A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS SES in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 757
- 试验地点
- 1
- 主要终点
- Device-oriented composite endpoint
研究概览
简要总结
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.
详细描述
The Genoss SES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of the Genoss SES in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention.
The Genoss SES study is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss SES implantation in ACS patients undergoing percutaneous coronary intervention from 10 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 10 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<Inclusion Criteria>
- •Patients of 19 and over
- •Patients with acute coronary syndrome treated with GENOSS SES
- •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.
排除标准
- •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
- •Patients who are pregnant or planning to become pregnant
- •Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration.
- •Patients with a life expectancy of less than 1 year
- •Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment.
- •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.
- •Patients currently participating in a randomized controlled trial involving medical devices.
研究组 & 干预措施
GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]
Patients with acute coronary syndrome treated with the GENOSS SES
干预措施: GENOSS Sirolimus Eluting Coronary Stent System (Device)
结局指标
主要结局
Device-oriented composite endpoint
时间窗: 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).
次要结局
- Target lesion failure (TLF)(3 years after the procedure)
- Target vessel failure (TVF)(3 years after the procedure)
- All-cause death(3 years after the procedure)
- Cardiac death(3 years after the procedure)
- All-cause death and any myocardial infarction(3 years after the procedure)
- Cardiac death and target vessel-related myocardial infarction(3 years after the procedure)
- Target lesion revascularization (TLR)(3 years after the procedure)
- Stent thrombosis(3 years after the procedure)
- Target vessel revascularization (TVR)(3 years after the procedure)