INCA: Intracranial Aneurysm Treatment With NeXsys

Cerus

Status

Terminated

Conditions

Intracranial Aneurysm

Treatments

Device: NeXsys Embolization System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02507531

DNX-041

Details and patient eligibility

About

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

Full description

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.

Enrollment

3 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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