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NCT Number: NCT06143488

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Mental Disorders Mild Neurocognitive Disorder Nervous System Diseases Neurocognitive Disorders Stroke Thrombectomy Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

Location status: Recruiting

Location contact

Xianjun Huang, PhD

CONTACT

[email protected]

(++)86-(+)-553-5739543

Zhiming Zhou, PhD

CONTACT

[email protected]

(++)86-(+)-553-5739543

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Aged 18 years or older;
  • The time from onset of acute ischemic stroke to arterial puncture is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
  • Low NIHSS score (2-5 points), with at least one of the following items:
  • Altered mental status (lethargy or worse);
  • Facial palsy (facial weakness score ≥ 1 point);
  • Motor dysfunction (limb weakness score ≥ 1 point);
  • Aphasia (language disturbance score ≥ 1 point);
  • Hemispatial neglect (neglect score ≥ 1 point);
  • Intracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion (excluding tandem lesions) confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke;
  • All patients receive CTP/MR perfusion imaging, with a volume of perfusion delay (Tmax>6 s) ≥ 50 mL;
  • Written informed consent is obtained from the patient or legal surrogate, with agreement for long-term follow-up.

Treatment and study plan

Endovascular therapy

Procedure

Drug: 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.

Procedure: Endovascular therapy 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. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.

Best Medical Management

Drug

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.

Primary outcomes

  1. 90-day excellent clinical outcome

    Time frame: 90±7 days after randomization

    a dichotomized mRS 0-1 outcome

Secondary outcomes

  1. Good clinical outcome

    Time frame: 90±7 days after randomization

    defined as a dichotomized mRS 0-2

  2. early recovery

    Time frame: 72 hours after randomization

    72-hour NIHSS score≥4 points drop as compared with baseline

Other outcomes

  1. Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard

    Time frame: within 72 hours after randomization

    Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below:

    4 points total NIHSS at the time of diagnosis compared to immediately before worsening.

    2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention.

    Absence of alternative explanation for deterioration.

  2. All-cause mortality rate

    Time frame: 90±7 days after randomization

    All-cause mortality rate

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiming Zhou, PhD

CONTACT

[email protected]

(++)86-(+)-553-5739543

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 22, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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