Safety and Efficacy of SINOMED SR for Endovascular Treatment of Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Cerebrovascular Disorders; Ischemic Stroke, Acute; Brain Diseases
• Interventions: Device: Intracranial thrombectomy stent

• Registration Number: NCT04973332
• Lead Sponsor: Sinomed Neurovita Technology Inc.

Brief Summary

A prospective, multicenter, randomized controlled, non-inferiority study to investigate the effectiveness and safety of SINOMED SR for endovascular treatment of acute ischemic stroke

Detailed Description

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 Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-22
• Study Start: 2021-08-08
• Primary Completion: 2022-04-07
• Study Completion: 2022-06-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thrombectomy-SINOMED SR	Intracranial thrombectomy stent	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Thrombectomy-Solitaire FR	Intracranial thrombectomy stent	Intracranial thrombectomy was performed with a control product（name:Solitaire FR）

Primary Outcome Measures

Name	Time	Method
Success rate of immediate recanalization	Within 24 hours post-procedure	The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade

Secondary Outcome Measures

Name	Time	Method
Mortality within 90 days	within 90 days	All-cause mortality = the number of deaths in this group/the number of subjects receiving intracranial thrombectomy stent for thrombectomy in this group ×100%
mRS 0-2 ratio	pre-procedure, and 90 days post-procedure	The ratio of mRS 0-2 points = the number of subjects with mRS 0-2 points 90 days after surgery/the number of subjects receiving thrombectomy by intracranial thrombectomy device ×100%
The incidence of symptomatic intracranial hemorrhage within 24 h post-procedure	within 24 hours post-procedure	Symptomatic intracranial hemorrhage within 24 h, specifically intracranial hemorrhage (intracranial parenchymal hematoma, subarachnoid hemorrhage, and ventricular hemorrhage) accompanied by neurological deterioration (NIHSS score increased by ≥4 points compared with preoperative)
Incidence of AE (adverse events)	intra-operative, 24 hours, 7 days and 90 days post-procedure	Incidence of AE = number of subjects with AE/number of subjects receiving thrombectomy with intracranial thrombectomy device ×100%
The time from femoral artery puncture to vascular recanalization or the end time of surgery for patients with no vascular recanalization	intra-operative	Vascular recanalization time = successful recanalization time - femoral artery puncture time
Success rate of instrument operation	intra-operative	Device operation success = the number of devices completed conveying, releasing and retracting in the group/the number of all test devices used in the group ×100%
Incidence of SAE (serious adverse events)	intra-operative, 24 hours, 7 days and 90 days post-procedure	Incidence of SAE = number of subjects with SAE/number of subjects receiving thrombectomy with intracranial thrombectomy device ×100%
The NIHSS score decreased the rate of subjects with > 4 points	pre-procedure, 24 hours and 7 days post-procedure	The ratio of subjects with NIHSS score decreased \> 4 points = the number of subjects with NIHSS score decreased \> 4 points/the number of subjects with thrombotic stent thrombectomy ×100% in this group
Incidence of device defects	intra-operative	Defects of research devices during clinical trials, such as broken devices, incorrect labeling, etc

Trial Locations

Locations (1)

General Hospital of Eastern Theater Command, PLA; 🇨🇳 Nanjing, China