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

December 4, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Hopital Henri Mondor
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Suresnes, France, 92151
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 82 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Medical treatment
Conventional medical non-interventional treatment
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
Other: Endovascular treatment
Conventional medical treatment plus endovascular treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in NIHSS score after 7 days
Time Frame: 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)
7 days
Functional recovery after 3 months
Time Frame: 3 months
modified Rankin Score (mRS) after 3 months ("positive recovery" if mRS <=2, "excellent recovery" if mRS<=1)
3 months
Fatality within 7 days
Time Frame: 7 days
Proportion of patients deceased within seven days after stroke
7 days
Fatality within 3 months
Time Frame: 3 months
Proportion of patients deceased within 3 months after stroke
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Marc-Antoine Labeyrie, MD, Hôpital Lariboisière, Paris
  • Principal Investigator: Michel Piotin, MD, Fondation Ophtalmologique Adolphe de Rothschild, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

August 31, 2015

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00519-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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