An Observational Study of Basilar Apex Brain Aneurysms Treated With WEB Aneurysm Embolization System
- Conditions
- Intracranial wide-neck basilar apex aneurysmsNeurological - Other neurological disordersCardiovascular - Hypertension
- Registration Number
- ACTRN12612000439842
- Lead Sponsor
- Sequent Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
- 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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stasis and chronic occlusion of aneurysm after treatment with WEB Aneurysm Embolization System. Outcome will be evaluated by an independent core lab using a three-point classification system in addition to other occlusion assessment methods.[6-month post procedure and for at least 12 months after the initial embolization procedure. All follow-ups will be conducted per institutional standard of care.]
- Secondary Outcome Measures
Name Time Method il[Nil]