WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

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

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