BIOTRONIK - SaFety and Performance Registry for an aLl-comers Subject Population With the Limus Eluting Orsiro Mission Stent System Within Daily Clinical Practice: BIOFLOW-VIII
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Biotronik AG
- 入组人数
- 872
- 试验地点
- 41
- 主要终点
- Rate of Target Lesion Failure (TLF) at 12 months follow-up
研究概览
简要总结
The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
详细描述
BIOFLOW-VIII is a national, prospective, non-randomized, multi-center, open-label registry to confirm both, the acute performance as well as the mid- and long-term safety and clinical performance of the Orsiro Mission stent in an all-comers patient population within daily clinical practice.
A total of 868 subjects will be enrolled at approximately 50 study sites in France. Clinical follow-ups will take place at 6, 12, 36 and 60 months post index-procedure. Follow-ups can be conducted by telephone.
A subgroup analysis will evaluate the outcomes for patients treated ambulatory with same day discharge.
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 intended to be treated with an Orsiro Mission DES (silent ischemia is permitted)
- •Subject has 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 for data release
- •Pregnancy
- •Known allergy (which cannot be pre-treated) to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt- chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), silicon carbide, PLLA, mTOR inhibiting drugs such as sirolimus, or contrast media
结局指标
主要结局
Rate of Target Lesion Failure (TLF) at 12 months follow-up
时间窗: 12 months
TLF according to Academic Research Consortium-2 (ARC-2) definition: Composite of Cardiovascular Death, target-vessel Myocardial Infarction and clinically-driven Target Lesion Revascularization
次要结局
- Percent of participants with Clinical Procedural Success defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method without occurrence of in-hospital death, myocardial infarction or target lesion revascularization(From the intervention/procedure/surgery until hospital discharge, assessed up to 3 days)
- Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up(6, 36, and 60 months)
- Rate of Target Vessel Revascularization (TVR) at 6, 12, 36, and 60 months follow-up(6, 12, 36, and 60 months)
- Rate of Target Lesion Revascularization (TLR) at 6, 12, 36, and 60 months follow-up(6, 12, 36, and 60 months)
- Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up(6, 12, 36, and 60 months)
- Percent of participants with Clinical Device Success defined as attainment of < 30% residual stenosis of the target lesion using Orsiro Mission only(Immediately after the intervention/procedure/surgery)