Endovascular TherapyNCT07347665
Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery
A study testing Endovascular therapy in people with Endovascular Therapy and Acute Ischemic Stroke, run by Hyogo Medical University at 3 sites in 3 countries.
Trial summary
RESCUE-M2O trial is a prospective, open label, blinded endpoint (PROBE), two-arm, randomized, controlled, post-market study to assess the efficacy and safety of endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Endovascular Therapy, Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
- What is being tested?
- Endovascular therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Dec 2025to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute cerebral infarction
- Aged 18-84 years
- NIHSS score at admission ≥ 8
- Prestroke mRS scores of 0-1 (able to carry out all usual activities)
- Occlusion of the M2 segment of MCA on digital subtraction angiography
- ASPECTS ≥ 8 or DWI-ASPECTS ≥ 8
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- Ineligible or failed intravenous tPA (no recanalization within 30 min after injection)
- Randomization can be completed within 24 h from the last known well time
- EVT can be initiated within 30 min from randomization.
- The patient or their legally authorized representative has signed the informed consent form.
Who cannot join
- Occlusion of the anterior temporal artery, duplicate M1, or accessory M1
- Occlusion of multiple major intracranial arteries
- Difficulty in endovascular access due to tortuous vascular anatomy
- Significant mass effect with midline shift on CT (or MRI)
- Known allergy (more severe than skin rash) to contrast agents
- Evidence of acute intracranial hemorrhage on CT (or MRI)
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- Pregnant or potentially pregnant
- Clinical evidence of chronic occlusion
- High risk of hemorrhage (platelet < 40,000/ul, APTT > 50 sec or PT-INR > 3.0)
- Participating in any other therapeutic investigational trial
- Judgment of the investigator to be non-compliant or uncooperative during the study
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Japan1 site, 1 recruiting
- Recruiting
Hyogo Medical University
Nishinomiya, Hyōgo, 663-8501
Kazutaka Uchida, MD, PhD, +81-798-45-6458, fu-sakakibara@hyo-med.ac.jp
Thailand1 site, 1 recruiting
- Recruiting
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120
Tantongtip Dilok, +66 2 926 9999, diloktan@tu.ac.th
Vietnam1 site, 1 recruiting
- Recruiting
S.I.S Can Tho International General Hospital
Can Tho, Can Tho City, 94118
Cuong Chi Tran, +84 292 378 9911, drthangle@dotquy.vn
About this study
Official title: Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery (the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-M2 Occlusion Trial: RESCUE-M2O Trial)
RESCUE-M2O trial is a prospective, open label, blinded endpoint (PROBE), two-arm, randomized, controlled, post-market study to assess the efficacy and safety of endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
- Conditions
- Endovascular Therapy, Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
- Being tested
- Endovascular therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular therapyProcedure or surgery
Endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy with endovascular therapy | Experimental | Not described Receives: Procedure: Endovascular therapy |
| Medical therapy alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2
modified Rankin Scale (mRS) is an ordinal scale ranging from 0 (no symptoms) to 6 (death) measuring the degree of disability or dependence in everyday life.
Measured: 90 days after randomization
Secondary outcomes (9)
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-1
Measured: 90 days after randomization
modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) shift analysis
Measured: 90 days after randomization
National Institutes of Health Stroke Scale (NIHSS; range, 0-42; higher scores indicate more severe neurological impairment) improvement of 8 points or more
Measured: 48 hours after randomization
Health-related quality of life assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L; range, 0-1.0; higher scores indicating better health-related quality of life)
Measured: 90 days after randomization
Symptomatic intracranial hemorrhage
Measured: 48 hours after randomization
Any intracranial hemorrhage
Measured: 48 hours after randomization
All cause death
Measured: 90 days after randomization
Recurrence of cerebral infarction
Measured: 90 days after randomization
Decompressive craniectomy
Measured: 7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyogo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazutaka Uchida, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347665
- Sponsor's protocol ID
- R000066936
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery (the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-M2 Occlusion Trial: RESCUE-M2O Trial)
- ClinicalTrials.gov ID
- NCT07347665
- Acronym / sponsor ID
- R000066936
- Conditions
- Endovascular Therapy, Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hyogo Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RESCUE-M2O trial is a prospective, open label, blinded endpoint (PROBE), two-arm, randomized, controlled, post-market study to assess the efficacy and safety of endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy with endovascular therapy | Experimental | Procedure: Endovascular therapy |
| Medical therapy alone | No intervention | – |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Acute cerebral infarction
- Aged 18-84 years
- NIHSS score at admission ≥ 8
- Prestroke mRS scores of 0-1 (able to carry out all usual activities)
- Occlusion of the M2 segment of MCA on digital subtraction angiography
Key exclusion criteria (11 listed)
- Occlusion of the anterior temporal artery, duplicate M1, or accessory M1
- Occlusion of multiple major intracranial arteries
- Difficulty in endovascular access due to tortuous vascular anatomy
- Significant mass effect with midline shift on CT (or MRI)
- Known allergy (more severe than skin rash) to contrast agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular therapyEndovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery. | Procedure or surgery | Medical therapy with endovascular therapy |
Primary outcome
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2
Time frame: 90 days after randomization
modified Rankin Scale (mRS) is an ordinal scale ranging from 0 (no symptoms) to 6 (death) measuring the degree of disability or dependence in everyday life.
9 secondary outcomes
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-1
Time frame: 90 days after randomization
modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) shift analysis
Time frame: 90 days after randomization
National Institutes of Health Stroke Scale (NIHSS; range, 0-42; higher scores indicate more severe neurological impairment) improvement of 8 points or more
Time frame: 48 hours after randomization
Health-related quality of life assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L; range, 0-1.0; higher scores indicating better health-related quality of life)
Time frame: 90 days after randomization
Symptomatic intracranial hemorrhage
Time frame: 48 hours after randomization
Any intracranial hemorrhage
Time frame: 48 hours after randomization
All cause death
Time frame: 90 days after randomization
Recurrence of cerebral infarction
Time frame: 90 days after randomization
Decompressive craniectomy
Time frame: 7 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular therapy in people with Endovascular Therapy and Acute Ischemic Stroke, run by Hyogo Medical University at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan, Thailand, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kazutaka Uchida, MD, PhD (81+798-45-6458, fu-sakakibara@hyo-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2 (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.