Post MArket Surveillance of SeQuent Please Neo With ScORing Balloon Lesion Preparation in Real WorlD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 481
- 试验地点
- 1
- 主要终点
- Target Vessel Failure
研究概览
简要总结
The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.
详细描述
The aim of this post market surveillance is to document the safety and efficacy of the drug-coated balloon Sequent® Please Neo in combination with the NSE Alpha scoring balloon in the treatment of both in-stent restenosis and de-novo lesions in native coronary arteries with reference diameters of 2.5 mm up to 4.0 mm with lesion lengths of 30 mm 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 with in-stent restenosis and de-novo lesions in coronary arteries
排除标准
- •Intolerance to paclitaxel and/or the balloon coating
- •Allergy to components of the balloon 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
结局指标
主要结局
Target Vessel Failure
时间窗: 9 months
Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death
次要结局
- Target Lesion Revascularization rate = Re-PCI + CABG(TLR)(9 months)
- procedural success rate(intraprocedural)
- cardiac death(9 months)
- Rate of coronary arterial bypass grafting (CABG)(9 months)
- rate of myocardial infarction(9 months)