Acute Ischemic StrokeNCT06146790
Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke
A study testing endovascular treatment and Standard medical management in people with Acute Ischemic Stroke and Endovascular Thrombectomy, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
Rationale: Distal Medium Vessel Occlusion (MeVO) are thought to cause as many as 25% to 40% of all acute ischemic strokes (AIS). Despite their relatively high frequency, there is no consensus regarding the optimal management of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Endovascular Thrombectomy
- What is being tested?
- endovascular treatment and Standard medical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years (no upper age limit).
- Evidence of a primary (e.g., not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the co/non-dominant M2 segment* or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) resulting in significant clinical deficits and expected to be treatable by endovascular thrombectomy.
- Co/non-dominant M2 segment vessel diameter should not exceed 2.0 mm. Co-dominant supplying 50% of the MCA territory vs non-dominant supplying <50% of the MCA territory.
- Premorbid mRS ≤ 2.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6 at the time of randomization.
- Time from onset (or time last seen well) to randomization<24 hours.
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- For patients with more than 6 hours of onset (or time last seen well), Clinical-Imaging mismatch assessment defined as any of the following scenarios (A or B):
- Non-contrast CT of the head or Brain MRI DWI lesion with <50% involvement of the vascular territory corresponding to the clinical manifestation:
- Target Mismatch Profile on CT perfusion or MRI (Mismatch Volume >10cc and mismatch Ratio >1.4 ).
- Informed consent obtained from patient or acceptable patient surrogate.
Who cannot join
- Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
- Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of <6 at randomization.
- Significant ischemic changes in a territory other than the occluded site that in the opinion of the investigator could reduce the benefit of endovascular treatment.
- Contra indication to imaging with MR or CT with contrast agents.
- Any terminal illness such that patient would not be expected to survive more than 1 year.
- Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
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- Any imaging findings suggestive of futile recanalization in the judgment of the local investigator.
- seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.
- Baseline blood glucose of <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol).
- Known history of hereditary or acquired hemorrhagic diathesis and/or platelet count <50×109/L.
- Known renal failure as defined as serum creatinine levels > 260umol/l（3.0 mg/dL）.
- Presumed septic embolus or suspicion of bacterial endocarditis.
- Any other condition that, in the opinion of the investigator could impose hazards to the patient or affect the participation of the patient in the study if an endovascular procedure was performed.
- History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation)
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Known pregnancy.
- Prisoner or incarceration
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Wei Hu, MD, +8615155510611, andinghu@ustc.edu.cn
About this study
Official title: Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke - a Multicenter, Randomized Controlled, Clinical Trial
Rationale: Distal Medium Vessel Occlusion (MeVO) are thought to cause as many as 25% to 40% of all acute ischemic strokes (AIS). Despite their relatively high frequency, there is no consensus regarding the optimal management of these patients. However, the fact that AIS related to MeVO often results in significant disability despite best medical treatment (including intravenous thrombolysis, IVT) calls for novel treatment approaches. Fortunately, a growing number of non-randomized studies have now been published demonstrating the feasibility of endovascular treatment (EVT) for MeVO strokes. These studies have demonstrated that distal EVT leads to high rates of successful reperfusion and may be performed with a comparable safety profile to that of EVT for proximal arterial occlusions. Therefore, a strong rational exists to test the safety and efficacy of EVT for MeVO stokes in a prospective randomized clinical trial.
Objectives: The primary objective of this study is to evaluate the hypothesis that endovascular thrombectomy is superior to standard medical management in achieving more favorable outcomes according to the modified Rankin Scale scores at 90 days in subjects presenting with acute ischemic stroke related to a distal medium vessel occlusion within 24 hours from symptom onset (defined as time last know well, TLKW).
Read more
Secondary objectives include the assessment of the cost-effectiveness of endovascular thrombectomy in the medium vessel occlusion (MeVO) population as well as its impact on health-related quality of life.
Study design: The study is a prospective, multicenter, investigational, randomized, controlled, open-label study with blinded endpoint evaluation (PROBE design) and an adaptive design with population enrichment.
Study population: Subjects presenting with acute ischemic stroke within 24 hours from TLKW and whose strokes are attributable to a distal medium vascular occlusion defined as co/non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) with evidence of salvageable brain tissue on perfusion imaging, M2 segment vessel diameter should not exceed 2.0 mm.
Primary outcome: Shift in distribution of all levels of the 90-day the modified Rankin Scale with levels 5-6 combined (mRS; 0, 1, 2, 3, 4, 5-6) as assessed by structured assessment.
- Conditions
- Acute Ischemic Stroke, Endovascular Thrombectomy
- Being tested
- endovascular treatment, Standard medical management
- Keywords
- Medium Vessel Occlusion, Stroke Due To Medium Vessel Occlusion, Endovascular Treatment, Standard Medical Management
- 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 treatmentProcedure or surgery
For the subjects randomized to endovascular treatment (EVT) treatment initiation is defined as the date and time of arterial puncture. Ideally, femoral artery puncture will occur within 30 minutes of randomization and no longer than 60 minutes after the completion of the qualifying imaging. Treatment initiation (arterial puncture) must occur before 24 hours since the subject was last known well.Date and time of arterial puncture, revascularization, and procedure end will be recorded. It is expected that the interventional procedure will be completed within two (2) hours of arterial access. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.
