An Investigator Initiated and Conducted, Prospective, Multicenter, Randomized Outcome-blinded Study of Treating Mechanical Thrombectomy Exceeding 24 Hours in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion

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

A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS

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

• Age ≥18 years

• Present 24-72 hours of stroke onset or last seen well

• Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging

• National Institute of Health stroke scale (NIHSS) ≥6 at randomisation

• Viable cerebral tissue on computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) assessed: infarct core volume \<50mL, mismatch ratio ≥1.8 and mismatch volume ≥15mL

• Written informed consent (by patient or proxy, according to local requirements)

Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Lily Song, PhD
lsong@georgeinstitute.org.cn
+86 13916466400
Backup
Craig Anderson, PhD
canderson@georgeinstitute.org.au
+61 2 8052 4521
Time Frame
Start Date: 2022-11-03
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 382
Treatments
Experimental: Intervention group
Mechanical thrombectomy to be initiated as soon as possible after randomisation.
No_intervention: Control group
Patients assigned to the control group will avoid treating MT and only receive the standard medical treatment according to local guidelines.
Related Therapeutic Areas
Sponsors
Leads: The George Institute for Global Health, China
Collaborators: Changhai Hospital

This content was sourced from clinicaltrials.gov

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