Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With L… (NCT06143488) | Clinical Trial Compass
RecruitingNot Applicable
Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS
China264 participantsStarted 2024-02-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
1. Aged 18 years or older;
2. 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);
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 (excluding tandem lesions) 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 informed consent is obtained from the patient or legal surrogate, with agreement for long-term follow-up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
90-day excellent clinical outcome
Timeframe: 90±7 days after randomization
Trial details
NCT IDNCT06143488
SponsorFirst Affiliated Hospital of Wannan Medical College