Evaluation of Clinical Results of Treatment of Cerebral Artery Occlusion by Mechanical Thrombectomy, in the Acute Phase of Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- clinical score for handicap (mRS)
研究概览
简要总结
The Ischemic Brain Vascular Accident (CVA) is a major public health issue. An Early and appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency and promote recovery of autonomy. Intravenous fibrinolysis in patients with cerebral infarction (NINDS 1995), is reserved for a small proportion of highly selected patients. It therefore remains a significant therapeutic challenge, especially for patients with against-indications to fibrinolysis or in whom there is no immediate benefit. For twenty years of mechanical devices have been developed to remove, as quickly as possible, the cause of intracranial arterial occlusion and allow restoration of blood flow before brain damage is irreversible.
NTF The protocol is part of the evaluation process of our clinical practices recommended by the National Health Authority (HAS), in the specific context of mechanical thrombectomy performed in French centers of interventional neuroradiology working with neurovascular units (A V).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Signature of the information notice by the patient or his legal representative
- •Age> 18 years
- •Clinical and imaging consistent with ischemic stroke whose symptoms start back within 8h
- •Thrombosis (TICI 0 or 1) of the carotid T, M1, M1-M2 bifurcation of the basilar artery occlusion in TANDEM ACI / M1.
排除标准
- •Pregnant or lactating women
- •Rapid improvement of NIHSS (gain of more than 4 points) between two pre-treatment assessments.
- •ASPECT score <7 on the scanner or <5 on the diffusion-weighted imaging (DWI)
- •Intracranial hemorrhage on imaging
- •Inability of clinical evaluations at 3 months
- •extensive lesions of the brain stem (the presence of a complete section of the brainstem hyperintense b1000)
- •0 Refusal to participate in the study
结局指标
主要结局
clinical score for handicap (mRS)
时间窗: at 3 months
次要结局
- presence of neoplasia(baseline)
- unblocking rate based on the score TICI(at 3 months)
- NIHSS evaluation(at 24h)
- Influence of hemorrhagic complications on NIHSS(at 3 months)
- presence of diabetes(baseline)
- hemorrhagic complications on postoperative imaging(at 1 day)
- physiological parameter : age(baseline)
- presence of intracranial stenosis(baseline)
- presence of haematological disorders(baseline)
- ASPECTS score(baseline)
- MRI imaging of stroke(baseline)
- presence of coronary artery disease(baseline)
- presence of occlusive arterial disease(baseline)
- Influence of collaterality score on the NIHSS(at 24h)
- Influence ASPECTS score on the NIHSS(at 3months)
- presence of arterial hypertension(baseline)
- presence of hypercholesterolemia(baseline)
- NIHSS score(baseline)
- influence of anesthesia on the NIHSS(at 24h)
- hemorrhagic complications(at 24h)