NCT04973332

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Sinomed Neurovita Technology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke, Acute
• Brain Diseases
• Cerebrovascular Disorders

Interventions

Type	Name	Description
DEVICE	Intracranial thrombectomy stent	Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Timeline

• Start date: 2021-08-08
• Primary completion: 2022-04-07
• Completion: 2022-06-24
• First posted: 2021-07-22
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

14 sites across 1 country: China