None listed
Conditions
Brief summary
An observational post-market, open label, multicenter study designed to assess the clinical utility of the WEB Aneurysm Embolization System. The proposed clinical study is a non-randomized, multi-center, prospective confirmatory study to assess the safety and efficacy of the WEB Aneurysm Embolization System.
Interventions
An observational post-market, open label, multicenter study designed to assess the clinical utility of the WEB Aneurysm Embolization System in the treatment of basilar apex aneurysms. The study is longitudinal and will follow study participants for at least a year after treatment.
Sponsors
Sequent Medical, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Saccular basilar apex (BA) aneuryms - Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm - Embolization System per device Instructions for Use - Aneurysm neck size >= 4mm - Dome-to-Neck (DN) ratio >= 1.0 - Sign and date EC-approved written informed consent prior to initiation of study
Exclusion criteria
- Must not have clinical or angiographic evidence of vasospasm - Must not have lesion with characteristics unsuitable for endovascular treatment - Must not have neurologic or psychiatric conditions, which preclude ability to comply with al aspects of the screening, evaluation, treatment, and the post-procedure fol ow-up schedule Must not be concurrently involved in another investigational or post-market study - Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
Outcome results
None listed