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

NCT03702413 | Completed DMC

• 1 other identifier: R000038184
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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).

Conditions

Mechanical Thrombectomy; Large Ischemic Core

Keywords

Acute cerebral infarction due to large vessel occlusion; Mechanical thrombectomy; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale ≤3 at 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.

  90 days

Secondary Outcomes (9)

• modified Rankin Scale≤2 at 90 days

  90 days

• modified Rankin Scale≤1 at 90 days

  90 days

• Distribution of patients across the ordinal modified Rankin scale

  90 days

• NIHSS improvement 8 points or more at 48 hours

  48 hours

• Symptomatic intracranial hemorrhage within 48 hours

  48 hours

Study Arms (2)

Best medical treatment

NO INTERVENTION

Best medical treatment

Endovascular treatment

EXPERIMENTAL

Best medical treatment plus endovascular treatment

Procedure: Endovascular treatment

Interventions

Endovascular treatment PROCEDURE

Acute thrombectomy

Endovascular treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute cerebral infarction
• Age ≥ 18
• NIHSS ≥ 6
• Prestroke Modified Rankin Score 0-1
• ICA or M1 Occlusion on CT angiography or MR angiography
• ASPECTS 3-5 or DWI-ASPECTS 3-5
• 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.
• Endovascular treatment can be initiatedwithin 60 minutes from randomization
• Patient or Legally Authorized Representative has signed the Informed Consent form

You may not qualify if:

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

Sponsors & Collaborators

• Hyogo Medical University: lead

Study Sites (1)

Hyogo collage of Medicine

Nishinomiya, Hyōgo, 665-8501, Japan

Location

Related Publications (7)

• Tanaka K, Yoshimoto T, Koge J, Yamagami H, Imamura H, Sakai N, Uchida K, Beppu M, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Sakakibara F, Morimoto T, Yoshimura S, Toyoda K; RESCUE-Japan LIMIT Investigators. Detrimental Effect of Acute Hyperglycemia on the Outcomes of Large Ischemic Region Stroke. J Am Heart Assoc. 2024 Dec 3;13(23):e034556. doi: 10.1161/JAHA.124.034556. Epub 2024 Nov 22.

  PMID: 39575760 DERIVED

• Inoue M, Yoshimoto T, Yamagami H, Toyoda K, Sakai N, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Uchida K, Beppu M, Sakakibara F, Morimoto T, Yoshimura S; RESCUE-Japan LIMIT Investigators. Expanding the Treatable Imaging Profile in Patients With Large Ischemic Stroke: Subanalysis From a Randomized Clinical Trial. Stroke. 2024 Jul;55(7):1730-1738. doi: 10.1161/STROKEAHA.124.046828. Epub 2024 May 28.

  PMID: 38804134 DERIVED

• Shindo S, Uchida K, Yoshimura S, Sakai N, Yamagami H, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Sakakibara F, Nakajima M, Ueda M, Morimoto T. Intravenous alteplase before endovascular therapy for acute large vessel occlusion with large ischemic core: subanalysis of a randomized clinical trial. J Neurointerv Surg. 2024 Oct 14;16(11):1094-1100. doi: 10.1136/jnis-2023-020846.

  PMID: 37890987 DERIVED

• Ospel JM, Kunz WG, McDonough RV, Goyal M, Uchida K, Sakai N, Yamagami H, Yoshimura S; RESCUE-Japan LIMIT Investigators. Cost-effectiveness of Endovascular Treatment for Acute Stroke with Large Infarct: A United States Perspective. Radiology. 2023 Oct;309(1):e223320. doi: 10.1148/radiol.223320.

  PMID: 37787675 DERIVED

• Namitome S, Uchida K, Shindo S, Yoshimura S, Sakai N, Yamagami H, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Inoue M, Beppu M, Sakakibara F, Shirakawa M, Ueda M, Morimoto T; RESCUE-Japan LIMIT Investigators. Number of Passes of Endovascular Therapy for Stroke With a Large Ischemic Core: Secondary Analysis of RESCUE-Japan LIMIT. Stroke. 2023 Aug;54(8):1985-1992. doi: 10.1161/STROKEAHA.123.042552. Epub 2023 Jul 7.

  PMID: 37417239 DERIVED

• Uchida K, Shindo S, Yoshimura S, Toyoda K, Sakai N, Yamagami H, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Yoshida A, Inoue M, Beppu M, Sakakibara F, Shirakawa M, Morimoto T; RESCUE-Japan LIMIT Investigators. Association Between Alberta Stroke Program Early Computed Tomography Score and Efficacy and Safety Outcomes With Endovascular Therapy in Patients With Stroke From Large-Vessel Occlusion: A Secondary Analysis of the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-Japan Large Ischemic Core Trial (RESCUE-Japan LIMIT). JAMA Neurol. 2022 Dec 1;79(12):1260-1266. doi: 10.1001/jamaneurol.2022.3285.

  PMID: 36215044 DERIVED

• 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.

  PMID: 35138767 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shinichi Yoshimura, phD

  Hyogo Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurosurgery

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 11, 2018
• Study Start: November 30, 2018
• Primary Completion: December 21, 2021
• Study Completion: March 30, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)