Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,111
- 试验地点
- 19
- 主要终点
- Device Oriented Cardiac Events
研究概览
简要总结
The prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The second includes the centers partecipating into the MAGIC retrospective study. Both networks joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in indications and strategy implanatation described by the protocol. In each center, after IRB approval, the patients will be enrolled according to established criteria.
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 prospective study is to investigate the clinical performance and long-term safety of scaffold in a real world regional setting.
The investigators agreed in the following preferential/optimal indications:
- complete revascularization in patients with age <65 years
- revascularization of long lesions (>24 mm), especially located in left anterior descending
- spontaneous coronary dissection
The investigators agreed in the following strategy implantation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •subjects >18 years
- •sign of the patients informed consent
- •implanation of at least one scaffold
排除标准
- •inability to garantuee at least one year follow-up
- •inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen
研究组 & 干预措施
scaffold
Patients receiving during PCI the implantation of at least one scaffold
干预措施: scaffold (Device)
结局指标
主要结局
Device Oriented Cardiac Events
时间窗: 1 year
cumulative occurence of cardiovascular death, target vessel myocardial infarction and target vessel revascularization. Target is defined the vessel treated with scaffold
次要结局
未报告次要终点
研究者
Gianluca Campo
Associate Professor
University Hospital of Ferrara