Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS

Launched by FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness of a treatment called endovascular therapy (EVT) compared to standard medical treatment for patients who have had a mild stroke caused by a blockage in a major blood vessel in the brain. The trial focuses on patients whose strokes score between 2 and 5 on a specific scale, indicating mild symptoms. The goal is to see if EVT can help these patients recover better than those who only receive medical management, especially since many patients with mild strokes still face significant challenges in their recovery.

To be eligible for this trial, participants must be at least 18 years old and can be enrolled within 24 hours of their stroke symptoms starting. They should also have a specific type of blockage in their brain arteries confirmed by imaging. However, certain conditions, like severe heart or kidney issues, or recent bleeding, would prevent someone from joining the study. Those who participate will have the chance to receive either the EVT treatment or standard care, and throughout the trial, their recovery and health will be closely monitored. This trial is important as it may help improve treatment options for patients with mild strokes, who currently have limited options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• • 3.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).
• • 4.CTA or MRA proven occlusion of the Internal Carotid Artery (ICA) terminal or M1/M2 segment of Middle Cerebral Artery
• • 5.CTP/MRP Imaging shows the volume of Tmax\>6s ≥ 50ml.
• • 6. Informed consent signed
• Exclusion Criteria:
• • 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)
• • 10.The expected survival time is less than 1 year (such as patient with malignant tumor, advanced heart or lung diseases, etc.)
• • 11.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