Intracranial Aneurysm
Conditions
Brief summary
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms
Detailed description
The following parameters will be evaluated as part of this study: * Aneurysm morphology * Aneurysm size * For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH) * Size of the embolization device(s) used in the procedure * Intra-procedural assessment of aneurysm occlusion and flow stasis * Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate) * Aneurysm occlusion durability * Recanalization rate * Device-related changes in Modified Rankin Scale from baseline * Complications/adverse events * Rebleed/new bleed
Interventions
PROCEDUREIntracranial aneurysm embolization
Treatment of intracranial aneurysms
Sponsors
Microvention-Terumo, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must be at least 18 years of age * Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures
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 all aspects of the screening, evaluation, treatment, and the post-procedure follow-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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durability of occlusion | 6 months | Evaluated by the Corelab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence/recanalization rate | 6 months | Evaluated by the Corelab, based on Raymond Roy occlusion scale |
| Modified Raymond Scale | 6 months | Evaluation of patient's functional level of activity by the physician |
| Percentage occlusion of target aneurysm | 6 months | Evaluated by the Corelab |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy time | procedure | Duration of fluoroscopy time will be recorded during the procedure |
Countries
Denmark, France, Germany, Hungary
Outcome results
None listed