Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography
研究概览
简要总结
demonstrate that FD-OCT guidance is feasible and possibly results in reduction of frequency-domain Optical Coherence Tomography-defined residual thrombus burden after thrombus-aspiration.
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 (Outcomes Assessor)
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
- •ST elevation myocardial infarction
- •Ages Eligible for Study: >18 years old
- •Genders Eligible for Study: Both (female sex with child-bearing potential excluded)
排除标准
- •occluded (TIMI 0) or sub occluded (TIMI 1) proximal vessel of estimated diameter ≥3mm
- •intended use of thrombus aspiration
研究组 & 干预措施
angio-guided thrombus aspiration
thrombus aspiration guided by angiography
干预措施: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) (Device)
OCT-guided thrombus aspiration
thrombus aspiration guided by optical coherence tomography
干预措施: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) (Device)
结局指标
主要结局
number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography
时间窗: within the primary PCI procedure
Whether FD-OCT guidance of manual thrombus aspiration (TA) is superior to conventional angio-guided TA in reducing residual thrombus burden after stenting (defined as the number of cross-sections with thrombus area more than 10% at post-stenting FD-OCT)
次要结局
- major adverse cardiac events(at 6 months)
研究者
Leonardo Bolognese, MD
Director
Ospedale San Donato