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

Not Applicable

Completed

• Conditions: Cerebrovascular Disorders; Ischemic Stroke, Acute; Brain Diseases

• 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

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%
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%
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 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