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

Recruiting

• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention

• Registration Number: NCT06086496
• Lead Sponsor: Genoss Co., Ltd.

Brief Summary

In real-world practice, the investigators plan to evaluate the effectiveness and safety of using the GENOSS (GENOSS DES II) stent, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

Detailed Description

This study will enroll patients who underwent percutaneous coronary intervention using the GENOSS DES stent.

This study is a single-arm, registry, observational study, so it is not necessary to calculate the number of subjects, but the investigators plan to enroll approximately 1,000 patients at 7 institutions during the registration period.

Study Timeline

• Study Start: 2022-07-15
• Status Verified: 2023-10
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
device-oriented composite end point	12 months	The composite rate of cardiac death, TVMI, and TL will be evaluated by the incidence of target lesion failure(TLF).

Secondary Outcome Measures

Name	Time	Method
patient-oriented composite end point	12 months	1 year all death incidence rate (All deaths); 1 year cardiac death rate; 1-year target vessel myocardial infarction incidence rate (TVMI); 1. year all-vascular myocardial infarction incidence rate (any MI) 1-year ischemia-driven target vessel revascularization (ischemia driven TVR) 1-year ischemia-induced target lesion revascularization (ischemia driven TLR) 1-year stent thrombosis (ARC standard)

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of