Intracranial Aneurysm
Conditions
Brief summary
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion
Detailed 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.
Interventions
DEVICENeXsys Embolization System
Woven metallic mesh placed in aneurysm fundus
Sponsors
Cerus Endovascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: occurrence of major ipsilateral stroke or neurologic death | 3-6 months |
| Ability of the investigator to place the device in an acceptable position in the target IA, judged at the time of placement, with no migration or change in position of the device at 3-6 month angiogram. | 3-6 mo |
Secondary
| Measure | Time frame |
|---|---|
| Occlusion status of the target IA at 30 days, 3-6 months, 1 year and 5 years as judged by an independent physician using the Raymond classification system. | 30 days, 3-6 months, 1 year and 5 years |
| Occurrence rate of any neurologic or vascular adverse event related to the target IA or device placement procedure | Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours) |
Countries
Argentina
Outcome results
None listed