Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms
NCT07022249 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-06-15
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.
Conditions
- Intracranial Aneurysms
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Ton-Bridge Medical Tech. Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-30
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
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