Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms
Not Applicable
Not yet recruiting
- Conditions
- Intracranial Aneurysms
- Registration Number
- NCT07022249
- Lead Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which intrasaccular embolization devices promote aneurysm occlusion and prevent recurrence in intracranial aneurysms?
How does the novel intrasaccular embolization device in NCT07022249 compare to standard-of-care coiling and stent-assisted techniques in terms of efficacy and safety for unruptured intracranial aneurysms?
Which biomarkers or angiographic features could predict optimal patient selection for treatment with intrasaccular embolization devices in complex intracranial aneurysms?
What are the potential adverse events associated with intrasaccular embolization devices, and what management strategies are recommended for complications like thromboembolic events or coil migration in cerebral aneurysm treatment?
Are there any combination approaches involving intrasaccular embolization devices and flow diverters or endovascular stents that enhance therapeutic outcomes for wide-necked intracranial aneurysms compared to monotherapy?