INCA: Intracranial Aneurysm Treatment With NeXsys

Intracranial Aneurysm Clinical Trial

— INCA  

Official title:

INCA: Intracranial Aneurysm Treatment With NeXsys

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02507531
• Other study ID #: DNX-041
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: January 8, 2019

Study information

• Verified date: May 2016
• Source: Cerus Endovascular, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• NeXsys Embolization System
Woven metallic mesh placed in aneurysm fundus

Locations

Country	Name	City	State
Argentina	Instituto Clinico ENERI	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Cerus Endovascular, Ltd

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: occurrence of major ipsilateral stroke or neurologic death		3-6 months
Primary	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	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
Secondary	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)