Stroke, Acute
Conditions
Keywords
Stroke, Endovascular treatment, Tandem carotid occlusions, Fibrinolysis
Brief summary
This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery. The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours. The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone
Interventions
OTHERHospitalization in specialized neuro-vascular unit
DRUGAlteplase if patient is eligible
Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
OTHERSupportive care
Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition
PROCEDUREEndovascular treatment
Recanalization treatment (thrombectomy / intraarterial thrombolysis)
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
* Radiologically proven acute proximal occlusion of middle cerebral artery AND one of the three following : 1. tandem internal carotid / middle cerebral artery occlusion 2. intravenous thrombolysis contraindicated because of high risk of haemorrhage 3. intravenous thrombolysis not possible because of delay \> 4.5 hours
Exclusion criteria
* Impossibility to perform endovascular recanalization within 6h * Clinically minor stroke (NIHSS score below 5 at baseline) * Extended cerebral infarction * Severe comorbidity * Life expectancy below 3 months before stroke * Pregnancy or breastfeeding * modified Rankin Score superior to 2 before stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in NIHSS score after 24h | 24 hours | Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and h24 (t1) calculated as follow : \[NIHSS(t0) - NIHSS(t1)\] / NIHSS(t0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in NIHSS score after 7 days | 7 days | Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and day7 (t2) calculated as follow : \[NIHSS(t0) - NIHSS(t2)\] / NIHSS(t0) |
| Functional recovery after 3 months | 3 months | modified Rankin Score (mRS) after 3 months (positive recovery if mRS \<=2, excellent recovery if mRS\<=1) |
| Fatality within 7 days | 7 days | Proportion of patients deceased within seven days after stroke |
| Fatality within 3 months | 3 months | Proportion of patients deceased within 3 months after stroke |
Countries
France
Outcome results
None listed