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Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core

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ClinicalTrials.gov Identifier: NCT03702413
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Shinichi Yoshimura, Hyogo College of Medicine

Brief Summary:

RESCUE-Japan LIMIT(Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism Japan Large IscheMIc core Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone in the acute ischemic stroke patients with an low ASPECTS (CT-ASPECTS 3-5 or DWI-ASPECTS 3-5).

The purpose of this study is to investigate the efficacy of endovascular treatment for acute large vessel occlusion with large ischemic core (CT-ASPECT score 3-5 or DWI-ASPECT score 3-5).


Condition or disease Intervention/treatment Phase
Mechanical Thrombectomy Large Ischemic Core Procedure: Endovascular treatment Not Applicable

Detailed Description:

In the American Heart Association guideline 2018, endovascular therapy (EVT) has been strongly recommended as class of recommendation (COR) I for for the patients with acute cerebral large vessel occlusion (LVO), the Alberta Stroke Program Early CT Score (ASPECTS) 6 or more. The efficacy of EVT for the patients with low ASPECTS remains unclear.

This study is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone for acute large vessel occlusion patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTS 3-5).

Up to 200 subjects will be enrolled in the study and randomized for the Intention to treat analysis set. The randomization will be stratified by treatment institutes, patient's age (less than 75 years old or not), time from symptom onset (0-2 hours or more than 2 hours), and stroke severity (NIHSS 21 or more/less than 21), and administration of rt-PA.

Subjects who meet the inclusion criteria will be randomized in a 1:1 ratio to one of the following two treatment arms: Arm 1: best medical treatment Arm 2: best medical treatment plus endovascular treatment

Primary outcome of this study is to investigate efficacy of endivascular treatment in acute stroke patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTs 3-5) as compared to best medical treatment alone.

Approximately 40 sites in Japan Patients presenting with acute ischemic stroke (AIS) based on focal occlusion in the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA), and who meet all eligibility criteria will be considered for study enrollment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core (RESCUE Japan LIMIT)
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
No Intervention: Best medical treatment
Experimental: Endovascular treatment
Best medical treatment plus endovascular treatment
Procedure: Endovascular treatment
Acute thrombectomy




Primary Outcome Measures :
  1. modified Rankin Scale ≤3 at 90 days [ Time Frame: 90 days ]

    The primary endpoint of the trial is the modified Rankin Scale (mRS) ≤3 at 90 days post-stroke.The scale runs from 0-6 with 0 being perfect health without symptoms to 6 being death.

    0: No symptoms.

    1. No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. Slight disability. Able to look after own a符airs without assistance, but unable to carry out all previous activities.
    3. Moderate disability. Requires some help, but able to walk unassisted.
    4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. Severe disability. Requires constant nursing care and a悦ention, bedridden, incontinent.
    6. Dead.


Secondary Outcome Measures :
  1. modified Rankin Scale≤2 at 90 days [ Time Frame: 90 days ]
    Functional independence as difined by modified Rankin ScalemRS≤2 at 90 days

  2. modified Rankin Scale≤1 at 90 days [ Time Frame: 90 days ]
    Excellent outcome as difined by modified Rankin Scale≤1 at 90 days

  3. Distribution of patients across the ordinal modified Rankin scale [ Time Frame: 90 days ]
    The difference in linear trends in ordinal mRS outcomes between treatment groups (mRS shift analysis)

  4. NIHSS improvement 8 points or more at 48 hours [ Time Frame: 48 hours ]
    Early improvement of neulogical findings

  5. Symptomatic intracranial hemorrhage within 48 hours [ Time Frame: 48 hours ]
    Defined as NIHSS worsening of 4 or more points associated with ICH within 48 hours of randomization

  6. Intracranial hemorrhage within 48 hours [ Time Frame: 48 hours ]
    The incidence of hemorrhage

  7. Death [ Time Frame: 90 days ]
    Death due to any cause at 90 days

  8. Recurrence of cerebral infarction within 90 days [ Time Frame: 90 days ]
    Recurrence of cerebral infarction

  9. Propotion of subjects who required decompressive craniectomy within 7 days [ Time Frame: 7 days ]
    Propotion of subjects who had space-occupying infarction (malignant brain edema) and requred decompressive craniectomy within 7 days



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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:

  1. Acute cerebral infarction
  2. Age ≥ 18
  3. NIHSS ≥ 6
  4. Prestroke Modified Rankin Score 0-1
  5. ICA or M1 Occlusion on CT angiography or MR angiography
  6. ASPECTS 3-5 or DWI-ASPECTS 3-5
  7. Randamization can be finished within 6 hours from last known well time, or 6 to 24 hours from last well known well time without positive lesion on MRI-FLAIR image.
  8. Endovascular treatment can be initiatedwithin 60 minutes from randomization
  9. Patient or Legally Authorized Representative has signed the Informed Consent form

Exclusion Criteria:

  1. Significant mass effect with midline shift
  2. Known allergy to contrast agents
  3. Evidence of acute intracranial hemorrhage
  4. Female who is pregnant or suspicision of pregnant
  5. Clinical evidence of chronic occlusion
  6. High risk of hemorrhage (platelet < 40,000 /µL, APTT > 50 second or PT-INR > 3.0)
  7. Participating in any other therapeutic investigational trial
  8. Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.

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): NCT03702413


Contacts
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Contact: Shinichi Yoshimura, PhD +817986455 s-yoshi@hyo-med.ac.jp

Locations
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Japan
Hyogo collage of Medicine Recruiting
Nishinomiya, Hyogo, Japan, 665-8501
Contact: Kazutaka Uchida    +81798456458    kuchidans@yahoo.co.jp   
Contact: Toshinori Takagi    +81798456458    to-takagi@hyo-med.ac.jp   
Sponsors and Collaborators
Hyogo College of Medicine
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Responsible Party: Shinichi Yoshimura, Department of Neurosurgery, Hyogo College of Medicine
ClinicalTrials.gov Identifier: NCT03702413    
Other Study ID Numbers: R000038184
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shinichi Yoshimura, Hyogo College of Medicine:
Acute cerebral infarction due to large vessel occlusion
Mechanical thrombectomy
Ischemic stroke
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes