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临床试验/NCT04098042
NCT04098042Unknown不适用

Retrospective, Observational Register to Investigate the Procedural and Post Procedural Implantation of Bioabsorbable Magnesium Scaffolds MAGMARIS (MAGIC Registry)

San Luigi Gonzaga Hospital2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2016年7月30日最近更新:
适应症

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

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

发起方
San Luigi Gonzaga Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Cerrato

MD

San Luigi Gonzaga Hospital

研究点 (2)

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