Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds MAGMARIS (MAGIC Registry)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Device Oriented Cardiac Events (DOCE) rate
研究概览
简要总结
The retrospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world setting including high volume PCI centers in Italy
详细描述
Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.
The aim of this observational retrospective study is to investigate the clinical performance and long-term safety of scaffold in a real world setting.
Institution involved in the present registry are high volume PCI centers. Operators have experience in PCI with bioresorbable scaffolds technology
The study organization is based on:
DATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. In case of clinical events, coronary artery angiographies and percutaneous coronary interventions was reviewed by an independent core-lab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects >18 years
- •Able to provide an informed consent
- •implantation of at least one scaffold
排除标准
- •inability to provide at least one year follow-up
结局指标
主要结局
Device Oriented Cardiac Events (DOCE) rate
时间窗: 1 year
Rate of DOCE, a composite of cardiovascular death, target vessel myocardial infarction and target lesion revascularization.
次要结局
- Cardiac death rate(1 year)
- Target vessel myocardial infarction rate(1 year)
- Target lesion revascularization rate(1 year)
研究者
Enrico Cerrato
MD
San Luigi Gonzaga Hospital
