Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase (EASY)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Stroke, Acute

Treatments: Other: Hospitalization in specialized neuro-vascular unit; Procedure: Endovascular treatment; Other: Supportive care; Drug: Alteplase if patient is eligible

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02216565

2014-A00519-38

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18 to 82 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2 participants in 2 patient groups

Medical treatment

Other group

Description:

Conventional medical non-interventional treatment

Treatment:

Drug: Alteplase if patient is eligible

Other: Hospitalization in specialized neuro-vascular unit

Other: Supportive care

Endovascular treatment

Other group

Description:

Conventional medical treatment plus endovascular treatment

Treatment:

Drug: Alteplase if patient is eligible

Other: Hospitalization in specialized neuro-vascular unit

Procedure: Endovascular treatment

Other: Supportive care