INCA: Intracranial Aneurysm Treatment With NeXsys

Launched by CERUS ENDOVASCULAR, INC. · Jul 22, 2015

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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