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INCA: Intracranial Aneurysm Treatment With NeXsys (INCA)

Primary Purpose

Intracranial Aneurysm

Status
Terminated
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
NeXsys Embolization System
Sponsored by
Cerus Endovascular, Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Clinico ENERI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Safety: occurrence of major ipsilateral stroke or neurologic death
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.

Secondary Outcome Measures

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.
Occurrence rate of any neurologic or vascular adverse event related to the target IA or device placement procedure

Full Information

First Posted
July 20, 2015
Last Updated
January 29, 2019
Sponsor
Cerus Endovascular, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02507531
Brief Title
INCA: Intracranial Aneurysm Treatment With NeXsys
Acronym
INCA
Official Title
INCA: Intracranial Aneurysm Treatment With NeXsys
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerus Endovascular, Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Placement of study device (currently called NeXsys) into target aneurysm via standard endovascular procedure.
Intervention Type
Device
Intervention Name(s)
NeXsys Embolization System
Other Intervention Name(s)
Contour Neurovascular System
Intervention Description
Woven metallic mesh placed in aneurysm fundus
Primary Outcome Measure Information:
Title
Safety: occurrence of major ipsilateral stroke or neurologic death
Time Frame
3-6 months
Title
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.
Time Frame
3-6 mo
Secondary Outcome Measure Information:
Title
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.
Time Frame
30 days, 3-6 months, 1 year and 5 years
Title
Occurrence rate of any neurologic or vascular adverse event related to the target IA or device placement procedure
Time Frame
Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Instituto Clinico ENERI
City
Buenos Aires
ZIP/Postal Code
C1428ARJ
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

INCA: Intracranial Aneurysm Treatment With NeXsys

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