A Randomized Study Comparing the Effectiveness and Security of the Use of Two Stentrievers Simultaneously Versus One Stentriever as a Primary Treatment in Acute Ischemic Stroke Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- SAFETY OBJECTIVE: Intracerebral hemorrhage.
研究概览
简要总结
Several studies have demonstrated that simultaneous treatment with two stentrievers (STs) as rescue treatment is very effective, with high recanalization rates even in this group of patients where other revascularization techniques have failed. There has been no observed increase in hemorrhagic complications. Recently, a prospective study has been published where treatment with two ST has been shown to be effective and safe if used as a first-choice treatment (not as rescue) with a successful recanalization rate (eTICI 2c/3) after the first pass of 69%. These results have been reinforced after the publication of a randomized study that confirms, in vitro, the superiority of using two ST over one.
详细描述
The use of a double stent retriever has been proposed as a safe and effective technique. The investigators hypothesized that the use of double stentriever primary could lead to higher first pass effect rates and better outcomes compared to single stentriever primary.
Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving endovascular treatment.
A randomized study to compare the efficacy of double primary stentriever versus single primary stentriever.
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
- Double (Participant, Investigator)
盲法说明
Patient & Outcomes adjudicator
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
- •A new disabling focal neurological deficit compatible with acute cerebral ischemia.
- •Any age. Informed consent obtained from the patient or representative.
- •NIHSS score ≥
- •Pre-existing functional clinical status less than or equal to 2 according to the mRS clinical scale.
- •Maximum time of 24 hours from symptom onset to arterial puncture. • TICI 0-1 in the diagnosed TICA (terminal internal carotid artery) , MCA (middle cerebral artery), and BA( basilar artery confirmed by angioCT and angiography).
- •ASPECTs score on baseline CT greater than or equal to
- •In cases where it is indicated, prior intravenous fibrinolysis will be administered according to the protocols of each center.
排除标准
- •Those described in the usual protocols for mechanical thrombectomy of each hospital.
- •Pre-existing functional clinical status greater than 2 according to the mRS clinical scale
- •Patients with tandem lesions of dissection or arteriosclerotic origin located in the extracranial internal carotid artery.
- •Initiation of treatment with a different technique than the one described.
- •Inability to use a proximal balloon guide catheter.
- •Use of aspiration catheter.
- •Intracranial atherosclerotic plaque as the cause of occlusion.
- •Advanced or terminal disease with a life expectancy of less than 6 months.
- •Patient who is participating in another study that may affect this one.
- •ASPECTS score less than or equal to 6 on baseline CT.
- •Evidence of significant hemorrhage or mass effect with midline shift on baseline CT.
- •Patients with occlusions in multiple vascular territories.
- •Evidence of intracranial tumor (except for small meningiomas)
结局指标
主要结局
SAFETY OBJECTIVE: Intracerebral hemorrhage.
时间窗: 24 hours
Rate of patients with symptomatic intracranial hemorrhage (neurological deterioration in National Institutes of Health Stroke Scale \[NIHSS\] \>4) at 24h observed between both groups and, fundamentally, evaluated by CT.
EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass
时间窗: 90 days
Comparison of the complete recanalization rate in the first pass in the double stent group compared to the single stent group, defined as TICI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale).
次要结局
- Complications related to the intervention.(During the procedure)
- Arterial Recanalization (eTICI scale) on first pass.(During the procedure)
- Early neurological improvement.(24 hours)
- Procedure time.(During the procedure)
- Mortality rate.(90 days)
- Intracerebral hemorrhage.(24 hours)
- Intervention success.(During the procedure)
- Embolism in new territories.(During the procedure)
- Number of passes with the devices.(During the procedure)
- Arterial recanalization at the end of the procedures.(During the procedure)
- National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge.(5 days)
- Modified Rankin Scale (mRS) scale at 90 days.(90 days)