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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702413
Recruitment Status : Active, not recruiting
First Posted : October 11, 2018
Last Update Posted : December 23, 2021
Sponsor:
Information provided by (Responsible Party):
Shinichi Yoshimura, Hyogo College of Medicine

Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE October 11, 2018
Last Update Posted Date December 23, 2021
Actual Study Start Date  ICMJE November 30, 2018
Actual Primary Completion Date December 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • modified Rankin Scale≤2 at 90 days [ Time Frame: 90 days ]
    Functional independence as difined by modified Rankin ScalemRS≤2 at 90 days
  • modified Rankin Scale≤1 at 90 days [ Time Frame: 90 days ]
    Excellent outcome as difined by modified Rankin Scale≤1 at 90 days
  • 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)
  • NIHSS improvement 8 points or more at 48 hours [ Time Frame: 48 hours ]
    Early improvement of neulogical findings
  • 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
  • Intracranial hemorrhage within 48 hours [ Time Frame: 48 hours ]
    The incidence of hemorrhage
  • Death [ Time Frame: 90 days ]
    Death due to any cause at 90 days
  • Recurrence of cerebral infarction within 90 days [ Time Frame: 90 days ]
    Recurrence of cerebral infarction
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core
Official Title  ICMJE Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core (RESCUE Japan LIMIT)
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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mechanical Thrombectomy
  • Large Ischemic Core
Intervention  ICMJE Procedure: Endovascular treatment
Acute thrombectomy
Study Arms  ICMJE
  • No Intervention: Best medical treatment
    Best medical treatment
  • Experimental: Endovascular treatment
    Best medical treatment plus endovascular treatment
    Intervention: Procedure: Endovascular treatment
Publications * Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 9, 2021)
203
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2018)
200
Estimated Study Completion Date  ICMJE March 30, 2022
Actual Primary Completion Date December 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03702413
Other Study ID Numbers  ICMJE R000038184
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Shinichi Yoshimura, Hyogo College of Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hyogo College of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shinichi Yoshimura, phD Hyogo College of Medicine
PRS Account Hyogo College of Medicine
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP