Neurothrombectomy France

NCT ID: NCT02880579

Last Updated: 2016-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Cerebral Artery Occlusion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hubert DESAL, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Other Identifiers

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RC11_0097

Identifier Type: -

Identifier Source: org_study_id

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