Standard medical managementOther
Standard medical management
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment+ standard medical management | Experimental | For the subjects randomized to endovascular treatment (EVT), treatment initiation is defined as the date and time of arterial puncture. Ideally, femoral artery puncture will occur within 30 minutes of randomization and no longer than 60 minutes after the completion of the qualifying imaging. Treatment initiation (arterial puncture) must occur before 24 hours since the subject was last known well. Date and time of arterial puncture, revascularization, and procedure end will be recorded. It is expected that the interventional procedure will be completed within two (2) hours of arterial access. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial. Receives: Procedure: endovascular treatment |
| Standard medical management | Active comparator | Standard medical management Receives: Other: Standard medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 90-day modified Rankin Scale (mRS)
Shift in distribution of all levels of the 90-day modified Rankin Scale with levels 5-6 combined (mRS; 0, 1, 2, 3, 4, 5-6) as assessed by structured assessment.
Measured: 90 (± 14 days) after procedure
Secondary outcomes (4)
Modified Rankin Scale (mRS)
Shift in distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment.
Measured: 90 (± 14 days) after procedure
Independent Outcome
Rates of Independent Outcome defined as mRS ≤2 and/ or equal to Baseline mRS at 90 days
Measured: 90 (± 14 days) after procedure
Excellent Outcome
Rates of Excellent Outcome defined as mRS ≤1 and/ or equal to Baseline mRS at 90 days
Measured: 90 (± 14 days) after procedure
Good Functional Outcomes
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days as following:
- If NIHSS <10 and Baseline mRS 0 or 1: 90-day mRS ≤1
- If NIHSS <10 and Baseline mRS 2: 90-day mRS ≤2
- If NIHSS ≥10 and Baseline mRS 0 or 1: 90-day mRS ≤2
- If NIHSS ≥10 and Baseline mRS 2: 90-day mRS ≤3
Measured: 90 (± 14 days) after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start14 Dec 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies 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
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
- Investigators
- Wei Hu, MD, PhD, Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146790
- Sponsor's protocol ID
- ORIENTAL-MeVO
- Status last verified
- Aug 2024
- First submitted
- 10 Nov 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu W, Jing X, Chen Z, Zheng J, Yi T, Zheng T, Li Z, Liu J, Cui T, Wen J, Feng G, Song C, Yang L, Jiang S, Tong L, Jiang C, Ruan Z, Zhou P, Wang S, Wang T, Zhou Z, Ren Y, Qiu T, Zheng C, Wang H, Liu Y, Luo Y, Wang J, Ma Z, Mei B, Liang Y, Zhu Y, Li R, Sun J, Wang L, Zhang C, Liu T, Song J, Tao C, Wang A, Wang J, Xu P, Guo X, Shu L, Qureshi AI, Nguyen TN, AbdalKader M, Saver JL, Chen W, Nogueira RG. Endovascular Treatment of Medium-Vessel-Occlusion Strokes. N Engl J Med. 2026 May 14;394(19):1894-1904. doi: 10.1056/NEJMoa2514120.
PubMed 42127389Jing X, Nogueira RG, Nguyen TN, Tao C, Zhu Y, Li R, Sun J, Wang L, Zhang C, Liu T, Song J, Saver JL, Hu W. Endovascular treatment in acute intracranial distal medium vessel occlusion stroke: Study protocol and rationale. Int J Stroke. 2025 Jul;20(6):763-768. doi: 10.1177/17474930251332753. Epub 2025 Mar 25.
PubMed 40134089
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke - a Multicenter, Randomized Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT06146790
- Acronym / sponsor ID
- ORIENTAL-MeVO
- Conditions
- Acute Ischemic Stroke, Endovascular Thrombectomy
- Keywords
- Medium Vessel Occlusion, Stroke Due To Medium Vessel Occlusion, Endovascular Treatment, Standard Medical Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Nov 2023 (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.
Rationale: Distal Medium Vessel Occlusion (MeVO) are thought to cause as many as 25% to 40% of all acute ischemic strokes (AIS). Despite their relatively high frequency, there is no consensus regarding the optimal management of these patients. However, the fact that AIS related to MeVO often results in significant disability despite best medical treatment (including intravenous thrombolysis, IVT) calls for novel treatment approaches. Fortunately, a growing number of non-randomized studies have now been published demonstrating the feasibility of endovascular treatment (EVT) for MeVO strokes. These studies have demonstrated that distal EVT leads to high rates of successful reperfusion and may be performed with a comparable safety profile to that of EVT for proximal arterial occlusions. Therefore, a strong rational exists to test the safety and efficacy of EVT for MeVO stokes in a prospective randomized clinical trial.
Objectives: The primary objective of this study is to evaluate the hypothesis that endovascular thrombectomy is superior to standard medical management in achieving more favorable outcomes according to the modified Rankin Scale scores at 90 days in subjects presenting with acute ischemic stroke related to a distal medium vessel occlusion within 24 hours from symptom onset (defined as time last know well, TLKW).
