6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Endothelization and Malapposition of Three New Generation Drug Eluting Stent: CRE8, Biomatrix and Xience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- stent struts coverage assessed by means of intracoronary optical coherence tomography
研究概览
简要总结
Aim of this study is to compare at 6 months follow-up, endothelization and malapposition, evaluated by means of optical coherence tomography, in terms of number of struts not endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience.
详细描述
This is a randomized study aimed at evaluating in 60 patients with either acute coronary syndromes or stable coronary artery disease submitted with PCI and stenting, endothelization and malapposition at 6 months follow-up (primary endpoint), evaluated by means of optical coherence tomography in terms of number of struts not re-endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience. Further clinical follow-up will be performed to evaluate MACE at 12 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable angina or acute coronary syndromes submitted to coronary angioplasty on a coronary with a vessel diameter > 2,5 mm
排除标准
- •Known allergy to antithrombotic drugs or to other components of the stent studied Planned surgery 6 months within angioplasty
研究组 & 干预措施
CRE8 stent
Treatment with CRE8 stent implantation and evaluated with optical coherence tomography at 6 months
干预措施: optical coherence tomography at 6 months (Device)
Biomatrix stent
Treatment with Biomatrix stent implantation and evaluated with optical coherence tomography at 6 months
干预措施: optical coherence tomography at 6 months (Device)
patients treated with Xience stent
Treatment with Xience stent implantation and evaluated with optical coherence tomography at 6 months
干预措施: optical coherence tomography at 6 months (Device)
结局指标
主要结局
stent struts coverage assessed by means of intracoronary optical coherence tomography
时间窗: 6 months
次要结局
- MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization)(12 months)
- inducible ischemia at myocardial scintigraphy(12 months)
研究者
Cristina Giglioli, MD
MD
Azienda Ospedaliero-Universitaria Careggi