NCT01261273已完成不适用
Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients
Terumo Europe N.V.257 个研究点 分布在 9 个国家目标入组 18,000 人开始时间: 2010年8月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18,000
- 试验地点
- 257
- 主要终点
- FREEDOM OF TARGET LESION FAILURE
研究概览
简要总结
Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.
Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.
Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year
详细描述
- Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.
- Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.
- Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year
- Clinical Site Locations:
Up to 200 centres across Europe, Asia and Central and South America
-Patient Population : ~18000 eligible patients suitable for treatment with the Nobori® DES will be entered in the e-NOBORI registry
Eligibility Criteria
- Patient is more or equal 18 years old;
- Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes);
- Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is more or equal 18 years old;
- •Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes);
- •Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists.
排除标准
- 未提供
结局指标
主要结局
FREEDOM OF TARGET LESION FAILURE
时间窗: 1 YEAR
TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION
次要结局
- Clinically driven target lesion revascularization (TLR)(1 & 2 YEARS)
- Peri-procedural myocardial infarction(1 MONTH)
- Acute/subacute stent thrombosis(1 MONTH)
- Cardiac death/ Myocardial Infarction(1 AND 2 YEARS)
- Device success(1 MONTH)
- Major vascular and bleeding complications(1 MONTH)
- Stent thrombosis(1 month, 1 and 2 years post-procedure)
- Clinically driven Target Lesion Revascularization(1 MONTH)
- Procedural success(1 MONTH)
- Rate of Major Adverse Cardiac Events (MACE)(1 MONTH)
- Composite Endpoint of Cardiac death and MI(1 MONTH, 1 AND 2 YEARS)
- Primary Stent thrombosis(1 month, 1 and 2 years post-procedure)
- Composite Endpoint of Cardiac death, post-procedural MI and stent thrombosis rate during the course of DAT versus the same events after cessation of DAT(UP TO 2 YEARS)
- Clinically driven target vessel revascularization (TVR)(1 AND 2 YEARS)
- Target Lesion Failure (TLF)(1 MONTH AND 2 YEARS)
- Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR(1 MONTH, 1 AND 2 YEARS)
- Composite Endpoint of Cardiac death and post-procedural MI(1 month, 1 and 2 years post-procedure)
- Duration of dual antiplatelet therapy(UP TO 2 YEARS)
- Secondary Stent thrombosis(1 month, 1 and 2 years post-procedure)
- Clinically driven Target Vessel Revascularization(1 MONTH)
研究者
研究点 (257)
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