Comparing endovascular therapy and best medical treatment for mild acute stroke with large vessel occlusion
Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS
This study is testing whether a special treatment for stroke called endovascular therapy can help people with mild strokes caused by a blocked blood vessel feel better compared to just using standard medical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wannan Medical College Academic / other |
| Locations | 1 site (Wuhu, Anhui) |
| Trial ID | NCT06143488 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endovascular therapy (EVT) compared to best medical management in patients experiencing mild acute ischemic stroke with a radiologically confirmed large vessel occlusion (LVO). It focuses on patients with a National Institutes of Health Stroke Scale (NIHSS) score of 2-5, who are at risk for poor outcomes despite mild symptoms. The trial aims to determine if EVT can improve functional outcomes and reduce the risk of early neurological deterioration in this specific patient population. Randomization will occur within 24 hours of stroke onset, ensuring timely intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with mild acute ischemic stroke symptoms and a confirmed large vessel occlusion.
Not a fit: Patients with pre-existing disabilities or those with vascular occlusions unsuitable for endovascular treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved functional outcomes for patients with mild strokes caused by large vessel occlusions.
How similar studies have performed: While the effectiveness of EVT in mild stroke patients with LVO is debated, this approach has shown promise in other studies focusing on more severe cases.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhu, Anhui
- The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College — Wuhu, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Zhiming Zhou, PhD
- Email: neuro_depar@hotmail.com
- Phone: (++)86-(+)-553-5739543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.