INCA: Intracranial Aneurysm Treatment With NeXsys

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

Detailed Description
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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.

Official Title
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INCA: Intracranial Aneurysm Treatment With NeXsys

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: NeXsys Embolization System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Placement of study device (currently called NeXsys) into target aneurysm via standard endovascular procedure. | Device: NeXsys Embolization System<br>* Woven metallic mesh placed in aneurysm fundus<br>* Other names: Contour Neurovascular System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |