Neurothrombectomy France

Completed

• Conditions: Cerebral Artery Occlusion

• Registration Number: NCT02880579
• Lead Sponsor: Nantes University Hospital

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-22
• Last Update Submitted: 2016-08-22
• Study First Posted: 2016-08-26
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical score for handicap (mRS)	at 3 months

Secondary Outcome Measures

Name	Time	Method
presence of arterial hypertension	baseline	Factors of good clinical prognosis
presence of hypercholesterolemia	baseline	Factors of good clinical prognosis
NIHSS score	baseline	Factors of good clinical prognosis
influence of anesthesia on the NIHSS	at 24h
hemorrhagic complications	at 24h
unblocking rate based on the score TICI	at 3 months
NIHSS evaluation	at 24h
presence of neoplasia	baseline	Factors of good clinical prognosis
Influence of hemorrhagic complications on NIHSS	at 3 months
presence of diabetes	baseline	Factors of good clinical prognosis
hemorrhagic complications on postoperative imaging	at 1 day
physiological parameter : age	baseline	Factors of good clinical prognosis
presence of intracranial stenosis	baseline	Factors of good clinical prognosis
presence of haematological disorders	baseline	Factors of good clinical prognosis
ASPECTS score	baseline	Factors of good clinical prognosis
MRI imaging of stroke	baseline	Factors of good clinical prognosis
presence of coronary artery disease	baseline	Factors of good clinical prognosis
presence of occlusive arterial disease	baseline	Factors of good clinical prognosis
Influence of collaterality score on the NIHSS	at 24h
Influence ASPECTS score on the NIHSS	at 3months