Efficacy and Safety of GENOSS® SES in Patients with Acute Coronary Syndrome (GENOSS ACS)

Launched by GENOSS CO., LTD. · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a specific type of heart stent called the Genoss Drug-Eluting Stent (DES) in patients with Acute Coronary Syndrome (ACS), a condition where blood flow to the heart is suddenly reduced. The trial is open to adults over 19 years old who have received the Genoss stent during a procedure to improve blood flow. Participants will be asked to agree in writing to take part in this study, which will track their health and how well the stent works over time.

If you or a loved one are eligible and choose to participate, you can expect to be part of a larger group of patients being monitored at various medical centers. The goal is to gather important information about how well the Genoss stent performs and to ensure it is safe for patients. It’s important to note that patients who have not consented to the study or who received a different type of stent during their procedure will not be included. This research is significant as it uses a stent developed with local technology, and your participation could help improve heart care for others in the future.

Gender

ALL

Eligibility criteria

• • \<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.