NCT05667103

The Safety and Efficacy of Embotrap in Treating Acute Ischemic Stroke Patients

The Safety and Efficacy of Mechanical Thrombectomy Using Embotrap Stent Retriever in Treating Acute Ischemic Stroke Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of Embotrap stent retriever to other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO). All enrolled patients will be followed up at 90 days after randomization.

Detailed description

AIS due to large vessel occlusion (LVO) remains a substantial cause of mortality and morbidity. Recent guidelines have recommended MT as the first-line therapy for AIS-LVO in the anterior circulation. Thrombectomy using a stent retriever is safe and effective in the treatment of AIS. As a new generation of stent retriever, Embotrap stent retriever has a unique design including an open outer cage for clot capture and a closed inner channel for clot stabilization. Previous studies showed Embotrap stent retriever can achieve a successful recanalization of 88% and favorable outcome of 51%. Also, the Multicenter ARISE II Study showed the first-pass effect of EmboTrap stent retriever was 40.1%, higher than other stent retrievers, such as Solitaire FR and Trevo device. But most studies were single-armed without direct comparison. Thus, this prospective cohort study is designed to compare the safety and efficacy of Embotrap stent retriever with other stent retrievers without inner channel.

Conditions

• Stroke
• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Embotrap stent retriever	Embotrap has a novel design of an open outer cage for clot capture and a closed inner channel for clot stabilization, with great thrombus fixation and anti-escape ability, to improve the successful recanalization rate and good prognosis of patients.
DEVICE	Solitaire FR, Trevo stent retriever without inner channel	Other stent retriever without inner channel, such as Solitaire FR, Trevo, and other stent retrievers approved by FDA or NMPA.

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2022-12-28
• Last updated: 2023-11-13

Locations

1 site across 1 country: China