ClinicalTrials.gg
RecruitingNCT06143488Updated Sep 25, 2026

Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS

An interventional study of Endovascular therapy and Best medical management in Acute Ischemic Stroke, Mild Neurocognitive Disorder and Thrombectomy, sponsored by First Affiliated Hospital of Wannan Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by First Affiliated Hospital of Wannan Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Updated Sep 25, 2026Start date movedEligibility revised+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END).

Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials.

The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.

02

Conditions studied

  • Acute Ischemic Stroke
  • Mild Neurocognitive Disorder
  • Thrombectomy
03

In context

Ischemic Stroke

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

This study's planned enrollment of 264 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

First Affiliated Hospital of Wannan Medical College is the lead sponsor of 37 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 25, 2026. See what changed

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

Eligibility criteria

  1. Aged 18 years or older;
  2. The time from onset of acute ischemic stroke to randomization is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
  3. Low NIHSS score (2-5 points), with at least one of the following items:

    1. Altered mental status (lethargy or worse);
    2. Facial palsy (facial weakness score ≥ 1 point);
    3. Motor dysfunction (limb weakness score ≥ 1 point);
    4. Aphasia (language disturbance score ≥ 1 point);
    5. Hemispatial neglect (neglect score ≥ 1 point);
  4. Intracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke;
  5. All patients receive CTP/MR perfusion imaging, with a volume of perfusion delay (Tmax>6 s) ≥ 50 mL;
  6. Written is obtained from the patient or legal surrogate, with agreement for long-term follow-up.
Terms in these criteria, in plain language(1)

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
264 participants (estimated)

Study arms

  • Experimental
    EVT group

    In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice.

    Procedure: Endovascular therapy

  • Active comparator
    Best medical management

    All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.

    Procedure: Endovascular therapy · Drug: Best medical management

Interventions

  • ProcedureEndovascular therapy

    Drug: Best medical management All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate. Procedure: Endovascular therapy In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.

  • DrugBest medical management

    All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.

06

What researchers measure

Primary outcomes

  1. 90-day excellent clinical outcome

    modified Rankin scale score: 0-1; , 0 \[no disablility\] to 6 \[death\]

    Time frame: 90±7 days after randomization

Secondary outcomes

  1. Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard

    Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration.

    Time frame: within 48 hours after randomization

  2. All-cause mortality rate

    All-cause mortality rate

    Time frame: 90±7 days after randomization

  3. Good clinical outcome

    modified Rankin Scale score: 0-2; 0 \[no disablility\] to 6 \[death\]

    Time frame: 90±7 days after randomization

  4. 90-day ordinal modified Rankin Scale score shift

    ordinal modified Rankin Scale score shift; 0 \[no disablility\] to 6 \[death\]

    Time frame: 90±7 days after randomization

  5. Rates of early neurological deterioration

    early neurological deterioration during hospitalization

    Time frame: at 24 hours, 72 hours, and 7 days/discharge

  6. EuroQol Group 5- Dimension 5-Level (EQ-5D-5L) questionaire score

    Score range from -0.39 to 1.00, with higher scores indicating better quality of life

    Time frame: 90±7 days after randomization

Other outcomes

  1. incidence of adverse events

    Any ICH post-randomization; vessel perforation; embolus migration in a new territory; rescue endovascular treatment; acute coronary syndrome, venous thrombosis or embolus events; brain herniation, and pneumonia, respiratory failure, circulatory failure, stress ulcers, renal failure, etc.

    Time frame: within 7 days after randomization

07

Study locations

1 of 1 sites recruiting
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 reachedDate before it movedWhere the date was before it movedSimilar 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

Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 47 months is above that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

Start moved once since we started tracking on Sep 25, 2026: Feb 2024 → Jan 2024, on Sep 25, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Nov 16, 2023
First posted
Nov 22, 2023
StartActual
Jan 21, 2024was Feb 2024
Primary completionEst.
Dec 31, 2027
CompletionEst.
Mar 31, 2028
Last update
Sep 25, 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.
Start date
Feb 7, 2024→Jan 21, 2024
Sep 25, 2026
Eligibility
2 criteria edited
What changed in the criteria
  • EditedThe time from onset of acute ischemic stroke to arterial puncturerandomization is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
  • EditedIntracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion (excluding tandem lesions) confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke;
Sep 25, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • Description90-day excellent clinical outcome: how it is measured was reworded
Sep 25, 2026
Secondary outcomes
6 added, 3 removed, 1 description edited
What changed in the outcomes
  • AddedRate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standardTime frame: within 48 hours after randomization
  • AddedAll-cause mortality rateTime frame: 90±7 days after randomization
  • Added90-day ordinal modified Rankin Scale score shiftTime frame: 90±7 days after randomization
  • AddedRates of early neurological deteriorationTime frame: at 24 hours, 72 hours, and 7 days/discharge
  • AddedEuroQol Group 5- Dimension 5-Level (EQ-5D-5L) questionaire scoreTime frame: 90±7 days after randomization
  • Removedearly recoveryTime frame: 72 hours after randomization
  • DescriptionGood clinical outcome: how it is measured was reworded
  • Addedother outcomeincidence of adverse eventsTime frame: within 7 days after randomization
  • Removedother outcomeRate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standardTime frame: within 72 hours after randomization
  • Removedother outcomeAll-cause mortality rateTime frame: 90±7 days after randomization
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Start date Feb 7, 2024→Jan 21, 2024
    Eligibility 2 criteria edited
    What changed in the criteria
    • EditedThe time from onset of acute ischemic stroke to arterial puncturerandomization is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
    • EditedIntracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion (excluding tandem lesions) confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke;
    Primary outcomes 1 description edited
    What changed in the outcomes
    • Description90-day excellent clinical outcome: how it is measured was reworded
    Secondary outcomes 6 added, 3 removed, 1 description edited
    What changed in the outcomes
    • AddedRate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standardTime frame: within 48 hours after randomization
    • AddedAll-cause mortality rateTime frame: 90±7 days after randomization
    • Added90-day ordinal modified Rankin Scale score shiftTime frame: 90±7 days after randomization
    • AddedRates of early neurological deteriorationTime frame: at 24 hours, 72 hours, and 7 days/discharge
    • AddedEuroQol Group 5- Dimension 5-Level (EQ-5D-5L) questionaire scoreTime frame: 90±7 days after randomization
    • Removedearly recoveryTime frame: 72 hours after randomization
    • DescriptionGood clinical outcome: how it is measured was reworded
    • Addedother outcomeincidence of adverse eventsTime frame: within 7 days after randomization
    • Removedother outcomeRate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standardTime frame: within 72 hours after randomization
    • Removedother outcomeAll-cause mortality rateTime frame: 90±7 days after randomization
    + 1 other change: verification date

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
NCT06143488
Lead sponsor
First Affiliated Hospital of Wannan Medical College
Responsible party
Sponsor
First posted
Nov 22, 2023
Start date
Jan 21, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Zhiming Zhou, PhD
Contact
neuro_depar@hotmail.com
(++)86-(+)-553-5739543

Oversight

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

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