NCT02905214已完成不适用
Coroflex ISAR 2000 Extended Postmarket Surveillance Non-Interventional Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,369
- 试验地点
- 3
- 主要终点
- clinically driven Target Lesion Revascularization
研究概览
简要总结
Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries.
详细描述
The aim of the study is to assess the safety and efficacy of elective deployment of the Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.
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
- •patients suitable for percutaneous coronary intervention with proof of ischemia
- •at least 18 years of age
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
- •Severely calcified stenosis
- •Cardiogenic shock
- •Risk of an intraluminal thrombus
- •Haemorrhagic 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 PTCA 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
clinically driven Target Lesion Revascularization
时间窗: 9 months
re-intervention of the target lesion
次要结局
- Target lesion revascularization rate(9 months)
- Myocardial infarction rate(9 months)
- Cardiac death rate(9 months)
- Procedural success(immediately after stent implantation (within the first 30 minutes))
- Major Adverse Cardiac Events(9 months)
- Stent thrombosis rates(0-9 months)
研究者
研究点 (3)
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