Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase

Not Applicable

Terminated

• Conditions: Stroke, Acute
• Interventions: Other: Hospitalization in specialized neuro-vascular unit; Drug: Alteplase if patient is eligible; Other: Supportive care; Procedure: Endovascular treatment

• Registration Number: NCT02216565
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Study Start: 2014-12-01
• Primary Completion: 2015-08-31
• Study Completion: 2017-08-24
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical treatment	Supportive care	Conventional medical non-interventional treatment
Endovascular treatment	Supportive care	Conventional medical treatment plus endovascular treatment
Medical treatment	Hospitalization in specialized neuro-vascular unit	Conventional medical non-interventional treatment
Endovascular treatment	Endovascular treatment	Conventional medical treatment plus endovascular treatment
Medical treatment	Alteplase if patient is eligible	Conventional medical non-interventional treatment
Endovascular treatment	Alteplase if patient is eligible	Conventional medical treatment plus endovascular treatment
Endovascular treatment	Hospitalization in specialized neuro-vascular unit	Conventional medical treatment plus endovascular treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Fatality within 7 days	7 days	Proportion of patients deceased within seven days after stroke
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 3 months	3 months	Proportion of patients deceased within 3 months after stroke

Trial Locations

Locations (3)

Hopital Henri Mondor; 🇫🇷 Creteil, France

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France