Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 17
- 主要终点
- Device-oriented composite end point (TLF)
研究概览
简要总结
This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
详细描述
Percutaneous coronary intervention (PCI) is the main stream of treatment of coronary artery disease. Drug-eluting stents (DES) have dramatically reduced the rates of restenosis and target lesion revascularization (TLR) compared with bare-metal stents (BMS). Newer-generation DES with a durable polymer such as Xience (Abbott, US) and Resolute (Medtronic, US) were widely used. However, the concern about late stent thrombosis due to hypersensitivity reaction from the polymer is still existed. Recently, DES with a biodegradable polymer such as Biomatrix (Biosensors, Switzerland), Nobori (Terumo, Japan), Orsiro (Biotronik, Switzerland), and Synergy (Boston Scientific, US) was rapidly adopted and it is expected to reduce the late stent thrombosis.
Recently, new biodegradable DES with thin struts was developed in South Korea. The Genoss DES (Genoss, Korea) has an L-605 cobalt chromium (CoCr) platform with a strut thickness of about 70 µm and the stent is coated a combination of Sirolimus drug with concentration of 1.15µg/mm2 and an abluminal biodegradable PLA and PLGA polymers.
This study is conducted to evaluate efficacy and safety of Genoss DES in the treatment of patients with coronary artery disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subject is ≥ 19 years
- •Subject implanted Genoss DES within 1 month
- •Subject has signed informed consent for data release
- •Subject is geographically stable and willing to participate at all follow-up assessments
排除标准
- •Subject did not sign informed consent for data release
- •Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
- •Pregnancy
- •Subject with life expectancy less than 12 months
- •Subject with cardiogenic shock
- •Planned surgery within 12 months of PCI unless dual antiplatelet therapy will be maintained
- •Currently participating in another study and primary endpoint is not reached yet.
结局指标
主要结局
Device-oriented composite end point (TLF)
时间窗: 12 months
Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization
次要结局
- Patient-oriented composite end point(12 months)
- Clinically indicated target-lesion revascularization(12 months)
- Any myocardial infarction(12 months)
- Any myocardial infarction not clearly attributable to a nontarget vessel(12 months)
- ARC defined stent thrombosis(12 months)
- Non-cardiac death(12 months)
- Any revascularization(12 months)
- Clinically indicated target-vessel revascularization(12 months)
- Cardiac death(12 months)
研究者
Young Jin Youn, MD, PhD
Professor
Yonsei University