Acute Ischemic StrokeNCT06143488
Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS
A study testing Endovascular therapy and Best medical management in people with Acute Ischemic Stroke and Mild Neurocognitive Disorder, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Mild Neurocognitive Disorder, Thrombectomy
- What is being tested?
- Endovascular therapy and Best medical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2024to 31 Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Aged 18 years or older;
- 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);
- Low NIHSS score (2-5 points), with at least one of the following items:
- Altered mental status (lethargy or worse);
- Facial palsy (facial weakness score ≥ 1 point);
- Motor dysfunction (limb weakness score ≥ 1 point);
- Aphasia (language disturbance score ≥ 1 point);
- Hemispatial neglect (neglect score ≥ 1 point);
- 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;
- All patients receive CTP/MR perfusion imaging, with a volume of perfusion delay (Tmax>6 s) ≥ 50 mL;
- Written informed consent is obtained from the patient or legal surrogate, with agreement for long-term follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241000
Zhiming Zhou, PhD, (++)86-(+)-553-5739543, neuro_depar@hotmail.com
Xianjun Huang, PhD, (++)86-(+)-553-5739543, doctorhuangxj@hotmail.com
About this study
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.
- Being tested
- Endovascular therapy, Best medical management
- Medical subject headings
- Ischemic Stroke, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular therapyProcedure or surgery
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.
Best medical managementDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| EVT group | Experimental | 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. Receives: Procedure: Endovascular therapy |
| Best medical management | Active comparator | 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. Receives: Procedure: Endovascular therapy; Drug: Best medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day excellent clinical outcome
modified Rankin scale score: 0-1; , 0 [no disablility] to 6 [death]
Measured: 90±7 days after randomization
Secondary outcomes (6)
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.
Measured: within 48 hours after randomization
All-cause mortality rate
All-cause mortality rate
Measured: 90±7 days after randomization
Good clinical outcome
modified Rankin Scale score: 0-2; 0 [no disablility] to 6 [death]
Measured: 90±7 days after randomization
90-day ordinal modified Rankin Scale score shift
ordinal modified Rankin Scale score shift; 0 [no disablility] to 6 [death]
Measured: 90±7 days after randomization
Rates of early neurological deterioration
early neurological deterioration during hospitalization
Measured: at 24 hours, 72 hours, and 7 days/discharge
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
Measured: 90±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 posted22 Nov 2023
- Study start21 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Drug: Best medical management Procedure: Endovascular therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143488
- Sponsor's protocol ID
- 2023090
- Status last verified
- Sep 2026
- First submitted
- 16 Nov 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS
- ClinicalTrials.gov ID
- NCT06143488
- Acronym / sponsor ID
- 2023090
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 21 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: Best medical management Procedure: Endovascular therapy
| Arm | Type | Receives |
|---|---|---|
| EVT group | Experimental | Procedure: Endovascular therapyIn the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. |
| Best medical management | Active comparator | Procedure: Endovascular therapy, Drug: Best medical managementAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 therapyDrug: 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. | Procedure or surgery | Best medical management, EVT group |
| Best medical managementAll 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. | Drug | Best medical management |
Primary outcome
90-day excellent clinical outcome
Time frame: 90±7 days after randomization
modified Rankin scale score: 0-1; , 0 [no disablility] to 6 [death]
6 secondary outcomes
Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard
Time frame: within 48 hours after randomization
All-cause mortality rate
Time frame: 90±7 days after randomization
Good clinical outcome
Time frame: 90±7 days after randomization
90-day ordinal modified Rankin Scale score shift
Time frame: 90±7 days after randomization
Rates of early neurological deterioration
Time frame: at 24 hours, 72 hours, and 7 days/discharge
EuroQol Group 5- Dimension 5-Level (EQ-5D-5L) questionaire score
Time frame: 90±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 25 Sep 2026.
- 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.
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 therapy and Best medical management in people with Acute Ischemic Stroke and Mild Neurocognitive Disorder, run by First Affiliated Hospital of Wannan Medical College 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?
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 25 Sep 2026. 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?
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 Zhiming Zhou, PhD ((++)86-(+)-553-5739543, neuro_depar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day excellent clinical outcome (time frame: 90±7 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 25 Sep 2026.