Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion

Not Applicable

Recruiting

• Conditions: Endovascular Treatment

• Registration Number: NCT06179017
• Lead Sponsor: Zhangzhou Municipal Hospital

Brief Summary

Exploring the Efficacy and Safety of Emergent Endovascular Treatment in Patients with Mild Ischemic Stroke Caused by Acute Anterior Circulation Large Vessel Occlusion based on Perfusion Imaging Screening

Detailed Description

This study aims to select suitable patients with mild AIS caused by anterior circulation LVO with mismatch volume of the ischemic penumbra based on screen of cerebral perfusion imaging. It is a prospective, multicenter, endpoint-blinded, randomized controlled trial design, and aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.

Study Timeline

• Study First Submitted: 2023-12-02
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2023-12-21
• Study Start: 2024-02-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2027-08-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1. Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;
2. Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;
3. Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;
4. Aortic dissection;
5. Multiple intracranial large vessel occlusions confirmed by CTA or MRA, unable to clearly identify the symptomatic vessel, such as bilateral MCA occlusions or occlusions involving both the MCA and basilar artery;
6. Suspected or confirmed occluded artery is non-acute occlusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the rate of excellent outcome at () days	90±7 days and 365±30 days	mRS score 0-1

Secondary Outcome Measures

Name	Time	Method
proportion of subjects with good neurological function prognosis	90±7 days and 365±30 days	mRS score 0-2
mRS shift	90±7 days and 365±30 days	distribution of mRS scores

Trial Locations

Locations (1)

Zhangzhou Municipal Hospital; 🇨🇳 Zhangzhou, Fujian, China