A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study to Investigate the Effectiveness and Safety of Intracranial Embolization Stents for Endovascular Treatment of Acute Ischemic Stroke

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• The incidence of symptomatic intracranial hemorrhage within 24 h post-procedure(within 24 hours post-procedure)
• Incidence of AE (adverse events)(intra-operative, 24 hours, 7 days and 90 days post-procedure)
• mRS 0-2 ratio(pre-procedure, and 90 days post-procedure)
• The time from femoral artery puncture to vascular recanalization or the end time of surgery for patients with no vascular recanalization(intra-operative)
• Success rate of instrument operation(intra-operative)
• Incidence of SAE (serious adverse events)(intra-operative, 24 hours, 7 days and 90 days post-procedure)
• The NIHSS score decreased the rate of subjects with > 4 points(pre-procedure, 24 hours and 7 days post-procedure)
• Mortality within 90 days(within 90 days)
• Incidence of device defects(intra-operative)