Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion:a Multicenter Randomized Controlled Trail

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80 years old;

• Symptoms onset or last known well to randomization is within 24 hours.

• Clinical diagnosis of acute ischemic stroke due to anterior circulation intracranial large vessel occlusion (LVO) (including intracranial internal carotid artery \[ICA\], middle cerebral artery \[MCA\] M1 segment, MCA M2 segment, with or without ipsilateral extracranial ICA occlusion) confirmed on Computerized tomography angiography (CTA) or Magnetic resonance imaging angiography (MRA) ;

• Baseline NIHSS score \<6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);

• ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization, and computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) imaging presented infarct core volume (relative cerebral blood flow (rCBF) \<30%/DWI-ADC\<620) ≤50ml, and mismatch volume (Tmax\>6 seconds volume - rCBF \<30% /DWI-ADC\<620) ≥50mL;

• The patient or their legal representatives voluntarilysigned the informed consent form.

Locations
Other Locations
China
Zhangzhou Municipal Hospital
RECRUITING
Zhangzhou
Contact Information
Primary
Wenhuo Chen, MD
13806906089@126.com
+8613806906089
Backup
Tingyu Yi, MD
siyuyufen@163.com
+8615859635985
Time Frame
Start Date: 2024-02-07
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Intervention Group:Endovascular treatment
Interventionist choose the optimal EVT strategy and device based on the patient's condition and local guidelines. This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. The EVT regimen and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to the local guidelines.
Placebo_comparator: Control group: Best medical treatment
Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on.
Related Therapeutic Areas
Sponsors
Leads: Zhangzhou Municipal Hospital
Collaborators: The Affiliated Hospital Of Guizhou Medical University, Changhai Hospital

This content was sourced from clinicaltrials.gov

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