UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058537 |
|---|---|
| Receipt number | R000066936 |
| Scientific Title | Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke with Occlusion of the M2 Segment of Middle Cerebral Artery |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/07/21 21:59:51 |
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Basic information
Public title
Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke with Occlusion of
the M2 Segment of Middle Cerebral Artery
Acronym
RESCUE-M2O
Scientific Title
Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke with Occlusion of
the M2 Segment of Middle Cerebral Artery
Scientific Title:Acronym
RESCUE-M2O
Region
| Japan | Asia(except Japan) |
Condition
Condition
Acute Ischemic Stroke with Occlusion of the M2 Segment of Middle Cerebral Artery
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Achievement of mRS scores of 0-2 at 90 days after randomization
Key secondary outcomes
(1) Achievement of mRS scores of 0-1 at 90 days after randomization
(2) mRS shift analysis at 90 days after randomization
(3) NIHSS improvement of 8 points or more at 48 hours after randomization
(4) QOL (EQ-5D-3L) at 90 days after randomization
(5) Symptomatic intracranial hemorrhage (ICH) within 48 hours after randomization
(6) Any ICH within 48 hours after randomization
(7) All cause death (mRS 6) within 90 days after randomization
(8) Recurrence of cerebral infarction within 90 days after randomization
(9) Decompressive craniectomy within 7 days after randomization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Medical therapy+Endovascular therapy
Interventions/Control_2
Medical therapy alone
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Acute cerebral infarction
(2) Aged 18-84 years
(3) NIHSS score at admission 8 or more
(4) Prestroke mRS scores of 0-1
(5) Occlusion of the M2 segment of MCA on digital subtraction angiography (DSA)
(6) ASPECTS 8 or more, or DWI-ASPECTS 8 or more
(7) Ineligible or failed IV-tPA (no recanalization within 30 minutes after injection)
(8) Randomization can be completed within 24 hours from the last known well time.
(9) EVT can be initiated within 30 minutes from randomization.
(10) The patient or their legally authorized representative has signed the informed consent form.
Key exclusion criteria
(1) Occlusion of the anterior temporal artery, duplicate M1, or accessory M1
(2) Occlusion of multiple major intracranial arteries
(3) Difficulty in endovascular access due to tortuous vascular anatomy
(4) Significant mass effect with midline shift on CT (or MRI)
(5) Known allergy (more severe than skin rash) to contrast agents
(6) Evidence of acute intracranial hemorrhage on CT (or MRI)
(7) Pregnant or potentially pregnant
(8) Clinical evidence of chronic occlusion
(9) High risk of hemorrhage (platelet < 40,000/ul, APTT > 50 second or PT-INR > 3.0)
(10) Participating in any other therapeutic investigational trial
(11) Judgment of the investigator to be non-compliant or uncooperative during the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Yoshimura |
Organization
Hyogo Medical University
Division name
Department of Neurosurgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6455
fu-sakakibara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Uchida |
Organization
Hyogo Medical University
Division name
Department of Neurosurgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6455
Homepage URL
fu-sakakibara@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards at Hyogo Medical University
Address
1-1 Mukogawa, Nishinomiya, Hyogo
Tel
0798-45-6455
rinri@hyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066936
