INCA: Intracranial Aneurysm Treatment With NeXsys

INCA: Intracranial Aneurysm Treatment With NeXsys

Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion

Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion. Target aneurysms are small unruptured aneurysms in the anterior and posterior circulation.

Inclusion Criteria:

• Age 18-80 years at screening
• Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
• IA appears suitable for NeXsys device
• Patient willing to comply with study requirements
• Patient able to understand and sign a study-specific informed consent form

Exclusion Criteria:

• Ruptured IA
• Any other IA that requires treatment in the next year
• IA width >10 mm
• IA neck >9 mm
• IA has important flow from its base such that occluding the IA would cause stroke
• Target IA contains any device (e.g., coils)
• Inability to access the target IA with microcatheter
• Any congenital or iatrogenic coagulopathy
• Platelet count <50,000/microliter
• Known allergy to platinum, nickel or titanium
• Known allergy to contrast agents
• Stenosis of the target IA's parent vessel >50%
• Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent)
• Taking any anticoagulants (e.g., warfarin)
• Pregnant or planning pregnancy in the next 2 years
• Other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.)
• Participating in another study with investigational devices or drugs