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

Primary Purpose

Stroke, Acute

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hospitalization in specialized neuro-vascular unit
Alteplase if patient is eligible
Supportive care
Endovascular treatment
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Stroke, Endovascular treatment, Tandem carotid occlusions, Fibrinolysis

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Henri Mondor
  • Fondation Ophtalmologique Adolphe de Rothschild
  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Medical treatment

Endovascular treatment

Arm Description

Conventional medical non-interventional treatment

Conventional medical treatment plus endovascular treatment

Outcomes

Primary Outcome Measures

Improvement in NIHSS score after 24h
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

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

Full Information

First Posted
August 13, 2014
Last Updated
December 4, 2017
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02216565
Brief Title
Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase
Acronym
EASY
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
After results of other studies published : EASY study became lapsed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
August 31, 2015 (Actual)
Study Completion Date
August 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Stroke, Endovascular treatment, Tandem carotid occlusions, Fibrinolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical treatment
Arm Type
Other
Arm Description
Conventional medical non-interventional treatment
Arm Title
Endovascular treatment
Arm Type
Other
Arm Description
Conventional medical treatment plus endovascular treatment
Intervention Type
Other
Intervention Name(s)
Hospitalization in specialized neuro-vascular unit
Intervention Type
Drug
Intervention Name(s)
Alteplase if patient is eligible
Intervention Description
Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
Intervention Type
Other
Intervention Name(s)
Supportive care
Intervention Description
Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition
Intervention Type
Procedure
Intervention Name(s)
Endovascular treatment
Intervention Description
Recanalization treatment (thrombectomy / intraarterial thrombolysis)
Primary Outcome Measure Information:
Title
Improvement in NIHSS score after 24h
Description
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)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Improvement in NIHSS score after 7 days
Description
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)
Time Frame
7 days
Title
Functional recovery after 3 months
Description
modified Rankin Score (mRS) after 3 months ("positive recovery" if mRS <=2, "excellent recovery" if mRS<=1)
Time Frame
3 months
Title
Fatality within 7 days
Description
Proportion of patients deceased within seven days after stroke
Time Frame
7 days
Title
Fatality within 3 months
Description
Proportion of patients deceased within 3 months after stroke
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Radiologically proven acute proximal occlusion of middle cerebral artery AND one of the three following : tandem internal carotid / middle cerebral artery occlusion intravenous thrombolysis contraindicated because of high risk of haemorrhage 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc-Antoine Labeyrie, MD
Organizational Affiliation
Hopital Lariboisiere, Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Piotin, MD
Organizational Affiliation
Fondation Ophtalmologique Adolphe de Rothschild, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

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

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