Deutsches Dual Therapy Stent Register
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- OrbusNeich
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
The DTS.DE registry is an initiative for the collection of high quality process and historical data of implantations with the COMBO Dual Therapy Stent in Germany. DTS.DE was designed as a national, non- randomized, prospective, multicenter registry without a comparison group.
The responsible Steering Committee is of the opinion that the Combo stent qualifies for further documentation of treatment results in the form of a German registry, based the CE certification of the COMBO Dual Therapy stent in 2013 and its clinical and scientific investigation in the context of the REMEDEE study program, as well as company independent externally initiated studies with the COMBO Dual Therapy Stent.
It is expected that by mid- 2015, at least 1,000 patients will be enrolled and documented in the DTS.DE registry with the COMBO Dual Therapy Stent. A clinical follow-up is performed after 6 weeks and 12 months.
详细描述
It is the objective of the DTS.DE registry to capture the documentation of all patients who have been treated with a Combo Dual Therapy Stent in Germany, and who have been properly informed and consented with regards to their participation in the registry. All of these patients will be registered in the electronic data capturing system (eCRF) of the DTS.DE registry and will be followed and documented for a period of 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients has at least one coronary lesion, suitable for PCI treatment with the Combo stent in accordance with European Society of Cardiology Guidelines and local Guidelines of the Deutsche Gesellschaft für Kardiologie for drug eluting stents
排除标准
- •Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti- Murine Antibodies (HAMA)
- •Patient in whom anti-platelet and/or anticoagulant therapy is contraindicated
- •Patient in whom a complete inflation of the angioplasty balloon or correct stent placement is thought to be inhibited
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: 12 months
TVF is defined as the hierarchical composite of target vessel related Major Adverse Cardiac Events (MACE). MACE is defined as the composite of death, myocardial infarction and target lesion revascularization (TLR).
次要结局
- Stent thrombosis(12 months)
- Thrombolysis in Myocardial Infarction (TIMI) bleeding(12 months)
- Stent induced serious adverse events (SAE)(12 months)
- Procedural success(Day of procedure)
- MACE(6 weeks and 12 months)