Clinical trial NCT02880579: Neurothrombectomy France
Official title: Evaluation of Clinical Results of Treatment of Cerebral Artery Occlusion by Mechanical Thrombectomy, in the Acute Phase of Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Artery Occlusion
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 consecutive patients admitted to a stroke unit for cerebral infarction treated by thrombectomy included (with or without fibrinolysis by intra venous) prospectively over a period of 1 year and 3 months followed for clinical neurological assessment (primary endpoint) .

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).


Eligibility criteria: 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

Primary outcomes:
measure: clinical score for handicap (mRS)
timeFrame: at 3 months
Secondary outcomes:
measure: hemorrhagic complications on postoperative imaging
timeFrame: baseline
measure: hemorrhagic complications on postoperative imaging
timeFrame: at 1 day
measure: physiological parameter : age
timeFrame: baseline
measure: presence of coronary artery disease
timeFrame: baseline
measure: presence of arterial hypertension
timeFrame: baseline
measure: presence of diabetes
timeFrame: baseline
measure: presence of hypercholesterolemia
timeFrame: baseline
measure: presence of intracranial stenosis
timeFrame: baseline
measure: presence of occlusive arterial disease
timeFrame: baseline
measure: presence of haematological disorders
timeFrame: baseline
measure: presence of neoplasia
timeFrame: baseline
measure: NIHSS score
timeFrame: baseline
measure: ASPECTS score
timeFrame: baseline
measure: MRI imaging of stroke
timeFrame: baseline
measure: unblocking rate based on the score TICI
timeFrame: at 3 months
measure: NIHSS evaluation
timeFrame: at 24h
measure: Influence of collaterality score on the NIHSS
timeFrame: at 24h
measure: Influence ASPECTS score on the NIHSS
timeFrame: at 24h
measure: Influence ASPECTS score on the NIHSS
timeFrame: at 3months
measure: influence of anesthesia on the NIHSS
timeFrame: at 24h
measure: hemorrhagic complications
timeFrame: at 24h
measure: Influence of hemorrhagic complications on NIHSS
timeFrame: at 24h
measure: Influence of hemorrhagic complications on NIHSS
timeFrame: at 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Hubert DESAL, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: