Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

Recruiting

• Conditions: Stroke, Acute; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Brain Infarction; Nervous System Diseases
• Interventions: Other: Immediate endovascular therapy

• Registration Number: NCT06633809
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS.

Detailed Description

It was reported that about two third of the stoke patients might present with minor or mild stroke symptoms. 20-40% of those minor stroke patients had large vessel occlusion (LVO). AIS patients with LVO and low NIHSS are common and has been associated with early neurological deterioration and worse outcomes. Until now, the best therapy strategy for the acute stoke patients with minor stroke and large vessel occlusion is unknown. Thus, we sought to (1) explore the potential predictors of acute neurological deterioration and 90-day clinical outcome; (2) and evaluate the best therapy strategy.

Study Timeline

• Study Start: 2021-11-22
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Aged 18 years or older
2. Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset
3. Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel
4. Baseline ASPECTS ≥6 or infarct Core Volume of < 70 on NCCT/DWI/CTP
5. Pre-mRS≤1

Exclusion Criteria

1. Any sign of intracranial hemorrhage on baseline CT/MR;
2. Seizures at stroke onset
3. Baseline blood glucose of <2.78 mmol or >22.20 mmol, or platelet count < 100,000/uL or serum creatinine levels > 3.0 mg/dL
4. Participation in any investigational study in the previous 30 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immediate Endovascular Therapy	Immediate endovascular therapy	The immediate endovascular therapy is performed immediately after stroke onset with any thrombectomy device usually used.

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale at 90 days	90 days	modified Rankin Scale at 90 days
acute neurological deterioration	24 hours	It is neurological deterioration of presumed ischemic origin with an NIHSS score increase of 4 points or more within the 24 hours after onset.

Secondary Outcome Measures

Name	Time	Method
Incidence of symptomatic intracerebral hemorrhage	2-3 days	Incidence of symptomatic intracerebral hemorrhage according to ECASS II criteria
patients with good outcome comparing the two treatment groups	90 days	Good outcome is defined as a score of 0-2 on the 90-day mRS

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China