Stent Retriever Thrombectomy for Thrombus Burden Reduction in Patients With Acute Myocardial Infarction - RETRIEVE-AMI Study
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
- 否
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
Giovanni Luigi De Maria
Primary Investigator
Oxford University Hospitals NHS Trust
