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

NCT06143488 | Recruiting DMC

• 1 other identifier: 2023090
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke; Mild Neurocognitive Disorder; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• 90-day excellent clinical outcome

  a dichotomized mRS 0-1 outcome

  90±7 days after randomization

Secondary Outcomes (2)

• Good clinical outcome

  90±7 days after randomization

• early recovery

  72 hours after randomization

Other Outcomes (2)

• Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard

  within 72 hours after randomization

• All-cause mortality rate

  90±7 days after randomization

Study Arms (2)

EVT group

EXPERIMENTAL

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.

Procedure: Endovascular therapy

Best medical management

ACTIVE COMPARATOR

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; Drug: Best medical management

Interventions

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; EVT group

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.

Best medical management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Aged 18 years or older; 2. 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); 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 (excluding tandem lesions) 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

Study Sites (1)

The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Central Study Contacts

Zhiming Zhou, PhD

CONTACT

(++)86-(+)-553-5739543; neuro_depar@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Drug: Best medical management Procedure: Endovascular therapy

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: February 7, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)