PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,302
- 试验地点
- 1
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
详细描述
The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical data) with 80% power. Primary and secondary outcome variables are international accepted parameters in stent-trials, which sufficiently describe the efficacy and safety of the investigated device and allow clinical conclusions. Additional attention will be paid to those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT).
The aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4 mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion is longer than 34 mm, more than one stent needs to be used.
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
- •All common significant coronary lesions
- •Target lesion length >34mm need to be covered with at least 2 devices
- •Patients eligible for this study must be at least 18 years of age
- •The patient must fulfil the standard recommendations for percutaneous coronary intervention (PCI), based on the last 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
- •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 Failure (TLF)
时间窗: at 12 months
Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).
次要结局
- Dual Antiplatelet Therapy (DAPT) compliance(at 3 months)
- all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)(at 24 months)
- Probable or definite stent-thrombosis of In-stent treated lesions(accumulated at 24 months)
- major adverse coronary event (MACE)(at 24 months)
- Procedural success(immediately after procedure)
- Bleeding complications according to the Bleeding Academic Research Consortium (BARC)(accumulated at 24 months)
- Target Lesion Failure (TLF)(at 24 months)
- ischemia driven target lesion revascularization (TLR)(at 24 months)
- all-cause death, cardiac death(at 24 months)
- ischemia driven target lesion revascularization (TLR)(at 12 months)
- all-cause death, cardiac death(at 12 months)
- all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)(at 12 months)
- major adverse coronary event (MACE)(at 12 months)
- Dual Antiplatelet Therapy (DAPT) compliance(at 4 weeks)
- Probable or definite stent-thrombosis of In-stent treated lesions(accumulated at 12 months)
- Bleeding complications according to the Bleeding Academic Research Consortium (BARC)(accumulated at 3 months)
- Bleeding complications according to the Bleeding Academic Research Consortium (BARC)(accumulated at 12 months)