Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Number of uncovered stent struts at 3-months
研究概览
简要总结
To assess strut coverage in patients presenting an acute myocardial infarction and treated either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel group design.
详细描述
Single center, simple-blind randomized controlled trial, comparing the SYNERGY stent with the BVS device through a parallel group design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute coronary syndrome with ST-elevation,
- •One culprit lesion eligible for percutaneous coronary intervention (PCI) with stent implantation,
- •Reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity,
- •thrombolysis in myocardial infarction (TIMI) 3 flow before stent deployment in the target vessel,
- •Patient with at least 1 lesion eligible for planned PCI next to the culprit lesion,
- •Patient affiliated to the French national health care system,
- •Patient agreed to participate after full information on the study (signature of an informed consent).
排除标准
- •Acute coronary syndrome with ST-elevation,
- •One culprit lesion eligible for percutaneous coronary intervention (PCI) with stent implantation,
- •Reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity,
- •TIMI 3 flow before stent deployment in the target vessel,
- •Patient with at least 1 lesion eligible for planned PCI next to the culprit lesion,
- •Patient affiliated to the French national health care system,
- •Patient agreed to participate after full information on the study (signature of an informed consent).
研究组 & 干预措施
SYNERGY Stent
The SYNERGY™ stent is a Device marked CE (European Conformity), platinum chromium coronary stent, currently developped by Boston Scientific™. This stent has been designed with the goal of providing optimal and rapid healing within the vessel using a bioabsorbable polymer to elute everolimus.
干预措施: SYNERGY stent (Device)
BVS device
The ABSORB Everolimus-eluting Bioresorbable Vascular Scaffold (BVS 1.1, Abbott Vascular, California, USA, CE approved) is Device marked CE, currently the most studied PLA (Polylactic acid) based scaffold. It consists of PLLA (Poly I-lactic acid) backbone with 1:1 PDLLA (Poly-DL Lactic Acid) drug surface coating and a total strut thickness of 156 μm.
干预措施: ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold) (Device)
结局指标
主要结局
Number of uncovered stent struts at 3-months
时间窗: at 3-months
To assess strut coverage
次要结局
- Percentage of net volume obstruction(at 3 months)
- Rates of in-stent late loss(at 3 months)
- Rates of in-segment late loss(at 3 months)
- Rates of binary restenosis(at 3 months)
- Plasma CXCL10 protein as a potential of re-endothelialization(at 3 months)
- Percentage of malposed uncovered struts(at 3 months)
- Frequency of abnormal intrastent tissue(at 3 months)