Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endovascular therapy, Best medical management.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke, Mild Neurocognitive Disorder, Thrombectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Endovascular 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 accordin - 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.
Primary outcome measures
- 90-day excellent clinical outcome [Time frame: 90±7 days after randomization]
Secondary outcome measures (2)
- Good clinical outcome [Time frame: 90±7 days after randomization]
- early recovery [Time frame: 72 hours after randomization]
Eligibility criteria
- Aged 18 years or older;
- The time from onset of acute ischemic stroke to arterial puncture 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 (excluding tandem lesions) 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College — Wuhu
Identifiers
NCT: NCT06143488 · 2023090