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Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms
Sponsor: Ton-Bridge Medical Tech. Co., Ltd
Summary
The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.
Official title: Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-06
Completion Date
2027-06
Last Updated
2025-06-15
Healthy Volunteers
No
Conditions
Interventions
Intrasaccular Embolization Device
This is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.