INCA: Intracranial Aneurysm Treatment With NeXsys

Not Applicable

Terminated

• Conditions: Intracranial Aneurysm
• Interventions: Device: NeXsys Embolization System

• Registration Number: NCT02507531
• Lead Sponsor: Cerus Endovascular, Ltd

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.

Study Timeline

• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Status Verified: 2016-05
• Study Start: 2016-05
• Primary Completion: 2019-01-08
• Study Completion: 2019-01-08
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	NeXsys Embolization System	Placement of study device (currently called NeXsys) into target aneurysm via standard endovascular procedure.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Instituto Clinico ENERI; 🇦🇷 Buenos Aires, Argentina