Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,286
- 试验地点
- 74
- 主要终点
- Target lesion failure
研究概览
简要总结
The objective of this study is to evaluate the long-term efficacy and safety of coronary stenting with the various types of drug-eluting stents (DES) and to determine clinical device and procedural success during commercial use of DES in the real world.
The investigators will compare EES (Xience V/Promus and Xience Prime), SES (Cypher), ZES (Resolute Integrity, Endeavor Resolute, Endeavor), and BES (Biomatrix, Biomatrix Flex, and Nobori).
详细描述
The Grand Drug-Eluting Stent (Grand-DES) Registry incorporated five different multicenter registries in South Korea. The EXCELLENT prospective cohort and the EXCELLENT-PRIME registry were dedicated for durable polymer-coated everolimus-eluting stents (DP-EES; Xience V/Promus and Xience Prime) or 1st-generation sirolimus-eluting stents (Cypher), the HOST-RESOLINTE and RESOLUTE-Korea registry for durable polymer-coated zotarolimus-eluting stents (DP-ZES; Resolute Integrity and Endeavor Resolute) or 1st-generation Endeavor-ZES, and the HOST-BIOLIMUS-3000-Korea registry for biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, and Nobori). During the period of 2008 through 2014, all registries enrolled all-comers without any exclusion criteria except patient's withdrawal of consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient agrees to participate in this study by signing the informed consent form.
- •Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
排除标准
- •There are no exclusion criteria for this registry.
研究组 & 干预措施
HOST-BIOLIMUS-Korea-3000
Active prospective registration of patients receiving biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, Nobori)
干预措施: Biomatrix; Biomatrix Flex; Nobori (Device)
EXCELLENT-PRIME
Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents (DP-EES; Xience Prime)
干预措施: Xience Prime (Device)
EXCELLENT Prospective cohort
Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents and sirolimus-eluting stents (Xience V/Promus; Cypher)
干预措施: Xience V/Promus; Cypher (Device)
HOST-RESOLINTE
Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES-RI; Resolute Integrity)
干预措施: DP-ZES-RI (Device)
RESOLUTE-Korea
Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES; Endeavor; Resolute)
干预措施: Endeavor; Resolute (Device)
结局指标
主要结局
Target lesion failure
时间窗: 36 months
A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization
次要结局
- All-cause myocardial infarction(36 months)
- Cardiac death(36 months)
- Clinically-driven target lesion revascularization(36 months)
- Definite or probable stent thrombosis(36 months)
- Patient-oriented composite outcome(36 months)
- All-cause death(36 months)
- Any repeat revascularization(36 months)
- Target-vessel myocardial infarction(36 months)
- Clinically-driven target vessel revascularization(36 months)
研究者
Hyo-Soo Kim
Investigator
Seoul National University Hospital