ClinicalTrials.gg
Not yet recruitingNCT07931807ORIENTAL-MeVO2Updated Nov 12, 2026

Intravenous Thrombolysis, Endovascular Treatment, or Bridging Therapy for Medium Vessel Occlusion Stroke Within 24 Hours

A Phase 3 interventional study of Tenecteplase and Endovascular Treatment in Medium Vessel Occlusion Stroke (MeVO) and Acute Ischemic Stroke, sponsored by The First Affiliated Hospital of University of Science and Technology of China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by The First Affiliated Hospital of University of Science and Technology of China · Phase 3, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,395
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Ischemic Stroke by The First Affiliated Hospital of University of Science and Technology of China — 7 open to participants now, 7 under way, 2 of them phase 3. Ischemic Stroke · The First Affiliated Hospital of University of Science and Technology of China.

Planned enrollment
Largest of 11
1,395 · median 560
Started
2026
with 1 other
Phase 3
3 of 11
2 open now
Registered
11th of 11
by date

Among the 11 studies in Ischemic Stroke by The First Affiliated Hospital of University of Science and Technology of China, this one has the largest planned enrollment, is one of 2 that started in 2026, is one of 3 in phase 3, and was the 11th registered.

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

7 of the 11 studies in Ischemic Stroke by The First Affiliated Hospital of University of Science and Technology of China are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 655 Ischemic Stroke studies recruiting now, 394 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 41 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This trial compares intravenous thrombolysis (IVT) alone, endovascular treatment (EVT) alone, and bridging therapy (IVT followed immediately by EVT) in patients with acute ischemic stroke due to medium vessel occlusion (MeVO) and a baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6. The hypotheses are that EVT alone and bridging therapy each increase the proportion of patients with functional independence at 90 days compared with IVT alone. This is a multicenter, prospective, randomized, open-label trial with blinded outcome assessment. Patients will be randomized 1:1:1 within 24 hours of symptom onset or last known well. The primary outcome is functional independence, defined as a modified Rankin Scale (mRS) score of 0 to 2 at 90 days.

03

Conditions studied

  • Medium Vessel Occlusion Stroke (MeVO)
  • Acute Ischemic Stroke

Browse trials for

Keywords

  • Mechanical thrombectomy
  • Medium Vessel Occlusion Stroke
  • Thrombolysis
  • Bridging therapy
  • Endovascular treatment
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years.
  2. Clinical diagnosis of acute ischemic stroke with a disabling deficit and baseline NIHSS score ≥6 before randomization.
  3. Pre-stroke modified Rankin Scale score ≤2.
  4. Randomization within 24 hours of symptom onset or last known well, including wake-up and unwitnessed stroke.
  5. Eligible for intravenous thrombolysis and endovascular thrombectomy according to the trial criteria.
  6. Written from the patient or a legal representative.
  7. Primary MeVO confirmed by computed tomography angiography or magnetic resonance angiography and responsible for the acute neurological deficit, involving the co-dominant or non-dominant M2 segment (occluded branch diameter ≤2.0 mm), M3, anterior cerebral artery A1-A3, or posterior cerebral artery P1-P3.
  8. Anterior circulation occlusion within 6 hours: established infarct extent \<50% of the territory supplied by the occluded artery on non-contrast CT or diffusion-weighted MRI. For M2 or M3 occlusion, Alberta Stroke Program Early CT Score (ASPECTS) ≥6 is also required.
  9. Posterior circulation occlusion within 24 hours: posterior circulation ASPECTS (pc-ASPECTS) ≥8 and established infarct extent \<50% of the territory supplied by the occluded artery on non-contrast CT or diffusion-weighted MRI.
  10. Anterior circulation occlusion at >6 to 24 hours, meeting either of the following imaging profiles: (a) established infarction involving \<50% of the vascular territory corresponding to the clinical deficit on non-contrast CT or diffusion-weighted MRI; OR (b) target mismatch on CT or MR perfusion, defined as a mismatch volume >10 mL and a mismatch ratio >1.4.

