Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Hospitalization in specialized neuro-vascular unit
- Conditions
- Stroke, Acute
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Enrollment
- 2
- Locations
- 3
- Primary Endpoint
- Improvement in NIHSS score after 24h
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Radiologically proven acute proximal occlusion of middle cerebral artery
- •AND one of the three following :
- •tandem internal carotid / middle cerebral artery occlusion
- •intravenous thrombolysis contraindicated because of high risk of haemorrhage
- •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
Arms & Interventions
Medical treatment
Conventional medical non-interventional treatment
Intervention: Hospitalization in specialized neuro-vascular unit
Medical treatment
Conventional medical non-interventional treatment
Intervention: Alteplase if patient is eligible
Medical treatment
Conventional medical non-interventional treatment
Intervention: Supportive care
Endovascular treatment
Conventional medical treatment plus endovascular treatment
Intervention: Hospitalization in specialized neuro-vascular unit
Endovascular treatment
Conventional medical treatment plus endovascular treatment
Intervention: Alteplase if patient is eligible
Endovascular treatment
Conventional medical treatment plus endovascular treatment
Intervention: Supportive care
Endovascular treatment
Conventional medical treatment plus endovascular treatment
Intervention: Endovascular treatment
Outcomes
Primary Outcomes
Improvement in NIHSS score after 24h
Time Frame: 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 Outcomes
- Improvement in NIHSS score after 7 days(7 days)
- Fatality within 7 days(7 days)
- Functional recovery after 3 months(3 months)
- Fatality within 3 months(3 months)