NCT02216565

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
OTHER	Hospitalization in specialized neuro-vascular unit
DRUG	Alteplase if patient is eligible	Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
OTHER	Supportive care	Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition
PROCEDURE	Endovascular treatment	Recanalization treatment (thrombectomy / intraarterial thrombolysis)

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-08-31
• Completion: 2017-08-24
• First posted: 2014-08-15
• Last updated: 2017-12-05

Locations

3 sites across 1 country: France