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Endovascular Acute Stroke Intervention Trial - the EASI Trial (EASI)

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ClinicalTrials.gov Identifier: NCT02157532
Recruitment Status : Recruiting
First Posted : June 6, 2014
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. It has been shown that patients with a moderate to severe clinical score have occlusion of brain large vessels, resulting in a worse clinical outcome. Many studies have demonstrated that early recanalization after IV rtPA is more restricted, the larger and more proximal the artery. Several systems for mechanical intracranial arterial thrombectomy of large trunks have recently been proposed and are now available. Potential advantages of these mechanical systems on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic injection.

The objective of the EASI trial is thus to:

  • To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in patients treated with IV thrombolysis or in patients for whom thrombolysis is contra-indicated.
  • To determine whether a combined approach, standard treatment plus thrombectomy, is superior to standard treatment alone within 5 h of the appearance of symptoms, in patients with occlusion of proximal cerebral arteries following moderate to severe stroke (NIHSS larger than or equal to 8), evaluated at 3 months.

The design is a randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment.

480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3 months.

IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is carried out with already approved devices, according to the manufacturer's instructions, following a diagnostic cerebral angiography.

The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3 months.

The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage at 24 hours.

If the primary hypothesis is validated, expected benefits of this study is a higher rate of autonomy for stroke patients with all the attendant consequences: reduction in hospital stays, and a faster return to the activities of daily life.


Condition or disease Intervention/treatment Phase
Stroke, Acute Procedure: mechanical thrombectomy Drug: Best standard treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-arterial Thrombectomy as an Acute Treatment Intervention for Stoke: the Endovascular Acute Stoke Intervention (EASI) Trial
Study Start Date : January 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Active Comparator: Best standard treatment
intravenous r-tPA or any other medical management
Drug: Best standard treatment
Intravenous r-tPA infusion or any other medical management option
Other Name: Medical management

Active Comparator: Mechanical thrombectomy
Endovascular mechanical thrombectomy with stent-retrievers
Procedure: mechanical thrombectomy
Mechanical thrombectomy using any already approved stent-retriever device




Primary Outcome Measures :
  1. clinical (efficacy): favorable modified Rankin Score (less than or equal to 2) [ Time Frame: 3 months ]
    The efficacy of mechanical thrombectomy compared to standard stroke treatment will be evaluated using the modified Rankin scale score at 3 months. This measure includes the rate of death within 3 months

  2. Rate of symptomatic intracranial hemorrhage [ Time Frame: 24 hours ]
    the incidence of symptomatic hemorrhage on non-contrast CT at 24 hours will be recorded


Secondary Outcome Measures :
  1. Infarct evolution [ Time Frame: 24 hours ]
    the evolution of the infarct on CT will be carried out according to a semi-quantitative evaluation using the ASPECT score between the pre-treatment CT and the 24 hour cross-sectional imaging study

  2. Angiographic outcome in patients allocated to mechanical thrombectomy [ Time Frame: 2 hours ]
    In patients allocated to the mechanical thrombectomy arm, the occlusion state of the target vessel will be assessed at the end of the intervention according to the TICI scale

  3. Frequency and Severity of complications [ Time Frame: 3 months ]
  4. Rate of intracranial hemorrhage [ Time Frame: 24 hours ]
    The incidence of hemorrhage on non-contrast CT at 24 hours will be recorded



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18
  • NIHSS greater than or equal to 8
  • onset of symptoms is less than 5 hours OR symptom/imaging mismatch
  • suspected occlusion of the M1 or M2 segment of the MCA, supraclinoid ICA, or basilar trunk.

Exclusion Criteria:

  • established infarction of the target symptomatic territory
  • co-morbid diseases which suggest a poor 90 day outcome irrespective of management
  • radiologic evidence of hemorrhagic transformation of the infarcted territory

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157532


Contacts
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Contact: Ruby Klink, PhD 1-514-890-8000 ext 25245 ruby.klink@crchum.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Ruby Klink, PhD    1-514-890-8000 ext 25245    ruby.klink@crchum.qc.ca   
Principal Investigator: Jean Raymond, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Jean Raymond, MD Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator: Serge Bracard, MD Central Hospital, Nancy, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02157532     History of Changes
Other Study ID Numbers: CE 12.224
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Severe stroke
IV tPA
mechanical thrombectomy

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases