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History of Changes for Study: NCT03702413
Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core
Latest version (submitted July 10, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 8, 2018 None (earliest Version on record)
2 October 16, 2018 Recruitment Status, Study Status, Contacts/Locations and Conditions
3 May 24, 2019 Study Status, Arms and Interventions, Eligibility and Study Description
4 March 2, 2021 Study Status
5 November 9, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and Arms and Interventions
6 December 22, 2021 Study Status
7 July 10, 2022 Recruitment Status and Study Status
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Study NCT03702413
Submitted Date:  October 8, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: R000038184
Brief Title: Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core
Official Title: Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core (RESCUE Japan LIMIT)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Not yet recruiting
Study Start: November 1, 2018
Primary Completion: October 1, 2020 [Anticipated]
Study Completion: June 30, 2021 [Anticipated]
First Submitted: October 4, 2018
First Submitted that
Met QC Criteria:
October 8, 2018
First Posted: October 11, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 8, 2018
Last Update Posted: October 11, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hyogo College of Medicine
Responsible Party: Principal Investigator
Investigator: Shinichi Yoshimura
Official Title: Department of Neurosurgery
Affiliation: Hyogo College of Medicine
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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).

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 within 4.5 hours from onset 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.

Open or close this module Conditions
Conditions: Mechanical Thrombectomy
Large Ischemic Core
Keywords: Acute cerebral infarction due to large vessel occlusion
Mechanical thrombectomy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
No Intervention: Best medical treatment
Experimental: Endovascular treatment
Best medical treatment plus endovascular treatment within 4.5 hours from onset
Procedure: Endovascular treatment
Acute thrombectomy within 4.5 hours from stroke onset
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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. Endovascular treatment can be initiated within 4.5 hours from onset and within 60 minutes from randomization
  8. 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.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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