NCT03809715已完成不适用
Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,520
- 试验地点
- 1
- 主要终点
- Target Lesion Revascularization (TLR) rate at 12 months
研究概览
简要总结
The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.
详细描述
Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coroflex® ISAR NEO is intended to be used for
- •All common significant coronary lesions
- •Target lesion length >34mm need to be covered with at least 2 stents
- •Patients eligible for this study must be at least 18 years of age.
- •The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.
排除标准
- •Intolerance to sirolimus and/or probucol
- •Allergy to components of the coating
- •Pregnancy and lactation
- •Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
- •Cardiogenic shock
- •Risk of an intraluminal thrombus
- •Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
- •Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
- •Severe allergy to contrast media
- •Lesions which are untreatable with PCI or other interventional techniques
- •Patients with an ejection fraction of < 30 %
- •Vascular reference diameter < 2.00 mm
- •Treatment of the left stem (first section of the left coronary artery)
- •Indication for a bypass surgery
- •Contraindication for whichever accompanying medication is necessary
结局指标
主要结局
Target Lesion Revascularization (TLR) rate at 12 months
时间窗: 12 months
次要结局
- Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)(12 months)
- Rate of bleeding complications accumulated up to 12 months(12 months)
- Stent thrombosis rates accumulated up to 12 months(12 months)
- Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)(12 months)
- Technical/procedural success rate(immediately after procedure)
研究者
研究点 (1)
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