Status:
RECRUITING
Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS
Lead Sponsor:
First Affiliated Hospital of Wannan Medical College
Conditions:
Acute Ischemic Stroke
Mild Neurocognitive Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 functi...
Eligibility Criteria
Inclusion
- 1\. Age ≥18 years
- 2\. Randomization can be finished within 24 hours from stroke onset (stroke onset time is defined as last known well time)
- NIHSS score 2-5 at the time of randomization, but must include one of the following: any consciousness disorder (≥1 on NIHSS Question #1a); partial facial paralysis (≥1 on NIHSS Question #4); any weakness limiting sustained effort against gravity (≥1 on NIHSS Question #6 or #7); severe aphasia (≥1 on NIHSS Question #9), or visual or sensory extinction (≥1 on NIHSS Question #11).
- CTA or MRA proven occlusion of the Internal Carotid Artery (ICA) terminal or M1/M2 segment of Middle Cerebral Artery
- CTP/MRP Imaging shows the volume of Tmax\>6s ≥ 50ml.
- 6\. Informed consent signed
Exclusion
- 1\. Pre-stroke mRS score ≥1
- 2\. Vascular occlusion caused by special causes is not suitable for endovascular treatment, such as Moyamoya disease, arteritis, radiation vascular disease, or fibromuscular development defective, and combined intracranial tumors, aneurysms, or intracranial arteriovenous malformations;
- 3\. Severe comorbidities or unstable conditions, such as severe heart failure, pulmonary or renal failure (serum creatinine\>2.8mg/dL or 250 µ mol/L or glomerular filtration rate \<30ml/min), severe liver dysfunction and malignant tumors;
- 4\. Any active bleeding or recent bleeding (gastrointestinal bleeding, urinary bleeding, etc.) in the past six months
- 5\. Baseline platelet count \<100×109 /L;
- 6\. Refractory abnormal blood sugar that is difficult to control by medication (50mg/dL or 2.78mmol/L or 400mg/dL or 22.2mmol/L）;
- 7\. Angiography shows a tortuous vascular pathway, making it difficult for the experimental equipment to reach the target position or retrieve it;
- 8\. Known severe allergy for contrast agents or anesthetics;
- 9\. Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)
- The expected survival time is less than 1 year (such as patient with malignant tumor, advanced heart or lung diseases, etc.)
- Participation in other interventional randomized clinical trials that may confound the outcome assessment of the trial;
- 12\. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT06143488
Start Date
January 4 2024
End Date
September 30 2025
Last Update
January 8 2024
Active Locations (1)
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1
The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China, 241000