Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent

Launched by GENOSS CO., LTD. · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a special type of heart stent called the GENOSS stent. This stent is designed to help patients with coronary artery disease, a condition where the arteries that supply blood to the heart become narrow or blocked. The trial aims to see how well this stent works when inserted through a procedure called percutaneous coronary intervention, which is a way to open up blocked arteries without major surgery.

To participate in the trial, individuals must be adults over 19 years old who have symptoms of heart problems and are eligible for a procedure to open their arteries. They should have significant narrowing of their coronary arteries that can be treated with the GENOSS stent. Participants will need to agree to follow the study guidelines and provide written consent. Those with certain allergies to specific medications or who are pregnant or breastfeeding will not be eligible. If you choose to participate, you can expect regular follow-ups to monitor your health and the stent's performance after the procedure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults over 19 years of age
• • 2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
• • 3. Severe coronary artery stenosis suitable for Genoss stent insertion
• • 4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution.
• Exclusion Criteria:
• • 1. Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)
• • 2. Patients who also received other drug-eluting stents
• • 3. If you have a disease with a remaining life expectancy of less than 1 year
• • 4. Pregnant or lactating women or women who may be pregnant
• • 5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low.
• • 6. Patients judged by researchers to be unsuitable for research