BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III and Vulnerable Inflammation Parameter Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.
详细描述
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.
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
- •Symptomatic coronary artery disease
- •Subject signed informed consent for data release
- •Subject is geographically stable and willing to participate at all follow up assessments
- •Subject is ≥ 18 years of age
排除标准
- •Subject did not sign informed consent
- •Pregnancy
- •Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
- •Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- •Currently participating in another study and primary endpoint not reached yet
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
次要结局
- Clinical Device Success(participants will be followed for the duration of hospital stay, an expected average of 1 day)
- Clinical procedural success(up to seven days)
- Target Vessel Revascularization (TVR)(6 and 36 months)
- Target Lesion Revascularization (TLR)(6 and 36 months)
- Target Lesion Failure (TLF)(6 and 36 months)
- Stent Thrombosis(6, 12 and 36 months)
- Vulnerable Inflammation Parameter (VIP)(up to 36 months)