INCA: Intracranial Aneurysm Treatment With NeXsys

NCT02507531 | Terminated

• 1 other identifier: DNX-041
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: NeXsys Embolization System

Interventions

NeXsys Embolization System DEVICE

Woven metallic mesh placed in aneurysm fundus

Also known as: Contour Neurovascular System

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerus Endovascular, Inc.: lead

Study Sites (1)

Instituto Clinico ENERI

Buenos Aires, C1428ARJ, Argentina

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 24, 2015
• Study Start: May 1, 2016
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: January 31, 2019

Record last verified: 2016-05

Locations

AR (1)