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NCT06143488From ClinicalTrials.govRecruiting

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

  • Acute Ischemic Stroke
  • Mild Neurocognitive Disorder
  • Thrombectomy

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
First Affiliated Hospital of Wannan Medical College
Enrolment target
264
Started
21 January 2024
Main results due
31 December 2027
Study sites
1
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
1. Aged 18 years or older;
2. The time from onset of acute ischemic stroke to randomization is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
3. Low NIHSS score (2-5 points), with at least one of the following items:

   1. Altered mental status (lethargy or worse);
   2. Facial palsy (facial weakness score ≥ 1 point);
   3. Motor dysfunction (limb weakness score ≥ 1 point);
   4. Aphasia (language disturbance score ≥ 1 point);
   5. Hemispatial neglect (neglect score ≥ 1 point);
4. Intracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke;
5. All patients receive CTP/MR perfusion imaging, with a volume of perfusion delay (Tmax\>6 s) ≥ 50 mL;
6. Written informed consent is obtained from the patient or legal surrogate, with agreement for long-term follow-up.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

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

    Wuhu, Anhui, China

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06143488. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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