NCT03702413

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

Completed NA Last updated 12 July 2022

What this trial tests

NA trial testing Endovascular treatment in Mechanical Thrombectomy in 203 participants. Completed in 30 March 2022.

Timeline

30 November 2018

Primary endpoint
21 December 2021

30 March 2022

Quick facts

Lead sponsor	Hyogo Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	203
Start date	30 November 2018
Primary completion	21 December 2021
Estimated completion	30 March 2022
Sites	1 location across Japan

Drugs / interventions tested

• Endovascular treatment

Conditions studied

• Mechanical Thrombectomy — all drugs for Mechanical Thrombectomy →
• Large Ischemic Core — all drugs for Large Ischemic Core →

Sponsor

Hyogo Medical University

Who can join

18 and older, any sex, with Mechanical Thrombectomy or Large Ischemic Core. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endovascular Therapy for Acute Stroke with a Large Ischemic Region.
   Yoshimura S, Sakai N, Yamagami H, Uchida K, et al · · 2022 · cited 654× · PMID 35138767 · DOI 10.1056/nejmoa2118191
2. 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 Embolis
   Uchida K, Shindo S, Yoshimura S, Toyoda K, et al · · 2022 · cited 66× · PMID 36215044 · DOI 10.1001/jamaneurol.2022.3285
3. Outcomes of Mechanical Thrombectomy for Patients With Stroke Presenting With Low Alberta Stroke Program Early Computed Tomography Score in the Early and Extended Window.
   Almallouhi E, Al Kasab S, Hubbard Z, Bass EC, et al · · 2021 · cited 53× · PMID 34878550 · DOI 10.1001/jamanetworkopen.2021.37708
4. Identifying large ischemic core volume ranges in acute stroke that can benefit from mechanical thrombectomy.
   Yoshimoto T, Inoue M, Tanaka K, Kanemaru K, et al · · 2021 · cited 52× · PMID 33323502 · DOI 10.1136/neurintsurg-2020-016934
5. Expanding indications for endovascular thrombectomy-how to leave no patient behind.
   Sporns PB, Fiehler J, Ospel J, Safouris A, et al · · 2021 · cited 28× · PMID 33796144 · DOI 10.1177/1756286421998905
6. Benefit and risk of intravenous alteplase in patients with acute large vessel occlusion stroke and low ASPECTS.
   Broocks G, McDonough R, Bechstein M, Hanning U, et al · · 2023 · cited 27× · PMID 35078927 · DOI 10.1136/neurintsurg-2021-017986
7. Selection criteria for large core trials: rationale for the ANGEL-ASPECT study design.
   Ren Z, Huo X, Ma G, Tong X, et al · · 2022 · cited 27× · PMID 34326195 · DOI 10.1136/neurintsurg-2021-017798
8. Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial.
   Huo X, Ma G, Zhang X, Pan Y, et al · · 2023 · cited 21× · PMID 36137599 · DOI 10.1136/svn-2022-001865