Neurothrombectomy France (NTF)
Evaluation of Clinical Results of Treatment of Cerebral Artery Occlusion by Mechanical Thrombectomy, in the Acute Phase of Stroke
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).
研究概览
地位
条件
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 观测模型:仅案例
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
clinical score for handicap (mRS)
大体时间:at 3 months
|
at 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
hemorrhagic complications on postoperative imaging
大体时间:baseline
|
baseline
|
|
hemorrhagic complications on postoperative imaging
大体时间:at 1 day
|
at 1 day
|
|
physiological parameter : age
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
presence of coronary artery disease
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
presence of arterial hypertension
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
presence of diabetes
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
presence of hypercholesterolemia
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
presence of intracranial stenosis
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
presence of occlusive arterial disease
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
presence of haematological disorders
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
presence of neoplasia
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
NIHSS score
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
ASPECTS score
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
MRI imaging of stroke
大体时间:baseline
|
Factors of good clinical prognosis
|
baseline
|
unblocking rate based on the score TICI
大体时间:at 3 months
|
at 3 months
|
|
NIHSS evaluation
大体时间:at 24h
|
at 24h
|
|
Influence of collaterality score on the NIHSS
大体时间:at 24h
|
at 24h
|
|
Influence ASPECTS score on the NIHSS
大体时间:at 24h
|
at 24h
|
|
Influence ASPECTS score on the NIHSS
大体时间:at 3months
|
at 3months
|
|
influence of anesthesia on the NIHSS
大体时间:at 24h
|
at 24h
|
|
hemorrhagic complications
大体时间:at 24h
|
at 24h
|
|
Influence of hemorrhagic complications on NIHSS
大体时间:at 24h
|
at 24h
|
|
Influence of hemorrhagic complications on NIHSS
大体时间:at 3 months
|
at 3 months
|
合作者和调查者
调查人员
- 首席研究员:Hubert DESAL, PU-PH、Nantes University Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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