INCA: Intracranial Aneurysm Treatment With NeXsys

TerminadoClinicalTrials.gov

ID: NCT02507531Tipo: INTERVENTIONALInicio: 1 de may de 2016Fin estimado: 8 de ene de 2019

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

device

NeXsys Embolization System

Woven metallic mesh placed in aneurysm fundus

Ubicaciones

Instituto Clinico ENERI

Buenos Aires, Argentina

Patrocinadores

PrincipalCerus Endovascular, Inc.

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