INCA: Intracranial Aneurysm Treatment With NeXsys

NCT ID: NCT02507531

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-01-08

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.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Placement of study device (currently called NeXsys) into target aneurysm via standard endovascular procedure.

Group Type: EXPERIMENTAL

NeXsys Embolization System

Intervention Type: DEVICE

Woven metallic mesh placed in aneurysm fundus

Interventions

NeXsys Embolization System

Woven metallic mesh placed in aneurysm fundus

Intervention Type: DEVICE

Other Intervention Names

Contour Neurovascular System

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerus Endovascular, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Clinico ENERI

Buenos Aires, , Argentina

Countries

Argentina

Other Identifiers

DNX-041

Identifier Type: -

Identifier Source: org_study_id