Secondary objectives include the assessment of the cost-effectiveness of endovascular thrombectomy in the medium vessel occlusion (MeVO) population as well as its impact on health-related quality of life.
Study design: The study is a prospective, multicenter, investigational, randomized, controlled, open-label study with blinded endpoint evaluation (PROBE design) and an adaptive design with population enrichment.
Study population: Subjects presenting with acute ischemic stroke within 24 hours from TLKW and whose strokes are attributable to a distal medium vascular occlusion defined as co/non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) with evidence of salvageable brain tissue on perfusion imaging, M2 segment vessel diameter should not exceed 2.0 mm.
Primary outcome: Shift in distribution of all levels of the 90-day the modified Rankin Scale with levels 5-6 combined (mRS; 0, 1, 2, 3, 4, 5-6) as assessed by structured assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment+ standard medical management | Experimental | Procedure: endovascular treatmentFor the subjects randomized to endovascular treatment (EVT), treatment initiation is defined as the date and time of arterial puncture. Ideally, femoral artery puncture will occur within 30 minutes of randomization and no longer than 60 minutes after the completion of the qualifying imaging. Treatment initiation (arterial puncture) must occur before 24 hours since the subject was last known well. Date and time of arterial puncture, revascularization, and procedure end will be recorded. It is expected that the interventional procedure will be completed within two (2) hours of arterial access. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial. |
| Standard medical management | Active comparator | Other: Standard medical managementStandard medical management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years (no upper age limit).
- Evidence of a primary (e.g., not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the co/non-dominant M2 segment* or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) resulting in significant clinical deficits and expected to be treatable by endovascular thrombectomy.
- Premorbid mRS ≤ 2.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6 at the time of randomization.
- Time from onset (or time last seen well) to randomization<24 hours.
Key exclusion criteria (18 listed)
- Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
- Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of <6 at randomization.
- Significant ischemic changes in a territory other than the occluded site that in the opinion of the investigator could reduce the benefit of endovascular treatment.
- Contra indication to imaging with MR or CT with contrast agents.
- Any terminal illness such that patient would not be expected to survive more than 1 year.
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 treatmentFor the subjects randomized to endovascular treatment (EVT) treatment initiation is defined as the date and time of arterial puncture. Ideally, femoral artery puncture will occur within 30 minutes of randomization and no longer than 60 minutes after the completion of the qualifying imaging. Treatment initiation (arterial puncture) must occur before 24 hours since the subject was last known well.Date and time of arterial puncture, revascularization, and procedure end will be recorded. It is expected that the interventional procedure will be completed within two (2) hours of arterial access. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial. | Procedure or surgery | Endovascular treatment+ standard medical management |
| Standard medical managementStandard medical management | Other | Standard medical management |
Primary outcome
The 90-day modified Rankin Scale (mRS)
Time frame: 90 (± 14 days) after procedure
Shift in distribution of all levels of the 90-day modified Rankin Scale with levels 5-6 combined (mRS; 0, 1, 2, 3, 4, 5-6) as assessed by structured assessment.
4 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: 90 (± 14 days) after procedure
Independent Outcome
Time frame: 90 (± 14 days) after procedure
Excellent Outcome
Time frame: 90 (± 14 days) after procedure
Good Functional Outcomes
Time frame: 90 (± 14 days) after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Derived from this study: PubMed 42127389Hu W, Jing X, Chen Z, Zheng J, Yi T, Zheng T, Li Z, Liu J, Cui T, Wen J, Feng G, Song C, Yang L, Jiang S, Tong L, Jiang C, Ruan Z, Zhou P, Wang S, Wang T, Zhou Z, Ren Y, Qiu T, Zheng C, Wang H, Liu Y, Luo Y, Wang J, Ma Z, Mei B, Liang Y, Zhu Y, Li R, Sun J, Wang L, Zhang C, Liu T, Song J, Tao C, Wang A, Wang J, Xu P, Guo X, Shu L, Qureshi AI, Nguyen TN, AbdalKader M, Saver JL, Chen W, Nogueira RG. Endovascular Treatment of Medium-Vessel-Occlusion Strokes. N Engl J Med. 2026 May 14;394(19):1894-1904. doi: 10.1056/NEJMoa2514120.
- Derived from this study: PubMed 40134089Jing X, Nogueira RG, Nguyen TN, Tao C, Zhu Y, Li R, Sun J, Wang L, Zhang C, Liu T, Song J, Saver JL, Hu W. Endovascular treatment in acute intracranial distal medium vessel occlusion stroke: Study protocol and rationale. Int J Stroke. 2025 Jul;20(6):763-768. doi: 10.1177/17474930251332753. Epub 2025 Mar 25.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Wei Hu, MD, PhD study chair
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular treatment and Standard medical management in people with Acute Ischemic Stroke and Endovascular Thrombectomy, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
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 18 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Hu, MD, PhD (+86 055162284313, andinghu@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 90-day modified Rankin Scale (mRS) (time frame: 90 (± 14 days) after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146790, which also lists 2 linked publications.
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 5 Sep 2024.