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临床试验/NCT05307965
NCT05307965已完成不适用

Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients With Acute Myocardial Infarction - RETRIEVE-AMI Study

Oxford University Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2022年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
2
主要终点
Thrombus Volume (mm^3)

研究概览

简要总结

Heart attacks are caused by the sudden formation of a clot inside a diseased coronary artery which reduces blood flow beyond the blockage site. During conventional treatment of the blockage with what is known as a stent; a stainless steel tub that keeps the artery open, the clot that has formed is disrupted and is pushed further down leading to damage in smaller blood vessels supplying the heart muscle. This additional damage can lead to long-term heart muscle damage influencing recovery and wellbeing. The original concept that was tested to prevent this 'clot shower' was that of a suction device to withdraw the clot before stenting. However, this approach has not translated to patient benefit. Amongst the reasons put forward for the inefficacy of the suction device was that it does not remove the entire clot as it does not interact with it. A new device that physically interacts with the clot and traps it before pulling it out - the stent retriever - is now routinely used in stroke therapy to remove clots in the arteries supplying the brain. This device has been successfully used as a last resort to remove clots in a small number of heart attacks. The investigators hypothesize that stent retriever therapy will be more effective in clot removal than the current standard of care; suction or stenting. To study this, the investigators propose the RETRIEVE-AMI randomised controlled trial.

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)

盲法说明

Due to the interventional nature of the trial, masking is not feasible for operators, the clinical care team and participants. However, analysis of the OCT-derived primary and secondary end-points will be conducted offline in a blinded fashion.

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

入选标准

  • Primary PCI patient with ST elevation myocardial infarction (STEMI)
  • TIMI 0/1 flow at presentation
  • Angiographic thrombus score ≥ 4
  • Vessel diameter at site of occlusion ≥ 3.0 mm (measured by quantitative coronary angiography)

排除标准

  • Female participant who is pregnant or lactating
  • Participant with known hypersensitivity to nickel-titanium
  • Unconscious at presentation
  • Late presenter (pain to wire time > 12 h)
  • Class Killip III/IV and/or profound bradycardia (Heart rate < 40 bpm)
  • Known history of kidney failure
  • Ostial occlusion
  • Highly tortuous vessel
  • Highly calcified vessel
  • Suspected (angiographically) spontaneous coronary artery dissection
  • Stent thrombosis
  • Previous stent implanted proximal to the occlusion site
  • Previous coronary artery bypass graft surgery (CABG)
  • Previous STEMI/Transient Ischemic Attack/Stroke
  • Known anaemia (Hemoglobin <9)

结局指标

主要结局

Thrombus Volume (mm^3)

时间窗: During PCI prior to stent implantation (typically 30 min from start of procedure)

Assessed with Optical Coherence Tomography \[OCT\]

Device-related Target Vessel Complications

时间窗: During PCI prior to stent implantation (typically 30 min from start of procedure)

Assessed with angiography and/or OCT

Device Deficiency

时间窗: During PCI prior to stent implantation (typically 30 min from start of procedure)

Assessed with angiography and/or OCT

Major Adverse Cardiac and Cerebrovascular Events (MACCE)

时间窗: Up to 30 days after PCI

MACCE

时间窗: At 6 months after PCI

次要结局

  • Flow Volume (mm^3)(Post-stent implantation during PCI (typically 50 min after procedure start))
  • Thromboatheroma Volume (mm^3)(Post-stent implantation during PCI (typically 50 min after procedure start))
  • Number of Participants With Stent Underexpansion & Malapposition(Post-stent implantation during PCI (typically 50 min after procedure start))
  • Thrombolysis in Myocardial Infarction (TIMI) Flow(Post-stent implantation during PCI (typically 60 min after procedure start))
  • Number of Participants With Myocardial Blush Grade (MBG) < 3(Post-stent implantation during PCI (typically 60 min after procedure start))
  • Angiograpicy Derived Index of Microcirculatory Resistance(Post-stent implantation during PCI (typically 60 min after procedure start))

研究者

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

Giovanni Luigi De Maria

Primary Investigator

Oxford University Hospitals NHS Trust

研究点 (2)

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