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

NCT ID: NCT02216565

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-01

Study Completion Date

2017-08-24

Brief Summary

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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

Detailed Description

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Conditions

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Stroke, Acute

Keywords

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Stroke Endovascular treatment Tandem carotid occlusions Fibrinolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medical treatment

Conventional medical non-interventional treatment

Group Type OTHER

Hospitalization in specialized neuro-vascular unit

Intervention Type OTHER

Alteplase if patient is eligible

Intervention Type DRUG

Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)

Supportive care

Intervention Type OTHER

Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition

Endovascular treatment

Conventional medical treatment plus endovascular treatment

Group Type OTHER

Hospitalization in specialized neuro-vascular unit

Intervention Type OTHER

Alteplase if patient is eligible

Intervention Type DRUG

Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)

Supportive care

Intervention Type OTHER

Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition

Endovascular treatment

Intervention Type PROCEDURE

Recanalization treatment (thrombectomy / intraarterial thrombolysis)

Interventions

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Hospitalization in specialized neuro-vascular unit

Intervention Type OTHER

Alteplase if patient is eligible

Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)

Intervention Type DRUG

Supportive care

Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition

Intervention Type OTHER

Endovascular treatment

Recanalization treatment (thrombectomy / intraarterial thrombolysis)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc-Antoine Labeyrie, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisiere, Paris

Michel Piotin, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild, Paris

Locations

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Hopital Henri Mondor

Créteil, , France

Site Status

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00519-38

Identifier Type: -

Identifier Source: org_study_id