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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
RECRUITING
Wuhu
Contact Information
Primary
Zhiming Zhou, PhD
neuro_depar@hotmail.com
(++)86-(+)-553-5739543
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 264
Treatments
Experimental: EVT group
In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice.
Active_comparator: Best medical management
All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Wannan Medical College

This content was sourced from clinicaltrials.gov

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