Exclusion criteria

Exclusion Criteria:

  1. Intracranial hemorrhage on CT or MRI; fewer than 10 cerebral microbleeds on MRI are permitted.
  2. to thrombolysis, including intracranial hemorrhage or acute ischemic stroke within the previous 3 months; intracranial surgery or severe head trauma within 3 months; any previous intracranial hemorrhage; clinically suspected subarachnoid hemorrhage; arterial puncture at a non-compressible site within 7 days; major surgery or serious trauma within 14 days; gastrointestinal or urinary tract hemorrhage within 21 days; active internal bleeding or an acute bleeding tendency; hereditary or acquired bleeding diathesis or clotting-factor deficiency; count \<100 × 10⁹/L; current therapeutic-dose heparin anticoagulation (including therapeutic-dose low-molecular-weight heparin within 24 hours); >1.7 or prothrombin time >15 seconds after anticoagulant use; or full-dose heparin or heparinoid use within 24 hours with an activated partial thromboplastin time above the .
  3. Intravenous thrombolysis already administered at a referring center.
  4. Rapidly improving neurological deficit, as judged by the investigator.
  5. Pre-existing neurological disease or psychiatric disorder that precludes reliable examination or follow-up assessment.
  6. Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg despite antihypertensive treatment.
  7. Blood glucose \<2.8 or >22.2 mmol/L.
  8. Known allergy to tenecteplase or its ; a contraindication to contrast agents, such as severe contrast allergy; or known allergy to nickel-titanium alloys or other materials used in thrombectomy devices.
  9. Severe cardiac or hepatic dysfunction or another serious systemic disease with a of less than 1 year.
  10. Renal impairment with estimated \<30 mL/min/1.73 m² or creatinine >176.8 µmol/L, or a requirement for dialysis.
  11. Suspected or previous cerebral vasculitis or infective endocarditis, including suspected septic embolism.
  12. Medium vessel occlusion arising from distal migration or fragmentation of a more proximal thrombus, whether spontaneous, after intravenous thrombolysis, or during endovascular thrombectomy.
  13. Established infarction involving the arterial territory proximal to the target occlusion.
  14. Hypodensity on non-contrast CT exceeding the perfusion lesion, suggesting distal thrombus migration.
  15. Severe tortuosity, anatomical variant, or dissection precluding device access to the target vessel.
  16. Simultaneous occlusion in more than one vascular territory, such as anterior and posterior circulation occlusion or bilateral anterior circulation occlusion.
  17. Use of a direct thrombin inhibitor or a direct factor Xa inhibitor within 48 hours, unless dabigatran has been reversed with idarucizumab.
  18. Pregnancy or breastfeeding, or a positive pregnancy test before enrollment in a woman of .
  19. Current participation in another interventional clinical trial, or participation within the previous 3 months in a study involving an drug or device that could affect the present study.
  20. History of arteriovenous malformation or aneurysm; intracranial tumor.
  21. Seizure at stroke onset that precludes an accurate baseline NIHSS assessment, or Todd paresis.
  22. History of drug or alcohol abuse or dependence that, in the investigator's judgment, would interfere with adherence to study requirements.
  23. Inability to complete the 90-day follow-up (e.g., no fixed residence or living overseas).
  24. Prisoners or incarcerated persons.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,395 participants (estimated)

Study arms

  • Active comparator
    IVT Alone

    Participants receive intravenous tenecteplase 0.25 mg/kg (maximum 25 mg) as a single bolus. Endovascular treatment is not performed.

    Drug: Tenecteplase

  • Experimental
    EVT Alone

    Participants receive endovascular treatment without intravenous thrombolysis.

    Procedure: Endovascular Treatment

  • Experimental
    Bridging IVT Plus EVT

    Participants receive intravenous tenecteplase 0.25 mg/kg (maximum 25 mg) as a single bolus, followed immediately by endovascular treatment.

    Drug: Tenecteplase · Procedure: Endovascular Treatment

Interventions

  • DrugTenecteplase

    Intravenous tenecteplase 0.25 mg/kg (maximum 25 mg) is administered as a single bolus.

    Also known as: rhTNK-tPA, recombinant human TNK tissue-type plasminogen activator, Mingfule

  • ProcedureEndovascular Treatment

    A credentialed neurointerventionalist selects stent-retriever thrombectomy, aspiration thrombectomy, or intra-arterial thrombolysis. Intra-arterial thrombolysis uses tenecteplase, alteplase, or urokinase. Thrombectomy uses approved low-profile aspiration catheters or stent retrievers, generally with no more than three passes in the target vessel. The procedure is stopped earlier if further manipulation is judged unsafe.

06

What researchers measure

Primary outcomes

  1. Functional Independence at 90 Days

    Proportion of participants with a modified Rankin Scale (mRS) score of 0 to 2 at 90 days, assessed by a blinded rater. The mRS ranges from 0 (no symptoms) to 6 (death).

    Time frame: 90 days after randomization (±14 days)

Secondary outcomes

  1. Symptomatic Intracranial Hemorrhage Within 36 Hours

    Proportion of participants with symptomatic intracranial hemorrhage within 36 hours of randomization, classified as definite or probable according to the Heidelberg Bleeding Classification. This is the primary safety outcome.

