Intracranial Aneurysms
Conditions
Brief 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.
Interventions
DEVICEIntrasaccular 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
Ton-Bridge Medical Tech. Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient must be 18-75 years of age at the time of screening. * Patient must have a single ruptured or unruptured IA requiring treatment. * Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.
Exclusion criteria
* Patient had an IA with characteristics unsuitable for endovascular treatment. * Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device. * Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device. * Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation. * Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy. * Patient was pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365. | 12 months |
| Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment. | 12 months |
Contacts
Primary ContactXiaoyan Yang
Outcome results
None listed