Efficacy and Safety of GENOSS SES in Patients with Coronary Artery Disease

Launched by GENOSS CO., LTD. · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a specific type of stent called GENOSS SES in patients with coronary artery disease (CAD). A stent is a small, tube-like device that helps keep the arteries open, allowing blood to flow more freely to the heart. The trial is currently active but not recruiting new participants, meaning they are not looking for more individuals to join at this time.

To be eligible for this trial, patients must be 19 years or older and have been treated with the GENOSS SES stent. They also need to willingly agree to participate, follow the study guidelines, and provide written consent. However, certain individuals cannot participate, including those with specific medical conditions, pregnant women, or those who have recently undergone certain surgeries. Participants can expect to receive close monitoring throughout the study to ensure their safety and to gather information on how well the stent works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients of 19 and over
• • 2. Patients with coronary artery disease 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
• • 2. Patients who are pregnant or planning to become pregnant
• • 3. Patients with a planned surgery to discontinue antiplatelet agents within 12 months
• • 4. Patients with a life expectancy of less than 1 year
• • 5. Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
• • 6. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
• • 7. Patients participating in randomized controlled trials using other medical devices