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

NCT02216565 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-12-05

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Marc-Antoine Labeyrie, MD · Hopital Lariboisiere, Paris

  • Michel Piotin, MD · Fondation Ophtalmologique Adolphe de Rothschild, Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-01
Primary Completion
2015-08-31
Completion
2017-08-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02216565 on ClinicalTrials.gov