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

Last updated: January 4, 2024
Sponsor: First Affiliated Hospital of Wannan Medical College
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Mild Cognitive Impairment

Blood Clots

Treatment

Endovascular therapy

Best medical management

Clinical Study ID

NCT06143488
2023090
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Age ≥18 years
    1. Randomization can be finished within 24 hours from stroke onset (stroke onset timeis 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 onNIHSS Question #4); any weakness limiting sustained effort against gravity (≥1 onNIHSS Question #6 or #7); severe aphasia (≥1 on NIHSS Question #9), or visual orsensory extinction (≥1 on NIHSS Question #11).
  • 4.CTA or MRA proven occlusion of the Internal Carotid Artery (ICA) terminal or M1/M2segment of Middle Cerebral Artery
  • 5.CTP/MRP Imaging shows the volume of Tmax>6s ≥ 50ml.
    1. Informed consent signed

Exclusion

Exclusion Criteria:

    1. Pre-stroke mRS score ≥1
    1. Vascular occlusion caused by special causes is not suitable for endovasculartreatment, such as Moyamoya disease, arteritis, radiation vascular disease, orfibromuscular development defective, and combined intracranial tumors, aneurysms, orintracranial arteriovenous malformations;
    1. 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 glomerularfiltration rate <30ml/min), severe liver dysfunction and malignant tumors;
    1. Any active bleeding or recent bleeding (gastrointestinal bleeding, urinarybleeding, etc.) in the past six months
    1. Baseline platelet count <100×109 /L;
    1. Refractory abnormal blood sugar that is difficult to control by medication (50mg/dLor 2.78mmol/L or 400mg/dL or 22.2mmol/L）;
    1. Angiography shows a tortuous vascular pathway, making it difficult for theexperimental equipment to reach the target position or retrieve it;
    1. Known severe allergy for contrast agents or anesthetics;
    1. Other circumstances that the investigator considers inappropriate for participationin the trial or that may pose significant risks to patients (such as inability tounderstand and/or follow the study procedures and/or follow up due to mentaldisorders, cognitive or emotional disorders)
  • 10.The expected survival time is less than 1 year (such as patient with malignanttumor, advanced heart or lung diseases, etc.)
  • 11.Participation in other interventional randomized clinical trials that may confoundthe outcome assessment of the trial;
    1. Females who are pregnant, or those of childbearing, potential with positive urineor serum beta Human Chorionic Gonadotropin test

Study Design

Total Participants: 264
Treatment Group(s): 2
Primary Treatment: Endovascular therapy
Phase:
Study Start date:
January 04, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui 241000
    China

    Active - Recruiting

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