Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of uncovered stent struts
研究概览
简要总结
This study is designed to assess the pathophysiology of ST by studying the main procedural and anatomical factors involved in the genesis of ST such as those related to stent and the vascular wall, as well as to the individual platelet residual reactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •previous PCI with bare metal stent (BMS) or drug eluting stent (DES) and a definite subacute coronary ST
- •previous PCI with DES and a definite late or very late coronary ST
排除标准
- •Development of ST within 72 hours of stent implantation (acute and early subacute ST).
- •Late and very late ST of BMS.
- •Absence of informed consent.
- •Age less than 18 years.
- •Creatinine values greater than 2.5 g/dl (this is to avoid the negative effects related to the contrast medium necessary to perform the OCT evaluation).
研究组 & 干预措施
Stent Thrombosis
Consecutive patients with stent thrombosis with stent strut assessment by OCT
干预措施: OCT guided PCI (Device)
Controls
Control subjects without stent thrombosis from the RHR OCT database
干预措施: OCT guided medical therapy (Drug)
结局指标
主要结局
Percentage of uncovered stent struts
时间窗: After thrombectomy
The percentage of uncovered stent struts by OCT in patients with subacute stent thrombosis (either DES and BMS) and the percentage of uncovered stent struts in patients with late (after one month) and very late thrombosis of DES.
次要结局
- Percentage of patients with high residual platelet reactivity(Baseline)
- Percentage of malapposed stent struts(After Thrombectomy)
研究者
David Antoniucci
Head Division of Invasive Cardiology
Careggi Hospital