跳至主要内容
临床试验/NCT01914055
NCT01914055Unknown4 期

Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.

Ospedale San Donato2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
4 期
入组人数
20
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Bolognese, MD

Director

Ospedale San Donato

研究点 (2)

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