndromePercutaneous Coronary Intervention
Investigational drug(s) / intervention(s)
GENOSS Sirolimus Eluting Coronary Stent System
GENOSS Sirolimus Eluting Coronary Stent System: The GENOSS SES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt chromium stent platform and thin strut.
Study 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.
Eligibility
\<Inclusion Criteria\>
1. Patients of 19 and over
2. Patients with acute coronary syndrome treated with GENOSS SES
3. 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\>
1. 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
2. Patients who are pregnant or planning to become pregnant
3. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration.
4. Patients with a life expectancy of less than 1 year
5. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment.
6. 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.
7. Patients currently participating in a randomized controlled trial involving medical devices.
Primary outcome measure(s)
- Device-oriented composite endpoint — 12 months after the procedure
DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
More Genoss Co., Ltd. trials in South Korea
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
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The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR
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Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease
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Other trials for the same condition
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 NCT06075368 on ClinicalTrials.gov ↗ ← All trials in South Korea