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).
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Nantes, Frankrike, 44093
- CHU de Nantes
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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clinical score for handicap (mRS)
Tidsram: at 3 months
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at 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
hemorrhagic complications on postoperative imaging
Tidsram: baseline
|
baseline
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hemorrhagic complications on postoperative imaging
Tidsram: at 1 day
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at 1 day
|
|
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physiological parameter : age
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of coronary artery disease
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of arterial hypertension
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of diabetes
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of hypercholesterolemia
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of intracranial stenosis
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of occlusive arterial disease
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of haematological disorders
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of neoplasia
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
NIHSS score
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
ASPECTS score
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
MRI imaging of stroke
Tidsram: baseline
|
Factors of good clinical prognosis
|
baseline
|
|
unblocking rate based on the score TICI
Tidsram: at 3 months
|
at 3 months
|
|
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NIHSS evaluation
Tidsram: at 24h
|
at 24h
|
|
|
Influence of collaterality score on the NIHSS
Tidsram: at 24h
|
at 24h
|
|
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Influence ASPECTS score on the NIHSS
Tidsram: at 24h
|
at 24h
|
|
|
Influence ASPECTS score on the NIHSS
Tidsram: at 3months
|
at 3months
|
|
|
influence of anesthesia on the NIHSS
Tidsram: at 24h
|
at 24h
|
|
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hemorrhagic complications
Tidsram: at 24h
|
at 24h
|
|
|
Influence of hemorrhagic complications on NIHSS
Tidsram: at 24h
|
at 24h
|
|
|
Influence of hemorrhagic complications on NIHSS
Tidsram: at 3 months
|
at 3 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Hubert DESAL, PU-PH, Nantes university hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RC11_0097
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