INCA: Intracranial Aneurysm Treatment With NeXsys

Cerus Endovascular, Inc.3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intracranial Aneurysm

Interventions

NeXsys Embolization SystemDEVICE

Woven metallic mesh placed in aneurysm fundus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Clinico ENERI

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Safety: occurrence of major ipsilateral stroke or neurologic death

Time frame: 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.

Time frame: 3-6 mo

Secondary Outcomes

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.

Time frame: 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

Time frame: Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours)

Data from ClinicalTrials.gov

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