A prospective, multicenter, randomized controlled, non-inferiority study to investigate the effectiveness and safety of SINOMED SR for endovascular treatment of acute ischemic stroke
This is a multicenter, prospective, randomized, 1:1, controlled trial with blinded outcome assessment assessing non-inferiority of SINOMED SR compared to Solitaire FR. The trial aims to randomize 220 patients 1:1 to receive SINOMED SR or Solitaire FR.The primary outcome is the Success rate of immediate recanalization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
Ganzhou Municipal Hospital
Ganzhou, China
Ganzhou People's Hospital
Ganzhou, China
Handan Central Hospital
Handan, China
Number of Participants With Successful Immediate Recanalization
The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade
Time frame: Within 24 hours post-procedure
Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery
The Modified Rankin Scale is a global measure of functional disability ranging from 0 (no symptoms) to 6 (death), where lower scores indicate a better outcome. A score of 0-2 is commonly interpreted as a favorable functional outcome.
Time frame: pre-procedure, and 90 days post-procedure
Vascular Recanalization Time
The time from femoral artery puncture to vascular recanalization or the end time of surgery for patients with no vascular recanalization. Vascular recanalization time = successful recanalization time - femoral artery puncture time
Time frame: intra-operative
The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points
The number of subjects exhibiting a \>4-point decrease on the National Institutes of Health Stroke Scale (NIHSS; range 0-42, where higher scores indicate worse neurological deficit).
Time frame: 7 days post-procedure
Number of Devices Successfully Operated
Devices Successfully Operated defined devices completed conveying, releasing and retracting.
Time frame: intra-operative
Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure
Symptomatic intracranial hemorrhage within 24 h, specifically intracranial hemorrhage (intracranial parenchymal hematoma, subarachnoid hemorrhage, and ventricular hemorrhage) accompanied by neurological deterioration
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The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hehui, China
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
Jiangmen, China
Jinan Central Hospital
Jinan, China
Meizhou People's Hospital
Meizhou, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
General Hospital of Eastern Theater Command, PLA
Nanjing, China
Qingdao Center Hospital
Qingdao, China
...and 4 more locations
Time frame: within 24 hours post-procedure
Number of Participants Who Died Within 90 Days
The count of all deaths from any cause occurring within 90 days post-procedure among participants who received the intracranial thrombectomy stent.
Time frame: within 90 days
Number of Device Defects
The count of defects (e.g., device breakage, incorrect labeling) identified in the research devices during the clinical trial.
Time frame: intra-operative
Number of Participants With Serious Adverse Events (SAE)
The count of participants who experienced at least one serious adverse event (SAE) after receiving thrombectomy with the intracranial thrombectomy device.
Time frame: Within 90 days post-procedure
Number of Participants With Adverse Events (AE)
The count of participants who experienced at least one adverse event (AE) after receiving thrombectomy with the intracranial thrombectomy device.
Time frame: Within 90 days post-procedure