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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Start date: Feb 7, 2024 to Jan 21, 2024
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 2 to 6
  2. Notable Primary completion date: Jun 30, 2025 to Dec 31, 2027
    • Start date: Jan 4, 2024 to Feb 7, 2024
    • Study completion date: Sep 30, 2025 to Mar 31, 2028
    • Eligibility criteria shortened, about 221 words
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 8, 2023 to Jan 4, 2024
    v3
  4. Minor Study Status, Eligibilityv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06143488
Lead Sponsor First Affiliated Hospital of Wannan Medical College
Conditions
(from sponsor)
Acute Ischemic Stroke, Mild Neurocognitive Disorder, Thrombectomy
Related terms Ischemic Stroke, Neurocognitive Disorders
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov