Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA" :a Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 主要终点
- Clinical neurological outcome
研究概览
简要总结
Mechanical thrombectomy recently has revolutionized the treatment of stroke. Trials have demonstrated the superiority of mechanical thrombectomy in large vessel occlusions, such as in the intracranialinternal carotid artery and proximal, middle cerebral artery (M1), middle cerebral artery trunk (M1), have relatively high rates of revascularization and favorable clinical outcomes after MT. , However second-order branches of the middle cerebral artery (M2) occlusions (postbifurcation in the Sylvian fissure) were underrepresented or not represented in the trials. Posing a more significant technical challenge to the available endovascular devices because of the smaller size and tortuosity of these arteries and the greater likelihood of recanalization with intravenous thrombolysis, the overall risk-benefit remains uncertain.
详细描述
this study aims to:
- compare efficacy of mechanical thrombectomy over medical treatment in occlusion of M2 division of MCA.
- improve outcome of acute ischemic stroke.
The study will include all patients with AIS attending to emergency deparment with proven occlusion of M2 division of MCA, and deviding then into 2 groups:
Group 1 will receive medical treatment (rTPA if presented in the first 4 hours, and antiplatelet if passed time window for IVT) Group 2 will underwent mechanical thrombectomy (if accessible), and even after receiving medical treatment and not improved and comparing the outcomes of these 2 groups
c. Sample Size Calculation: Sample size was calculated using G*power, version 3.1.9.7. Estimation based on results of previous study which reported that, median (IQR) discharge NIHSS in mechanical thrombectomy group was 2 (0-4) compared to 1 (0-2) in medical management group giving medium effect size . With a power of 80% (using one-sided t-test, effect size = 0.65 and α of 0.5) the sample needed for the study was estimated to be 60 patients (30 in each group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Cerebral infarction in anterior circulation involving occlusion of M2 MCA, proven by CTA
- •With or without IV thrombolysis
- •Access to endovascular treatment within 24 hours from onset.
排除标准
- •Proven proximal occlusion of MCA.
- •Disability prior to the stroke (mRS >3)
- •Opposition of the patient or their family
研究组 & 干预措施
Mechanical thrombectomy
this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.
干预措施: Mechanical thrombectomy (Drug)
Mechanical thrombectomy
this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.
干预措施: medical treatment (Drug)
medical managemnet
this arm will include all patients who received medical treatment only, either anti-platelet or alteplase.
干预措施: medical treatment (Drug)
结局指标
主要结局
Clinical neurological outcome
时间窗: 3 months
Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points.
次要结局
- Functional outcome(3 months)
研究者
Mahmoud Nageeb
assistant lecurer of neurology
Assiut University