    Time frame: Within 36 hours after randomization

  2. Shift in Modified Rankin Scale Score Distribution at 90 Days

    Distribution of mRS scores at 90 days. The mRS ranges from 0 (no symptoms) to 6 (death).

    Time frame: 90 days after randomization (±14 days)

  3. Modified Rankin Scale Score of 0 to 1 at 90 Days

    Proportion of participants with an mRS score of 0 to 1 at 90 days. The mRS ranges from 0 (no symptoms) to 6 (death).

    Time frame: 90 days after randomization (±14 days)

  4. Modified Rankin Scale Score of 0 to 3 at 90 Days

    Proportion of participants with an mRS score of 0 to 3 at 90 days. The mRS ranges from 0 (no symptoms) to 6 (death).

    Time frame: 90 days after randomization (±14 days)

  5. Early Neurological Improvement at 24 Hours

    Proportion of participants with an improvement in the National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points from baseline or an NIHSS score of 0 to 1 at 24 hours. The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits.

    Time frame: 24 hours after treatment (±6 hours)

  6. NIHSS Score at 24 Hours

    The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits.

    Time frame: 24 hours after treatment (±6 hours)

  7. Change From Baseline in NIHSS Score at 24 Hours

    Change in NIHSS score from baseline to 24 hours, calculated as the 24-hour score minus the baseline score. The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits.

    Time frame: Baseline and 24 hours after treatment (±6 hours)

  8. Barthel Index at 90 Days

    Activities of daily living at 90 days assessed using the Barthel Index total score. Scores range from 0 to 100, with higher scores indicating greater independence.

    Time frame: 90 days after randomization (±14 days)

  9. EQ-5D-5L Utility Index at 90 Days

    EQ-5D-5L utility index at 90 days, calculated with the Chinese value set (Luo et al., 2017). The index ranges from -0.391 to 1.000, with higher values indicating better health.

    Time frame: 90 days after randomization (±14 days)

  10. Successful Reperfusion

    Proportion of participants with successful reperfusion, defined as an expanded Thrombolysis in Cerebral Infarction (eTICI) score ≥2b50 on final angiography. This outcome is assessed in the EVT-alone and bridging groups.

    Time frame: At final angiography during the endovascular procedure

  11. First-Pass Effect

    Proportion of participants achieving eTICI 2c to 3 reperfusion after the first thrombectomy pass without rescue treatment. This outcome is assessed in the EVT-alone and bridging groups.

    Time frame: During the endovascular procedure

  12. Successful Reperfusion at Initial Angiography

    Proportion of participants randomized to bridging IVT plus EVT with successful reperfusion (eTICI ≥2b50) at initial angiography.

    Time frame: At initial angiography during the endovascular procedure

  13. All-Cause Mortality at 90 Days

    Proportion of participants who die from any cause within 90 days after randomization.

    Time frame: Within 90 days after randomization

  14. Target Artery Recanalization at 24 to 72 Hours

    Proportion of participants with patency of the target artery on computed tomography angiography (CTA) or magnetic resonance angiography (MRA), defined as a modified Arterial Occlusive Lesion (mAOL) score of 2 or 3. The mAOL scale ranges from 0 (no recanalization) to 3 (complete recanalization). This outcome is assessed in all three groups.

    Time frame: 24 to 72 hours after randomization

Other outcomes

  1. Any Intracranial Hemorrhage at 24 Hours

    Proportion of participants with any new intracranial hemorrhage identified on follow-up computed tomography (CT) or magnetic resonance imaging (MRI) and classified according to the Heidelberg Bleeding Classification.

    Time frame: 24 hours after treatment (±6 hours)

  2. Procedure-Related Vascular Complications

    Proportion of participants with at least one vascular complication related to an endovascular procedure, including vessel perforation or dissection, distal embolization or embolization into a new vascular territory, vasospasm, acute vessel occlusion, and vascular access-site hematoma, bleeding, or pseudoaneurysm. Events will be adjudicated by an independent clinical events committee.

    Time frame: During the endovascular procedure and through the 90-day follow-up (±14 days)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Apr 2029, 28 months later.

Of 143 non-industry phase 3 interventional studies under Ischemic Stroke, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 28 months is below that.

Counting every sponsor, half of 165 studies reached it within 30 months; a quarter within 19 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Dec 2026
Primary completionEst.
Apr 30, 2029
CompletionEst.
Apr 30, 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931807
Lead sponsor
The First Affiliated Hospital of University of Science and Technology of China
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Dec 2026 (estimated)
Primary completion
Apr 30, 2029 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Wei Hu, MD, PhD
Contact
andinghu@ustc.edu.cn
+86 551 62284313
Wei Hu, MD, PhD
principal investigator · The First Affiliated Hospital of University of Science and Technology of China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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